Author Archives: Millie Nelson

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…

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…

CGT Catapult partnership to develop AAV gene therapies for dementia

The Cell and Gene Therapy Catapult (CGT Catapult) and the UK Dementia Research Institute (UK DRI) have partnered to drive the development of adeno-associated virus (AAV) based gene therapies for dementia. According to CGT Catapult, dementia is one of the leading causes of mortality in the UK and while treatments are emerging and improving, with no effective treatment options currently available for neurodegenerative conditions, dementia-related deaths are continuing to increase. The UK DRI’s role is to develop an understanding of…

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…

Univercells partners with CBET to prep students for CGT space

The partnership will see Univercells Technologies provide support to prepare Albany College of Pharmacy and Health Sciences (ACPHS) students for careers in cell and gene therapy. APHS’ Stack Family Center for Biopharmaceutical Education and Training (CBET) provides research and training solutions for the biopharmaceutical manufacturing space and is Univercells first US-based training partner. Under the terms of the deal, of which financial details have not been divulged, Belgian-based firm Univercells is set to give on-site access and training on cutting…

Avid doubles mammalian capacity with $6m investment

Avid Bioservices says the expansion of its laboratories could support a further $20 million in annual process development revenue, doubling its current capacity. Contract development manufacturing organization (CDMO) Avid says it is not specifying what facility the expansion will take place at but did confirm it will be located on the firm’s main campus in Tustin, California. “The company is expanding to keep up with market demand for these CDMO services. Avid is focused on ensuring that it always has…