Facilities & Capacity

NorthX jumping into cell therapy space with help from Alder

Alder Therapeutics will help CDMO NorthX expand its services into pluripotent stem cells and help to design and validate process development and GMP-manufacturing labs in Sweden. Investor group Flerie launched contract development and manufacturing organization (CDMO) NorthX Biologics in 2021, through the acquisition of a former-Cognate plant in Matfors, Sweden from Charles River Laboratories. The entity has focused on providing plasmid DNA and technical protein production at commercial scale but is now expanding into cell therapy services, establishing GMP-manufacturing labs…

Commercial CAR-Ts: Ensuring lentivirus supply key for J&J and BMS

J&J and Bristol-Myers Squibb have spoken of plans to increase supply of lentivirus as they continue to roll out their respective CAR-T therapies. Bristol-Myers Squibb, meanwhile, achieved commercial chimeric antigen receptor T-cell (CAR-T) success in early 2021 with the approval of both Breyanzi (liso-cel) – which last week was granted second-line approval for relapsed or refractory large B-cell lymphoma (LBCL) by the US Food and Drug Administration (FDA) – and Abecma (ide-cel) for multiple Myeloma. In March 2022, the FDA…

Tenaya launches operations at its California plant

The modular facility in Union City, California will support the development of cardiovascular gene therapies and lessen Tenaya Therapeutics’ reliance on CDMOs. The firm announced its plans for the Genetic Medicines Manufacturing Center after a $106 million Series C funding round in April 2021. The 94,000 square-foot modular facility will advance a pipeline of adeno-associated virus (AAV) gene therapy candidates for the potential treatment for heart disease, including lead programs TN-201 for genetic hypertrophic cardiomyopathy (gHCM) and TN-401 for arrhythmogenic…

From UK to Rwanda: mRNA driving localized manufacturing model

Moderna is bringing local mRNA manufacturing to the UK through a large-scale facility, while BioNTech has broken ground on a modular scalable mRNA plant in Kigali, Rwanda. Is this the start of a localized production trend? BioNTech this morning announced its efforts to bring localized vaccine manufacturing to Africa have reached a milestone with the commencement of construction of a manufacturing facility in Kigali, Rwanda expected to produce around 50 million doses of mRNA vaccine. The news comes eight months…

VIVEbiotech Spain plant fully operational after GMP accreditation

VIVEbiotech says its facility in San Sebastian is fully operational after it received renewal of its GMP accreditation for a further three years. Contract development manufacturing organization (CDMO) VIVEbiotech claims the good manufacturing practice (GMP) accreditation means it is now certified for in vivo applications as well as ex vivo. Additionally, the CDMO’s capabilities will continue to be expanded through the incorporation of automated processes. VIVEbiotech says that it is looking at automation as a potential solution to cost challenges…

Elektrofi bags $40m funding to establish manufacturing line

Elektrofi has received $40 million in a Series B financing round to fund a manufacturing line to support clinical trials and double its headcount. Elektrofi, a Boston-based biotech that focuses on drug formulation and delivery, says part of the $40 million will be used to establish a centralized manufacturing line to support numerous upcoming clinical trials. “This financing sets the stage for advancement of multiple lead programs to human trials, clinical validation of Elektrofi’s high concentration technology, and pipeline expansion…

Batavia ups capacity at Netherlands plant

Batavia Biosciences will increase capacity for viral vectors and vaccine research and development at its plant in the Netherlands. Contract development manufacturing organization (CDMO) Batavia (acquired by CJ Cheiljedang in November 2021) will add 22,500 square feet at its Netherlands plant for an undisclosed fee. According to the CDMO, the expansion will enable it to increase its R&D activities for viral vector-based product development. This includes adeno-associated (AAV), lentivirus, adenovirus, and measles virus vectors. “At Batavia, we are reminded daily…

Entegris opens plant to address cold-chain supply challenges

The center in Billerica, Massachusetts will give clients the opportunity to test equipment and containers for freeze and thaw processes, says firm. According to Entegris, the facility will offer life sciences customers the chance to make use of the company’s knowledge surrounding cold-chain supply challenges. In turn, the firm says it can improve processes, decrease costs, and increase speed-to-market. Entegris is offering clients its Aramus Shaped 2D single-use bags with custom sizes, shapes, and assembly configurations as a part of…

CBM accelerates plans to add capacity for 10,000 patient therapies

The Center for Breakthrough Medicines (CBM) and Discovery Labs respond to the critical shortage of cell therapies by accelerating plans to build capacity to produce over 10,000 patient therapies. The plant expansion at CBM’s King of Prussia, Philadelphia, which was initially outlined to begin planning in 2024-2025, has now been started due to “the critical lack of cell therapy supply,” a spokesperson for CBM told us. “We are also seeing shortages for already approved products, long waitlists, and doctors being…

REGENXBIO opens Maryland AAV plant

REGENXBIO has launched operations at its $65 million Manufacturing Innovation Center gene therapy facility in Rockville, Maryland. In 2019 the firm announced its plans to construct a GMP facility at its 132,000 square-foot headquarters in Maryland to produce adeno-associated viral vectors (AAV’s) for its gene therapy programs using its NAV technology-based platform. Now, REGENXBIO has opened what is has named the “Manufacturing Innovation Center” in Rockville and says it includes AAV vectors at scales of up to 2,000 L. According…