Therapeutic Class Archives - Page 9 of 53 - BioProcess InternationalBioProcess International

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

by Dan Stanton

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

by Gareth Macdonald

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

by Dan Stanton

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

by Dan Stanton

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

by Dan Stanton

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…

BioNTech on mRNA vaccine production: ‘50,000 steps but easy to modify’

by Dan Stanton

BioNTech says the manufacture of messenger RNA (mRNA) is simple and quick to adapt when dealing with COVID-19 variants threatening the efficiency of approved vaccines. Just 15 months ago, BioNTech was a relatively unknown player in the biopharma industry. With a global pandemic, partnership with Pfizer, and a historically fast vaccine development, approval and roll-out under its belt, the German mRNA firm is now a household name. In December 2020, the firm’s BNT162b2 became the first mRNA vaccine to be …

Lifecycle approach could cut cell and gene therapy costs

by Gareth Macdonald

Cell and gene therapy firms should consider a ‘lifecycle approach’ to process development and manufacturing to reduce cost of goods, says ElevateBio. Developing cell and gene therapies is highly complex. Such work requires specialist skills and hard to make materials like vectors, the lack of capacity for which has been raised as a constraint in the scientific and mainstream press. But cell and gene therapy firms also need to keep commercialization in mind according to Mike Paglia, COO at cell…

Bursting the bubble: COVID-19 and the gene therapy skills base

by Tony Hitchcock - Technical Director, Cobra Biologics

Despite various global lockdowns during the ongoing COVID-19 pandemic, the development of gene therapy products is on a significant upward curve with record fundraising in 2020. However, manufacturing is an increasing bottleneck in realizing the full potential of many DNA and viral vector facilities, and COVID vaccine production will have undoubtedly exposed this shortfall in production capacity. Such a deficit was and is being addressed on one level by significant investment in production facilities, and secondly by the development of…

Biotech and CDMOs need to evolve to support innovate therapies, says Ilya Pharma

by Gareth Macdonald

CDMOs and the cell and gene therapy sector need to evolve to support the increasing number of innovative therapies entering trials, says Ilya Pharma. Ilya CEO Evelina Vågesjö made the comments about innovative therapy manufacturing after the Sweden-based biotech released first-in-human (FIH) trial data indicating ILP100 – a bacteria-based therapeutic candidate designed to treat chronic wounds – shortens healing time by six days. “We have evaluated multiple CMOs [contract manufacturing organizations] for clinical material production and commercial supply already and…