Therapeutic Class

Lonza adds AbTis conjugation tech to its ADC toolbox

CDMO Lonza has bolsted its antibody-drug conjugate (ADC) technology offering through the transfer of Korean biotech AbTis’ AbClick bioconjugation platform. Swiss contract development and manufacturing organization (CDMO) Lonza is a self-proclaimed “pioneer in bioconjugation,” having been involved in the space since 2006 and being the names third-party for the majority of the approved ADC products, as well as a wide range of other protein conjugates. The firm has built out its network over the past few years to support greater…

IASO collaborates with Umoja for allogenic CAR-T therapies

Umoja Biopharma of Seattle to test the efficacy of its iCIL off-the-shelf cell therapy platform with Shanghai IASO Bio’s CAR candidates. Umoja’s allogeneic stem cell-based cell therapy platform uses a proprietary manufacturing process to direct differentiation and expansion of iCILs, a novel class of innate lymphocytes with potent anti-tumor activity. Initially, the companies will work to develop off-the-shelf therapies for patients with acute myeloid leukemia. IASO’s lead product is an autologous BCMA CAR-T currently at NDA stage in China that…

Making facilities commercialization-ready is next big challenge for CGT sector

Bulging late-stage R&D pipelines suggest many in the cell and gene therapy sector are preparing to go market. For such firms, having the right manufacturing infrastructure will be vital for commercial success, says Ken Green from Vertex. Commercializing a cell or gene therapy is a complex process. Once a therapy is approved, the developer has to manufacture it and bring it to market in a stable and sustainable way. “The big question for us as an industry is how are…

eBook: Vaccines — From Disease Prevention to Treatment

For over two years, the biopharmaceutical industry has revolved around rapid development, manufacture, and rollout of vaccines in response to the COVID-19 pandemic. Now as the world reverts to some sense of normality, demand has plummeted for the likes of J&J’s viral vector vaccine and Moderna’s messenger RNA (mRNA) vaccine, resulting in the lowering of financial forecasts, ending of manufacturing contracts, and freeing of production capacity. But where do vaccines — the great pharmaceutical success story of the past few…

$50m PE injection for Orgenesis’ cell therapy POC business

Cell and gene therapy (CGT) biotech Orgenesis has set up a subsidiary focused on streamlining its cell therapy point-of-care (POC) service offerings. Metalmark Capital Partners will invest up to $50 million in Orgenesis’s POC subsidiary, Morgenesis, through an upfront investment of $30 million and two future investments of $10 million each, subject to certain milestones. Morgenesis brings together the full range of Orgenesis’ advanced therapy POC options, including its Orgenesis Mobile Processing Units and Labs (OMPULs) platform, which are based…

Cell and gene sector expanding at ‘astonishing pace,’ say researchers

Kymriah and Yescarta may have finally established the commercial viability of cell and gene therapies, but it is advances in manufacturing and distribution that define the market, according to new analysis. The research – published in the journal Cytotherapy in October – looked at innovation in cell and gene therapy research, in particular in cancer which has been a very active area for developers according to the authors. “With the early successes of ex vivo–expanded, autologous tumor-infiltrating lymphocytes (TILs) in patients…

Galapagos goes hard on CAR-T in strategic restructure

Galapagos has announced a business restructure that includes trimming its fibrosis and kidney disease programs and axing 200 staff in favor of its immune-oncology pipeline. The ‘Forward, Faster’ strategy, announced in line with Galapagos’ third quarter 2022 results, aims to move the Belgian biopharma’s focus from novel target-based discovery to patient centric medical need R&D with a focus on immunology and oncology. As part of this, CEO Paul Stoffels stressed the firm will “build on our current capabilities and derisk…

Cell line platform reduces timelines by 33%, says Aragen

Aragen Life Sciences has launched its RapTr 2022 cell line development platform, which it says offers reduced timelines and delivers increased titres. Contract development manufacturing organization (CDMO) Aragen has launched its optimized RapTr 2022 cell line development (CLD) platform. BioProcess Insider spoke to the firm’s chief commercial officer, Ramesh Subramanian, at CPHI, Frankfurt who told us that RapTr stands for “rapid titers.” “We provide solutions to the customer and titres are important because the more protein you can make equals…

CBM ramps up bioanalysis services with AAV testing

The Center for Breakthrough Medicines (CBM) has launched an AAV testing service it claims reduces the time to GMP batch release from 22 to six weeks. Pennsylvania-based CBM’s niftily named ‘Analytical Accelerator for AAV Testing’ service aims to help gene therapy developers meet quality, safety, purity, potency, and demands in a reduced timeline. According to the contract development and manufacturing organization (CDMO), the platform speeds up time to GMP batch release for its customers by more than three times, from…

A supply chain existential crisis? Cell therapy firms must move from paper

There is an existential crisis in the cell therapy space as firms face limited and outdated options to track personalized medicines, says supply chain technology developer ATMPS. ATMPS’ software, Hataali, uses blockchain technology to track cell therapy products from the initial harvesting of cells from a clinical trial participant to the production facility and back through a series of nodes. The software received a US patent for the use of blockchain in personalized medicine earlier this year, and hopes to…