Therapeutic Class

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…

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

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

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

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

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…

Turning a corner in CAR-T: FDA approves ide-cel

The US FDA has approved Abecma (ide-cel); the first CAR-T for a non-CD19 target and the second cell therapy in eight weeks for Bristol-Myers Squibb. This weekend, the US Food and Drug Administration (FDA) approved Abecma (idecabtagene vicleucel, commonly referred to as ide-cel) as the first cell-based gene therapy for the treatment of multiple myeloma. Developed by Bristol-Myers Squibb acquisition Celgene and fellow advanced therapy maker bluebird bio, Abecma is a B-cell maturation antigen (BCMA)-directed genetically modified autologous chimeric antigen…

Cytovia driving CAR NK manufacturing to Puerto Rico

Cytovia Therapeutics will set up a facility in Aguadilla, Puerto Rico to support production of its off-the-shelf iPSC-derived CAR NK therapeutics. Cell therapy developer Cytovia has signed a long-term joint collaboration manufacturing and operations agreement with BioSciencesCorp to integrate Cytovia’s manufacturing processes within an existing 95,000 square-foot facility. The plant, which will include more than 40,000 square feet of cleanroom and biomanufacturing space, will be located in Aguadilla, Puerto Rico, and the firm says it will recruit manufacturing personnel beginning…

‘mRNA has been validated’ – Pfizer looks beyond COVID

Pfizer is set to make around $15 billion from its COVID vaccine this year, but going forward the firm expects mRNA to be key in other applications. Through its partnership with BioNTech, Pfizer became the first company to receive US and EU approval for a messenger RNA-based product, namely the COVID-19 vaccine BNT162b2. Rollout of the vaccine continues across the globe and as such Pfizer has estimated it will realize approximately $15 billion in sales in 2021 alone. Speaking at…