API Synthesis and Manufacturing, Large Molecule

Polyplus-transfection Expands GMP Portfolio for Gene and Cell Therapy Manufacturing

January 06, 2020

Pharmaceutical Technology's In the Lab eNewsletter

The new GMP conditioning product offering is designed to support clinical phase and commercialization stages of cell and gene therapy production.

Seeking Solutions for Large-Scale GMP Viral Vector Manufacturing

September 02, 2019

Innovation in manufacturing technologies must occur to ensure the availability of gene therapies and cell therapies.

Designing Phase-Appropriate CMC Analytical Programs

August 01, 2019

A one-size-fits-all strategy is not the best approach for the development of a chemistry, manufacturing, and controls program.

Mind the Gap: Tech Transfer from Early Stage Cell Culture to Phase I Clinical Manufacture

February 01, 2019

Tech transfer is key to succession advancing biopharmaceutical pipeline products from research to preclinical.

Almac Group Implements Continuous Flow Expertise at Global HQ

January 17, 2019

Almac Sciences has announced the expansion of its technology capabilities within its API services and chemical development portfolio through implementation of continuous flow expertise.

FDA Marks Record Year for New Drug Approvals

January 02, 2019

Orphan and cancer drugs continue to lead, but treatments for many common diseases were also approved in 2018.

Fighting Bacterial Resistance with Biologics

December 02, 2018

Antibody-based drugs offer new mechanisms of action and greater specificity.

ADC Bio Secures Additional Equity Round Investment

November 26, 2018

ADC Biotechnology will invest downstream formulation, fill/finish capabilities, and Lock-Release conjugation technology.

Efficiency Demands Drive Advances in API Labs

October 02, 2018

Integration of new modeling and analytical tools with flow chemistry are notable trends.

EU and Japan Strengthen Collaboration on GMP Inspection

July 18, 2018

Both parties have agreed to recognize each other’s inspection of manufacturing sites for a broader range of medicines, including sterile products, APIs, biologics, and vaccines.