Facility Design and Engineering

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

The company is investing approximately $14 million to expand biologics packaging capabilities and capacity at its biologics manufacturing facility in Bloomington, IN.

The company will use GE Healthcare’s off-the-shelf KUBio biologics factory, which is expected to start operations in 2020, to provide development and manufacturing for early- to late-clinical and early-commercial manufacturing stages.

FDA’s 21st Century goals can be realized by using a multi-purpose manufacturing facility with a flexible design that provides reliable production without extensive regulatory oversight.

A multi-purpose biopharmaceutical manufacturing facility using a matrix of multi-functional cleanrooms can be adapted to efficiently meet the capacity challenges of both supplying clinical trials and launching products.

A matrix of multi-functional cleanrooms can be adapted for launching products.

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

The vaccine producer announced an expansion to its Holly Springs, NC, manufacturing facility where it will increase production of its cell-based quadrivalent influenza vaccine.

The new collaborative center aims to serve as a hub for innovations in drug development and manufacturing.

GE Healthcare will collaborate with Wego Pharmaceutical in China for local production and supply of GE Healthcare’s Fortem single-use consumables.

The expanded Frederick, MD, site will help meet global demand for diagnostic instruments and cell and gene therapies for clinical trials.

The company has rolled out the first batch of TRACON Pharmaceutical’s lead product candidate from its Singapore-based single-use bioreactor.

The expansion adds new capabilities and enhances existing service offerings for both oral and parenteral dosage forms.

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

The company added a new EUR 63-million (US$72-million) packaging center at its manufacturing site in Darmstadt, Germany.

The companies partnered to build a 500-L single-use pilot-scale plant for biologics production.

A collaboration using Pall’s bioprocessing technology in G-CON’s PODs enables flexible continuous bioprocessing and viral vector facility solutions.

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.

BeiGene is set to build late-stage clinical and commercial production capacity for cancer monoclonal antibodies with GE Healthcare’s KUBio, the prefabricated biopharma facility based on single-use technologies.

The biopharmaceutical company will invest approximately $800 million to expand facilities and manufacturing capacity at its campus in Rensselaer County, NY.

The drug particle engineering and nanotechnology company offers a nanotechnology platform that can revive failed drugs in the pharma pipeline.

Avara Pharmaceutical Services acquired Sandoz’s sterile manufacturing facility for injectable medicines in Boucherville, Quebec, Canada.

The company is increasing manufacturing capacity at its Copenhagen, Denmark facility with the addition of six new bioreactors.

FDA grants support US research in continuous manufacturing monitoring and control techniques for bio/pharmaceutical manufacturing at Rutgers, MIT, and Georgia Tech.

The agency issued a warning letter to Canadian API manufacturer, Les Produits Chimiques B.G.R, citing cGMP violations at its API facility in Pointe-Claire, Quebec.

The company broke ground on its $200-million, 120,000-ft2 biomanufacturing plant in West Greenwich, RI.

Moderna’s new manufacturing plant in Norwood, MA gives the company capacity for preclinical and Phase I and II clinical manufacturing for its mRNA development candidates, including personalized cancer vaccines.

The expansion at the company’s Gillingham, UK, site, worth EUR 9 million (approximately US$10.5 million), will improve the company’s distribution capabilities.

Modern technologies, including Industry 4.0 and the Industrial Internet of Things, offer opportunities to increase biopharmaceutical manufacturing efficiency.

The company has completed the first phase of expansion at its headquarters in Freiburg, Germany, in anticipation of increasing demand as cell and gene therapies approach commercialization.