5 Step Strategy To Accelerate Biologics Manufacturing And Ensure Robust Scale-Up Process

“Speed to milestone” – “Speed to Market” – “Speed to Patient” is the universal rally cry and well known for all BioPharmaceutical drug developers. Companies ranging from small Biotech to large Pharma are constantly driving to shorten development time and gain faster approval for their high quality, lifesaving therapies. Biologics, such as monoclonal antibodies, fusion proteins, and antibody drug conjugations, present unique and time-consuming challenges when balanced against our collective goal to accelerate development and regulatory approvals. Biologics add an extra level of complexity, whereby factors such as cell line and analytical development, biologic instability, scale up, and limited capacity may negatively impact time to market and budget outcomes.

Biologics are defined by their manufacturing process, which requires complete understanding through formal process characterization.¹ Process characterization is an essential component of process validation and represents a critical area of importance, yet an opportunity in prompt milestone achievement. Process characterization provides an in-depth understanding of a drug product to establish effective process control strategies and it defines the critical product and process parameters for determining the proven acceptable ranges for efficient manufacturing.

Even a small change to the structure of a biologic during the manufacturing process can result in a significant impact on safety, efficacy and function. Something as simple as a deviation in pH, a temperature fluctuation, a variation in the method of thawing a vial or the switch to a different consumable supplier can affect a biopharmaceutical’s identity, purity or potency. By knowing in advance, the influence of different manufacturing events on a biologic and being able to provide supporting data to back up these occurrences through process characterization, the risk of manufacturing failures and regulatory time delays is significantly reduced.