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 ...

Until the late 1990s, quality assurance in the pharmaceutical industry largely depended on the traditional strategy of manufacturing the product, then testing a sample of the finished batch against a ...

While the pharmaceutical industry and its stakeholders constantly develop and advance new drugs, products, and treatments, the drug development life cycle always needs new discoveries and additions in ...

The biopharmaceutical industry is facing unprecedented challenges to its fundamental business model and currently cannot sustain sufficient innovation to replace its products and revenues lost due to ...

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.

Batch remains advantageous for development, variable demand, and bounded risk, benefiting from natural hold points, simpler investigations, and lower upfront capital, despite longer lead times and ...

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.

Formulation scientists are behind the conversion of active pharmaceutical ingredients (API) into stable, bioavailable, and commercially viable dosage forms, rarely a simple process. Image Credit: ...

Particle size analysis (Figure 1) is the preferred method for characterizing raw materials used in pharmaceuticals, setting specifications for incoming raw material in order to determine appropriate ...