Company Category: CMO

Bioengineering AG

Bioengineering AG is an indipendent and autonomous company that has been successfully turning customers’ ideas into reality since 1972. We offer comprehensive solutions in the areas of Engineering & Design, Services, Plants, Bioprocess Control, Lab & Pilot, and Components. We build plants for the production of vaccines, biosimilars, starter cultures and other products and develop automation solutions and components for controlling and monitoring the plants. Over 50 years of experience in plant construction and our innovative strength enable us to successfully realise even the most complex plants. | Bioengineering AG is an independent and autonomous company that has been successfully turning customers’ ideas into reality since 1972. We offer comprehensive solutions in the areas of Engineering & Design, Services, Plants, Bioprocess Control, Lab & Pilot, and Components. We build plants for the production of vaccines, biosimilars, starter cultures and other products and develop automation solutions and components for controlling and monitoring the plants. Over 50 years of experience in plant construction and our innovative strength enable us to successfully realise even the most complex plants. | Our fields of study may be diverse, but we are all engineers at heart. And citizens of the world. Here at Bioengineering, we work for those creating and making discoveries in laboratories and production facilities around the world. What unites us with them is a certain mindset: excellence. That’s what we fly the flag for, regardless of nationality. Our claim to excellence underlines our position as an intelligent and reliable partner who, with their bioreactors and fermentors, works in collaboration with the best companies in the world: inspiring excellence.

Read More

Biocatalysts Ltd

Biocatalysts are a global biotechnology company producing speciality enzymes at commercial scales for a variety of industries, such as food, flavour & fragrance, pharmaceutical, life sciences, fine chemicals and many more. Our state-of-the-art facility has a vertically integrated manufacturing process that optimises the large-scale production of novel enzymes, fermented proteins, and pharmaceutical biocatalysts. Biocatalysts offer off-the-shelf enzyme products and a customised enzyme development and manufacturing service. Biocatalysts have the tools and flexibility to provide tailored solutions specific to customers’ needs and can deliver rapid enzyme scale up from discovery through to full commercialisation. Biocatalysts develop and manufacture speciality enzymes for both food and non-food applications. More specifically this can include enzymes for flavour enhancement, the production of ‘enzyme modified cheese’, the hydrolysis of whey protein for the sports nutrition and infant formula markets, reprocessing of meat and fish to produce value-added ingredients, and for the hydrolysis of plant protein substrates to produce vegetable protein hydrolysates for increasing protein in a wide variety of food applications | Biocatalysts Ltd are a global biotechnology company producing speciality enzymes at commercial scales for a variety of industries, such as food, flavour & fragrance, pharmaceutical, life sciences, fine chemicals and many more. Our state-of-the-art facility has a vertically integrated manufacturing process that optimises the large-scale production of novel enzymes, fermented proteins, and pharmaceutical biocatalysts. Biocatalysts Ltd offer enzyme products and a customised enzyme development and manufacturing service. Biocatalysts Ltd have the tools and flexibility to provide tailored solutions specific to customers’ needs and can deliver rapid enzyme scale up from discovery through to full commercialisation. Biocatalysts Ltd develop and manufacture speciality enzymes for both food and non-food applications. More specifically this can include enzymes for flavour enhancement, improving functionality and digestibility of plant and animal-derived proteins, as well as enzymes used in fundamental molecular biology techniques to advance drug discovery, and modify and manipulate DNA for diagnostic and therapeutic purposes. | BRAIN Biocatalysts is a UK-based enzyme development and manufacturing company with over 40 years of experience supplying customised enzyme solutions to global markets. As part of BRAIN Biotech Group, BRAIN Biocatalysts combines deep expertise in fermentation, scale-up and downstream processing with cutting-edge enzyme discovery and engineering capabilities. BRAIN Biocatalysts Life Science Solutions was recently launched as a dedicated brand focused on delivering fully integrated, end-to-end enzyme development for the pharmaceutical and life science industries. From early discovery through to large-scale manufacturing, the brand offers tailored and scalable enzyme solutions – underpinned by a transparent IP model and supported by world-class bioprocessing infrastructure.

