Drugs

Ori is focused on bringing automated manufacturing to the cell and gene therapy (CGT) industry, while the CTMC is a joint venture between National Resilience Inc and MD Anderson Cancer Center.  The alliance is aimed at speeding up process development, clinical implementation, and commercialization of novel cell therapies. It will leverage Ori’s technology platform with CTMC’s

The decision will have widespread implications for the cell and gene therapy (CGT) sector as well as for patient safety, says the International Society for Cell & Gene Therapy (ISCT). The judgement is flawed, according to the industry organization. It said the decision has inserted regulatory uncertainty into the CGT market, creating opportunities for clinics offering

The aim is to create a ‘sustainable, safe and secure American bioeconomy’. Among the goals outlined are ethical and responsible uses of biotechnology and biomanufacturing; and measures to reduce biological risks associated with advances in biosecurity. “The COVID-19 pandemic has demonstrated the vital role of biotechnology and biomanufacturing in developing and producing life-saving diagnostics, therapeutics,

The company said it commissioned independent research among 31 key players in the UK and Irish biopharma industry to discover key areas for business improvement. The study was conducted between late 2019 and early 2022, covering the period affected by the global pandemic. The findings reveal that with much pharma manufacturing still employing heavy use

The study, which was commissioned by APAC focused biotech specialist CRO, Novotech, found that all phases of clinical trials in the region registered higher growth than both the US and the EU. The region registered significantly higher growth than the US and the EU across all analysed therapeutic areas, including CNS diseases, cardiovascular diseases, gastrointestinal

The new RNA capabilities are available to scientists using Benchling’s R&D cloud across the globe. The platform is the first purpose-built offering on the market to help R&D organizations accelerate the delivery of drug candidates, said the developer. Comprising an RNA-aware registry with visualization tools for oligo and mRNA design and the only tool with

Under the terms of the agreement, Lonza can now provide its customers with seamless access to Touchlight’s enzymatic DNA technology. The Hampton, UK headquartered company said the synthetic DNA source enables GMP production at unprecedented speed, scale, and purity.   Both parties have agreed not to disclose financial or contractual terms of the collaboration. A spokesperson

The German biopharma company has secured access on a target-specific basis to Synaffix’s proprietary antibody drug conjugate (ADC) technologies. Emergence said the first program will commence at signature, with the option to expand the collaboration to additional targets. The agreement, said the entities, is the result of positive proof of concept data following a successful

ABNCoV2 is a next-generation COVID-19 vaccine candidate, initially developed by Denmark’s AdaptVac (spun out from the University of Copenhagen) using its proprietary capsid virus like particle (cVLP) technology. Bavarian Nordic gained the global commercialization rights to the vaccine in 2020​ with a €4m ($3.97m) upfront payment to AdaptVac, assuming the responsibility for further clinical development towards

It has invested in high-level expertise, personnel, and facilities globally, with the goal of rapid transition into the launch of its innovative cell and gene therapy (CGT) manufacturing platform. The developer has boosted its senior leadership team with several new appointments, including three directors, to support further growth and push the commercialization of its platform,

Broadly speaking, Industry 4.0 refers to the ongoing automation and digitalization of manufacturing and industrial practices, benefiting from smart tech. In biopharma, it offers the chance to improve quality and supply as well as reducing costs. And yet the sector is behind other advanced manufacturing industries when it comes to adopting these disruptive technologies. Helping drive

The European Commission authorized the Omicron bivalent vaccines on Thursday, with the two vaccines adapted to provide broader protection against COVID-19. The decision follows the US FDA’s move to grant emergency use authorization to Omicron vaccines​​ on August 31. Member states to decide roll out Comirnaty Original/Omicron BA.1 (Pfizer/BioNTech) and Spikevax bivalent Original/Omicron BA.1 (Moderna)

The biotechnology as a service (BaaS) company wants to boost biologics manufacturing in the company – noting a particular opportunity for the uptake of biosimilars – cutting import costs and thus encouraging the local industry to develop. “Brazilian universities, startups, and medium-large companies face enormous challenges in developing biological Active Pharmaceutical Ingredients (APIs),”​ notes the

Thinking about ways in which to improve the output of the manufacture of biologics has often led the pharma industry to look to other industries. The continuous process that was developed in the car manufacturing industry, as an example, provided a model where production could be streamlined through the use of automation and the harnessing

SUTs: Greater collaboration between suppliers and developers can address challenges linked to viral vector manufacturing SUTs manufactured from single-use components made from polymeric materials, sterilized, and ready to use, are widely used for various purposes, ranging from classical biomanufacturing of proteins, monoclonal antibodies (mAbs), and vaccines on a large scale; they are now being adopted

Dr Haifer was the former chairman of Australian biotech firms Agilex Biolabs and Avance Clinical. Based in the US and with more than US$3bn in assets under management, Ampersand has partnered with CDMOs such as Brammer Bio, ArrantaBio, Vibalogics, and Genezen. AcuraBio has expertise in the areas of recombinant proteins, whole cell vaccines, viral vaccines,

Pfizer’s modified booster secured an emergency use authorization (EUA) from the US Food and Drug Administration (FDA) for people aged 12 and older, while Moderna’s shot was given an EUA for use in individuals aged 18 and up. The bivalent vaccines or ‘updated boosters’ contain two messenger RNA (mRNA) components of SARS-CoV-2 virus, one of

RoosterBio, a Maryland, US, supplier of human mesenchymal stem/stromal cells (hMSCs), highly engineered media, and bioprocess development services, says the partnership ties in with its aims to expand globally this year and beyond. “RoosterBio’s engineered media products are creating transformative impact for cell and exosome therapy developers all over the world,”​ said Tim Kelly, CEO.

Running over three years, the award will support preclinical, manufacturing and non-clinical safety studies, along with development and regulatory support for the tech for rapid pandemic influenza response through Phase 1 clinical studies. It will be used to develop a low-dose, freeze-dried, pandemic influenza vaccine candidate using Arcturus’ Starr self-amplifying mRNA vaccine platform technology. This

What steps are needed to enable wider adoption of process intensification in biopharma? “This maturation requires robust and flexible manufacturing strategies that fit variable market demand, reduce production costs and support increasingly regionalized supply needs,”​ according to an article published in Chemical Engineering and Processing: Process Intensification.​ That paper​​ focuses on showcasing concrete implementation examples and

Higher yielding processes, faster manufacturing and fewer consumables can all help drive significant reductions in environmental impact, highlight a group of authors including scientists from Genentech, GlaxoSmithKline and Merck & Co in a paper published in New Biotechnology.​ “The process intensification approach aligns perfectly with the direction of the biopharmaceutical industry striving to reduce cost

The Milpitas, California cell and gene therapy CRO/CDMO, whose focus is on supporting the research community and biotechnology industry in developing and manufacturing cell and gene products, has successfully carried out cell banking and product manufacturing projects in its current cGMP suite and is now set on building 4 additional cGMP cleanrooms, cryo-storage space, and