ARTES Biotechnology, CDMO for pharma and life science industry Our expertise is on yeast (Hansenula, Pichia) and E. coli cell line development for recombinant biopharmaceutical products (subunit vaccines, sdAB´s, therapeutics and biosimilars), highly efficient upstream and downstream process development and manufacturing (from lab to pilot scale) as well as transfer of the technology to our customers. We are a valued partner for the pharmaceutical and life science industry. Several contract developments and technology transfers are successfully implemented worldwide at clients’ sites. Our offer in a nutshell: • Development of microbial expression cell lines from yeast (Hansenula, Pichia) and bacteria (E. coli) • Development of up- and downstream processes and the optimization • nonGMP manufacturing • protein analytics • transfer of the developed or optimized strains and processes to customer’s plant including support until implementation of the process • transfer of in-house developed cell lines or production processes (technology transfer) • sales of antigens, recombinant enzymes and functional proteins as lab reagents Our proprietary technologies have resulted in innovative products marketed worldwide. There are WHO recommendation, worldwide registrations and approvals at EMA resp. FDA and GRAS certification for enzymes. This all is part of the track record achieved in international collaborations. You are invited to have a closer look at: www.artes-biotechnology.com
Argonaut Manufacturing Services
Argonaut Manufacturing Services Inc. is a contract manufacturing organization (CMO) headquartered in Carlsbad, CA. The company is dedicated to supporting life science, diagnostic, and biopharmaceutical innovators with high quality GMP manufacturing services in the areas of formulation, aseptic fill/finish, kitting, and distribution. Argonaut’s Aseptic Drug Product Fill/Finish facility is designed for biopharmaceutical product teams in pre-clinical through commercial phase who need to maximize product yield and reduce risk without compromising product quality and safety. Argonaut has experience manufacturing biologics, oligos, peptides, small molecules, and vaccines and can provide aseptic formulation of high-viscosity and adjuvanted molecules. The fully automated filling line features SKAN isolators, single-use RTU consumables, and 100% in-line non-destructive weight checks. Earlier this year, Argonaut announced a significant capital investment to expand the company’s fill/finish offering with an additional isolator-based filling line that will support clinical and commercial production of vials, cartridges, and syringes. To support Diagnostic and Life Science organizations, Argonaut provides partners with scalable and flexible manufacturing options, from product configuration to shipping and storage, to complete supply chain management. Argonaut has proprietary lyophilization technologies for diagnostic solutions which greatly simplify POCT devices, extend shelf-life, and allow storage and shipping at ambient temperatures. Argonaut recently launched LyoDots™, the world’s smallest lyophilized spheres to work in miniaturized diagnostic, POCT devices, and microfluidic applications. Find out more about how Argonaut can assist with your manufacturing needs by visiting https://www.argonautms.com or calling +1 888-834-8892. | Argonaut Manufacturing Services Inc. is a contract manufacturing organization (CMO) headquartered in Carlsbad, CA. The company is dedicated to supporting life science, diagnostic, and biopharmaceutical innovators with high quality GMP manufacturing services in the areas of formulation, aseptic fill/finish, kitting, and distribution. Argonaut’s Aseptic Drug Product Fill/Finish facility is designed for biopharmaceutical product teams in pre-clinical through commercial phase who need to maximize product yield and reduce risk without compromising product quality and safety. Argonaut has experience manufacturing biologics, oligos, peptides, small molecules, and vaccines and can provide aseptic formulation of high-viscosity and adjuvanted molecules. The fully automated Bausch+Ströbel filling line features SKAN isolators, single-use RTU consumables, and 100% in-line non-destructive