Read More

BioCina

We are a global end-to-end biologics Contract Development and Manufacturing Organisation (CDMO), offering highest-quality, cost-effective cell line, process, analytical and formulation development, and cGMP clinical & commercial manufacturing of the microbial, pDNA and mRNA modalities. Our US FDA, EMA and TGA approved site in South Australia, which was previously part of Pfizer, is staffed with a tremendously experienced technical and operations team, with most critical SME’s having an average tenure of 15+ years at the Adelaide site. Because we are not a drug developer, we only serve our client’s products and through our partnership with NovaCina, we are also able to offer our clients a highest-quality fill-and-finish solution. | BioCina is a global end-to-end Contract Development and Manufacturing Organisation (CDMO) offering clients unparalleled quality, adherence to the highest regulatory standards, and industry-leading on-time and in-full delivery, setting a new benchmark in the industry for quality and reliability. With deep expertise in small molecules, microbial, pDNA and mRNA modalities, BioCina’s comprehensive service offerings include cell line development, process development, analytical and formulation development, and cGMP clinical and commercial manufacturing. BioCina operates two state-of-the-art facilities in Adelaide, South Australia and Perth, Western Australia. The facilities boast a rich history of developing and manufacturing clinical and commercial drug substances and drug products, backed by highly experienced Subject Matter Experts (SMEs) with an average tenure of more than 10 years. BioCina maintains an elite quality record, meeting the highest international standards. The facilities have successfully passed regulatory inspections by the US FDA, EMA, and Health Canada, and are licensed by the Australian TGA for cGMP manufacturing of bulk drug substance and sterile drug product. BioCina has a proven track record of producing high-quality drug products distributed to 98 countries across North America, South America, Europe, Asia, and Africa. BioCina is proud to serve clients from every major market in the global industry, and because BioCina is not a drug developer, its focus is solely on serving its clients’ products. Australia offers one of the most attractive tax incentives available globally (up to 48.5% cash refund), making it an ideal destination for drug developers looking to invest in scaling-up and manufacturing their products. As one of the fastest growing companies in the biopharmaceutical industry across Australia, BioCina was awarded the 2024 South Australia “Emerging Business of the Year” award. Learn more at https://biocina.com. | BioCina is a global, end-to-end contract development and manufacturing organisation (CDMO) headquartered in Australia, serving pharma and biotech clients from early clinical development through to commercial supply. With GMP facilities spanning drug substance biologics and sterile fill-finish drug product, BioCina is the leading end-to-end CDMO in Australia and the Southern Hemisphere — offering clients a single project team and seamless progression from molecule to market. A Heritage Built for Complex Manufacturing BioCina’s GMP facilities carry a combined pharmaceutical heritage of over 50 years, previously part of Pfizer’s global manufacturing network by way of Hospira. Our specialists carry an average tenure of 15 years, delivering industry-leading OTIF performance across clinical and commercial supply, across modalities, and across 100+ countries. Over 600 approved products bear that manufacturing history. Drug Product: The Full Spectrum of Sterile Fill-Finish BioCina operates 10 state-of-the-art filling lines with annual capacity exceeding 225 million units, serving both small molecule and biologics programs across the full range of sterile formats: Blow-Fill-Seal (BFS): Seven dedicated lines producing preservative-free, aseptically filled sterile liquids for ophthalmic, inhalation, irrigation, and injectable applications. Multiformat Injectables (Terminal Sterilisation): High-volume vials and glass bottles for IV medications, hospital generics, and small molecule injectables. Cytotoxic Fill-Finish: A dedicated line under Restricted Access Barrier System (RABS) containment for oncology and high-potency liquid injectables. SA25 Cytiva Robotic Aseptic Isolator: Fully closed, robotic filling for vials, prefilled syringes, and cartridges — highest sterility assurance for biologics, biosimilars, and oxygen-sensitive products. EU Annex 1 compliant. Controlled Substances: Manufacturing licences for scheduled drugs enabling GMP production of opioids, benzodiazepines, stimulants, methadone, and more. Non-Sterile Oral Liquids: Commercial-scale production in PET and HDPE bottles, including paediatric, oncology supportive care, and controlled substance formulations. Drug Substance: From Cell to Bulk BioCina offers fully integrated biologics drug substance development and manufacturing, from upstream through to purified and characterised bulk material. Microbial fermentation is the foundation — over 35 years of expertise, scales from development through to commercial production, with full downstream processing and in-house analytical development, method validation, and stability programs. BioCina also offers fully integrated pDNA, mRNA, and LNP manufacturing at clinical and commercial scale — covering plasmid DNA production, in vitro transcription, mRNA capping and purification, and precision microfluidic LNP encapsulation across mRNA, pDNA, saRNA, proteins, peptides, and small molecule payloads — with direct handoff to fill-finish under one organisation. Regulatory Credentials That Travel With Your Product BioCina’s facilities are registered with and inspection-ready, holding product approvals from the US FDA, EMA, TGA, PMDA (Japan), Health Canada and many other leading regulatory authorities, spanning 100+ countries. Australia as a Strategic Advantage Manufacturing in Australia is a competitive position. The Clinical Trial Notification (CTN) pathway enables first-in-human studies to begin in as little as 30 days from submission. The Australian Government’s R&D Tax Incentive provides eligible companies with a refundable tax offset of up to 43.5% on qualifying development expenditure — meaningfully extending program runway. Australia’s political stability, strong IP framework, and English-language operating environment reduce risk. BioCina’s APAC position also provides practical advantages for clients targeting Korean, Japanese, and Southeast Asian markets.

