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

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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

View All Upcoming Webinars

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

View All Past Webinars

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