Manufacturing

Articles

Texcell North America’s new lab facility in Frederick, Md., will expand the CRO’s capabilities in R&D cell culture, viral clearance studies, and viral safety testing.

Texcell North America Builds New Laboratory Facility

The new resin used a combination of “jetting” technology and a high-performance Protein A ligand.

Purolite Launches New Protein A Resin

James P. Agalloco is the president of Agalloco & Associates, P.O. Box 899, Belle Mead, NJ 08502, tel. 908.874.7558, jagalloco@aol.com. He is also a member of Pharmaceutical Technology’s editorial advisory board.

Understanding the purpose of the biological indicator can guide the development of an effective sterilization process.

Kill the Bioburden, Not the Biological Indicator

FDA issued a warning letter to the Worthing, UK facility for cross contamination and microbial contamination cGMP violations.

SmithKline Beecham Gets Warned for Contamination

The new sizes follow the 2014 launch of the company’s fully disposable purifier.

3M Launches Production-Scale Sizes of its Upstream Purifiers

The new column features Natrix’s signature macroporous hydrogel.

Natrix Introduces New Disposable mAb Purification Column

Medicago's new production facility will make plant-based vaccines and therapeutics.

Medicago Plans Vaccine Facility In Quebec City

The all-synthetic 3M Emphaze AEX Hybrid Purifier contains both an anion-exchange nonwoven media and a fine-particle, bioburden reduction membrane.

Single-use Purification Media Improves Efficiency

Cynthia A. Challener is a contributing editor to Pharmaceutical Technology.

Advanced analytical methods are speeding up the targeted evaluation of potential viral contaminants.

The Challenge of Finding the Unknown

Mark Wagner is purification technology and business development specialist at EMD Millipore, 290 Concord Road, Billerica, MA 01821.

Jeffrey Shumway is associate director, bioavailability enhancement at EMD Millipore, 290 Concord Road, Billerica, MA 01821.

Juan Castano is process development scientist at EMD Millipore, 290 Concord Road, Billerica, MA 01821.

Claire Scanlan is process development scientist at EMD Millipore, 290 Concord Road, Billerica, MA 01821.

Ruta Waghmare is group leader, process development sciences at Millipore Corporation, Billerica, MA 01821.

Antibody fragments pose unique challenges in terms of recovery, purification, and formulation.

Viral Clearance