Biopharmaceutical companies face a broad range of challenges when developing new large-molecule products, including Potential failures in the clinic or, even worse, an inability to manufacture because of an increase in the number of complex molecules in a company’s pipeline Under- or over-manufacture of a drug substance raw material because of demand uncertainty Limited access to right-sized capacity, driven by the bioprocess industry’s shift away from large-volume stainless steel tanks toward mid-scale bioreactors A company’s inability to find a manufacturing…

The pathway from conception to regulatory approval and commercialization of a cell therapy is long, complex, and resource intensive. To help inform numerous decisions along the way, an effective commercial manufacturing strategy for a cell therapy should be built on the four principles of what PCT calls development by design (DbD): quality, cost of goods (COGs), scalability, and sustainability. Proactively implementing a DbD strategy does not force a cell therapy developer to make a large manufacturing investment early in a…

Rentschler is a full-service contract development and manufacturing organization (CDMO) and one of the leaders in the industry. Focused on the development and manufacturing of biopharmaceuticals in mammalian cell culture, we support our global clients through to market approval of their products. Delivering successful projects allows us to make an essential contribution to the global availability of biopharmaceuticals. Thanks to many years of experience, the high quality of our consulting services, and our flexibility, we can react quickly and effectively…

Richter-Helm is a Hamburg, Germany–based contract development and manufacturing company with a proven 25-year track record, specialized in products derived from bacteria and yeasts. Count on us to flexibly provide a comprehensive range of services and customized solutions. Clients worldwide already have benefited from our commitment to good manufacturing practice (GMP) and total transparency. Our work focuses on recombinant proteins, plasmid DNA, antibody fragments, and vaccines. Our seasoned, 160-strong team supports you with process development, supply of products for clinical…

Vetter is an international specialist in the production of aseptically prefilled syringe systems, cartridges, and vials. We are a family-owned, independent company and do not manufacture our own drugs. Resources for Every Stage of Growth Vetter’s full portfolio of services includes dedicated resources for both clinical development and commercial manufacturing. In addition, we provide expert packaging technologies and solutions tailored to your product’s specific market needs. Vetter Development Service Planning for Success:

Wacker Biotech is “The Microbial CMO” — the partner of choice for contract manufacturing of therapeutic proteins using microbial hosts. Our service portfolio covers molecular biology, process and analytical development, and the GMP production of biologics for clinical trials and commercial supply. Founded in 1999 as a spin-off from the Hans-Knöll Institute in Jena, we are a 100% subsidiary of Wacker Chemie AG since 2005. The sites in Jena and Halle provide a complete range of services for the development…