Upstream Processing

The European Medicines Agency has added granularity to its biosimilars approval pathway by releasing a guideline on mAbs.

Patrick Jackson of Vindon Scientific offers key considerations for choosing an outsourced sample storage facility.

This article discusses the evaluation of a novel single-use fluidized bed centrifuge for harvesting of antibodies.

The manufacturing capacity-sharing model between Merck and MedImmune ushers in a new paradigm of "co-opetition."

A new report highlights the industry's contributions to neglected diseases and calls for further collaboration.

Understanding opportunities and challenges across all major phases of development.

MIT survey results address product and site characteristics that statistically correlate with quality performance.

Michiel E. Ultee of Laureate Biopharmaceutical Services gives an update on 1988 article regarding virus testing and how the advance of monoclonal antibodies has changed processes.

The authors describe a simple method to remove endotoxins from highly viscous formulations.

A perspective on why platform processes are not and should not define the future of bioprocess development efforts. This article is part of a special section on biopharmaceutical trends.

NIBRT's Ian Nelligan on what to expect when starting an upstream process, including the choice between single-use and stainless-steel bioreactors.

Members from an ASQ working group provide analytical methods to enable PAT.

Steven S. Kuwahara, PhD, principal consultant at GXP BioTechnology LLC, gives an update on "Engineering the Cell-System Interface."

Industry wants more innovation, but can suppliers meet customers' needs?

This article contains online-exclusive supplemental material for Malik's article entitled, "Allogenic Versus Autologous Stem-Cell Therapy."

The author discusses potential manufacturing costs & challenges of allogeneic & autologous stem-cell therapy.

Industry experts discuss methods for optimizing protein expression in bacterial and mammalian cell lines.

Selection of the right cell line, culture medium, and bioreactor conditions is key to setting up the upstream portion of the biopharmaceutical manufacturing process.

Cell-line specific complex media supplements combine chemically defined media additives into a single supplement.

The authors present scale-up from a 5-L fermentor to a 50-L pilot-scale using the criterion of constant power consumption per unit liquid volume.

A review of new biologic drug approvals over the years, featuring highlights from 2010 and 2011.

Mike Clayman, CEO of Flexion Therapeutics, talks about his company's strategy to focus on a single therapeutic area.

A review of key industry shifts and promises for the future.

Charles H. Squires of Pfenex discusses advances in expression platform solutions.

Formulators and developers are at the heart of the industry's basic premise-they are saving lives.

Industry experts discuss significant achievements. Plus: What's in store for the future.

The author highlights novel strains and methods that have recently been shown to express multidisulfide bonded proteins.

This article discusses potential opportunities to improve the patient experience through formulation and delivery device technologies.

The author describes expression technology that produces cell lines with high genetic stability.

MAb polishing using salt tolerant interaction membrane chromatography.