Read More

BINEX Co., Ltd.

Binex has been a true biologics CDMO partner with a reliable GMP production record over 1,111 batches providing top quality CDMO service to its clients. Binex offers full range of CDMO services from cell-line development to GMP manufacturing for drug substance and drug product and has production lines ranging from 180L to 5,000L for mammalian cell culture and microbial fermentation. Binex has been globally supplying clinical materials and commercial products (mAbs, bispecific mAbs, Fc-fusion proteins, recombinant proteins, DNA vaccines, etc.) to our CDMO clients who have established time-honored business relationship with Binex. | BINEX is your reliable Contract Development and Manufacturing Organization (CDMO) partner that complies with GMP and EU GMP requirements. Based on our global track records and vast GMP manufacturing experience of drug substance and drug product, we are committed to provide client-oriented CDMO services. We cater to clients utilizing our facilities, which offer a diverse range of bioreactors, as well as our accumulated know-how in manufacturing service across mammalian cell cultivation and microbial fermentation.

Read More

BiBo Pharma

BiBo Pharma is a full spectrum CDMO covering the entire CMC lifecycle of biologics. BiBo Pharma has multiple technology platforms, including microbial fermentation, mammalian cell culture, gene and cell therapy, XDC & GMP facility engineering service. Empowered by PanFlex®-Engineering, BiBo’s specialist team innovated the world’s first and largest 30,000 L stainless steel ultra-large bioreactor for mammalian cell culture production, and 30,000L high cooling capacity fermenters enabling ultra-high-cell-density fermentation. BiBo Pharma, which started in 2014 based in Boston, USA, now has two R&D centers and three GMP facilities in operation globally. BiBo established the first GMP facility P01 site in Shanghai in 2019, the P02 GMP site in 2021, and the P03 GMP site in 2023. Two more mega-GMP facilities, P04 and P05, have been initiated and will be in operation in the next three to seven years. BiBo’s core team members come from world-leading companies in the US, Europe, and China. BiBo has accomplished over 100 biologics projects, including over 30 in clinical and commercial stages. Our CMC service package includes cell line and strain development, process development, analytical development, formulation development, toxicological and GMP production of drug substance and drug product, process characterization, and large-scale production. BiBo is the world leader in the fourth wave of biomanufacturing. Not only has BiBo established the world’s first and largest 30,000L ultra-large mammalian production line, but it has also achieved a 100% success rate on all scale-up projects by applying our innovative “success on the first time” system.

Read More

Axcelead Drug Discovery Partners, Inc.

