Drug Development

Articles

The European Commission (EC) approved Pfizer’s Trazimera (trastuzumab), a biosimilar to Roche’s Herceptin, to treat certain breast and gastric cancers.

EC Approves Pfizer’s Biosimilar to Roche’s Herceptin

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

Regeneron, bluebird bio Partner on Cell Therapy Development

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

Formulation characteristics must be optimized, following device selection, to achieve the desired performance for the capsule loaded in the dry powder inhaler. 

Developing Capsules for DPIs

The companies will collaborate to bring InnoCore Pharmaceuticals’ proprietary SynBiosys biodegradable polymer platform to market.

MilliporeSigma, InnoCore to Partner on Biodegradable Drug Delivery Platform

Materials in contact with a drug must be fully characterized to ensure they do not negatively affect the safety and efficacy of the product.

E&L Risk Assessment for Biologic Drug Products

Sai V. Nudurupati is assistant director at AbbVie Inc. (North Chicago, IL)

Michael J. Kukulka is senior manager, Global Labeling, Regulatory Affairs, PRA Health Sciences (Deerfield, IL)

Takako Ono is principal scientist, Analytical Development, Pharmaceutical Sciences, Takeda Pharmaceutical Co. Ltd. (Osaka, Japan)

Haiyan Grady is associate scientific director CMCC, Takeda Development Center Americas, 300 Massachusetts Ave (4274), Cambridge, MA 02139, Tel: 1-224-554-2067, haiyan.grady@takeda.com

This article describes the approaches used during the development of a dexlansoprazole delayed-release orally disintegrating tablet (ODT) to evaluate tablet size and texture as they relate to disintegration rate and patient experience; in addition, the resistance to alcohol was also characterized. 

Evaluation of Physical Characteristics of Dexlansoprazole Orally Disintegrating Tablets

Jean-Yves Balfin, product manager at Korsch AG, speaks to Pharmaceutical Technology about the ins and outs of multilayer tableting. 

Key Considerations in Multilayer Tableting

Rita Peters is the former editorial director of 

Pharmaceutical Technology, Pharmaceutical Technology Europe

Frustrated by slow market adoption, Gottlieb maps out new plan for biosimilar competition.

FDA is Not Playing Games with Biosimilars

Increasing dwell time can improve tablet production.

The Case for Extended Dwell Flat Tooling

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

Formulation and Drug Delivery