Drugs

The French companies’ objective is to to enter clinical phase in 2023.  Cell-Easy, based in Toulouse, is specialized in the development and production of Advanced Therapy Medicinal Products (ATMPs). Its facilities include suites for customized process development, process scale-up, cGMP manufacturing along with analytical services for immune cells and adult stem cells. Emercell, whose R&D

The 1,858 sq. m (20,000 sq. ft) expansion will include modular clean rooms, purification suites and a column packing room. The work is expected to be completed in late 2023/early 2024, enabling the manufacturing capacity of the large-scale microbial production facility to increase by 70%. Microbial expression technologies continue to be the pillar of the

The $53m deal will create ‘strong synergies’ by combining key assets, personnel, capabilities and IP; while Rocket gains Renovacor’s REN-001, an AAV-based gene therapy targeting BAG3-associated dilated cardiomyopathy (DCM), a severe form of heart failure (for which Rocket highlights ‘compelling preclinical data’ generated by Renovacor) New Jersey headquartered Rocket currently has four gene therapies in

The grant has been awarded under the Australian Federal Government’s Modern Manufacturing Initiative (MMI).  In 2021, Vaxxas received AU$4.4m in first round MMI funding to support the specialized infrastructure necessary to manufacture its high-density microarray patch (HD-MAP) device at its facility currently under construction at Northshore, Brisbane. That new site will support late-stage clinical trials

Boasting an outstanding safety record, lentiviral vectors (LVV) are key components in CAR-T cell therapy manufacturing. Unfortunately, owing to the lack of a robust and scalable production platform, therapy providers too often experience highly variable quality, inconsistent yields, and poor recoveries, leading to severe disruptions in the supply chain, said the partners. By combining Cellares’

jCell is a regenerative cell therapy for retinitis pigmentosa (RP) and other retinal degenerative diseases, which has received FDA Regenerative Medicine Advanced Therapy (RMAT) designation. Under the terms of the agreement, CBM will provide Phase 3 clinical trial supplies and commercial drug product following Biologics License Application (BLA) approval of jCyte’s proprietary jCell platform technology.

Tofersen is an antisense oligonucleotide being evaluated for the potential treatment of superoxide dismutase 1 amyotrophic lateral sclerosis (SOD1 ALS). In October 2021, the Phase 3 Valor trial failed to meet its primary endpoint after six months, although trends of reduced disease progression across multiple secondary and exploratory endpoints encouraged an extension of the study.

Ten batches of the new shots, equivalent to millions of doses, manufactured at the CDMO’s facility in Bloomington are to be released, amid concerns of supply shortages for Moderna’s Omicron-specific booster vaccine in the US. The Catalent facility was subject to a long FDA inspection in August, and, on Tuesday this week, the watchdog sent

US research and treatment center for cancer, diabetes and other life-threatening diseases, City of Hope, will use ProBioGen’s cell-based and scalable viral manufacturing platform, AGE1.CR.pIX, for the production of its Cytomegalovirus (CMV) vaccine. The two organizations teamed up previously on City of Hope’s modified vaccinia Ankara (MVA) based-COVD-19 vaccine development work​​. Financial terms of the

In August the European Commission and Valneva signed an amendment to the Advance Purchase Agreement, with the Commission now purchasing 1.25 million doses in 2022 (a previous agreement in November 2021 had covered up to 24.3 million doses in 2022 with up to 60 million across two years). Manufacture in Germany VLA2001 is the only

Building up Australia’s vaccine manufacturing capacity Onshore manufacturing has an obvious advantage during a pandemic, as importing products from international manufacturers can face competition from other countries. This was seen during the COVID-19 pandemic, with Australia falling far behind​ other developed countries in vaccination campaigns and struggling to receive vaccines from abroad.​ By 2030, Australia

The EU started procurement later than the UK and the US, and when severe supply shortfalls occurred in the first half of 2021, it became clear that most contracts signed by the EU Commission did not include specific provisions to address supply disruptions, according to a overview released this month by the European Court of

It has launched a transfection reagent for in vivo mRNA delivery using a preformed liposome to further support the growing demand of mRNA developers. It says its in-vivo-jetRNA+​ supports in vivo mRNA delivery with liposomes and offers an alternative to lipid nanoparticles (LNPs). mRNA delivery using in vivo-jetRNA+​ can be used for vaccination purposes, anti-cancer

The facility will be the second of its kind and the first in Europe (with the first being opened last August in Redmond, WA in the US). It will employ the J.POD technology from its subsidiary Just-Evotec to create commercial manufacturing capacity for biologics. Traditional fed-batch biologics manufacturing presents significant challenges, especially at the upscaling

New York-based Innervace, a regenerative medicine company developing the first implantable biofabricated neural pathway to restore brain circuitry, has raised up to $40m in Series A financing. The funding was led by healthcare investment firm, Deerfield Management, and the round also saw participation from founding investor IP Group, Inc, in addition to Penn Medicine, WARF

Bioprocessing 4.0 is embodied in the tools that increase efficiency and help companies keep an edge in today’s competitive biopharma landscape. In this webinar we review approaches that use digitization to give companies the flexibility needed to adjust process parameters quickly and easily while maintaining quality and reducing time and costs.  Register now​​ to hear

Spanning both drug substance and drug product development, Novartis said the multi-year investment will be implemented across existing Novartis locations in Switzerland, Slovenia, and Austria. The company said its early-stage biologics portfolio has grown significantly in the last 15 years, expanding beyond conventional monoclonal antibodies into antibody-drug conjugates (ADCs) and therapeutic proteins. This investment is

The global biotech’s M600 R&D center is situated on the grounds of the research campus in Marburg’s Görzhausen Industrial Park. Construction began in November 2019 and will be completed later this calendar year. The R&D campus is nearly 40,000 sqm in size and includes 7,000 sqm of laboratory space, 7,000 sqm of workspace, and 800 sqm of

Currently, MenACWY and MenB vaccines are licensed separately; with no single vaccine addressing all five serogroups. Pfizer, therefore, believes it can make its mark with a pentavalent vaccine: with its candidate meeting all primary and secondary endpoints in the Phase 3 trial. Boosting vaccination schedules Five serogroups (A, B, C, W and Y) account for

Spanning both drug substance and drug product development, Novartis said the multi-year investment will be implemented across existing Novartis locations in Switzerland, Slovenia, and Austria. The company said its early-stage biologics portfolio has grown significantly in the last 15 years, expanding beyond conventional monoclonal antibodies into antibody-drug conjugates (ADCs) and therapeutic proteins. This investment is

Through the partnership, Microsoft is providing AI technology, foundational science models and expertise and is working alongside Novo Nordisk’s data scientists and domain experts from early research and development areas to accelerate Novo Nordisk’s R&D. A spokesperson for the Danish diabetes giant told BioPharma-Reporter: “The collaboration with Microsoft focuses on early research and drug development

This facility will support the late-stage clinical development and commercialization of Orca Bio’s precision cell therapies, including Orca-T, which is currently being evaluated in a Phase 3 registrational trial. The new facility is located in Sacramento’s newly developed Metro Air Park next to the Sacramento International Airport, enabling direct shipping access to transplant centers across