Quinta-Analytica, as a member of Conscio Group, is a GCP/GLP/GMP-certified, EMA and FDA-inspected CRDO specializing in services for both small and large molecules. These services include formulation development, IMP manufacturing, method development and QC, clinical (PK) studies and bioanalytics for both human and veterinary drugs. Our main service areas include: 1) Clinical Testing: With 2 in-house clinical units providing BE/BA/PK studies, with capacity for 60+36 beds. 2) Bioanalytical Testing: GLP/GCP solutions for preclinical & clinical studies, small & large molecules, BE/BA/PK. 3) Biologics Quality Control: GLP/GMP bioanalysis, CMC, characterizations of peptide & protein IMPs, cell-based assays, biosimilars. 4) Pharmaceutical Quality Control: GMP quality control, batch testing, stabilities, HAPIs, inhalation, API sourcing. 5) Research & Development: Analytical R&D, impurities, extractables & leachables, degradation, trace studies. 6) Formulation development and IMP manufacturing: Innovative approaches in solid & semi-solid and special dosage forms, bioavailability improvement, up to OEB 5 class and narcotic molecules.
Purisys
Purisys offers a broad lineup of manufacturing and personnel assets for the development, manufacture and support of pharmaceutical APIs and other chemical synthesis projects. Our flagship, 17,000-square-foot innovation center and manufacturing facility in Athens, GA provides complex, high-barrier custom synthetic chemistry and manufacture of pharmaceutical APIs, as well as comprehensive controlled substance expertise, including: DEA-secure manufacturing, reference standard synthesis and qualification, process development and optimization, analytical method development, optimization, validation and transfer, small-scale cGMP clinical and commercial manufacturing, non-sterile, parenteral processing and milling, product design and development, formulation development and testing, and milling and custom packing. Purisys offers a fully operational global supply chain and export to more than 30 countries—with full international regulatory compliance.
PSC Biotech
Founded in 1996, PSC Biotech Corporation is a global organization that has spent over two decades providing life science services and solutions through our professional service consultancy for CQV, CSV, auditing, IT services, and much more. PSC Software provides inspection/audit management and eQMS services and BioTechnique provides CRDMO services. We also distribute equipment (Lives International data loggers and thermal mapping systems). Since its inception, PSC has served as a strategic partner to emerging and established life science companies, helping them bring their life-saving products to market. | PSC Biotech® is a global specialty life sciences consultancy firms, supporting over 1000 clients in more than 35 countries. PSC Biotech Corporation® provides life science services and solutions through our professional service consultancy (CQV, CSA/CSV, Audit, and much more.) PSC Software® provides inspection management and electronic quality management systems that enable businesses to stay compliant while effectively and efficiently delivering products to market. PSC Software® has 4 proprietary, 21 CFR Part 11 compliant, cloud-based systems that accelerate and streamline quality processes. BioTechnique® is a division of PSC Biotech Corporation®. BioTechnique® is a Contract Research, Development, and Manufacturing Organization (CRDMO) that provides lyophilization and therapeutic sterile injectable fill-finish solutions to cater to both large and small investigational/clinical stage or commercial batch sizes. BioTechnique® provides a comprehensive platform for success, beginning with Formulation Studies, extending through Analytical and Formulation Development, and culminating in Product Launch (clinical or commercial). | . | BioTechnique is a CRDMO, pharmaceutical manufacturing facility located in York, PA. A highly potent sterile injectable and clinical oncolytics manufacturing company dedicated to providing cytotoxic and high potency sterile injectable fill-finish services. Our project management and client services staff work closely with clients to meet all their manufacturing needs. We provide formulation and compounding, fill-finish, lyophilization, shipping, storage, and 3rd party logistics for a wide variety of liquid injectables. BioTechnique utilizes our expertise to create process designs for client product needs. To learn more, visit www.biotechnique.com
PRONAV Clinical
PRONAV Clinical Your All-in-One Partner for Early Phase Clinical Supply Chain Operations” Keep your clinical development programs on track with expert, bespoke consultancy, fully GMP-compliant labeling, packaging, kitting, and blinding services, with integrated document and project management solutions. PRONAV Clinical eliminates quality or supply delays, accelerating the journey of your therapeutic to clinical trials—and the patients who need it most. With an industry-leading 99.3% on-time delivery rate over the past 12 months, PRONAV Clinical ensures reliable, seamless support across every trial we serve. Navigating the complex regulatory and quality landscape can be overwhelming, especially for emerging pharma and biotech companies in preclinical or Phase 1 stages. Mistakes in supply chain management or quality oversight can result in costly delays or the loss of irreplaceable drug products. At PRONAV Clinical, we specialize in helping early-stage biotech and pharma innovators navigate supply chain complexities swiftly and safely. With a collaborative, boutique approach, we forecast and address challenges before they arise. Unlike larger providers, we are committed to supporting even the smallest batch sizes, ensuring no project or medicine is overlooked – particularly for critical or rare disease treatments. With bases in Ireland, and Maryland, USA, we seamlessly access European and US markets to ensure compliance, accessibility, and timely delivery for clinical trials worldwide. Don’t risk the safety or integrity of your next-generation therapeutic. * EU Site of Importation * Qualified Person (QP) Batch Certification and Release for Sale * Secondary Packing of Solid and Liquid Dosage Forms * Labelling and Blinding * Controlled Temperature Storage [-80°C] [-20°C] [2 – 8°C] [15 – 25°C] * Inventory Management and Depot Services * Logistics and Distribution * Comparator Medicines Sourcing * Ancillary Medicines and Medical Device Sourcing * Kit Assembly * Auditing of Supply Chain Partners and QP Certification * Project Management and Consulting
