There is a great need for sensitive, precise, and easily accessible analytical detection techniques for protein sequencing.

Biologics Quality Control: The Growing Need for Accessible Proteomics

The emergence of mRNA vaccines and cell and gene therapies has pushed innovation in analytical methods.

Emerging Therapies Drive Analytical Advancements

Effective analytics will eliminate failures, deviations, and non-conformances.

 Analyzing Exabytes

Topic

Ad Gerich is managing director, InProcess-LSP, The Netherlands

Michiel Damen is application specialist, InProcess-LSP, The Netherlands.

Willy Verhoeven is senior scientist, Polymeric Dosage Forms, MSD Oss, The Netherlands.

Sai Prasanth Chamarthy is associate director, Respiratory Product Development, Merck & Co, Rahway, NJ USA.

Rut Besseling is director, Science and Technology, InProcess-LSP, The Netherlands.

Articles

This study shows that the presence of API lumps can be detected by inline NIR, and elaborates on why NIR sensor dimensions and actual measured sample volume by the NIR sensor are important variables for adequate interpretation of obtained results.

Detection of Lumps in Powder Blends by Inline NIR

Graham A. McGibbon is director of Strategic Partnerships at ACD/Labs, media@acdlabs.com

Sanjivanjit K. Bhal is director of Marketing and Communications, all at ACD/Labs, media@acdlabs.com

Andrew Anderson is vice-president of Innovation and Informatics Strategy at ACD/Labs, media@acdlabs.com

Informatics software can be used to address the challenges of quality by design, such as managing impurity data when developing an impurity control strategy.

Applying QbD in Process Development

FDA approves Novartis’ CAR-T therapy, marking the first time a cell therapy based on gene transfer has been approved in the United States for any indication.

FDA Approves Novartis’ CAR-T Drug, First Gene Therapy Approval in US

Gilead will gain a robust pipeline of cell therapy products, with one lead candidate, a CAR T therapy, anticipated to gain FDA approval in the fourth quarter.

Gilead to Buy Kite Pharma for $11.9 Billion

AstraZeneca and Takeda will partner to develop and commercialize MEDI1341, an alpha-synuclein antibody currently in development as a potential treatment for Parkinson’s disease (PD).


AstraZeneca and Takeda to Partner for PD Treatment

Steris added the Amsco 430LS and 630LS sterilizers to its line of medium steam sterilizers.

Steam Sterilizers for Laboratory Applications

FDA grants priority review for emicizumab, an investigational bispecific monoclonal antibody, for treating hemophilia A with factor VIII inhibitors.

Genentech Gets Priority Review for Hemophilia A Biologic

With £4.5 million (US$5.8 million) in funding, the consortium is tasked with developing a new automated continuous biologics purification unit to make biologic drug manufacturing more efficient.

CPI Joins Consortium for Automated Continuous Biologics Purification

The first program of this collaboration will focus on the development of a candidate for severe acute pancreatitis. 

Samsung Bioepis Partners with Takeda to Develop Novel Biologics

FDA approves new molecular entity developed by Pfizer for treating a rare form of leukemia in adults.


Analytics

Biologics Quality Control: The Growing Need for Accessible Proteomics

Emerging Therapies Drive Analytical Advancements

Analyzing Exabytes