Newsletter | November 28, 2022

11.28.22 -- Is Outsourcing Drug Development A Short-Term Solution Or A Long-Term Strategy?

Components Of An Effective Disinfectant Prequalification Strategy

It is incumbent upon pharmaceutical product manufacturers to ensure microbial control in the production environment through environmental monitoring, microbial identification and trending, and the use of proven and continually updated cleaning/disinfectant protocols. These steps must be taken to ensure compliance with applicable regulatory requirements 1-8 intended to ensure the quality of drugs and medical devices and thus patient safety.

Qualified Reference Standards: Setting The Standard For Product Quality

Drug producers face increasing stringency from regulatory authorities to substantiate the purity of drug products and to demonstrate control of impurities. Qualified reference standards play a critical role in providing validated benchmarks to satisfy regulatory requirements pertaining to purity.

Outsourced Drug Development: Short-Term Solution Or Long-Term Strategy?

Through strategic partnerships and outsourcing strategies, pharmaceutical and biotech companies are enabling acceleration through collaboration. As we look forward to the future of drug development, a panel comprising industry consultants and early development experts discussed examining new short- and long-term CDMO and supply chain strategies.

Embrace A 360-Degree Approach To Biopharmaceutical Testing Services

A 360-degree approach entails full CMC development and analytical release testing in support of biopharmaceutical products in development and in clinical trials — all from one partner. Outsourced testing also ensures biopharma clients can change manufacturing partners between early development and commercial production while having their analytics needs reliably fulfilled in one place.

Peptide Crystallization

Cambrex’s understanding of crystal formation and thermodynamics allows us to develop custom, scalable crystallization processes for peptides. We leverage the right tools with the best experts to bridge success from the bench to the plant.

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