Manufacturing

Articles

The guidance is intended to build on the existing International Council for Harmonisation (ICH) quality guidance.

Guidance on Q13 Continuous Manufacturing of Drug Substances and Drug Products

Feliza Mirasol is the science editor for 

Learning from early market failures, the biopharma industry has worked to improve the fate of antibody drug conjugates.

Improving the Fate of ADCs

ImmunoGen has formed a research collaboration with Oxford BioTherapeutics to develop novel antibody-drug conjugates for cancers with high unmet needs.

ImmunoGen Partners with Oxford BioTherapeutics to Develop Novel ADCs

Markus Hörburger is product and service manager Secondary Packaging & Device Assembly at Vetter.

The author describes how to seize market opportunities while navigating the requirements of both drug therapies and delivery devices.

Converting Injectable Therapies to Combination Drug-Device Products

Piramal Pharma Solutions plans to construct a multipurpose ADC manufacturing and aseptic fill/finish facility in Grangemouth, Scotland, and to upgrades its existing API manufacturing facility in Morpeth, England.

Piramal Pharma Solutions Expands and Upgrades UK Manufacturing Facilities

ADC development is on a positive trajectory from a deeper understanding of therapeutic mechanisms and technological advances.

Research Advances are Improving ADC Development

Jessica Baseggio is research laboratory analysts at SG Lab Analytics, Stevanato Group.

Chiara Callegari is research laboratory analysts at SG Lab Analytics, Stevanato Group.

Enrico Barichello is SG Alba Platform product manager, Stevanato Group, 

A coating technology for a staked needle prefillable syringe reduces the potential risks associated with silicone oil as a lubricant.

Considering a Coating Technology as an Alternative to Silicone Oil

The company has expanded its high-potency API capability at its Riverview, MI, facility to serve the growing antibody drug conjugates market.

Piramal Pharma Solutions Invests $10 million to Expand HPAPI Capability

Drug makers continue to explore innovative ways to develop antibody-drug conjugates based on their unique potential to neutralize cancer cells.

Demonstrating Results with Antibody-Drug Conjugates

Cynthia A. Challener, PhD, is a contributing editor to BioPharm International.

Both empty and filled syringes must pass a range of tests to meet quality standards for biopharmaceutical drugs. 

Manufacturing, Combination Drugs