Scale Up

A look at recent investments by contract manufacturers to increase single-use bioreactor capacity.

For rapid scale-up of biomanufacturing under expedited review status, facility design must better integrate product development and manufacturing lifecycle activities.

Advances in single-use technologies, sensors, and cell retention systems facilitate processes designed for the long run.

The new center will integrate biologics drug discovery, development, clinical manufacturing, and commercial manufacturing.

Platform processes have improved monoclonal antibody scale-up. Can they do the same for personalized therapies?

Advanced therapy medicinal products pose unique manufacturing challenges that will require appropriate and thoughtful facility design and equipment.

Bioconjugation requires aseptic manufacturing and containment for cytotoxic payloads.

The maturation of single-use technologies presents commercial bioprocessing options for small-volume drug products.

The CHF 400-million (US$416-million) investment in Lonza's biopark in Visp, Switzerland, will expand Ibex Solutions with two new offerings, drug substance development and drug substance and drug product manufacturing.

The new Testa Center in Uppsala, Sweden is a collaborative test bed offering biotechnology equipment from GE Healthcare for process development.

Biopharma seeks alternatives that meet the needs for next-gen biologic drug production.

The company has run into a snag in producing Kymriah for the diffuse large B-cell lymphoma patient population, the second indication for which the therapy was recently approved by FDA.

Late-stage and commercial biomanufacturing pose a challenge to cell-culture processing.

The company will provide the first FlexFactory manufacturing platform for cell therapy manufacturing.

GE Healthcare and the Centre for Commercialization of Regenerative Medicine (CCRM) will support scale-up efforts by DiscGenics for a new cell therapy intended to treat back pain.

More published data and initial regulatory approvals are needed to drive adoption of continuous bio-manufacturing.

The company is launching a new pre-fabricated, ready-to-run manufacturing facility that is expected to significantly decrease the production timeline for viral vector-based therapeutics.

On Tuesday, April 24, 2018, Evan Boswell, senior principal scientist at Pfizer CentreOne Contract Manufacturing, Pfizer CentreOne will give a presentation on scaling up the manufacturing process of active pharmaceutical ingredients at CPhI North America in Philadelphia, PA.

Avid Bioservices will provide commercial manufacture of an enzyme replacement therapy by Roivant Sciences' Enzyvant subsidiary.

Anna Kireieva/Shutterstock.comSpeed to market is essential in the biopharmaceutical industry today.

Can bioprocessing runs be consistently replicated in an inherently variable production environment?

Prokarium in the UK and Probiomed in Mexico hope to demonstrate large-scale production of oral vaccines that will reduce cost compared to injections and improve availability.

There is much work to do to achieve efficient, cost-effective production processes.

Plant transient expression offers a flexible approach in drug development and enables rapid production and scale up of therapeutics.

This new method uses inter-alpha inhibitors to promote attachment and long-term growth in stem cells.

Scale-up of complex, innovative products requires commercialization models that are sustainable.

BioPharm sat down with an intellectual property lawyer to examine how companies are protected when they engage in activities where sharing of trade secrets must occur.

A modular cell-culture platform demonstrates accelerated process development.

The novel antibody-engineering platform works differently than most of the currently employed antibody-modifying technologies, according to UM Baltimore.

Barry Holtz, Principal, at Holtz Biopharma Consulting, and Klyo Collaborative, spoke with BioPharm International about collaborative success strategies for biopharm companies.