weight checks. In March of 2024, Argonaut announced the completion of a $45 million financing round to support its new drug product fill/finish expansion. This expansion will quadruple Argonaut’s existing drug product fill/finish capacity and will augment existing vial filling capabilities with the ability to fill syringes and cartridges for clinical and commercial supply. To support Diagnostic and Life Science organizations, Argonaut provides partners with scalable and flexible manufacturing options, from product configuration to shipping and storage, to complete supply chain management. Argonaut has proprietary lyophilization technologies for IVD solutions which greatly simplify POCT devices, extend shelf-life, and allow storage and shipping at ambient temperatures. Argonaut’s proprietary lyophilization technology includes LyoDots™, the world’s smallest lyophilized spheres designed to work in miniaturized diagnostic, POCT devices, and microfluidic applications. For Combination Products, Argonaut provides custom manufacturing expertise for devices including microelectronics, injectors, oral delivery, and topical systems. We support both single-entity products and co-packaged products with assembly and packaging in ISO 8 cleanrooms. Extended services include CCIT, chemical compatibility testing, process validation, stability studies, and regulatory support. Argonaut is FDA registered and CA FDB-audited, and is compliant with ISO 13485:2016, cGMP, and quality system regulations 21 CFR 820 including Part 4 update, 21 CFR 210, 21 CFR 211. Find out more about how Argonaut can assist with your manufacturing needs by visiting https://www.argonautms.com or calling +1 888-834-8892. | Argonaut Manufacturing Services is your CMO for aseptic fill finish, IVD & life science kitting, and drug device combination product manufacturing. Our experienced team provides your organization with flexible and responsive manufacturing options. Based in Carlsbad CA, we provide US based manufacturing services in our FDA inspected facilities, saving your team both time and infrastructure capital costs. Argonaut’s aseptic drug product fill finish facility supports clients at pre-clinical through commercial phase who need to maximize product yield and reduce risk for high value biopharmaceutical products. We specialize in the formulation and aseptic filling of biologics, oligopeptides, peptides, and vaccines. Argonaut’s equipment and process are optimized to provide “near zero” line losses and as such, we have extensive experience filling low volume high value rare disease products. Our fill finish services include expert formulation (including complicated formulations), EU Annex 1 compliant aseptic filling, visual inspection, bulk packaging, storage, logistics and distribution support. Starting in Q4 2025, Argonaut will be offering aseptic filling of prefilled syringes and cartridges in addition to vials on our new filling line designed for mid to large scale batches. For Drug Device Combination Products, Argonaut delivers custom manufacturing expertise including microelectronics, injectors, oral delivery, and topical systems. We support both single-entity products and co-packaged products with assembly and packaging in ISO 8 cleanrooms. DDCP extended services include CCIT, chemical compatibility testing, process validation, stability studies, and regulatory support. Argonaut’s IVD and Life Science kitting services provides full-service contract manufacturing for POCT, IVD and RUO products. From formulation through kitting, sterilization, and warehousing, our experienced team has manufactured +4.2M kits. We feature the world’s smallest lyophilized format- LyoDots®- that are specifically designed for cartridges and POCT. Using Argonaut, you get the flexibility and scale that allows your team to rapidly adjust to market conditions. Argonaut is FDA registered and CA FDB-audited, and is compliant with ISO 13485:2016, cGMP, and quality system regulations 21 CFR 820 including Part 4 update, 21 CFR 210, 21 CFR 211. Our fill finish services are EU Annex 1 Compliant. Find out more about how Argonaut Manufacturing Services can assist with your manufacturing needs by visiting https://www.argonautms.com or calling +1 888-834-8892.
