Process development is the exercise of creating new and improved manufacturing methods, optimizing them in terms of time and financial efficiency while maintaining regulatory compliance and product ...

Regulatory pressure from GxP, 21 CFR Part 11, and AI/ML guidance elevates requirements for audit trails, data lineage, validation, and life cycle controls that hybrid architectures can operationalize.

Designing an efficient platform is crucial for any industrial process. This design process is known as process development, and it has become increasingly important in the pharmaceutical industry at ...

Crystallization plays a pivotal role in the manufacturing of pharmaceuticals. This Comment briefly reflects on past achievements and emerging opportunities in industrial crystallization, particularly ...

Proven bacterial, viral, conjugate, and E.coli expression platforms support partners from discovery and process development to GMP readiness and clinical manufacturing ...

The University of Hong Kong (HKU) and Grand Pharmaceutical Group Limited (Grand Pharmaceutical) have officially signed a research collaboration agreement, marking a significant step toward integrating ...

A pharmaceutical quality crisis involving nitrosamine contamination began in 2018 with the discovery of ...

Ten years after the launch of the Precision Medicine Initiative, its broader impact remains uncertain beyond select genetic and oncological cases. Here, we share our perspective as pharmaceutical ...

BOCA RATON, Fla.--(BUSINESS WIRE)--LGM Pharma today announced that it has acquired the formulation development and drug product contract manufacturing business of Nexgen Pharma, Inc. The combination ...

SANTA CLARA, Calif.--(BUSINESS WIRE)--Fortanix® Inc., a leader in data-first cybersecurity and pioneer of Confidential Computing, today announced that Xeureka Inc., a subsidiary of Mitsui & Co.

Process Development Scientists (process chemists) research and develop ways to manufacture products and monitor existing processes and products for quality and efficiency. A process development ...