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…

Catalent: ‘Dedicated Moderna line frees space for our non-COVID customers’

Catalent has dedicated a high-speed vial filling line to Moderna at its site in Indiana, which it says will free up space for its non-COVID related customers.  The high-speed vial filling line expands upon an agreement inked between the two firms last June, and provides Moderna with a dedicated fill-finish service through to June 2023. It will initially be used to manufacture Moderna’s COVID-19 vaccine, approved by the US FDA under an emergency use authorization (EUA) last December, though there is potential for it to produce other clinical products in the firm’s pipeline. According to the…

CyanVac selects Exothera to make intranasal COVID-19 vaccine

CyanVac has partnered with CDMO Exothera to develop and manufacture its intranasal COVID-19 vaccine candidate CVXGA1 using the scale-X platform. Georgia, US-based vaccine developer, CyanVac has selected contract development manufacturing organization (CDMO) Exothera to advance development of a manufacturing process for its COVID-19 vaccine candidate that is administered intranasally as a single dose to prevent SARS-CoV-2 infection. “We have been working on intranasal vaccines for over 20 years,” Biao He, CEO and founder of CyanVac told BioProcess Insider. “The viral vector…

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…

Oxford BioMedica to supply viral vectors to Boehringer Ingelheim

Oxford BioMedica has signed a three-year contract to manufacture and supply viral vectors to support Boehringer Ingelheim’ s cell and gene therapy pipeline. Under the terms of the Development and Supply Agreement (DSA), Oxford BioMedica will manufacture batches for German pharmaceutical company Boehringer Ingelheim. The agreement also enables Oxford BioMedica to produce and supply viral vector products in the future. The manufacturing will take place at Oxford BioMedica’s Windrush Court site, located in Oxford, UK as well as at one…

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…

BARDA to give Emergent another $23m for tech after J&J jab mix-up

BARDA to give Emergent Biosolutions an extra $23 million for new tech after plant mix up ruined millions of doses of J&J’s single-shot COVID vaccine. The facility in question is Emergent’s plant in Baltimore, Maryland which made the news after it emerged the contract development and manufacturing organization (CDMO) had mistakenly mixed ingredients of the J&J jab with those of the AstraZeneca shot, rendering 15 million doses unusable. The incident prompted the Biden administration to place Johnson & Johnson in…

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…