Author Archives: Millie Nelson

Biocon hit by FDA 483 with 6 observations at Malaysian plant

Biocon’s insulin manufacturing facility in Malaysia has received a US FDA Form 483 with six observations but firm says it will not affect commercialization plans in the US. Indian biopharma giant Biocon reported this week it has been issued with a Form 483 by the US Food and Drug Administration (FDA) after the agency conducted an on-site pre-approval inspection (PAI) at its Malaysian  manufacturing plant for its biosimilar insulin product. “The US FDA conducted a (PAI) of our Malaysian subsidiary…

Sartorius expands presence in North America with Michigan plant

Sartorius plans to build a plant in Ann Arbour, Michigan expanding its business operations in North America. German life sciences firm Sartorius is expanding its presence in Michigan with plans to open an 130,000 square-foot facility in the Tech Loop at Ann Arbor Research Park by the end of 2023, creating a flag ship plant for the firm in North America. In total, the firm has purchased over 15 acres of land at an undisclosed price, providing it with sufficient…

Boston Labs and Germfree launch mobile CGT platform

Boston Labs and Germfree Laboratories have partnered to launch a mobile cell and gene therapy (CGT) manufacturing platform in Boston, US. The partnership between clinical logistics firm, Boston Labs, and manufacturer of mobile and modular laboratories, Germfree, aims to reduce client CGT production expenses and complexities by delivering access to mobile manufacturing facilities wherever they are required. The CGT mobile manufacturing platform will be launched in the fourth quarter of 2021 in Boston, Massachusetts offering a decentralized cell and gene therapy…

Quell bolsters manufacturing capabilities with CGT Catapult collaboration

Quell Therapeutics has partnered with Cell and Gene Therapy Catapult expanding its manufacturing capabilities to develop engineered T-regulatory cell therapies. The collaboration will see T-regulatory (Treg) cell therapy firm, Quell, bolster its clinical manufacturing capacity and capabilities at Cell and Gene Therapy Catapult’s (CGT Catapult) recently opened large-scale production facility in Stevenage, UK. “By collaborating with CGT Catapult at the manufacturing innovation center in Stevenage, Quell can setup additional GMP manufacturing operations benefitting from infrastructure, expertise and a surrounding cell…

Novartis boosts optogenetics portfolio with Arctos buy

Novartis will bolster is adeno-associated virus (AAV) gene therapy-based options for different forms of blindness through the acquisition of Arctos Medical. Swiss pharma giant Novartis has acquired gene therapy firm Arctos for an undisclosed fee, gaining one pre-clinical optogenetic AAV gene therapy program and its technology platform. Optogenetics uses light to modulate molecular events in a targeted manner in organisms or living cells and according to Novartis the acquisition supports its commitment to using optogenetics-based therapies to restore vision to patients…

Sartorius inks deal for virus clearance center in Scotland

Sartorius has bolstered its virus clearance R&D capabilities in Lanarkshire, Scotland after signing a 15-year lease. The deal, of which financial details have not been disclosed, sees German life sciences firm Sartorius take over more than 8,500 square-feet within Maxim 3 at the Eurocentral park for various research. Lonza already has a presence in Glasgow, Scotland with a competence center for bioanalytics and a small team of experts for virus clearance services following its acquisition of BioOutsource in 2015. “This…

Lonza to expand DP capabilities in Switzerland

Lonza will invest in additional drug product manufacturing capabilities in Switzerland to accelerate existing service offerings in Basel and Visp. The expansion will see contract development manufacturing organization (CDMO) Lonza install an aseptic fill-finish line in Stein, Switzerland and expand drug product services in Basel and Visp. “We constantly assess our assets and invest in developing and installing new capacity and technology to meet the market demand in biologics,” Peter Droc, head of drug product services at Lonza told BioProcess…

Chinese CDMO market growing rapidly despite talent shortage, says Lonza

Lonza says its presence in China is growing despite a short-term talent shortage in the industry. “The Chinese pharma market is big and growing very quickly [with] a lot of molecules that are in development,” Lonza’s general manager of China, Hong Pan, tells BioProcess Insider. “China was very generically driven but more companies are putting their money into innovative pharma. The added growth is due to a few factors, [such as] the increased wealth of the population. People are getting…

Moderna and AbCellera join forces to develop antibody therapies

Moderna’s mRNA technology platform will be combined with AbCellera’s AI-powered antibody discovery platform to develop mRNA-encoded antibody therapeutics. The multi-year deal, of which financial details have not been disclosed, will see Moderna use AbCellera’s antibody discovering platform to search and examine natural immune responses to identify therapeutic antibodies against up to six targets. AbCellera’s platform will be combined with Moderna’s messenger RNA (mRNA) technology platform with a shared aim of accelerating the development of mRNA-encoded antibody therapeutics. Under the terms…

CEVEC and UCB ink AAV manufacturing agreement

UCB will use CEVEC’S adeno-associated virus (AAV) vector manufacturing technology platform to research, develop and produce AAV gene therapy products. Under the terms of the agreement, CEVEC Pharmaceuticals will grant UCB the non-exclusive rights to its ELEVECTA technology to research, develop, and manufacture Adeno-Associated Virus (AAV) vectors for gene therapy applications. The deal also provides UCB with the option to obtain licenses for use of the ELEVECTA producer cell lines in commercial production of potential AAV gene therapy candidates, and…