Manufacturing Biologics: Challenging & Expensive

Suresh Choudhary, Associate Scientist II of Formulation Sciences at MedImmune will be joining the speaking faculty at the upcoming Bioprocess Internation Conference & Exposition this October in Boston, MA. Suresh was kind enough to sit down with the KNect365 Bioprocessing team to discuss the challenges associated with manufacturing biologics and other current trends he sees as important in the industry.

He began by addressing the topic holistically and said, “Manufacturing biologics is very challenging and expensive.” but continued on to note that the driving force behind all of this is getting to market as quickly as possible.

Here are the remainder of his comments regarding manufacturing biologics, “To achieve that goal the industry is moving toward use of disposable technologies which can help accelerate manufacturing timeline, minimize capital expenditure and prevent cross contamination. The disposable systems do have challenges which need to be addressed to expand their use. Some of the challenges are lack of harmonized regulatory expectations on extractable & leachable, appropriate container closure integrity verification methods and supply chain controls.”

The challenges associated with manufacturing biologics was not the only thing that Suresh addressed while chatting with us, he also made note of key industry trends. One trend that he felt to be extremely relevant was “the need to reduce the number of dose and dosing frequency which require high concentration formulations.”

He dug into this by saying, “Manufacturing of high concentration formulation poses unique challenges such as filtration pressures, product drying in filling system and need of high force required for delivery of such products. In order to increase patient compliance the industry is also moving toward use of novel delivery devices with the need to add connectivity for better data management and control. These novel delivery devices tend to involve several parts which makes manufacturing/assembly process very complex with the need of significant capital expenditure.”

To hear more from Suresh Choudhary, join him at the upcoming Bioprocess International Conference & Exposition, taking place October 4-7 in Boston, MA. Click here for more information.

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