Prince Sterilization Services
Prince Sterilization Services is the leading contract sterilization service provider specializing in moist heat steam, low-temperature vaporized hydrogen peroxide, pre-filled syringes, dry heat sterilization and depyrogenation services. With decades of expertise and state-of-the-art facilities and equipment, Prince is positioned to support medical device and pharmaceutical customers’ packaging, washing, and sterilization needs from development to commercialization. Operating in over 50,000 square feet of cGMP space, we ensure FDA and ISO 13485 compliance while prioritizing sustainability. All of Prince’s Contract Sterilization solutions satisfy cGMP while being the eco-friendliest, nontoxic, and sustainable modalities available. Prince is also a supplier of Ready-to-Use (RTU) vials, stoppers, seals, bottles, and other pharmaceutical and pharmacy drug product components. All processing of materials, including inspection, washing, depyrogenation/sterilization, and final packaging, is performed in ISO certified clean rooms. Water for injection (WFI) that meets USP and EN285 standards is used for all critical processes, including vial washers, component washers, and steam sterilizers. Prince is a leading provider of terminal sterilization for a variety of healthcare products, including medical devices, single-use bottles, and tubing sets, stainless steel components, APIs, filled drug products in vials, syringes, and IV bags, and many other materials and products. Our technical staff is ready to provide case-by-case consultation support when needed. Explore our comprehensive sterilization services at www.princesterilization.com or connect with us directly at info@princesterilization.com. | Prince Sterilization Services (Prince) is a trusted partner to the medical device, pharmaceutical, and broader life sciences industries as a premier provider of contract sterilization modalities, including steam, low-temperature vaporized hydrogen peroxide (VH2O2), and dry heat sterilization services, and sterile, ready-to-use (RTU) custom components. A third-generation business built on quality, technical confidence, and care; Prince delivers comprehensive contract sterilization services, ready-to-use components (RTU), and cleanroom kitting and packaging solutions from our FDA-registered, CGMP-compliant, and ISO 13485-certified facilities. Prince’s New Jersey campus spans over 100,000 ft² of GMP manufacturing, warehousing, and administrative space, equipped with full-facility backup generators. Prince is an industry-leading provider of ready-to-use vials, stoppers, seals, and sterile components. Take a virtual tour of the NJ campus at https://princesterilization.com. Reach our technical experts at info@princesterilization.com.
Prestige Biopharma Limited
Prestige Biopharma (PBP) is a Singapore-based biopharmaceutical company focusing on discovery, research, development and registration of biosimilars, first-in-class antibody drugs and vaccines, with the aim of finding cures and preventive medicines for devastating diseases, and to provide through our partners access to affordable quality biologics to the patients of the world. Prestige Biopharma strives to become a global innovator through the development of first-in-class antibody therapeutics including PBP1510 anti-PAUF mAb for pancreatic cancer (INN-ulenistamab) that obtained orphan designation from FDA, EMA and MFDS. Another 10 bispecific antibody projects based on PBP’s proprietary oncology therapeutic targets, PAUF and CTHRC1, are currently in development. Prestige Biopharma’s rich portfolio of biosimilars in various stages consist of the lead program, HD201, a trastuzumab biosimilar, currently under review by Health Canada and Korean MFDS, HD204, a bevacizumab biosimilarin Phase 3 of clinical development and planned to be filed in Q4/2023, PBP1502 an adalimumab biosimilar currently in phase I. Other biosimilars in the pipeline include aflibercept, eculizumab, ipilimumab, nivolumab, pembrolizumab, pertuzumab, and others. Prestige Biopharma’s area of capabilities also includes full value chain technological platform for drug discovery leading to expedited development, from drug discovery, non-clinical and clinical development, to regulatory registration and global commercialization together with our partners. Prestige Biopharma, together with Prestige Biologics, also expanded its business into development and manufacturing of vaccines at global scale vaccine center, starting with partnered commercial production of COVID-19 vaccines, and collaboration in developing next generation vaccines for potential future pandemics. Prestige Biopharma’s dedicated manufacturing facility, Prestige Biologics, is a biopharmaceutical CDEMO (Contract Development Engineering Manufacturing Organization) that provides complete solutions to the development and manufacturing requirements in drug discovery from early stage to product registration and commercialization. With its fully established antibody drug and vaccine manufacturing capabilities, Prestige Biologics offers CDEMO services in which customized engineering solutions are provided for manufacturing process in a customized manufacturing suite speed-built with its proprietary technology, ALITA Smart BioFactory™. Currently, a total production capacity of 154,000L with Full Single-Use System and ALITA Smart BioFactory™ is available for global clients. | PRESTIGE BIOPHARMA LTD (PBP) is a rapidly-expanding, biopharmaceutical company, with an Innovative