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 ...

A new mini review argues that Quality by Design and Analytical Quality by Design could serve as a Pandemic-Ready Development ...

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 ...

The pharmaceutical industry is facing substantial criticism from many directions, including financial barriers to access to drugs in both developed and developing countries, high profits, spending on ...

Future-ready pharma manufacturing requires flexible capacity, digital innovation, strong quality systems, integrated value ...

A new Journal of Pharmaceutical Investigation special issue curated by three Korean guest editors will highlight ...

Scientific advancement and increasingly complex pharmaceutical products have reshaped the healthcare industry, providing novel tools and solutions for managing broad conditions, from acute viral ...

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 ...

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 ...

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.

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.