Drug Development

Adeline Siew is editor for Pharmaceutical Technology Europe. She is also science editor for Pharmaceutical Technology.

Articles

Immobilizing the antibodies on a solid-phase support, such as a resin, and carrying out the conjugation of the payload-linker while the antibodies are bound to that support will prevent aggregation at its source.

Tackling Aggregation Challenges in ADC Production

Amina Faham is global associate director at The Dow Chemical Company.

True Rogers is R&D Technologies leader at The Dow Chemical Company.

Kathryn Hewlett is an Application Development & Innovation scientist at The Dow Chemical Company.

Commonly referred to as the future of advanced pharmaceutical manufacturing, continuous manufacturing has gained major traction in the past 10 years to enable significant improvements in efficiency, safety, cost, and speed to market.

Paving the Way for Modernized Drug-Product Manufacturing Through Excipients

Ralph D. Lindblad, ASQ CQA, is product quality manager, Catalent Pharma Solutions.

David B. Klug is vice-chair of user relations at IPEC-Americas.

Douglas G. Muse is consultant—Compendial Affairs, Eli Lilly & Co.

Phyllis Walsh is associate director of Merck and Company, Inc.

Katherine L. Ulman is president of KLU Consulting.

Priscilla Zawislak is global regulatory affairs advocacy manager, DuPont Nutrition & Biosciences

Increasingly stringent audit requirements will make third-party accredited GMP audits critical for pharmaceutical excipients and raw materials.

Third-Party Audits: Ensuring That Excipients Meet cGMP Requirements

The company installed a ZSE-3D twin screw extrusion system at its Somerville, NJ process laboratory.

Leistritz Expands NJ Laboratory

Drug product approval from FDA follows previous approvals from European and Japanese authorities.

FDA Approves Drug Product Manufacturing for Samsung BioLogics

The new drug, Onpattro (patisiran), by Alnylam Pharmaceuticals, is in a new class of drugs called small interfering ribonucleic acid (siRNA) treatment.

FDA Approves First-of-its-Kind RNA Therapy

The companies will collaborate on the discovery, development, and commercialization of cell therapies for cancer.

Regeneron, bluebird bio Partner on Cell Therapy Development

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

Low-temperature chemistry enables performance of more challenging and selective chemistry.

Increasing API Complexity Drives Demand for Cryogenic Capabilities

Development costs and time to market continue to put pressure on the biopharma industry, driving the need for innovation in methods and technologies.

The Challenge of Building Better Biologic Drugs

Jeff Pavlovich is senior process safety engineer at Cambrex.

Determining how much containment is needed for API handling requires evaluation of multiple factors.

APIs and Excipients