Development

Cynthia A. Challener is a contributing editor to Pharmaceutical Technology.

Articles

Customers are looking to reduce risk, increase performance, and optimize productivity.

Risk Reduction Top Driver for Biopharmaceutical Raw Material Development

Hovione announced that its API plant in Cork, Ireland has successfully passed a pre-approval inspection by FDA.

Hovione's API Facility in Cork, Ireland Passes FDA Inspection

Frank Milek is a member of the Good Distribution Practice (GDP) Committee of the International Pharmaceutical Excipients Council of Europe (IPECâEurope) and also works at Aug. Hedinger, tel. +49 711 402050.

IPEC Europe continues to promote the quality, safety and functionality of excipients used in pharmaceutical products.

Supply-Chain Security of Pharmaceutical Starting Materials

The EXCiPACT Certification Scheme ensures patient safety through supplier quality while minimising the audit burden and overall costs for assessing the excipient supply chain.

How Excipient Supplier Certification Helps Pharmaceutical Supply Chain in Europe

Trifarma cited for significant deviations in data collection and security, and employee training.

FDA Issues Warning Letter to Italian API Manufacturer

The pharma industry is moving toward commercial-scale continuous processes for small-molecule API manufacturing.

The Mainstreaming of Continuous Flow API Synthesis

Transition metal-containing catalysts are widely used in organic synthesis, but many are based on expensive, rare metals. Researchers are seeking more sustainable alternatives.

Seeking Alternative Catalyst Solutions

Appropriate process design and engineering are critical for the production of small-molecule and biologic HPAPIs.

HPAPIs: Fast-growing Segment Presents Challenges and Opportunities

The Bulk Pharmaceuticals Task Force asks FDA to respond to concerns about reduction in API facility compliance inspections.

BPTF Warns FDA on Reduced API Manufacturer Inspections

Aleksander Swietlow is principal scientist at Amgen.

Michael Verlander is technical advisor at PolyPeptide Group.

Brian Gregg is chief operating officer at Bachem Americas.

Harold Rode is a consultant at Rode Biologics Consulting.

Ivo Eggen is section lead global technical operations API chemistry at Aspen Pharma.

Anita Y. Szajek, PhD, is a senior scientist at the US Pharmacopeia, 12601 Twinbrook Parkway, Rockville, MD 20852-1790, tel. 301.816.8325.

USP's Therapeutic Peptides Expert Panel discusses manufacturing processes and impurity control for synthetic peptide APIs.

Ingredients