Author Archives: Millie Nelson

Ginkgo adds ‘circular’ RNA with Circularis buy

The addition of Circularis and its circular RNA technology will support growing demand for nucleic acid and advanced therapy services, says Ginkgo Bioworks. The deal, of which financials have not been disclosed, sees Ginkgo add Circularis’ promoter screening platform to its existing technology. According to Ginkgo, the platform enables ultra-high throughput screening of enhancers and promoters, and the firm sees circular RNA (circRNA) as a potential therapeutic modality. “Circularis is developing cutting edge circular RNA technology, and we expect a…

Series A funding to expand Wheeler Bio OK drug substance plant

Wheeler Bio has closed a Series A financing round, which it says will fund the expansion of its biologics drug substance facility in Oklahoma. Wheeler Bio, a contract development and manufacturing organization (CDMO) that uses its open-source platform, Portable CMC, to produce clinical batches of biologics and reagents says the financing round, led by Charles River Laboratories and various others, will expand its facility in the Ziggurat building in Oklahoma City. According to the CDMO, it is solving “the momentum drop”…

Kite receives US FDA nod for California viral vector plant

The US FDA has approved Kite’s retroviral vector manufacturing plant in Oceanside, California for commercial production. According to Gilead company Kite Pharma, the authorization received from the US Food and Drug Administration (FDA) concerning its retroviral vector (RVV) facility in California supports its worldwide chimeric antigen receptor (CAR) T-cell therapy production network and helps meet demand of the firms’ blood cancer treatments. “With today’s approval, we’ll begin transitioning viral vector supply to our inhouse Oceanside manufacturing facility, while maintaining our…

Thermo Fisher launches Dynabeads tech to support mRNA production

Thermo Fisher Scientific has introduced a customized Dynabeads solutions, which it says supports synthesis and purification of mRNA for manufacturing and vaccine development. According to the firm, the Dynabeads Streptavidin for in vitro transcription and Dynabeads for carboxylic acid for RNA purification solutions can support messenger RNA (mRNA) synthesis and purification for vaccine development and production. Furthermore, Thermo Fisher says that when combined with its TheraPure portfolio of enzymes and nucleotides, it provides a simplified workflow that allows mRNA firms…

Modular systems make facility delivery fast, says Tenaya

Scott Bertch from heart disease gene therapy developer Tenaya Therapeutics told BWB delegates modular systems have the ability to accelerate facility delivery. When thinking of gene therapies “manufacturing is one of the biggest problems,” Bertch, executive director, clinical manufacturing site head at Tenaya Therapeutics told delegates at the BPI conference, part of Biotech Week Boston 2022. While there are pros and cons associated with both inhouse and outsource manufacturing models (Tanaya has previously spoken positively about the former for cell…

Boehringer Ingelheim rolls out VR training at fill-finish facilities

Boehringer Ingelheim has deployed Virtuosi, a virtual training (VR) educational platform, across three of its aseptic manufacturing sites. Virtuosi, developed by Quality Executive Partners (QxP), claims to be the “world’s first” and singular multi-language immersive training platform training platform for the pharmaceutical manufacturing operators in aseptic processing, cell and gene therapy processing, and microbiology. The VR training platform will be deployed at Boehringer Ingelheim’s Biberach and Ingelheim sites in Germany, as well as a plant in Lyon, France. According to…

Rocket bolsters AAV pipeline with Renovacor buy

Rocket Pharmaceuticals will gain Renovacor’s program REN-001, an AAV-based gene therapy targeting BAG3-associated dilated cardiomyopathy (DCM) through the acquisition. Under the terms of the deal, Rocket, a firm focused on genetic therapies for rare childhood disorders, has acquired Renovacor, a company aiming to deliver precision therapies for individuals battling genetically-driven cardiovascular and mechanistically-related diseases. Rocket claims that the acquisition strengthens its adeno associated virus (AAV) based cardiac gene therapy leadership and scales the firm’s clinical assets for the treatment of…

Platforms are pivotal to pandemic speed, says BMS

Only companies that have strong platforms will be able to meet specific timelines, says Bristol-Myers Squibbs’ Jim Xu. As COVID-19 transitions into an endemic, delegates at Biotech Week Boston discussed the challenges concerning the upstream process development process. Jianlin (Jim) Xu, scientific director, biologics development at BMS, explained told a packed room that monoclonal antibodies (mAbs) are difficult to produce with complex glycosylation profile, process related impurities, and amino acid oxidation. Xu also outlined other challenges, which included bioreactor operation…

PerkinElmer pulls out CGT platform at Biotech Week Boston

PerkinElmer says that its Cellaca PLX system is the cell analysis solution to streamline cell and gene therapy research and production. BioProcess Insider is back at BPI Boston – part of Biotech Week Boston – after three years away where among the many exhibitors PerkinElmer has launched its Cellaca PLX image cytometry system. According to the company, the technology designed by the firm’s Nexcelom unit offers researchers expanded cell sample critical quality attributes (CQA) beyond flow cytometry and staining methods.…

MilliporeSigma opens its first viral clearance lab in China

MilliporeSigma has completed the first construction phase of its China Biologics Testing Center, opening a viral clearance (VC) laboratory in Shanghai. MilliporeSigma, the life sciences division of Merck KGaA, says the 5,000 square meter center is the “first of its kind” for the firm in China. And according to the company, the $28 million VC laboratory helps meet the double-digit demand for VC services in the country as it enables its customers to locally conduct viral clearance studies from pre-clinical…