The Xuri cell expansion systems (Xuri W25 and W5) provide a functionally closed, single-use bioreactor that requires fewer operator intervention steps, reduces the risk of contamination, and controls the cellular environment to maximize cell yield. Data presented here highlight that at a cellular level, results from different bioreactors may appear similar, but differences can exist at the receptor expression level. Expansion of T Cells Peripheral blood mononuclear cells (PBMCs) were expanded in static culture. On Day 5, 2-L Xuri Cellbag…
Manufacturing
Bio on demandâ„¢
NNE Pharmaplan has developed a new facility concept called Bio on demandâ„¢, which enables facilities to be established in one to two years. The result is a flexible facility that is fully operational, locally compliant, and contains functioning quality systems. Bio on demandâ„¢ involves a high degree of single-use technology to ensure cost-effective production and fast establishment. Facilities based on our Bio on demandâ„¢ concept can be delivered globally, but they are primarily intended for growth markets where time-to-market is…
Development By Design
Unlike typical pharmaceuticals, cell therapies rely heavily on the manufacturing process for product attributes. As more products move out of the clinic and toward commercialization, the manufacturers of cell therapies are realizing that commercialization is unlikely to be successful without an effective methodology for manufacturing development. At PCT, we recognize that a successful commercial manufacturing vision includes the ability to provide consistently high product quality at a reasonable cost of goods that meets demand over the commercial life of a…
Quality, Performance, and Integrity Make the Difference
Pyramid Laboratories, Inc. is a contract aseptic manufacturing and analytical services organization for sterile injectable drugs. Pyramid provides expertise in formulation and process development, aseptic filling for vials and syringes, and lyophilization applications. Pyramid has established a reputation of exceptional performance, integrity, and quality. Technical Services Pyramid offers a wide array of services for all phases of drug development and production including formulation and process development lyophilized product formulation and cycle development clinical and commercial vial and syringe fill–finish clinical…
High-Performance Biopharmaceuticals Manufacturing
Identifying the most appropriate contract manufacturer that is most likely the best match for your lead pharmaceutical candidate is a true challenge. Rentschler is a biopharmaceutical manufacturer with a proven track record for over 40 years. Focused on mammalian cell lines, our experience covers the development, production, and aseptic filling of recombinant proteins such as cytokines, enzymes, monoclonal antibodies, and fusion proteins in compliance with international GMP standards (EMA/FDA). We don’t just claim to be reliable and experienced; our many…
Biopharmaceutical Development and GMP Manufacturing: Preclinical to Commercial Supply
Richter-Helm has more than 25 years of experience in the development and good manufacturing practice (GMP)–compliant production of a wide range of biopharmaceuticals, including recombinant proteins (e.g. cytokines, growth factors, antibody fragments, surface antigens) plasmid DNA microbial vaccines (e.g., live and attenuated whole cell vaccines), according to the EU and US GMP guidelines (FDA approval 2013). Customized Solutions Richter-Helm offers customized solutions for all steps in biopharmaceutical projects through contract development and manufacturing services, including Development of production strains (Escherichia…
Sandoz: Provider of Customized Solutions in Biotech Manufacturing
Sandoz is one of the leading specialists in biotech development and manufacturing. Comprehensive know-how is based on more than two decades in microbial and mammalian cell culture production at commercial scale. Today Sandoz offers a broad variety of integrated services, including innovative expression systems, process development, scale-up, and production of recombinant products derived from microbial systems and mammalian cell culture in state-of-the-art facilities. Our expertise is based on numerous projects successfully performed in collaboration with our customers. Currently, Sandoz is…
Client Experience Matters!
Contract manufacturing of biologics is more than having superior technology — it’s having experienced people who are passionate, responsive, and committed to developing and manufacturing your biotherapeutics to improve patient care. As a fully integrated contract development and manufacturing organization (CDMO), Therapure Biomanufacturing has the scientific and technical expertise to successfully deliver at every stage of product development (preclinical, clinical, and commercial). Our 130,000-ft2 (12,000-m2) current good manufacturing practice (cGMP) manufacturing facility meets FDA, EMA, and HPFB regulatory standards and…
Vetter Development Services: Filling Your Clinical Development Needs in Chicago
Vetter, a leading provider of aseptically prefilled drug-delivery systems, operates a state-of-the-art facility at the Illinois Science and Technology Park in suburban Chicago. The site offers a central US location with a domestic and international airline hub. It is uniquely situated in a thriving biopharmaceutical region that offers an established infrastructure and prominent research institutions. The company’s Chicago site supports preclinical through phase 2 development projects. The 27,000-ft2 facility’s functional areas include microbiology and chemical analysis laboratories; materials preparation; compounding;…
The Microbial CMO: Discovering Expertise in a New Scale
Wacker Biotech GmbH is “The Microbial CMO” — the partner of choice for the contract manufacturing of therapeutic proteins in microbial systems. The company is built on more than 20 years of experience in biopharmaceutical manufacturing. Founded in 1999 as a spin-off from the Hans- Knöll Institute in Jena, Wacker Biotech is a 100% subsidiary of Wacker Chemie AG since 2005. Wacker’s integrated service portfolio covers molecular biology, process and analytical development, and the GMP manufacturing of biologics for clinical…