Search results for " biopharmaceutical"
Article
Challenges and Trends in Biopharma Facility Design
26-30
Facility design is an important aspect of biopharmaceutical manufacturing. “Global deployment, cost pressure, time to market, and change/uncertainty” are some of the factors biopharma comp…
Article
Challenges in Analytical Method Development and Validation
The manufacture of biopharmaceuticals presents some unique challenges when ensuring product quality and patient safety. Analytical testing can provide the data needed to produce a safe and effective d…
Article
The Outlook for CMO Outsourcing in 2019
Rader
Biopharmaceutical industry-related indicators and trends are supporting continued incremental increases in outsourcing of pre- and commercial API and biopharmaceutical product ma…
Article
Driving Improved Access to Biosimilars
Although approved, these drugs are not “interchangeable” with name-brand biopharmaceuticals, as that term has been defined in the US. Unlike small-molecule generics, biosimilars cannot automatically b…
Article
Maximum Output Starts with Optimized Upstream Processing
Equipment suppliers, contract manufacturers, and biopharmaceutical companies are implementing new bioprocessing solutions and manufacturing strategies to increase efficiency and productivity, forging …
Article
Getting a Handle on Biopharma’s Most Critical Quality Attributes and Quality Control
…ng to apply quality-by-design (QbD) methods and process analytical technology (PAT) underpinnings to biopharmaceutical development and manufacturing. As Jose Menezes, CEO of 4Tune Engineering, pointe…
Article
Applying GMPs to the BioPharma Supply Chain
Manufacturing biopharmaceuticals carries great responsibility. The drugs produced must be available when needed, effective for their intended purpose, and safe to use. At an operational level, it is v…
Article
Biopharma Takes a Nervous Glance Over Its Shoulder
The US biopharmaceutical industry’s status as the global leader in innovative biopharmaceutical R&D is not guaranteed. Both R&D and manufacturing could shrink or shift to other countries if the busine…
Article
Understanding Validation and Technical Transfer, Part I
Subsequent revisions to US and international regulations and guidance documents stressed the need for process validation and quality management systems to ensure pharmaceuticals and biopharmaceuticals…
Article
Advanced Technologies Facilitate Scale-up and Technology Transfer
Challener
BioPharm International
Volume 28, Issue 6, pg 20-23
It is hard to believe, but the biopharmaceutical industry is already old enough to have aging facilities that are decades ol…