Therapeutic Class

Biosimilars: Roche and Biogen talk competition, price, opportunities

The complexity of the biosimilar market was much in evidence last week with Roche and Biogen both citing competition as challenges in Q1. Roche saw group revenues of CHF 14.9 billion ($16.3 billion) in the first three months of 2021, up 3% year-on-year. The contribution from diagnostics grew 55% to CHF 4.5 billion due to a surge in demand for COVID-19 testing. In contrast, revenue from medicines fell 9% to CHF 10.6 billion. Roche said the decline was mainly because…

Bayer confirms $200m Berkeley cell therapy facility

The Cell Therapy Launch Facility will support Bayer’s growing advanced therapy ambitions and comes in addition to a $1.2 billion investment in the Californian campus. Bayer has confirmed it is expanding its cell and gene capabilities through the addition of a Cell Therapy Launch Facility, which is set to join a Cell Culture Technology Center (CCTC) and Cell & Gene Therapy labs coming on-line later this year at its 46-acre campus in Berkeley, California. “The Cell Therapy Launch Facility is…

Autologous therapy firms should use tech to cut COGS, says expert

Autologous therapy developers should consider “turnkey” manufacturing systems and robotic arms to minimize costs and manual handling, says an expert. The medical benefits of patient-specific, autologous cell therapies are proven according to Greg Russotti, Century Therapeutics’ CTO who told BPI West attendees the challenge now is reducing the cost of making such products. “Autologous [therapies] are proven to make major differences in patients’ lives. And, you know, no one can say they’re cures yet, but in some cases they are…

Podcast: The future of cell and gene therapies

Collaboration, supply chain resilience, acknowledgement they work, and trust will drive the cell and gene therapy sector going forward, EY’s Adlai Goldberg says on the latest episode of the BioProcess Insider Expression Platform. The cell and gene therapy sector is on the cusp of flourishing in the vast pharma landscape. Money is flowing in, manufacturing challenges are being overcome, people are actually being treated and cured. Even COVID-19 may be seen as a driving force for the burgeoning sector. But…

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…