Analytics

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

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

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

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.


Drug Substance Analysis