Author Archives: Millie Nelson

Sheffield University to build gene therapy facility

The construction of a gene therapy facility in Sheffield, UK will advance scientific discoveries into treatment options for patients, says University. The Gene Therapy Innovation and Manufacturing Centre (GTIMC) is one of three hubs, which are part of an £18 million ($24 million) network funded by the Medical Research Council (MRC), LifeArc, and supported by the Biotechnology and Biological Sciences Research Council (BBSRC). The other two hubs are located at Kings College London and NHS Blood and Transplant in Bristol…

CureVac manufacturing switch-up as it shelves COVID-19 vax

CureVac will shift its manufacturing setup to produce clinical material for second-generation mRNA vaccine candidates as it abandons CVnCoV.   Just one month ago, CureVac dropped two contract development manufacturing organization’s (CDMOs) after demand for mRNA COVID-19 candidate CVnCoV diminished but the firm remained confident future clinical trials would still go ahead.   Now, CureVac has decided to withdraw the first-generation vaccine candidate from the approval process with the European Medicines Agency (EMA) in a bid to “refocus efforts on improved second-generation vaccine candidates we are developing in collaboration with GSK.” According to the firm, its second-generation candidates are based on an improved mRNA setup and includes flu…

Ins and outs: High level changes at BlueRock, Pfizer and the NIH

Emile Nuwaysir has stepped down from his position as CEO of BlueRock and moves to in vivo cell therapy firm Ensoma. Meanwhile, there are changes at Pfizer and the National Institutes of Health (NIH). Nuwaysir has been CEO of Bayer’s subsidiary BlueRock Therapeutics since 2017. Since then, the company has transitioned from a preclinical start-up to a clinical-stage firm that employs over 200 people across two countries. Nuwaysir will remain at the company as a board chair and continue to…

MilliporeSigma says viscosity tech overcomes manufacturing challenges

MilliporeSigma has launched a Viscosity Reduction Excipient Platform, which it says helps tackle production and formulation issues associated with highly concentrated protein solutions. According to Merck’s Life Science business MilliporeSigma, the Viscosity Reduction Platform can address specific needs of different protein-based therapeutics through the combination of amino acids and anionic components. “MilliporeSigma’s new Viscosity Reduction Excipient Platform reduces interactions between proteins (including antibodies) that make the product too thick to pass through an injection needle,” Matthias Bucerius, head of actives and formulation at MilliporeSigma told us. “The platform does…

HPNE to hire 150+ to support Rhode Island facility

High Purity New England (HPNE) will hire more than 150 employees as part of a larger strategic plan for the firm. HPNE, a supplier of equipment and solutions for the biopharmaceutical sector, will begin to immediately hire 150+ employees in what the company is dubbing as a “substantial hiring push” as it prepares to open its facility in early December. The firm has invested more than $10 million at its plant in Smithfield, Rhode Island – just 50 minutes south…

In brief: Moderna to invest in R&D headquarters

Moderna will build a science center in Cambridge, Massachusetts to support and advance its pipeline of mRNA vaccines and therapeutics.  Messenger RNA (mRNA) firm Moderna will construct a purpose-built space to support the company’s research and development efforts. The site will be known as the Moderna Science Center, located at 325 Binney Street in Cambridge. “We have been located in Massachusetts since our founding more than 10 years ago and are proud to be based here. As we advance our mRNA platform…

Thermo Fisher opens Swiss biologics plant

Thermo Fisher will assume operational responsibility for a biologics manufacturing facility in Lengnau, Switzerland as part of its collaboration with CSL Limited. The 1.5 million square-foot plant will become part of Thermo Fisher Scientific’s global biologics manufacturing network. The facility will house flexible bioproduction technologies, such as single-use and stainless steel with up to 12,500 L bioreactor capacity. Thermo Fisher took over operations at Lengnau in June 2020 after it entered a strategic partnership with CSL. “Through our partnership with…

Neurophth gene therapy plant a nod to China’s preference for inhouse

Neurophth Biotechnology has opened a gene therapy manufacturing plant at Suzhou Biomedical industrial park (BioBay) in China, eliminating dependence on CDMOs. Neurophth claims to be China’s first gene therapy firm for ophthalmic diseases headquartered in Wuhan with subsidiaries located in Shanghai and Suzhou, China, and San Diego, California. The recently opened 8,000 square meter gene therapy-focused manufacturing facility includes two drug substance production suites, a cell banking suite, two filling lines, a technology transfer laboratory, and a quality control laboratory.…

ViroCell partnership to double UK lentivirus vector capacity

ViroCell has partnered with Great Ormond Street Hospital to address the global viral vector manufacturing bottleneck for clinical trials. Contract development manufacturing organization (CDMO) ViroCell Biologics says its partnership with Great Ormond Street Hospital (GOSH) will more than double the UK’s lentivirus vector manufacturing capacity for clinical trials in 2022. Additionally, ViroCell claims the collaboration will secure its position as the first CDMO in the UK to deliver adeno-associated viruses (AAV) vectors to the cell and gene therapy (CGT) markets.…

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…