Search results for " bioprocesses"
Article
Continued Process Verification for Biopharma Manufacturing
The authors discuss complications of implementing continued process verification and provide recommended approaches.
Oct 1, 2014
By: Jeff Fleming, Robin Payne
BioPharm International
…
Article
Challenges and Trends in Biopharma Facility Design
Experts discuss the future of modular manufacturing and the challenges that biopharma manufacturers face in facility design.
Sep 1, 2014
By: Susan Haigney
BioPharm International
Volu…
Article
Pharma Investments Reflect Key Industry Trends
Shrinking facility size, growth of biologics, and emerging market demand influence pharma investments.
Aug 2, 2014
By: Cynthia Challener, PhD
Pharmaceutical Technology
Volume 37, Iss…
Article
Relationship Building at Top of Mind for Clients
Annual study shows technical expertise is not enough.
Aug 1, 2014
By: Eric Langer
BioPharm International
Volume 27, Issue 8, pp. 12-14
Contract manufacturing organizations (CMOs) shou…
Article
Single-Use and Continuous Processing Technologies Change Facility Design
Viewing Changes in Pharmaceutical Facility Design
Single-use systems, continuous processing and isolator technology use a smaller footprint. Experts predict how the facilities of the future may …
Article
Applying GMPs to the BioPharma Supply Chain
Defining best biopharmaceutical practices is necessary to ensure the safety of the supply chain.
Manufacturing biopharmaceuticals carries great responsibility. The drugs produced must be availab…
Article
Defining Critical Quality Attributes for Monoclonal Antibody Therapeutic Products
An approach for establishing the CQAs of a mAb product by evaluating impact and uncertainty during risk assessment.
A critical quality attribute (CQA) has been defined as “a physical, chemical, …
Article
Concentrating Feed—an Applicable Approach to Improve Antibody Production
In this study, the authors evaluated different approaches to prepare highly concentrated feed media for fed-batch Chinese hamster ovary cell culture. By raising the pH or by adding surfactants, the fe…
Article
Global Expansion Shapes Drug Oversight
Regulators and industry organizations explain policies and standards to manufacturers and authorities in all regions.
Few FDA officials discuss pharmaceutical regulation these days without …
Article
Biopharma Takes a Nervous Glance Over Its Shoulder
Changes are needed to maintain US biopharma innovation leadership.
The US biopharmaceutical industry’s status as the global leader in innovative biopharmaceutical R&D is not guaranteed. Both…