Increasing patent expirations of major drugs, the growing burden of chronic diseases, and elevated global aware­ness of vaccines are leading to a surge in outsourcing formulation development services. Industry experts say these trends put a value on the global pharmaceutical CDMO Market at $160.12 billion in 2020, and could reach $236.61 billion by 2026,1 while the North American CDMO market is expected to reach $101.1 billion by 2030.2 As more pharma/biopharma companies opt to partner with CDMOs, much of this activity is occurring in the early phase of de­velopment with the goal of overcoming risk, along with saving time and money as a drug passes through the develop­ment pipeline.

This annual Drug Development & Delivery report highlights the formulation development and manufacturing offer­ings from some of the leading CDMOs to address a myriad of challenges – from complex compounds to poor solubility to dual-release profiles.

Stelis Biosource: New Manufacturing Technology for Lyophilization & Viral Vectors

Stelis Biosource has expertise in biosimilars as well as vaccines and other biotherapeutics. The company is focused on growing its capacity, capa­bilities, and knowledge to scale up in the cell and gene therapy space. Ac­cording to Dr. Anand Khedkar, Sr. Vice President, R&D, Stelis Biosource, the company is investing in various man­ufacturing platforms for both drug substances and drug products.

“We already have microbial and mammalian platforms and are about to commission a viral vector manufac­turing platform,” he says. “We are also in the process of researching and integrating other platforms to help bring new kinds of therapeutic prod­ucts to the market. On the drug prod­uct side, we have invested in high-speed vial lines, a high viscosity prefilled syringe filling line as well as a cartridge filling line. We have cre­ated dedicated facilities for viral vac­cines, high viscosity products, monoclonal antibodies and other products. We also have the capability to manufacture lyophilized vials.”

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