Aragen Life Sciences
Aragen Life Sciences is a globally renowned R&D and manufacturing solutions provider to the global life sciences industries. It offers a range of solutions across the drug discovery, development and manufacturing continue to advance small and large-molecule programs. The Company operates through a global network of six sites with a team of ~5000 employees and 450+ PhDs. Its expertise and experience have enabled over 400 customers to advance their research programs from early discovery through development and commercialization. Aragen’s innovative mindset, infrastructure, flexible business models, clear purpose, and proprietary project management platform have enabled it to effectively scale and service large pharma, biotech, agrochemical, and animal health industries globally. | Aragen Life Sciences is a leading R&D and manufacturing solutions provider for the life sciences industries worldwide. We offer end-to-end integrated or standalone solutions for small and large molecules. Established in 2001, we now operate from our network of sites located globally with a team of 3700+ scientists and 475+ PhDs. Our expertise and experience have enabled over 450+ customers in advancing their research programs from discovery through commercialization. Aragen’s innovative mindset, infrastructure, flexible business models have enabled us to serve large pharma or biotech, agrochemical, animal health and performance chemical industries globally. All our facilities conform to stringent regulatory standards. Our infrastructure has a built-up area of 1.2 million square feet, housing chemistry and biology labs, AAALAC-accredited animal houses, analytical labs, formulation development labs, kilo labs, pilot plants and manufacturing facilities. Aragen has been inspected by all the leading regulatory agencies of the world, including USFDA, WHO, PMDA, EDQM and EMEA. Aragen has submitted its letter of intent to the Science Based Targets initiative (SBTi) and is part of a growing list of organizations that are committed to setting emission reduction targets in line with the Paris Agreement to limit global warming. It is also a signatory to the GRI South Asia Charter on Sustainability Imperatives, a framework that helps to realize the 17 Sustainable Development Goals (SDGs) defined by the United Nation. We are proud to be a Great Place to Work® (GPTW) certified company for the third consecutive year in 2022. This recognition confirms our High-Trust, High-Performance Culture™ and places us among ‘companies with the best culture’ to work with. For more details, visit www.aragen.com | Aragen Life Sciences is a leading full-service CRDMO offering end-to-end solutions across the drug development lifecycle. With expertise spanning both small and large molecules, Aragen supports global biopharma and biotech companies in advancing molecules from early discovery through development to commercial manufacturing. Our integrated capabilities include discovery research, process development, formulation, analytical services, and scalable manufacturing. Full-service CRDMO powered by digital and AI, Aragen is committed to accelerating innovation and delivering high-quality, timely, and cost-effective solutions.
Anivance AI
Anivance AI stands at the forefront of intelligent healthcare innovation, specializing in human organ model solutions. A decade of experience with respiratory models has driven us to achieve significant advancements in preclinical testing and earned us the prestigious 2023 Moderna Taiwan mRNA Innovation Award. This recognition is a testament to our unwavering commitment to improving healthcare and reflects our mission: Saving Lives: Now a Reality. Our comprehensive services, designed to accelerate the drug discovery and safety assessment processes, leverage human-simulated data to bridge the gap between laboratory findings and clinical applications. By precisely simulating human responses, we provide the pharmaceutical industry with powerful tools for thorough safety and efficacy evaluation. | Anivance AI is bridging Taiwan’s world-class semiconductor and manufacturing expertise with AI and life sciences, creating a new era of intelligent drug discovery. By integrating AI-powered organ-on-chip technology with automated high-throughput research, we provide pharmaceutical companies with a scalable, self-optimizing platform that accelerates preclinical testing and delivers breakthrough insights. Unlike traditional preclinical models, our platform is continuously learning and adapting, optimizing experiment design, mechanistic analysis (MOA), and real-time data interpretation. By embedding AI agents into automated research workflows, we help pharmaceutical companies make faster, smarter, and more data-driven decisions, significantly reducing preclinical failure rates and improving R&D efficiency. With 25 granted and pending patents, Anivance AI collaborates with leading global pharmaceutical companies and six clinical institutions, ensuring that our technology is aligned with real-world drug development needs. We have validated our high-throughput organ-on-chip platform in lung, liver, and oncology models, with expanding applications in autoimmune diseases and cardiovascular research. Our breakthroughs in inhalable nanoparticle delivery and respiratory disease modeling have earned global recognition, including a nomination for the LUSH Prize in Science. By leveraging Taiwan’s semiconductor supply chain and precision manufacturing ecosystem, we deliver a new level of automation, AI-driven analytics, and experimental scalability that was previously unattainable in biotech. Backed by two of Taiwan’s largest publicly traded companies and validated by over 50 collaborating physicians, Anivance AI is one of Taiwan’s fastest-growing biotech startups, now expanding into the global market. We are not just developing technology—we are reshaping the future of AI-powered drug discovery. With a foundation built on semiconductor precision, AI intelligence, and biotech innovation, Anivance AI provides pharmaceutical companies with the tools to make transformative breakthroughs, faster than ever before. | Anivance AI is a deep tech company developing Physical AI infrastructure for decision-grade human biology in early drug development and translational research. Rather than operating as a service provider or a single model technology, Anivance AI is designed as an integrated system. Physical organ models function as the sensing layer. Standardized execution and biological baselines form the control layer. Structured data intelligence provides the reasoning layer. Together, these components support closed loop experimentation and decision making. We integrate three tightly coupled layers into a single Physical AI platform. 1. Engineering grade physical organ systems Hard structured organ on chip and microphysiological systems designed for long term stability and reproducible operation under dynamic physiological conditions. The systems support continuous microfluidic circulation, vascular side dosing, dynamic exposure workflows including inhalation relevant conditions, and long duration experiments. 2. Standardized biological baselines and profiles Reusable organ and disease profiles that define execution and interpretation standards, reduce variability across batches and operators, and enable cross study comparability. 3. Human data foundry and decision loop Integrated imaging, functional readouts, and structured experimental metadata form a continuously accumulating human data infrastructure. This supports AI assisted analysis, iterative model refinement, and decision oriented reporting aligned with regulatory expectations. The platform has been deployed across lung and inhalation, liver, kidney, CNS and BBB, oncology, and rare disease applications, supporting more than 25 experimental programs across North America, Japan, South Korea, and Europe. | Anivance AI Corporation is a tech startup integrating miniaturized human organ systems on chips with Multi-Agent AI to accelerate drug discovery. Backed by 35 patents and thousands of data points across multiple organ and disease models, Anivance AI advances 20+ projects and expands across North America, Japan, South Korea, and Europe.
