Search results for " approval"
Article
Best Practices in Qualification of Single-Use Systems
…mblies as available, or if not, generate suitable drawings, which will then be subjected to internal approval within the end-user company. There are many factors to be evaluated, including technical …
Article
Robust Optimization, Simulation, and Effective Design Space
Movement out of the design space is considered to be a change and would normally initiate a regulatory post approval change process. Design space is proposed by the applicant and is subject to regulat…
Article
Biomanufacturing Outsourcing Globalization Continues
These CMOs continue to face domestic regulatory and legal hurdles, and are far from obtaining approvals for US and EU markets. Perceived cost-effectiveness offered by CMOs in these markets may be erod…
Article
Ensuring the Quality of Biologicals
May 02, 2015
By Stephen Wicks, PhD
Pharmaceutical Technology
Volume 39, Issue 5
The European Pharmacopoeia (Ph. Eur.), which celebrated its 50th anniversary in 2014, provides common …
Article
Modular Manufacturing Platforms for Biologics
As a result, biosimilar approvals may influence facility design needs, and these facilities may crop up in new areas. “Biosimilar production site [managers] look for a high degree of flexibility and o…
Article
Technologies and Practices Must Evolve to Meet Demand
3, 2014, nearly 30% of FDA’s new drug approvals for 2014 were for biologic-based therapies, up from 7% in 2013 (1). As the percentage of large-molecule drugs grows, bioprocessing capabilities must kee…
Article
Biopharma Manufacturers Respond to Ebola Crisis
GlaxoSmithKline’s (GSK) Okairos unit (Basel, Switzerland) recently obtained FDA approval for Phase I testing of a vaccine developed in collaboration with NIAID’s Vaccine Research Center and has launch…
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Challenges in Analytical Method Development and Validation
Experts give insight on method transfer, QbD, and regulations for analytical method development and validation for biopharmaceuticals.
The manufacture of biopharmaceuticals presents …
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Novel Vaccine Technologies Meet the Need for Pandemic and Therapeutic Solutions
The company received FDA approval for Flucelvax, the first cell-culture vaccine in the US designed to protect against seasonal influenza in individuals 18 years of age and older, in November 2012 and …
Article
The Affordable Care Act's Impact on Innovation in Biopharma
Similarly, while randomized controlled trials (RCTs) are still essential for regulatory approval and market entry, payers and healthcare administrators are becoming more focused on measuring outcomes …