APIs and Excipients

Appropriate Process Design Critical for Commercial Manufacture of Highly Potent APIs

April 02, 2014

Increasing potency and growing interest in antibody-drug conjugates are creating challenges for manufacturers of HPAPIs.

Synthetic Biology: The Next Frontier in Chiral Chemistry for API Synthesis

March 02, 2014

The commercial availability of an increasing diversity of enzymes has led to the growing use of biocatalysts for API synthesis.

Demand Increases for Novel Excipients, but Manufacturers Still Face Challenges

February 28, 2014

PTSM: Pharmaceutical Technology Sourcing and Management

Drug formulators are looking for new excipients to address solubility and bioavailability issues and extend patent protection, but there are hurdles to using novel, specialized ingredients.

Advances in UPLC Techniques and Column Chemistry Aid the Confirmation of Biosimilarity

February 02, 2014

Automated sample handling, advanced glycan analysis, and specially designed columns are help speed up confirmation of the biosimilarity.

Securing the Global API Supply Chain

February 02, 2014

Recent regulatory initiatives designed to secure the global pharmaceutical supply chain will directly impact the global supply chain and API manufacturers.

A Look Ahead for Custom Manufacturing and Pharma

January 02, 2014

Emerging markets are an engine for growth in the custom-manufacturing and pharma markets.

CMC Biologics and OncoSynergy Form Pact

December 19, 2013

CMC Biologics and OnoSynergy form an agreement from cell-line development.

Lonza, BioWa Sign Licensing Agreement

December 12, 2013

BioWa and Lonza have entered into a licensing agreement with MedImmune for cell line technology.

Deficiencies Found in API Inspections

December 02, 2013

PIC/S reviews deficiencies found during inspections of API manufacturing facilities, harmonizes GMP standards, and provides training for inspectors worldwide.

Tracking Innovation in New Molecular Entities of 2013

December 02, 2013

A review of this year's crop of the new molecular entities and new biologics license applications approved by FDA thus far in 2013.