By Rob Wright
Project Atlas is a 200,000 square foot biologics manufacturing facility. This facility is unique because its entire upstream line utilizes single-use systems, but what's more interesting is that the plant's $210M dollar price tag is $127.6M shy of the company's annual profit.
By Richard Mirro, Eppendorf Inc.
This application report presents a simple protocol for achieving high-density culture of Chinese hamster ovary (CHO) cells using a New Brunswick™ benchtop autoclavable stirred-tank bioreactor.
By Tom Fletcher, Scott D. Storms, and Jenny Y. Bang, Irvine Scientific
The challenge of effective cell culture process development often involves how to simultaneously meet two competing needs: the need to maximize improvement of process performance and the need to minimize time spent on process development.
By Stephen E. Szabo, Ph.D. and Sarah Monroe, B.S., Beckman Coulter, Inc.
Stem cells, due to their differentiation into mature blood cells, are the key to successful bone marrow transplantations. More recently, it has been found that umbilical cord blood is also a plentiful and rich source of hematopoietic stem cells.
By Jennifer Camarda, Sales Specialist, Premium Balances and Software, Sartorius Corporation
As of December 1, 2013, significant changes to the USP Chapter 41, a mandatory chapter, became effective, and now apply to all materials that must be accurately weighed. USP Chapter 41 has also been renamed, from Weights and Balances to Balances, and it does not reference the minimum sample weight anymore, but rather it defines repeatability and accuracy, which specifies the operating range of a balance.
By Cathy L. Burgess, Donald E. Segal, and Guillermo Cuevas, Alston & Bird LLP
Last month, the FDA released a draft guidance document entitled "Contract Manufacturing Arrangements for Drugs: Quality Agreements." The guidance addresses relationships between the entities that introduce a drug into interstate commerce (the “Owner”) and third parties that perform some or all of the manufacturing operations for the product (the “Contracted Facilities”). The guidance describes how Owners and Contracted Facilities can use quality agreements to define responsibilities associated with manufacturing activities in a manner that is consistent with regulatory requirements.
A Q&A With Chip Meyers, VP of UPS Corporate Public Affairs; and Tim Bishop, Manager of Healthcare Compliance, UPS
In part two of my interview, Chip and Tim share answers to their most-asked questions about serialization and how track and trace could impact supply chain integrity. They also weigh in on their concerns about the pharma industry's readiness from a logistics standpoint, as well as ways they can help manufacturers navigate the bumpy road toward serialization.
By Dan Catizone, QuickSTAT
Cold chain shipments often have to be transported to obscure parts of the world under strictly controlled temperature conditions. Making sure that clinical specimens, vaccines, drugs, or other biologicals reach their destination safely, securely, and at the right temperature is a critical element of the drug discovery process. As a shipper, you need to ensure that your "cold chain" runs efficiently and with the least amount of adverse incidents.