Orgenesis and Johns Hopkins University to build CGT Maryland Center

Orgenesis and Johns Hopkins University will build a cell and gene therapy processing facility in Maryland, US for point of care treatment. The 7,000 square-foot POCare Center, also known as the Maryland Center for Cell Therapy Manufacturing, has been partly funded by a $5 million grant from the State of Maryland with building expected to start in Q2 2022 and the facility anticipated to be operational by Q2 2023. “Orgenesis is a pioneer of decentralized processing and production of CGTs,…

Samsung Bio buoyed by COVID, citing mRNA and mAbs as drivers

Samsung Biologics says COVID-19 related demand drove growth in 2021 and predicts mRNA business will be key this year.  The Korean contract development and manufacturing organization (CDMO) saw revenue of KRW444.3 billion ($328 million) in the fourth quarter of 2021, up 18% on the comparable period in 2020.   Profits increase 39% to KRW128.8 billion. For the full year revenue and operating profit grew 35% and 84%, respectively.  Samsung also said its fourth quarter operating margin jumped 29% due to increased utilization across all…

Continuous processing and CGTs: MilliporeSigma on CDMO trends for 2022

BioProcess Insider spoke virtually with MilliporeSigma’s head of Process Solutions Andrew Bulpin about his predictions for the company and the CDMO space in 2022. The life sciences services division of Merck KGaA, MilliporeSigma, has been steadily increasing its contract development manufacturing organization (CDMO) services through a string of investments and expansions. The firm invested $110 million into its gene therapy CDMO business in April 2020 by building a second facility at its site in California, adding 11 production suites and more…

Limula on the future of cell therapies: Closed, automated, decentralized

An in-situ centrifugation-based point-of-care system could help push industry towards the decentralized and automated model needed to make cell therapies affordable and reliable, according to Limula Biotech. The approval of Novartis’ Kymriah (tisagenlecleucel) in 2017 was a milestone in the advanced therapy space, marking the arrival of the first genetically-modified autologous T-cell immunotherapy to the market. Since then, a handful of other autologous cell therapies have received the regulatory thumbs up – most recently Bristol-Meyer Squibb’s Breyanzi (liso-cel) and Abecma…

Cytiva and Nucleus team on custom cell media for CGTs

The collaboration with Nucleus Biologics will provide transparent and scalable manufacture of custom cell culture media, says Cytiva. Under the terms of the deal, Cytiva and cell culture firm Nucleus Biologics have partnered to develop custom media formulation and fulfillment solutions for the cell and gene therapy (CGT) space. Cytiva customers will be able to formulate their own custom cell culture media through Xuri Media AI Guide, which is based on Nucelus’ NB-AIR platform. Additionally, clients can configure their media…

In brief: Vetter opens clinical filling site in Austria

Vetter has received manufacturing authorization for a fill and finish site Austria, which the CDMO acquired in 2020. Contract development and manufacturing organization (CDMO) Vetter bought the clinical production site in Rankweil, on the Austrian border with Switzerland and Liechenstein, from Impletio – part of Rentschler, with which Vetter inked an alliance in July 2020. The firm has been working to modify and equip all laboratory, technical and production areas at the 10,000 square-meter facility and has announced this week…

HPNE to expand single-use capacity on back of $15m BARDA contract

Funding from BARDA gives High Purity New England (HPNE) the opportunity to expand into its fourth facility, the bioprocess vendor says. HPNE has been contracted to produce pharmaceutical consumable equipment for the Biomedical Advanced Research and Development Authority (BARDA) and its third parties, issued in response to a Presidential Declaration of Public Health Emergency. The $15 million contract – number 75A50122C00009 – forms part of the office of the Assistant Secretary for Preparedness and Response at the US Department of…

Novo Nordisk Foundation invests $343m to build stem-cell research center

Novo Nordisk Foundation will invest up to $343 million over a ten-year period to establish an international research center focused on stem cell medicine. The center is a partnership entitled reNEW between the University of Copenhagen, Denmark, Murdoch Children’s Research Institute, Australia, and Leiden University Medical Center, The Netherlands. The aim of the collaboration is to drive future stem cell-based treatments. The governing hub will be based at the Faculty of Health and Medical Sciences, University of Copenhagen and Melissa…

CBM and UPenn enter gene therapy manufacturing pact

A five-year deal will see the Center for Breakthrough Medicines (CBM) gain commercial rights to certain gene therapy manufacturing and analytics platforms from the University of Pennsylvania. The King of Prussia, Pennsylvania-based contract development and manufacturing organization (CDMO) has entered a collaboration with the University of Pennsylvania Gene Therapy Program (GTP) to help small biotech firms, universities, and large pharma firms advance gene therapies through the clinic. The collaboration brings CBM access to UPenn’s gene therapy expertise, which has helped…

AAV Downstream Process and Product Characterization: Integrating Advanced Purification and Analytical Tools into the Workflow

The optimization of the downstream process for Adeno-associated virus (AAV) production with consistent quality depends on the ability to characterize critical quality attributes affecting potency, purity and safety of the final product. As the gene therapy field continues to push products through the clinical pipeline, an increasing need for efficient purification and analytical tools has become evident. In addition, the regulatory space has expanded in parallel to the use of AAV, driving the demand for simple and efficient assays to…