Accelerating Biopharmaceutical Virtual FATs in a Pandemic
Heightened awareness, due to the pandemic, of the need for domestic manufacturing capacity has rejuvenated the biopharmaceutical manufacturing industry and resulted in new commissioning projects. However, cross-country/continental travel restrictions and social distancing–based work protocols during the first two years of the pandemic necessitated adopting unique commissioning approaches. Developing standardized factory acceptance test (FAT) execution approaches fit for the current times can allow for consistency across equipment vendors and their biopharmaceutical clients. This article describes pragmatic best practices that would support the momentum for new domestic manufacturing facilities.
How Regulatory Oversight Protects CBD Consumers
March 6th 2025Many consumers trust that a Certificate of Analysis (COA) guarantees product safety, but without strict regulatory oversight, that’s not always the case. This white paper provides insights into what consumers and businesses should look for in a truly safe, high-quality, and consistent product.
Advanced LC-MS Technology for Enhanced HCP Detection in Complex Biotherapeutics
February 26th 2025The identification, characterization, and quantitation of host cell protein (HCP) impurities are a critical challenge in the biopharmaceutical industry. Advanced LC-MS techniques can be integrated into manufacturing workflows to mitigate risks and ensure higher product quality and improved patient safety.