Andelyn Biosciences
Our Vision: Pioneering Solutions that turn Hope into Reality Our Mission: Accelerating the development and manufacturing of innovative therapies to bring more treatments to more patients Andelyn Biosciences (https://www.andelynbio.com/) is pioneering solutions that turn hope into reality as a cell and gene therapy CDMO. Capabilities span viral vector process and analytical development, small to large scale adherent and suspension based GMP manufacturing up to 2000L. Having 20+ years of experience with viral vector manufacturing, Andelyn offers access to globally recognized thought leaders with troubleshooting/characterization expertise and GMP material produced for 75+ worldwide clinical trials. In addition to producing 400+ cGMP clinical batches, Andelyn provides research and tox grade plasmids with an additional offering of GMP plasmid manufacturing, full quality system/regulatory support and supply chain vertical integration. Its state-of-the-art 185,000 sq ft commercial manufacturing facility will expand capacity across 8+ production suites for customization of new programs and tech transferred programs, offering clinical through commercial-scale capabilities that will help accelerate innovative therapies to bring more treatments to more patients. Gene and cell therapy, AAV viral vector manufacturing, Plasmid Manufacturing, Lentiviral vector Manufacturing, Commercial Manufacturing, CDMO, analytical method development, GMP, fill finish, QC/QA release testing, Process Characterization, Regulatory Affairs, Licensing Andelyn Biosciences is a pioneering cell and gene therapy organization born out of Nationwide Children’s Hospital, where the first FDA-approved systemic gene therapy was discovered. See all our Press Releases at: https://www.andelynbio.com/media-center | Andelyn Biosciences (https://www.andelynbio.com/) is pioneering solutions for Turning Hope into Reality (TM) as a gene therapy CDMO. Capabilities span viral vector process and analytical development, small to large scale adherent and suspension based GMP manufacturing up to 2000L. With 20+ years of experience in viral vector manufacturing, Andelyn offers access to globally recognized thought leaders with troubleshooting and characterization expertise and GMP material produced for 75+ worldwide clinical trials. In addition to producing 450+ cGMP sublots, Andelyn provides research, tox, and GMP grade plasmids Andelyn also has full quality and regulatory support and supply chain vertical integration. Its state-of-the-art 185,000 sq ft commercial manufacturing facility offers capacity across 16 production suites for customization of new programs as well as tech transfer programs, offering clinical through commercial-scale capabilities that will help accelerate innovative therapies to bring more treatments to more patients. Andelyn Biosciences is a pioneering gene therapy CDMO born out of Nationwide Children’s Hospital, where the first FDA-approved systemic gene therapy was discovered. | Andelyn Biosciences is a full-service cell and gene therapy CDMO focused on the development, characterization and production of viral vectors for gene therapy. With more than 20 years of experience, Andelyn’s deep scientific expertise has resulted in the production of cGMP material for more than 450 clinical batches and 75 global clinical trials. Operating out of its development and manufacturing facilities in Columbus, Ohio, Andelyn supports its clients in developing cell and gene therapies from concept through plasmid engineering and manufacturing, process and analytical development, and cGMP clinical and commercial manufacturing. Andelyn can accelerate programs and deliver high quality products by developing and manufacturing processes on its configurable, data-driven AAV CuratorTM Platform, or tech transferring in an established client program. Capabilities include cGMP manufacturing for suspension processes up to a 2,000-liter and adherent processes. A rigorous quality system, regulatory support, and supply chain vertical integration further support clients in bringing their critical therapies to market. For more information, visit andelynbio.com. For Andelyn media inquiries, please contact: media@andelynbiosciences.com
