Therapeutic Class

Moderna trialing refrigerator stable COVID-19 vaccine

Moderna has another COVID-19 vaccine in its clinical pipeline, which if successful will potentially make distribution and administration easier. The firm already has an mRNA cell-free COVID-19 vaccine, 1273, approved under FDA emergency authorization. However, it is developing an additional COVID-19 vaccine candidate coded 1283, which it believes will be easier to allocate and administrate due to it potentially being refrigerator stable. According to the firm, the next generation COVID-19 vaccine candidate is made from portions of the spike protein,…

Oxford Biomedica working to optimize vector production platform

Oxford Biomedica is optimizing its vector production system to boost yields and accelerate production in response to growing demand. The UK gene and gene therapy firm and contract development and manufacturing organization (CDMO) talked about efforts to improve its vector production platform last week during its Q4 presentation. The main aim – according to chief scientific officer Kyri Mitrophanous – is to increase viral vector production capacity and remain competitive. “We continue to invest in the lentiviral vector platform in…

Preparation key to gene therapy commercialization, MilliporeSigma

Gene therapy firms are under pressure to get to market quickly according to an expert from MilliporeSigma, who says process development and tech transfer are significant hurdles. The ability to treat – or cure – disease at the genetic level in a targeted manner is an attractive proposition for drug companies. The challenge now is to make these therapies in a cost and time efficient manner according to Ratish Krishnan, associate director for cell and gene therapy bioprocessing at Milliporesigma.…

Tenaya talks advantages of inhouse capabilities for CGT firms

Having internal AAV capabilities gives Tenaya Therapeutics control over its processes, timelines, and costs, but CEO Faraz Ali says it will also likely use third-party manufacturers as pipelines progress. Fresh from a $106 million Series C funding, South San Francisco-based cell and gene therapy firm Tenaya Therapeutics is establishing a dedicated facility for AAV (adeno-associated virus) manufacturing to support its emerging portfolio of gene therapy products. “We have leased a 94,000 square-foot space for our new cGMP facility, and we…

Ori and ATMPS team to lower advanced therapy COGS through blockchain

ATMP’s blockchain-based data sharing platform will be incorporated into Ori Biotech’s cell and gene therapy manufacturing platform. ATMPS, a spin out from Farmatrust, created the Hataali platform to record scheduling and ordering data for advanced therapy treatments within a blockchain system that enables secure and confidential sharing of data between partners. Ori Biotech, a developer of automated and scalable cell and gene therapy (CGT) manufacturing systems, has partnered with ATMPS in efforts to provide improved product tracking, scheduling as well…

CRISPR lauds easy scale-out of autologous sickle cell therapy

The autologous nature of its gene-edited stem cell candidate CTX001 means scaling manufacturing from clinical to commercial will be relatively easy, says CRISPR Therapeutics. Codeveloped with Vertex Pharmaceuticals, CRISPR Therapeutics’ CTX001 is an autologous CRISPR/Cas9 gene-edited hematopoietic stem cell therapy targeting patients suffering from β-thalassemia and sickle cell disease. Production of the candidate involves collecting a patient’s own blood stem cells via mobilization and apheresis and editing them with CRISPR/Cas9 to increase fetal hemoglobin (HbF) expression. When the edited cells…

CGT firms making progress but manufacturing remains a hurdle, says analyst

Cell and gene therapy developers have yet to address delivery, production and safety challenges but progress is being made. The conclusion came from RBC Capital Markets, which published analysis of trends in the cell and gene therapy sectors this week. According to executives quizzed by the market research firm, the biggest challenges that modern gene therapy firms face are pretty similar to those encountered by pioneers in the field a couple of decades ago. “Gene therapies hold considerable promise in…

Singapore site sets Sanofi’s vaccine spend at beyond $2bn

After investing heavily to develop sites in France and Canada, Sanofi will now spend €400 million to establish a vaccine production center in Singapore. The €400 million ($476 million) investment over five years will see Sanofi develop a modular and flexible vaccine manufacturing site in Singapore to supply the Asian market. The site, once operational (estimated in the first quarter 2026) will be capable of running multiple types of vaccine manufacturing platforms and will be able to produce several different…

Sterling makes good on ADC Biotechnology buy

Four months after making a strategic investment in fellow CDMO ADC Biotechnology, Sterling Pharma has acquired the company bolstering its antibody-drug conjugate offerings. In December, contract development and manufacturing organization (CDMO) Sterling Pharma entered in a strategic partnership with UK-based ADC Biotechnology, making a “significant” but undisclosed investment in the company with an eye to acquiring it. And this week, Sterling acted on the agreement and acquired the firm, cementing Sterling’s high potency active pharmaceutical ingredient (HPAPI) business with ADC…

TCR2 leases ex-Autolus plant in pivot away from CDMO reliance

A lack of control when relying on third-party manufacturers has been a learning lesson for many cell therapy firms says TCR2 Therapeutics as it leases an 85,000 square-foot plant in Rockville, Maryland. T-cell therapy firm TCR2 Therapeutics has entered a 15-year lease agreement for the facility at 9950 Medical Center Drive, Rockville, Maryland for a price of $39.78 per square foot, beginning July 1. According to chief scientific officer Robert Hofmeister, the facility will help expand supply for clinical trials and potential…