Therapeutic Class Archives - Page 37 of 53 - BioProcess InternationalBioProcess International

Samsung Bio to make $1bn worth of CytoDyn’s HIV antibody

CytoDyn has contracted Samsung BioLogics to produce the drug substance for its candidate leronlimab and says it will need at least two CMOs once the HIV inhibitor is approved. CytoDyn’s lead candidate leronlimab (PRO 140) has demonstrated antiviral activity and shown to significantly reduce viral burden in people infected with HIV in Phase II clinical trials. The fully humanized IgG4 monoclonal antibody blocks the predominant HIV (R5) subtype entry into T-cells by masking the required co-receptor, CCR5. The firm has…

‘Aging’ biotech AgeX to build Cali cell therapy plant

by Dan Stanton

AgeX Therapeutics will construct a cGMP laboratory facility in Alameda, California to manufacture cell lines and its biological aging cell-based product candidates. The biotech firm announced in an SEC filing that it has entered into an agreement to lease 23,911 square feet of space in Alameda, California. The space will be used as AgeX’s principal offices and research laboratory, but the firm also intends to construct a cGMP laboratory facility for the manufacture of cell lines and its cell-based product…

AZ inks $6.9bn ADC deal with Daiichi Sankyo

by Gareth Macdonald

AstraZeneca and Daiichi Sankyo will co-develop cancer antibody-drug conjugate (ADC) DS-8201 in a deal worth up to $6.9 billion. AstraZeneca will pay $1.35 billion (€1.2 billion) upfront for rights to DS-8201 (trastuzumab deruxtecan). The UK firm will pay a further $5.5 billion if the drug achieves regulatory and sales targets. Under the agreement, Daiichi will manufacture DS-8201. AstraZeneca will help develop and sell the drug worldwide, except in Japan where Daiichi has exclusive rights. Spokesman Rob Skelding told us AstraZeneca’s…

Novartis grabs AstraZeneca’s CO plant and staff for AveXis gene therapy

by Dan Stanton

Novartis has acquired a biomanufacturing facility – earmarked for closure by AstraZeneca – ahead of the potential launch of AveXis’ gene therapy for spinal muscular atrophy, Zolgensma. Since Novartis bought AveXis for $8.7 billion (€7 billion) in May 2018, the Swiss pharma giant has rapidly grown its gene therapy manufacturing network. The latest action sees the firm add the 700,000 square-foot Longmont facility to its AveXis operations in what it says is preparation for the launch of Zolgensma (onasemnogene abeparvovec-xioi1),…

Biocon: One eye on biologics IPO to support blossoming biosimilars

by Dan Stanton

Managing director Kiran Mazumdar-Shaw has told Indian news outlets Biocon could spin-out its biologics division to raise funds for further biosimilar development. Biocon is Indian’s largest pharmaceutical firm with a portfolio of small molecule and branded formulation products. But the Indian drugmaker has also begun to make its mark on the international biosimilars market with commercialization partner Mylan launching various products in both the US and European markets. Ogivri became the first biosimilar of Roche’s Herceptin (trastuzumab) to be approved…

CDMO Masthercell boosting capacity and adding 150 jobs at Belgium plant

by Dan Stanton

Months after doubling capacity at the Gosselies site, Orgenesis has announced further plans to expand its CDMO Masthercell too feed the demand for cell and gene therapies. Late last year, contract development and manufacturing organization (CDMO) Masthercell unveiled a wing with five cleanrooms at its site in Gosselies, Belgium, which it said effectively doubled its cell therapy production capacity. Four months on and the firm’s parent company Orgenesis has announced another expansion at the site having signed a lease on…

Manufacturing is the differentiator for CAR-T success, says Allogene

by Dan Stanton

Allogene has tweaked the manufacturing process for its allogeneic CAR-T candidate ALLO-501 to produce more robust and consistent product. Since raising $324 million (€283 million) in an initial public offering (IPO) last October, Allogene Therapeutics has announced plans to build a 118,000 square foot cell therapy manufacturing facility in Newark, California and reported its first fourth quarter financials. In the call discussing the latter, the firm’s CEO David Chang told stakeholders that success for chimeric antigen receptor (CAR) T-cell therapies…

Breaking the Big 4: How Takeda is taking on vaccines

by Dan Stanton

While vaccines will continue to be dominated by GSK, Merck, Pfizer, and Sanofi, manufacturing and collaborations can help to unblock this consolidated industry says recent entrant Takeda. Rahul Singhyi, COO of Takeda vaccines, told delegates at the BPI West event in Santa Clara, California that vaccines used to be viewed as “the backwaters of the pharma industry, largely considered part of corporate social responsibility,” but that has changed over the past 20 years due to innovations and approvals in disease…

Shanghai center aims to accelerate cell and gene therapy development

by BPI Staff

The ATLATL-MACS Center will support biotech firms in the burgeoning cell and gene therapy space and will include access to Miltenyi automated CAR-T preparation instruments. Having spent a year under construction, ATLATL-MACS Center opened this week. The center is a collaboration between ATLATL Innovation Cluster (AIC) – a Chinese innovation support firm offering lab space as a service – and cell and gene therapy vendor Miltenyi Biotec aimed at supporting the growing research in innovative and personalized medicines. ATLATL and…

Lonza’s POC CAR-T tech: Out with the cleanroom, in with the Cocoon

by Dan Stanton

Lonza will provide its point-of-care (POC) Cocoon cell therapy platform to the Sheba Medical Center in Israel to provide automated and closed CAR-T manufacturing. The collaboration between Sheba and Swiss contract development and manufacturing organization (CDMO) Lonza aims to confirm the benefits of using the Cocoon system to make autologous cell therapies in a POC environment. “The partnership with Sheba will test the Cocoon in the clinical setting,” Eytan Abraham, head of Personalized Medicine at Lonza Pharma Biotech, told Bioprocess…