Current Issue
Implementation Strategies and Challenges for Single-Use Technologies at Commercial Scale
Michelle Wong, Engineer Genentech Adam Goldstein, Principal Scientist Genentech/Roche
Single-Use Stainless Steel BioReactors: Quality Factors for Consideration When Selecting a...
Trevor Deeks, Ph.D., Principal and Consultant Deeks Pharmaceutical Consulting Services, L...
The Future of Pharmaceutical Manufacturing: Flexibility and Sustainability through Small-F...
Daniel O. Blackwood, Research Fellow Jeffrey Moriarty, Principal Scientist Pfizer
Current Technologies for Sub-Micrometer and Micrometer Particle Analysis for Biologics
Andrea Hawe, Chief Scientific Officer Coriolis Pharma Research Daniel Weinbuch, Manager ...
Continuous Chromatography Is Now Possible for Clinical Manufacturing
Marc Bisschops, PhD; Lynne Frick; and Peter Levison, PhD
Continuous processing optimization with smarter tools
Barbara Paldus, PhD, Vice President and General Manager, Finesse, a part of Thermo Fisher ...
Featured Articles
FDA’s Office of Pharmaceutical Quality Establishes the Center for Excellence in Manufacturing Science and Innovation Research
Kurt Brorson1 and Sau L. Lee2
(1) Office of Biotechnology Products, and (2) Office of Testing and Research, Office of Pharmaceutical quality, Center for Drug Evaluation and Research, US FDA. 10903 New Hampshire Ave., Silver Spring MD 20903. Views expressed in this article constitute the opinions of the authors and not necessarily FDA or US Government policy.
Challenges in the Development of Continuous Processes for Vaccines
By: Daniel C. Vellom, PhD, Senior Director, Global Technology & Innovation
Sanofi Pasteur Biologics, Inc.
Implementing global best practices and technology specifications for single-use systems
By: Jason Nisler
Bioprocessing Application Specialist, CPC – Colder Products Company
What is holding Industry back from Implementing Continuous Processing: Can Asia Adopt More Quickly?
By: Morten Munk, Senior Technology Partner
Global Business Development, NNE Pharmaplan, Gentofte, Denmark
Eric Langer, Managing Partner
BioPlan Associates, Inc. Rockville, MD USA
Headline News
SGS expands capabilities to undertake extractables and leachables testing at Shanghai lab
Takeda Announces Completion of New Manufacturing Facilities at the Oranienburg Site in Germany
Daiichi Sankyo Announces Launch of Narurapid® Tablets and Narusus® Tablets for Cancer Pain Treatment
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Upcoming Webinars
Characterisation of Host-Cell Proteins using Mass Spectrometry Enables Effective Purification Optimisation
Presented by Dr Li Zang of Biogen
31st October 2017
New Paradigm of Building Quality during Manufacture – Challenges with Biological Products
Presented by Dr Rajesh K. Gupta, Biologics Quality & Regulatory Consultants, LLC
23rd August 2017
Challenges in the Development of Continuous Processes for Vaccines
Presented by Danny Vellom of Sanofi Pasteur Biologics, Inc.
27th June 2018
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Past Webinars
Towards a lean Manufacturing: Implementing Single-Use Process Analytical Technologies (PAT) tools at the seed stage to simplify cell culture operations
Presented by Dr Jose R. Vallejos of Medimmune/AstraZeneca
24th May 2017
Accelerating the development of regenerative therapies: Large scale expansion of human mesenchymal stem cells
Presented by Jon Rowley, Ph.D. & Mark Szczypka, Ph.D.
28th March 2017
Subvisible Particle Identification & Characterisation by Multi-Technique Methods
Presented by Dr. Jonas Hoeg Thygesen, Novo Nordisk Pharmatech. Followed by Colin Merrifield, ProteinSimple
23rd February 2017
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Featured Companies
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Featured Video
Square Bioreactors - better than round!
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Technical Papers
Lipid Based SMEDDS Formulation of Ibuprofen and Phenylephrine for Softgels
Comparison of purification performance of Amsphere A3 to other commercially available Protein A resins
Platform purification of six biosimilar molecules using Amsphere A3 – protein A resin
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Featured Products
JSR Life Sciences
Purolite Life Sciences
AdvantaPure
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