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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