Search results for " emerging biotech"

Article Setting Standards for Biotech Therapeutics in India
The authors take a look at the past and future impact of the Indian Pharmacopoeia Commission. By: Anurag S. Rathore, PhD, Renu Jain, M. Kalaivani, Gunjan Narula, G. N. Singh BioPharm Inter…

Article Science Focus Fuels Successful Process Development for Startups
Converting challenges to opportunities While emerging biotechs face these numerous challenges, they also have some advantages over established pharma companies and can in some cases convert those …

Article Development and Commercialization of Biosimilars in India
The author aims to present the current status of India in this context, the challenges that need to be overcome, and some recommendations that may alleviate these challenges. By Anurag S. Rathor…

Article Quality by design for biotechnology products—part 1
A PhRMA Working Group's advice on applying QbD to biotech. By Taruna Arora, Roger Greene, Jennifer Mercer, Paul Tsang, Meg Casais, Stuart Feldman, Jutta Look, Tony Lubiniecki, Joseph Mezzatesta,…

Article The Tide Stays High
Robust venture capital investment gives CDMOs and CROs a positive outlook for 2017. By Jim Miller A year ago, the outlook for contract services was a little uncertain. Equity markets’ appeti…

Article Biomanufacturing Outsourcing Globalization Continues
May 02, 2015 By Eric S. Langer BioPharm International Volume 28, Issue 5 Biopharmaceutical manufacturing clusters continue to emerge outside of the traditional hubs of North America …

Article Biopharma Seeks Balance
Biopharma Seeks Balance Biopharma companies can balance competing demands from patients, investors, and regulators by keeping a focus on science. By Rita C. Peters …

Article Quality by design for biotechnology products—part 3
Guidance from the Quality by Design Working Group of the PhRMA Biologics and Biotechnology Leadership Committee on how to apply ICH Q8, Q8R1, Q9, and Q10 to biopharmaceuticals. By Taruna Arora, …

Article Moving PAT from Concept to Reality
The learning curve for process analytical technology has slowed widespread adoption. By Cynthia A. Challener alexlmx a- Stock.Adobe.com Process analytical technology (PAT) is…

Article Modular Manufacturing Platforms for Biologics
May 01, 2015 By Randi Hernandez BioPharm International Volume 28, Issue 5 It should come as no surprise that the good design principles governing the execution of pharmaceutical manu…

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