AMI Polymer
Since 1998, Ami Polymer Pvt Ltd is in the business of Silicone Elastomeric products and other Polymeric components. We provide solutions to Fluid Transfers, Sealing and Contamination controls for Biopharma, Pharma, Medical, Laboratory, Food & Beverages and Engineering sectors worldwide. We have ISO Class 7 and ISO Class 8 Cleanroom facilities certified with ISO 9001:2015, ISO 14001:2015, ISO 45001:2018, ISO 27001:2013, ISO 13485:2016. We also have a Toxikon, USA & BPOG Leachable & Extractable studies for our products for regulatory markets worldwide. The biopharmaceutical industry is increasingly moving towards the use of single-use disposable systems for the development and manufacturing of a wide range of therapeutic proteins, Mabs, and vaccines. APPL offers a wide range of gamma-irradiated single-use assemblies for various critical applications in biopharmaceuticals. Our products range from simple tubing with connectors to a complex manifold with several joints and connections. All the assemblies are manufactured and packed in an ISO Class 7-certified clean room. Most of the key components used in our single-use assemblies are manufactured in-house. Ami Polymer delivers multiple tubing options made of thermoplastic elastomers as well as platinum-cured silicone. These are offered in a wide range of internal and outer diameters to meet the process requirements with respect to fitment into peristaltic pumps and different size connections We offer single use product as 2D and 3D bags, Mixing and Sampling bags, sanitary tri-clamp, quick connectors, PP connectors, over molded assemblies, bellows, inflatable seals. | Since 1998, APPL is in the business of Silicone Elastomeric products and also, other Polymeric components which ultimately provide solutions to Fluid Transfers, Sealing, and Contamination controls for Biopharma, Pharma, Medical, Laboratory, Food, Beverages, and Engineering sectors worldwide. APPL is having ISO Class VII and ISO Class VIII Cleanroom facilities certified with ISO 9001:2015, ISO 14001:2015, ISO 45001:2018, ISO 27001:2013, ISO 13485:2016. We also have a BPOG extractables program for our products for regulatory markets worldwide. The company believes in “Be in business with ethics” and assure Quick Development, Fastest Delivery, Ultimate Quality and also very Competitive Rates. APPL has world-class manufacturing technology with end-to-end process capabilities to fulfill the needs of customers. which include Extrusion Technology with Laser Controlled system, Automatic Hose Production lines, Plastic Extrusion Lines, Automatic Hydraulic Presses for Elastomers & Polymeric components, Laboratory with R&D Equipment, In-house Tooling & Mould making machinery, Laser Cut Machines, and Online Printing as well as Marking systems on products. Over the years the Company expanded its capacity of manufacturing by adding a huge facility that provides end-to-end solutions to our clients worldwide. Our products are available across the globe directly and through the distribution networks. Product that we are offering 1. Single Use Bag ( 2D, 3D & Tank Liner ) 2. Single Use Assembly Along With Filters 3. Pump Grade Tubing 4. High Pressure Hose 5. Overmolded Assemblies 6. Tri-Clover Gaskets, O-rings, Extruded Profile | Ami Polymer is one of India’s leading manufacturers of high‑performance silicone elastomeric and advanced polymer components, serving regulated industries across the globe. The company was founded in 1998 and has since grown into a trusted partner for world‑class organizations in Biopharma, Pharmaceuticals, Medical Devices, Laboratory, Food & Beverage, and Engineering sectors.
AmbioPharm, Inc.
