There is a great need for sensitive, precise, and easily accessible analytical detection techniques for protein sequencing.

Biologics Quality Control: The Growing Need for Accessible Proteomics

The emergence of mRNA vaccines and cell and gene therapies has pushed innovation in analytical methods.

Emerging Therapies Drive Analytical Advancements

Effective analytics will eliminate failures, deviations, and non-conformances.

 Analyzing Exabytes

Topic

Pascal Martin is a project manager at Merial SAS, Lyon, France, tel. +33 4 72 72 39 61, fax +33 4 72 72 34 93.

Magnus Stering is head of Application Services South Europe Filtration, Sartorius Stedim Biotech SA, Aubagne, France.

Jens Meyer is a product manager of integrity testing at Sartorius Stedim Biotech GmbH, Goettingen, Germany.

Articles

The authors describe a novel approach for the integrity testing of large sterile filter systems such as multiround housings and describe a multipoint diffusion test capable of detecting minor failures.

Improving the Integrity Test Assurance of Multiround Housings Assessments

Jonathan Royce is a senior application scientist at GE Healthcare.

Jeffrey Carter, PhD, is director of filtration R&D, at GE Healthcare, 14 Walkup Drive, Westborough, MA

Jakob Liderfelt is a scientist at GE Healthcare, Björkgatan 30, 751 84 Uppsala, Sweden.

Proper selection of normal flow filters leads to increased process efficiency from early phase product development through to full-scale biopharmaceutical production.

Guidelines for Selecting Normal Flow Filters

Yves Mayeresse is senior manager and head of freeze-drying at GlaxoSmithKline Biologicals.

The authors present an aseptic-filling process for freeze-dried liquids using the closed-vial technology.

Freeze-Drying with Closed Vials

Jerold Martin was the senior vice president of global scientific affairs at Pall Life Sciences and the chairman of the Board and Technology Committee at Bio-Process Systems Alliance.

The author examines re-use of hydrophilic- or hydrophobic-membrane sterilizing-grade filters in liquid sterilizing applications.

Considerations on Re-Use of Sterilizing-Grade Filters

FDA advocates building quality into a product through PAT.

Rapid and convenient microsphere sizing

Efficiency is more than just a buzzword in today's pharmaceutical industry; declining productivity and diminishing returns on investment have made it an over-arching mindset that is critical to corporate survival.

Reaping the benefits of assay miniaturization

Also, Maxygen looks to costs, jobs; Receptor BioLogix appoints Dale R. Pfost CEO; more...

Company and People Notes: Avid Bioservices Signs Manufacturing Supply Pact with Catalyst Biosciences; Pfizer Named Mace L. Rothenberg Senior VP of Development for its Oncology Unit, More...

Pfizer and UCB formed a technology company named Cyclofluidic with the aim of accelerating the drug-discovery process.

Pfizer and UCB Form New Company to Speed Drug Discovery

Also, MedImmune opens Cambridge, UK, facility and makes reverse engineering pact with Omninvest; BD Medicine appoints Carol Adiletto VP of clinical and regulatory affairs; more...

Company and People Notes: Novartis to Acquire Nektar Drug Delivery Unit; LifeCycle Pharma Appoints Jim New As President and CEO; More...

Also, Millipore opens new membrane-casting manufacturing facility in Ireland; Surface Logix appoints Keith Dionne president, CEO, and a member of the board; more...

Analytics

Biologics Quality Control: The Growing Need for Accessible Proteomics

Emerging Therapies Drive Analytical Advancements

Analyzing Exabytes