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

Jill Wechsler is Pharmaceutical Technology's Washington Editor, jillwechsler7@gmail.com.

Articles

FDA works with industry on strategies for assuring high-quality regenerative medicines.

Manufacturing Standards Key to Advancing Cellular and Gene Therapies

Joseph F. Pekny is cofounder of Advanced Process Combinatorics, Inc. and professor of Chemical Engineering at Purdue University. 

Spencer Miller is Senior Engineer at Advanced Process Combinatorics, West Lafayette, IN, www.combination.com

Stephen Hunt is director of Process Engineering at KBI BioPharma, shunt@kbibiopharma.com

John Robinson was previously Principal Engineer at KBI Biopharma

Laurence T. Baxter is vice-president of R&D, both at Advanced Process Combinatorics, West Lafayette, IN, www.combination.com

Bob Todd is vice-president of Process Development at KBI BioPharma

Modeling tools help process engineers optimize a biopharmaceutical facility’s capacity.

Using Simulation to Address Capacity Limitations

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

Drug repurposing, repositioning, and rescue can be faster, cheaper, and target more diseases than traditional drug discovery approaches.

Expediting the Discovery and Development of Drugs

Natalia Belikova, PhD, is analytical services director at SGS Life Sciences, Lincolnshire, IL.

Hildegard Bruemmer, PhD, is operational laboratory manager at SGS Life Sciences, Germany. 

Forced degradation studies can identify stability problems for drug substance and drug products.

Stepping Up the Pace of Drug Stability Studies

Ronald A. Rader is senior director, Technical Research, at BioPlan Associates.

Eric Langer has over 25 years experience in biotechnology and life sciences strategic marketing management, market research, and publishing. He has held senior management and marketing positions at biopharmaceutical supply companies. He has published and authored many books and reports on topics in Biotechnology, Large-scale BioManufacturing, and bioscience commercialization and communication. He teaches at Johns Hopkins University marketing management, biotech marketing, services marketing, and marketing in a regulated environment. In 1989 he co-founded BioPlan Associates, Inc. to provide market analysis, and strategy to biotech and healthcare organizations.

Innovation speeds discovery, drives down costs, and improves productivity.

Top Trends in Biopharmaceutical Manufacturing, 2017

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.

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).


Analytics

Biologics Quality Control: The Growing Need for Accessible Proteomics

Emerging Therapies Drive Analytical Advancements

Analyzing Exabytes