AmbioPharm is a global leader in peptide manufacturing, specializing in the development and production of peptide-based Active Pharmaceutical Ingredients (APIs). Founded in 2005 and headquartered in North Augusta, South Carolina, USA, we are a patient-focused Contract Development and Manufacturing Organization (CDMO) with a reputation for technical excellence, innovation, and cost-effective solutions. Our state-of-the-art facilities in South Carolina, USA, and Shanghai, China, manufacture New Chemical Entities (NCEs) and peptide APIs under cGMP compliance, supporting pharmaceutical and biotech clients worldwide. AmbioPharm provides comprehensive peptide manufacturing solutions that support our clients from early-stage development through full-scale commercial production. Our expertise covers solid-phase, solution-phase, and hybrid synthesis, as well as organic conjugations to proteins, toxoids, antifungals, KLH (Keyhole Limpet Hemocyanin), and PEG (Polyethylene Glycol). We offer end-to-end peptide development services, including scale-up, validation, and process qualification leading up to New Drug Application (NDA) submissions with the U.S. Food and Drug Administration (FDA). With our advanced manufacturing facilities, robust quality systems, and cost-effective approach, AmbioPharm is the trusted partner for pharmaceutical and biotech companies seeking high-quality peptide APIs for both clinical and commercial applications. | AmbioPharm is a global peptide CDMO founded in 2005 and headquartered in North Augusta, South Carolina, USA specializing in developing highly efficient manufacturing processes for peptide-based Active Pharmaceutical Ingredients (APIs) at clinical and commercial stages. In our manufacturing facilities in South Carolina, USA and Shanghai, China, we manufacture New Chemical Entities (NCEs) under cGMP for clients worldwide. Both facilities have been inspected multiple times by the FDA as well as other global regulatory bodies with excellent outcomes. Our mission is to accelerate your peptides to patients.
Altruist Biologics
Altruist Biologics is a fully integrated CDMO, focusing on the development and commercial manufacturing of antibodies, fusion proteins, ADCs, cell and gene therapies, and other drugs. From cell line development to aseptic fill/finish, we are committed to supporting our clients develop affordable and high-quality biopharmaceuticals for the benefit of patients worldwide. We offer a total 60KL capacity at our Suzhou site, and commenced partial operations at our new Hangzhou facility with the completion of four 20KL bioreactors, one of the largest of its kind. The site will hold a total capacity of 172KL when it becomes fully completed in the second half of 2024. Guided by the values of “Perseverance for Altruism, Ingenuity for Sustainability,” we continuously strengthen our capabilities and quality systems in line with anticipated market and client needs to provide the most efficient and cost-effective services. | Altruist Biologics is a fully integrated CDMO, focusing on the development and commercial manufacturing of antibodies, fusion proteins, ADCs, and other drugs. From cell line development to aseptic fill/finish, we support our clients in producing affordable, high-quality biopharmaceuticals for the benefit of patients worldwide. We offer a total 60KL capacity at our Suzhou site, meeting the GMP requirements of the FDA, EMA, and NMPA, and commenced partial operations at our new Hangzhou facility with the completion of four 20KL bioreactors, the first and largest of its kind in China. The site will hold a total capacity of 172KL when it becomes fully completed in 2025. Altruist offers an end-to-end solution that includes: > Cell line development, process development/optimization, formulation development, analytical method development > Clinical sample production (200L/500L/1,000L/3,000L, liquid/lyo/PFS/AI), PCPV, BLA filing, PAI > Commercial manufacturing (3,000L/4,500L/20,000L, liquid/lyo/PFS/AI) > One-stop, integrated ADC platform: CMC development, clinical and commercial manufacturing for drug substance and drug product Building on our accumulated expertise and advanced technologies, we continuously strengthen our capabilities and quality systems in line with anticipated market needs, providing accessible services while accelerating your path to patients.
