BioPharm International September 2018

September 2018 | Volume 31, Issue 9
BioPharm International September 2018 Issue
Cover Story
Automation can improve many aspects of bioprocessing, but several hurdles must be overcome before the full range of benefits can be realized.
Features
Andrew Bulpin, head of Process Solutions, MilliporeSigma, shares insights on characterizing CQAs in biopharmaceutical development and the different tests that should be carried out when assessing an investigational drug.
The development and optimization of an efficient conjugation process involves identifying the critical quality attributes and monitoring critical process parameters.
Although there are some similarities between the way that US and European authorities uphold antibody patents, there are also some important differences.
Trace elements in raw materials may impact the quality and safety of the finished biologic product, according to industry experts.
Viral vaccines and viral vectors used in biotherapeutic applications carry the risk of microbial contamination, which must be addressed.
The US Pharmacopeial Convention (USP) is developing a new chapter for rapid sterility testing of short-life products based on the recommendations of a panel of experts and stakeholders.
Peer-Reviewed Research
This study was successful in establishing a reliable and effective method for evaluating cleaning processes based on risk.
Perspectives on Outsourcing
By BioPharm International Editors
Partnerships, mergers, and new services indicate that biologics are continuing to influence CMOs’ and CDMOs’ decisions to expand their biopharmaceutical services.
Regulatory Beat
More consistent and reliable production processes are critical for advancing innovative treatments.
From the Editor
Sharing of bioprocessing know-how can help resolve pressing industry problems.
Ask the Expert
Detailed process descriptions and robust documentation aid in compliance as well as training, says Siegfried Schmitt, principal consultant at PAREXEL.
Product Spotlight
By BioPharm International Editors
The SciLog SciPure FD System from Parker Bioscience is an automated single-use system for the filtration and dispensing of products into either bottles or bags.
By BioPharm International Editors
Watson-Marlow Fluid Technology Group added a new actuator suitable for applications where reduced weight is a concern.
native1_300x100
lorem ipsum