Axcelead Drug Discovery Partners is an integrated solutions provider in drug discovery and non-clinical research. We are uniquely positioned having carved out a Preclinical R&D Discovery Unit from Takeda Pharmaceuticals. We preserved the talent, the tools, the Pharma origin compound library and Legacy Data under the same roof. Our scientific team is pioneering disruptive and differentiated discovery solutions for diseases with high unmet needs. Axcelead’s integrated solution span the drug discovery continuum from early-stage exploration studies to candidate optimization and even a bridge process to clinical development. For example, hit identification service using pharma origin, huge, high-quality, and diverse compound library has more than 700 cases for multiple target classes with more than 90% hit rates. In the stage of lead generation/optimization, if your target of interest is in our legacy data, you can obtain a powerful jump start toward candidate selection. Legacy data, deep knowledge & extensive experience of the target enable generation of a high-quality candidate in the shortest approach. Our exceptional discovery engine improves success rates for your drug discovery campaigns. | Axcelead Drug Discovery Partners Inc. is an integrated drug discovery and development solution provider, serving biotechnology and pharmaceutical companies all over the world. Our well-experienced team works closely with you for every step of your drug discovery project, from target identification, hit identification/characterization, lead generation/optimization, candidate selection, to IND enabling and beyond. | Axcelead is a healthcare platform company that owns Axcelead Drug Discovery Partners, a Japan-based global drug discovery solution provider, and ARCALIS, a CDMO company capable of integrated manufacturing of mRNA pharmaceuticals. Axcelead Drug Discovery Partners offers integrated drug discovery services from target identification to IND enabling studies. With a mission to accelerate research as your drug discovery engine, Axcelead Drug Discovery Partners provides exceptional expertise, flexible partnerships, and access to valuable legacy data. We are uniquely positioned having carved out a Preclinical R&D Discovery Unit from Takeda Pharmaceuticals. | Axcelead Drug Discovery Partners (ADDP) is a Japan-based global provider of drug discovery solutions, established in 2017 as a spin-out from Takeda Pharmaceuticals. Our Drug Discovery Service offers a fully integrated, end-to-end approach, seamlessly connects all functions to advance drug discovery programs from target validation to IND enabling studies in wide-range therapeutic areas, including neuroscience, oncology, cardiovascular, metabolic diseases, immunology & inflammation, and musculoskeletal disorders. Leveraging legacy data from over 1,000 research projects inherited from Takeda—including hit and lead compounds as well as extensive biological datasets— we help clients accelerate progress and achieve success with their drug discovery programs. In addition to Drug Discovery service, each of our core technology platforms is also available as a standalone service, allowing clients to access specialized capabilities as needed: • Hit identification through high-throughput screening using our proprietary compound library • Proprietary in silico design tools supporting medicinal chemistry design and optimization • Validated in vivo and in vitro pharmacology evaluations delivering translational insights • Comprehensive DMPK, safety assessment, and bioanalysis capabilities • Expertise across multiple modalities, including small molecules, peptides, oligonucleotides, mRNA-targeted therapies, protein degraders, ADCs, and regenerative medicine This flexible model ensures that our clients benefit from world-class science—whether as part of a fully integrated program or by engaging individual, best-in-class services tailored to their specific needs.

Read More

Avid Bioservices, Inc.

Avid Bioservices (NASDAQ: CDMO) is a dedicated contract development and manufacturing organization (CDMO) focused on development and CGMP manufacturing of biologics. The company provides a comprehensive range of process development, CGMP clinical and commercial manufacturing services for the biotechnology, biopharmaceutical, and cell & gene therapy industries. With over 30 years of experience producing biologics, Avid’s services include CGMP clinical and commercial drug substance manufacturing, bulk packaging, release and stability testing and regulatory submissions support. For early-stage programs the company provides a variety of process development activities, including cell line development, upstream and downstream development and optimization, analytical methods development, testing and characterization. The scope of our services ranges from standalone process development projects to full development and manufacturing programs through commercialization. www.avidbio.comwww.avidbio.com | Avid Bioservices, a dedicated biologics CDMO, is transforming the CDMO experience. From concept to market, we are your advocate. We have more than 30 years of unrivaled expertise manufacturing biologics and a leadership team with a 10-year average operational leadership tenure. Our world-class mammalian protein facilities are located in Orange County, CA. We’ve produced more than 250 commercial batches, and 5 commercial products marketed in 90+ countries. We maintain the highest level of compliance with a dedication to continuously improving our quality systems and manufacturing processes. For more than 10 years, we’ve maintained a flawless quality track record which we’re committed to uphold. From early-stage to late-stage, concept to market, every part of our process is personalized. We’re your advocates, your trusted experts, your true partners. For more information, visit AvidBio.com. | Avid Bioservices, a dedicated biologics CDMO, is transforming the CDMO experience. From concept to market, we are your advocate. We have more than 30 years of unrivaled expertise manufacturing biologics and a leadership team with a 10-year average operational leadership tenure. Our world-class mammalian protein facilities are located in Orange County, CA. We’ve produced more than 250 commercial batches, and 5 commercial products marketed in 90+ countries. We maintain the highest level of compliance with a dedication to continuously improving our quality systems and manufacturing processes. For more than 10 years, we’ve maintained a flawless quality track record which we’re committed to uphold. From early-stage to late-stage, concept to market, every part of our process is personalized. We’re your advocates, your trusted experts, your true partners.

