Scale Up

Adherence to detail and thorough project management are required for successful tech transfer and scale up.

Takeda has exercised an option to co-develop and co-commercialize an investigational, brain-penetrant progranulin replacement therapy for the potential treatment of frontotemporal dementia-granulin.

Advances in simulation and the development of digital twins.

Corning’s new Ascent fixed bed reactor (FBR) system is an automated bioproduction platform designed to significantly improve yields and reduce bioproduction costs.

AGC Biologics has acquired Novartis’ Longmont, Colorado, manufacturing facility for the commercial production of cell and gene therapies.

Cellares has entered into a strategic relationship with Poseida Therapeutics to advance a closed, automated, and scalable cell therapy manufacturing system.

Sparx Therapeutics will build its first commercial manufacturing facility in Yangzhou, China, for antibody drug production.

VIVEbiotech has opened its new lentiviral vector manufacturing facilities in Spain, expanding capacity for lentiviral vectors for use in cell and gene therapies.

The emergence of new biotherapeutics is both the driver and result of innovative drug development technologies.

The Testa Center in Sweden provides access to equipment and expertise to help bridge the gap between biopharmaceutical discovery and industrialization.

Using rDNA technology to synthesize production of proteins and peptide hormones, the biotech startup has achieved synthetic production of insulin, potentially lowering insulin cost by 30%.

Wacker will support production of CureVac’s COVID-19 mRNA-based vaccine candidate at its biotech site in Amsterdam, with production scheduled to start in the first half of 2021.

The agreement will provide capacity for the manufacturing of AZD7442, currently being developed for the potential prevention and treatment of COVID-19, at Lonza's Portsmouth, NH site.

The company’s new closed cell therapy processing system enables scalable, cost-effective development and manufacturing of cell therapies.

The manufacture of gene therapy vectors is shifting to more modern technologies.

Industry experts discuss challenges and best practices for scaling up manufacturing under a short deadline.

Contract partners must help innovators, especially smaller and virtual companies, consider manufacturability as early as possible in development. This requires focusing on technical and operational performance, as well as cost.

As equipment evolves and use of PAT increases, DOE is becoming an integral part of upstream bioprocess development.

The company’s Custom Single Run product line now has available bioreactors with working volumes of up to 6000 L.

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.

Front-end focus and new approaches are speeding scale-up and reducing costs, while scale-down and scale-out become increasingly important.

Although continuous approaches offer significant benefits for some products and processes, batch manufacturing is not going away any time soon.

Continuous manufacturing may offer huge opportunities, but it will not be right for every facility or product.

New technologies in the digital factory enhance quality, efficiency, and flexibility for bio/pharmaceutical manufacturing.

Only careful planning can prevent problems that stem from differences between a sponsor’s and a CDMO’s equipment, practices, and culture. This article highlights best practices and case studies.

Boehringer Ingelheim plans to develop and test new strategies at its Solids Launch facility.

Once described as “throwing processes over the wall,” tech transfer is evolving into close collaboration and communication, as potential problems are considered sooner, and new technology is applied. Joseph Szczesiul, director of technical services for UPM Pharmaceuticals, shares best practices.

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

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.