Drug Development Platform from Discovery to CMC analysis to GMP Product Manufacturing. We are pioneers in pancreatic cancer, with novel antibody drugs and diagnostics targeting PAUF (biomarker for pancreatic cancer) under development. We also specialize in development and manufacturing of biosimilars. Located in Busan, Korea’s second largest city, the Innovative Discovery Center (IDC) stands as Prestige Biopharma’s global-scale R&D center, serving as the nucleus for pioneering novel drug development initiatives. Equipped with cutting-edge scientific infrastructure, IDC is dedicated to developing novel therapeutic antibodies to overcome unmet medical needs. Leveraging expertise and resources, we focus on first-in-class antibody drugs addressing life-threatening diseases and fostering innovation. To fulfill these roles, our scope covers from the initial stages of target identification, through the critical steps of the mechanism of action (MoA) studies, lead finding and optimization, to comprehensive preclinical studies, culminating in the IND (Investigational New Drug) filing. Additionally, we are dedicated to the in-house development of cell line development (CLD) technologies, focusing on engineering cell lines that can produce therapeutic proteins at high yields. Moreover, we develop bioanalytical analysis methods to ensure the integrity and performance of our biologics. This integrated approach ensures that the IDC contributes significantly to successful drug development. IDC aims to establish an open innovation platform by fostering synergy between science and technology, implementing a comprehensive innovative drug platform (‘Plug and Play’) and offering shared lab opportunities, allowing global academic institutions, enterprises, or entrepreneurs to assemble and collaborate for the development of pharmaceutical solutions. Prestige Biologics, our dedicated CDEMO, provides One-Stop Solutions for biomanufacturing from drug development to commercial manufacturing. We provide comprehensive support throughout the drug development lifecycle, including technical research, manufacturing process development, engineering, clinical production, commercial manufacturing, clinical support, and IND and BLA filings. Through this integrated approach, we deliver the most effective services to our customers in the rapidly evolving biopharmaceutical market. | Prestige Group has a comprehensive value chain platform, encompassing the entire drug discovery cycle, from R&D to manufacturing, clinical development, regulatory registration and commercialization, bringing innovative therapeutics to the market seamlessly and efficiently to address unmet medical needs. Prestige Biopharma Limited (PBP) is a Singapore-based biopharmaceutical company dedicated to the discovery, research, development and registration of biosimilars and first-in-class antibody drugs with a strong focus on oncology and immunology. Located in Busan, Korea, the Innovative Discovery Center (IDC) stands as PBP’s global-scale R&D center, fostering innovation, and driving the development of biologics including first-in-class antibody drugs and platform technologies aimed at addressing life-threatening diseases. Our scope spans the full range of activities, from early discovery and target identification to comprehensive preclinical studies, culminating in the Investigational New Drug (IND) filing for clinical trial initiation. Additionally, IDC has established a robust cell line development (CLD) system to engineer high-yield therapeutic protein-producing cell lines. PBP’s dedicated manufacturing facility, Prestige Biologics, is a biopharmaceutical Contract Development and Manufacturing Organization (CDMO) that provides complete solutions to the development and manufacturing requirements in drug discovery from early stage to product registration and commercial supply. Currently, a total production capacity of 154,000L with Full Single-Use System is available for clients worldwide.
Polpharma API
Polpharma API is one of the CDMO companies in Europe, specializing in the production of Active Pharmaceutical Ingredients (APIs). We partner with our clients throughout the entire product life cycle, from early-stage clinical candidates to commercial launches. Our cutting-edge facilities for R&D, pilot production, manufacturing, and quality control, combined with our extensive expertise in developing and manufacturing highly complex APIs, allow us to offer a diverse range of services across the value chain, ensuring tailored solutions for every project. What sets us apart? At Polpharma API, we specialize in: ✅ High-potency payloads ✅ Advanced linker technologies ✅ Customizable solutions, tailored to meet the unique needs of your ADC development pipeline. : Broad type of technologies, including #HPAPI, #Oligonucleotides and #Cryogenic with end-to-end solutions from process development to large-scale production : FDA-approved plant located in Europe with regulatory experience on +70 markets around the world : Fully integrated API Business Unit, from R&D, IO, Supply Chain to Commercial with fast-decision making and execution
Polpharma Biologics S.A.
Polpharma Biologics is an international biotechnology company with integrated operations in the European Union, developing and manufacturing biosimilar medicines. Using patented solutions and state-of-the-art platform technologies, Polpharma Biologics develops biosimilar products to treat a range of conditions in major therapeutic areas. Programs at Polpharma Biologics start in cell line development and transition through technical and clinical development to commercial-scale production ready to be commercialized by our partners in all major pharmaceutical markets. The company’s expertise is in the development and manufacturing of medicines based on microbial & mammalian expression. Company is currently developing 10 molecules and in addition, have 2 biosimilars approved in multiple markets. These leading biosimilars are partnered with multiple companies for marketing rights to different territories.