Upstream Processing

The authors present approaches used to reduce reconstitution time of a lyophilized high-concentration protein drug product.

Innovative products and a range of indications drive the therapeutic antibody market.

A look at vaccine history, markets, manufacturing, and overcoming the scale-up dilemma.

Tony Hitchcock of Cobra Biologics discusses challenges posed by production of viral vectors for vaccines.

What the industry's future holds and what needs to be done to get there.

Conjugation of a biologic to a carrier molecule can solve problems in solubility and stability, but introduces its own challenges.

GE Healthcare Life Sciences' ReadyToProcess platform aims to streamline bioprocessing.

Scaling up stem-cell cultures requires careful consideration of the bioreactor design.

This month, Jerold Martin of Pall Life Sciences takes a look at protein recovery through direct-flow microporous membrane filters over the past 25 years.

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.