Drug Development

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

Articles

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

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

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

Securing the Global API Supply Chain

Patricia Van Arnum was executive editor of Pharmaceutical Technology.

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

A Look Ahead for Custom Manufacturing and Pharma

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

CMC Biologics and OncoSynergy Form Pact

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

Lonza, BioWa Sign Licensing Agreement

Carmelo Rosa is chair of the PIC/S API Expert Circle and director, Division of International Drug Quality, US FDA.

Paula R. Katz, acting branch chief for Regulatory Policy and Collaboration, US FDA, CDER/Office of Compliance/Office of Manufacturing and Product Quality.

Alicia Mozzachio, branch chief, Division of International Drug Quality, US FDA, CDER/Office of Compliance/Office of Manufacturing and Product Quality.

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

Deficiencies Found in API Inspections

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

Tracking Innovation in New Molecular Entities of 2013

Merck Millipore has introduced a new solubility/bioavailability enhancement excipient, Parteck SLC, which has a unique pore structure that enables higher loading of amorphous APIs, thereby, improving dissolution rates and increasing drug solubility.

Merck Millipore Introduces New Excipient for Solubility/Bioavailability Enhancement

Fine-chemical companies, contract manufacturers, and researchers advance chemocatalysis and biocatalysis.

Applying Catalysis to Optimize API Synthesis

Eric Langer has over 25 years experience in biotechnology and life sciences strategic marketing management, market research, and publishing. He has held senior management and marketing positions at biopharmaceutical supply companies. He has published and authored many books and reports on topics in Biotechnology, Large-scale BioManufacturing, and bioscience commercialization and communication. He teaches at Johns Hopkins University marketing management, biotech marketing, services marketing, and marketing in a regulated environment. In 1989 he co-founded BioPlan Associates, Inc. to provide market analysis, and strategy to biotech and healthcare organizations.

Data from BioPlan Associates’ 10th Annual Report and Survey of Biopharmaceutical Manufacturing Capacity and Production suggest that the interest in disposable devices has begun to extend to biopharma operations beyond basic single-use bags and connectors.

APIs and Excipients