Scale Up

The new facility, located in Ness Ziona, Israel, will support clinical phage manufacturing and can be expanded in the future to support commercial-scale manufacturing.

The growing trend of partnerships between small biotech companies and CDMOs makes the need for conducting CMC due diligence increasingly important.

Increasingly complex monoclonal antibody molecules will require the right “tool box” for scaling up manufacturing.

Pharmaceutical Technology and BioPharm International will present a Keynote Session on Meeting Bioprocessing Manufacturing Capacity Demands on Wednesday, April 3, 2019, during INTERPHEX 2019 at the Javits Center in New York City.

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?