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
Challener Biopharmaceutical companies and contract manufacturers respond to changing demand dynamics for upstream bioprocessing capacity. Significant growth in the development and manufa…

Article Getting a Handle on Biopharma’s Most Critical Quality Attributes and Quality Control
…g 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, pointed…

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
Biopharmaceuticals are often complex molecules, or mixtures of molecules, produced in biological systems and it is not always possible to fully characterize these products in the laboratory. Therefore…

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…

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