Newsletter | March 1, 2023

03.01.23 -- 6 Risk-Mitigating Solutions For Your Biologic's Development

Early Product Characterization Mitigates Risks In Biologics Development

In today's complex world of biologics, drug developers are investing in advanced analytics much earlier in the development process. Learn why the relationship between physicochemical profile and biological activity — and how this relationship affects clinical performance — is key to informed decisions, accelerated development, and risk reduction.

Meeting Stability Testing Expectations In Today's Complex Pharma Landscape

The biopharma industry is constantly advancing and innovating. Stability testing is one area that may be considered a victim of the status quo. What was once a check-the-box procedure in standard stability testing now requires a deeper understanding of the molecule, its behavior, and what effect it has on the patient.

Mitigate Cross-Contamination Risk In The Expansion Process

In response to the increasing biologics manufacturing industry shift into single-use closed system processing technologies, as well as increasing regulatory requirements to de-risk processes, one of our facilities is moving routine expansion of suspension cells into a closed process format. Learn about our transition and its comparison to traditional processing.

The ICH Q5A Revision And Implementing The Next Generation Of QC Testing

Global regulatory guidance requires drug manufacturers to implement measures to prevent, remove, and detect contaminants to ensure patient safety. A revision to the ICH Q5A guideline was needed due to the emergence of new technologies. Explore regulatory expectations for incorporating alternative methods with a focus on comparability and strategies.

Storing Your Banks With Ease And Confidence

Discover a biorepository that will fulfill your need of long-term and short-term storage. You can never be too careful with your cell or virus banks. From a regulatory standpoint, using split-site storage is highly recommended. Explore three global sites that will ensure your bank will remain safe.

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Comprehensive Testing Services To Support Your Biologics Development Journey

Choosing the right partner for your analytical and biosafety testing is critical in the race to approval. We offer best-in-class, risk-mitigating solutions with technical and regulatory expertise to help you bring life-changing drugs to market. Our testing and manufacturing services span the product cycle from early preclinical development to licensed production. Partner with us to meet your needs for biosafety testing, analytical development, and biomanufacturing services.