Read More

AsymBio

Asymchem (Stock Code: 002821.SZ/6821.HK) is a global leading CDMO founded in 1995, offering integrated solutions across the pharmaceutical lifecycle—from R&D to commercial production. Specializing in small molecules, chemical macromolecules, biologics, and synthetic biology, Asymchem operates R&D and manufacturing facilities in China, the U.S., and the U.K., supported by a team of over 9,000 professionals . Its subsidiary, AsymBio, is committed to being a technology-driven CDMO with a global vision and best-in-class solutions for bioconjugates, antibodies, etc. With a proven track record, AsymBio is the innovative, reliable and client centric CDMO partner driven for your success in the competitive pharmaceutical landscape

Read More

Ascendia Pharmaceutical Solutions

Ascendia Pharmaceutical Solutions specializes in complex formulation development and manufacturing of pharmaceutical and biologic products using a suite of novel formulation technologies. We provide formulation, analytical, and manufacturing services to pharmaceutical companies, working collaboratively to provide innovative solutions to challenging drug delivery problems and to create advanced medicines. CREATING FORMULATIONS FOR CHALLENGING MOLECULES Ascendia’s expertise involves finding the most effective method of drug delivery for poorly soluble and/or bioavailable molecules. Our comprehensive range of capabilities enables clients to optimize their drug product formulation prior to initiating expensive clinical development. Ascendia provides practical, customized formulation solutions that enable rapid advancement of compounds from discovery to clinical testing. We create trial formulations suitable for PK and tox studies using our nano-emulsion, amorphous solid dispersion, controlled release, LNP and other nanoparticle engineering approaches. We conduct preformulation testing, formulation approach comparisons, dosage form design, and formulation optimization. By working with Ascendia, our clients can quickly determine the feasibility of multiple technical approaches in parallel, thus improving the probability of formulation success and reducing the time required to make critical early-stage formulation decisions. cGMP MANUFACTURING Following formulation selection and optimization, Ascendia can quickly transition a development program to cGMP manufacturing of first-in-man clinical materials. With both aseptic and non-aseptic manufacturing suites in its New Jersey (USA) facility, the company can handle various dosage forms, including those for oral, topical or parenteral administration. Ascendia offers its manufacturing services to third parties that need a CDMO partner for their formulations advancing from preclinical to clinical stages of development. LIFE-CYCLE MANAGEMENT AND 505(b)(2) PRODUCT DEVELOPMENT Ascendia is dedicated to the solubility, bioavailability and stability enhancement of difficult-to-formulate compounds. Our proprietary product development programs focus on creating novel specialty pharmaceutical products that are improved versions of existing medicines. We develop oral, topical and injectable products for clients via the 505(b)(2) NDA pathway, as well providing formulation development and manufacturing for complex generic (ANDA) products.

Read More

Ascend Advanced Therapies-ABL

X Ascend Advanced Therapies and ABL Inc. form a premier CDMO alliance with 50+ years of viral manufacturing expertise. We deliver high-quality, cost-effective development and commercial-scale production of gene therapies, oncolytics, and vaccines—accelerating time-to-market for biotech innovators across multiple advanced therapy modalities.

Read More