Almost half of pharmaceutical industry profits continue to come from biopharmaceuticals.

Trends Affecting Biopharmaceutical Manufacturing

How to apply ALCOA+ to a laboratory building management system.

Data Integrity Compliance in a GLP Test Facility

Data sharing facilitates traceability and boosts quality of APIs.

Digital Supply Chain Ensures API Quality

Topic

Chris Burgess, PhD, is an analytical scientist at Burgess Analytical Consultancy Limited, ‘Rose Rae,’ The Lendings, Startforth, Barnard Castle, Co Durham, DL12 9AB, UK; Tel: +44 1833 637 446; chris@burgessconsultancy.com; www.burgessconsultancy.co

Articles

Different methods to calculate limits for impurities will give different answers. The prediction interval method may be ideal.

From PharmTech: Detecting and Determining Quantitation Limits for Impurities

The Comirnaty vaccine received a positive opinion from the EMA’s CHMP for children five to under 12 years of age. 

EMA Recommends Pfizer and BioNTech’s COVID-19 Vaccine for Children 

PathoQuest is the first French contract research organization (CRO) capable of offering GMP grade NGS-based testing services for quality control of biological drugs.

PathoQuest Achieves GMP Certification for Quality Control Testing Services

Biogen received MHRA marketing authorization for VUMERITY (diroximel fumarate) for treatment of relapsing-remitting multiple sclerosis (RRMS).

MHRA Grants Marketing Authorization for Biogen’s MS Treatment

The EC has granted marketing authorization for Gilead’s Trodelvy for the treatment of adult patients with unresectable or metastatic triple-negative breast cancer.

EC Grants Marketing Authorization to Gilead’s Trodelvy

FDA has amended its EUA for Pfizer-BioNTech’s and Moderna’s COVID-19 booster to include all individuals aged 18 or older.

FDA Authorizes COVID-19 Boosters for All Adults

Editor of Pharmaceutical Technology Europe

Jordi Serrat, Product & Technology Director, Azbil Telstar talks about the role of disruptive and digital technologies in aseptic processing.

Evolution of Aseptic Processing: INTERPHEX Keynote Part 5

Chris Spivey is the editorial director of 

Global supply chain experts examine implications of the DSCSA as well as topical considerations around the EU's FMD in this serialization video series ft. manufacturing, packaging, software, and regulatory experts.

Serialization on a Global Scale: Deep Dive into the US DSCSA and EU FMD – Regulatory | Part 4

GSK has been granted approval by the EC for its monoclonal antibody therapy, Nucala (mepolizumab), as a treatment for three additional eosinophil-driven diseases.

GSK Receives European Approval for Three Additional Indications of Nucala

AbbVie's SKYRIZI (risankizumab) has gained approval for the treatment of active psoriatic arthritis in adults, which is the therapy’s second indication in the European Union.

Quality Systems

Trends Affecting Biopharmaceutical Manufacturing

Data Integrity Compliance in a GLP Test Facility

Digital Supply Chain Ensures API Quality