Author Archives: Dan Stanton

Podcast: The future of cell and gene therapies

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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…

April 22, 2021

Fareva to grow its newly acquired biomanufacturing capabilities

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Fareva will make a “major investment†within its newly formed GTP Biologics division a year after entering the biologics CDMO sector. Fareva, a prominent third-party manufacturer in the small molecule active pharmaceutical ingredient (API) and finished formulation space, entered the biologics sector last year through the acquisition of two facilities from fellow French firm Pierre Fabre. Along with an oncology injectable plant in Pau, southwestern France, the firm picked up a monoclonal antibody (mAb) production facility in Saint-Julien-en-Genevois, on the…

April 20, 2021

Emergent issues: FDA orders production halt at Bayview plant

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COVID-19 vaccine contract manufacturer Emergent BioSolutions has stopped production at its beleaguered Bayview, Maryland plant following a US FDA inspection that led to a Form 483 with nine observations. The US Food and Drug Administration (FDA) began an inspection at the Bayview site in Baltimore, Maryland on April 12 and, according to Emergent, four days later requested a manufacturing hold. “On April 16, 2021, at the request of the FDA, Emergent agreed not to initiate the manufacturing of any new…

April 20, 2021

Tenaya talks advantages of inhouse capabilities for CGT firms

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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…

April 19, 2021

Ori and ATMPS team to lower advanced therapy COGS through blockchain

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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…

April 15, 2021

Roche secures space at Novartis plant as COVID drives Actemra demand

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In the latest example of pandemic-related collaboration, Novartis is prepping to make the drug substance for Roche’s Actemra (tocilizumab), currently being investigated as a treatment for severe COVID-19-associated pneumonia. Novartis has signed an initial agreement with fellow Swiss pharma giant Roche to reserve capacity and implement a tech transfer for the drug substance production of Actemra (known as RoActemra in Europe) from its site in Tuas, Singapore. Actemra, a monoclonal antibody first approved in the US for rheumatoid arthritis (RA)…

April 15, 2021

CRISPR lauds easy scale-out of autologous sickle cell therapy

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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…

April 14, 2021

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

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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…

April 12, 2021

Sterling makes good on ADC Biotechnology buy

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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…

April 9, 2021

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

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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…

April 8, 2021