Newsletter | March 12, 2025

03.12.25 -- Optimize Your High Concentration Biologic Production Process

Manufacturing Challenges With High Concentration Biologics

Growth in the formulation of drugs for subcutaneous injection highlights manufacturing challenges associated with the higher concentration of active ingredients and formulation components. Explore key process operations, some of the challenges in manufacturing high-concentration biologics, and factors to consider for process optimization.

 

Sterilizing Grade Filter Performance With Biologic Drugs

New challenges emerge in filtration processes as the development and manufacturing of biologics for subcutaneous injection expands. Here, we analyze the throughput performance of sterilizing grade filters across moderate-to-high concentrations of mAbs and immunoglobulins to demonstrate how filter selection can impact your process.

 

High-Concentration Drug Manufacturing Challenges And Opportunities

As the applications continue to grow for mAb, ADC, and recombinant protein therapeutics, producing these drugs in a format that can be administered subcutaneously offers significant advantages compared to IV infusion. Gain insight into opportunities to enhance your platform for high-concentration/subcutaneous drug production.

 

Production Of A Highly Concentrated Monoclonal Antibody

The subcutaneous (SC) delivery of mAbs offers advantages over intravenous infusion. However, to meet the required dosage within the limited volume of SC administration, formulations often must be highly concentrated. Discover how you can achieve a final mAb concentration above 200 g/L while maintaining critical quality attributes.

 

UPCOMING WEBINAR

 

 

 

With the number of monoclonal antibodies (mABs) with high-concentration formulation increasing rapidly, meeting this demand in drug manufacturing brings unique challenges: lower production volume means that every drop is precious and product recovery must be maximized, and higher drug product viscosity and the need to minimize protein aggregation can make efficient processing difficult. 

 

Join us on April 10th to discover strategies that can elevate your product recovery and streamline your production methods for the manufacture of high-concentration drugs. Register.