Optimised development and manufacturing processes that accelerate biologic production timelines while keeping costs down are critical to meeting the market demand. Streamlining drug product (DP) manufacture helps shorten timelines for biologic production, but it requires expertise and experience.
As a result, an estimated 26% of biotech companies outsource activities to contract development and manufacturing organisations (CDMOs),1 forming a trusted partnership model for the production of biologics.2 Working with a biologics-focused CDMO partner gives companies access to specialist facilities and expertise, with the capacity to streamline and accelerate production timelines.
In this article, Jinhyeok Jeong and John Thomas, Senior Directors of DP Inspection & Packaging and DP MSAT, respectively, at Samsung Biologics, explore the major areas of DP manufacturing that can accelerate timelines along with the necessary qualities that should be sought after in a specialist service-providing partner.
Overcoming Challenges to Market
Developing a drug product is complex and comes with scientific, technical, and regulatory challenges potentially hindering progress to market. Companies are increasingly outsourcing activities to CDMOs to overcome development and manufacturing barriers. These barriers include scaling up biologic production while maintaining quality and the need for specialised equipment and expertise in drug product fill/ finish to ensure clinical studies are supplied with product on time, the PPQ batches effectively challenge critical process parameters, leading to commercialisation and continuous monitoring of commercial batches. Specialised CDMOs offer the proficiency and knowledge to overcome these obstacles, helping to streamline production processes. The capability of CDMOs to streamline workflows reduces production costs while increasing efficiency and capacity to help organisations gain a competitive market advantage.