Almac Group
Almac Diagnostic Services We are a precision medicine company specialising in biomarker driven clinical trials. Our global CLIA and CAP accredited laboratories cover UK, Europe, USA and APAC regions. Our cores services: * Multi-Omic Services: We offer a range of genomic & proteomic platform and chemistry options, alongside expert data sciences support & a specialty central lab service. * Clinical Biomarker & CDx Development: Custom Clinical Biomarker & CDx development, validation & delivery service from our CLIA & CAP accredited laboratories in USA, Europe and APAC. * Clinical Testing: Global clinical trial testing service from our clinical laboratories, including a menu of platforms & assays and an integrated specimen collection & logistics service. Find Out More www.almacgroup.com/diagnostics | The Almac Group is an established contract development and manufacturing organization providing an extensive range of integrated services across the drug development lifecycle to the pharmaceutical and biotech sectors globally. Operating from state-of-the-art facilities in the US, Europe, and the UK, Almac Pharma Services is a FDA, HPRA, and MHRA approved CDMO partnering with global pharmaceutical and biotechnology industries. We have over 50 years’ experience in providing a comprehensive range of tailored solutions. Almac possesses a wealth of technical expertise to support the delivery of your complex projects. Our scientists can develop your clinical candidate into an optimum formulation, and solid manufacture oral dose products for all stages of clinical trials. Almac’s integrated pharmaceutical development solutions are tailored to meet your needs. We specialise in the manufacture & primary packaging of solid, oral dosage forms (Tablets, Capsules and Powders). As well as customised secondary packaging for all drug products including ultra-low temperature drug products. Almac works in close partnership with our clients offering unique solutions designed to support the efficient and successful development, and commercialisation of new treatment options. | Operating from state-of-the-art facilities in the US, Europe, and the UK, Almac Pharma Services is a FDA, HPRA, and MHRA approved CDMO partnering with global pharmaceutical and biotechnology industries. We have over 50 years’ experience in providing a comprehensive range of tailored solutions. Providing end-to-end integrated solutions to bring your drug product from development through to commercialisation from a single source. We work with clients to provide pharmaceutical development, manufacturing, product launch, and packaging solutions to fit their unique needs. Our team of experts can support the development of fit-for-purpose formulation for First-in-Human trials, to developing a more robust formulations scaling up for late phase trials, and ultimately commercialisation. Supporting key development and manufacture areas such as paediatrics, potent and highly potent products. We provide primary and secondary packaging for all drug products including ultra-low temperature drug products and specialised kit assembly. Almac was one of the 1st EU CDMOs to support gene therapy product launches, and currently supports 25% of EU approved/pre-registration Gene Therapy solutions. We provide end-to-end management of drug product supply, including distribution, packaging design, and support initial and ongoing global product launch. We provide unique, tailormade solutions designed to support the efficient and successful development, and commercialisation of new treatment options. Partnering with our clients to provide flexible, stable, ongoing supply to meet their product pipeline needs. | The Almac Group is a global leader in providing a range of expert services and support across the drug development lifecycle. A privately owned organisation, under the McClay Foundation, Almac has grown organically over the past five decades, now employing over 7,500 highly skilled individuals across 18 locations in Europe, the US and Asia. Almac Group is comprised of 5 Business Units: • Almac Diagnostic Services • Almac Sciences • Almac Pharma Services • Almac Clinical Services • Almac Clinical Technologies Each Business Unit offers specialist and dedicated solutions at each phase of the product lifecycle providing the ability to select single or multiple, integrated solutions to meet your unique needs. Our unique combination of inspirational people, exceptional innovation and outstanding quality, enables us to provide tailored solutions for your specific requirements – either on a single, standalone project or on a long-term basis as your strategic partner. About Almac Pharma Services: With over 55 years’ experience, Almac Pharma Services is an established, reliable and world leading outsourcing partner to the global pharmaceutical and biotechnology industry. Employing over 1,800 highly skilled individuals across 4 locations in Europe and the US, we provide a range of tailored, quality-led and timely solutions from early and late phase pharmaceutical development, clinical and commercial drug product manufacture, product launch through to commercial packaging and global distribution. Currently supporting client portfolios across more than 70 countries, our fully integrated, end-to-end solutions are tailored to meet the needs of your unique products, and, ultimately, your patients. Pharmaceutical Development Solutions: Spanning both early and late phase development, our teams of expert scientists possess a wealth of experience in developing clinical candidates into optimal formulations and manufacturing high-quality oral dose products for all phases of clinical trials. Operating both non-GMP and GMP facilities we have