Dosage Forms

Articles

The project involves installation of a small-scale pressured agitated nutsche filter dryer in glass, integrated in a high-containment isolator to achieve an occupational exposure limit of less than 1 microgram per meter cube, 8-hour time weighted average.

Powder Systems Limited Installs High-Containment Filter Dryer in Australian API Manufacturing Plant

Hovione expands drug substance and HPAPI capacity in East Windsor, New Jersey.

Hovione Breaks Ground on API Facility in New Jersey

Combining powder micro-dosing services with the Xcelodose technology, Capsugel offers capabilities in both North America and Europe.

Capsugel Expands Micro-Dosing Services

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

The production of antibody-drug conjugates requires biopharmaceutical and chemical manufacturing, and conjugation capabilities.

ADCs Challenge Manufacturers’ Skill Sets

Safe handling of HPAPIs requires determining exposure potential and selecting appro-priate containment strategies.

Choosing Containment Strategies For Highly Potent APIs

Highly potent or cytotoxic drugs require special handling

Best Practice: Developing Drugs that are Highly Potent

Manufacturing highly toxic compounds in a biopharmaceutical environment tests equipment and systems.

Conjugation Chemistry with Highly Potent Compounds

Collaboration will provide for unified development and manufacture of antibody drug conjugates.

CMC Biologics and IDT Biologika Collaborate on ADC Manufacturing

The author lists five key areas to consider when selecting a CDMO to develop highly potent formulations.

Outsourcing Formulation Development for High-Potency Compounds

Richard Denk is Head Sales Containment at SKAN AG, www.skan.ch, Richard.Denk@skan.ch.

Manufacturing of antibody drug conjugates requires high-containment solutions, such as high-performance aseptic isolators.

Highly Potent Drugs