Does Your CDMO Have An Analytical Edge?
By Anna Małecka, Regulatory Manager; and Paulina Toboła, Analytics Development Division Manager, R&D

It is no secret that analytical technology is a critical component of biologic drug development. To best position your drug towards success, prioritize finding a CDMO partner with ample experience developing analytical panels that cover potency, purity, and microbial safety for biologics in the same class as your own. With an established platform approach to analytics, a CDMO will have the ability to start your project rapidly, leveraging previous experience to tailor their platform methods to suit the needs of your biologic.
As you begin your CDMO search, consider how a potential partner prioritizes collaboration between their critical teams and whether these key stakeholders are housed within the same facility. Experienced CDMO teams will also be able to provide guidance on how best to satisfy all relevant regulatory guidelines. By partnering with a CDMO with the knowledge and technology to support your biologic throughout its full life cycle, your drug will be positioned toward regulatory success and primed to reach patients safely and efficaciously.
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