complementary equipment trains and integrated technical teams to facilitate technology transfer providing a seamless transition between formulation and process development, and clinical trial material manufacturing. Through a range of flexible and fully tailored unit operations including blending, roller compaction, high shear granulation, encapsulation (including Xcelodose) micro encapsulation and fluid bed processing, we offer the following oral dose formulations with batch sizes ranging from grams to tons: • API / powder in hard gelatin capsules or bottles, including micro-dosing • Formulated blends in hard gelatin capsules or bottles • Tablets (coated) • Mini-tablets • Granules • Beads/pellets • Non-sterile liquid in capsules or bottles • Immediate and modified release • Fixed dose combination products • Potent and highly potent products (OEL as low as 0.05 ug/m3/8 hours) • Specialist paediatric drug development expertise Analytical Solutions: We employ over 700 highly skilled analysts working in state-of-the-art, fully certified GMP laboratories across Europe and the US with significant experience in the analysis of both small and large molecules. We support drug substance (API) and drug product (finished product) analytics across all phases of clinical development through to commercial release. We offer a range of tailored services including: • Method development • Method validation • Method transfer • Stability programmes • Release analysis: all lifecycle stages • Spectroscopy services • Investigational analysis • Reference standard management • Microbiological testing • Physical sciences • Bio-pharmaceutical testing • Analytical support for clinical trial supplies Commercial Manufacture Solutions: Scaling up from our oral dose development assets and expertise through registration and launch into commercial supply, or transferring existing commercial products, we support your commercial manufacturing needs with flexibility and expertise. With blend sizes from 10kgs up to 2.5 tons, our range of state-of-the-art processing equipment is designed to enable scalability to the batch size requirements of your product for a range of presentations including: • Tablets • Mini-tablets • Capsules • Powders • Granules • Beads/pellets • Non-sterile liquids • Potent and highly potent products (OEL as low as 0.05 ug/m3/8 hours) • Specialist paediatric drug manufacturing expertise Commercial Packaging Solutions: Our high and low throughput operations provide the flexibility and efficiency necessary to meet your ongoing and fluctuating demand. Our commercial facilities in Europe and the US, combined with our local expertise offers flexible, quality-led commercial pharmaceutical packaging solutions tailored to meet your specific needs. Our range of primary packaging solutions include: • Tablets • Mini-tablets • Capsules • Powders • Granules • Non-sterile liquid • Our secondary packaging, labelling and assembly capabilities include: • Bottles Vials / ampoules • Pre-filled syringes • Wallets / blister cards • Auto-injectors • Cartons • Sachets • Stick packs • Offline blister printing Innovative, specialist packaging solutions including: • Specialist paediatric drug packaging expertise • Expert cell and gene therapy (ATMP) Ultra Low Temperature (ULT) solutions (-20° to -80°) • Complex medical kit assembly solutions via our unique, custom built semi-automated packaging technology Support Solutions: We provide a wide range of tailored support and consultancy services to help guide you through every aspect of your unique development and commercialisation journey. Find out more – www.almacgroup.com
ALLTRISTA PLASTICS
Alltrista Plastics LLC specializes in innovative, high-volume, precision manufacturing for the medical, consumer packaging, and high-end industrial markets. With five locations worldwide, we use proprietary engineering processes and extensive manufacturing capabilities to design innovations the world needs now. From the first spark of an idea, through the design of the mold, to the actual manufactured product, we focus all efforts on creating superior solutions for our customers. This foundation gives us the incredible ability to integrate material science, machine, and automation manufacturing technologies for exceptional results. Pushing the boundaries of sustainable solutions for our customers are our core team of employees who live out our Alltrista values each and every day: Count on Me, Play to Win, and Positively Impacting Lives. Come join our family. | Alltrista’s innovations are everywhere. We make a variety of solutions for pharmaceutical, consumer health, and industrial applications, including high-quality medicine bottles and certified child-resistant caps that give parents peace of mind. Building on deep experience, Alltrista’s material scientists listen to our clients’ needs to quickly and constantly refine and optimize the tools of the trade. Our unique ability to rally strong teams around projects allows us to be agile with even the most demanding tasks. We reimagine manufacturing processes to give our clients unprecedented solutions. This is what makes Alltrista’s products and partnerships exceptional, and what keeps our clients coming back. This is how we make a material difference every day. | At Alltrista, we want to help bring your ideas to life from concept through commercialization. Our goal is to optimize and innovate across every industry and provde the service that you need for your product. We offer a cohesive lineup of stock rigid packaging products and services related to design, tooling & automation, cleanroom manufacturing, injection molding, compression blow forming, automated assembly, filling and kit packing across a variety of industries.