Therapeutic Class Archives - Page 11 of 67 - BioProcess InternationalBioProcess International

Cytiva and Caring Cross to develop CAR-T for HIV

Cytiva’s support will enable Caring Cross to develop and distribute its CAR-T cell therapy for HIV to low-to-middle-income countries, says firm. Caring Cross’ first therapeutic candidate is an anti-HIV duoCAR-T cell therapy, which the organization claims is designed to supress HIV replication and remove HIV-expressing cells in individuals with HIV. Additionally, it is developing a stem cell gene therapy for sickle cell disease and beta-thalassemia. “Approximately 38 million people worldwide are living with HIV. Current treatment options are limited to…

Cell therapy manufacturing studies suggest industry still needs better tech

by Gareth Macdonald

Cell therapies show real curative potential. However, recently published research suggests the industry still needs faster, more effective production methods to fulfil its potential. For one thing, turning candidate cell therapies into commercial products will require innovation in manufacturing systems according to a study by researchers at the US National Institutes of Health. The study – published in International Reviews of Immunology – looked at the use of engineering T cell therapies (including those based on CAR-T cells and TCR-T…

Bluebird wins US approval for world’s most expensive drug, Zynteglo

by Dan Stanton

Zynteglo’s $2.8 million price tag marks a new high, but bluebird bio says the one-time gene therapy works out cheaper than current beta-thalassemia treatment options. Following a positive Advisory Committee outcome in June, the US Food and Drug Administration (FDA) granted full approval for Zynteglo (betibeglogene autotemcel, or beti-cel) this week for the treatment of beta-thalassemia in adult and pediatric patients who require regular red blood cell (RBC) transfusions. The gene therapy, which was approved in Europe in 2019, is…

Mayo Clinic and Resilience enter biomanufacturing pact

by Dan Stanton

Biomanufacturing services firm National Resilience will collaborate with Mayo’s Center for Regenerative Medicine in Minnesota. The collaboration will see Resilience and Mayo create process development labs, analytical development labs, and quality control labs at Mayo’s Center for Regenerative Medicine in Rochester, Minnesota, to jointly develop and progress cell therapies and other advanced modalities into the clinic. The partnership also hopes to attract third-party biotech companies interested in sponsoring clinical trials for new therapeutics, as well as collaborating on their process…

Tonix looks to live virus vaccines to prevent the spread of monkeypox

by Millie Nelson

Tonix Pharmaceuticals claims that using a smallpox vaccine model could stop the spread of monkeypox. The technology is being applied to vaccines against COVID-19, smallpox, and monkeypox. According to Seth Lederman, CEO of Tonix, the firm has “recreated a vaccine that we think is similar to what Edward Jenner used” in 1798. While Lederman told us the undisclosed cell line is “pretty standard” in its technique, TNX-801 is a live virus vaccine based on synthesized horsepox (sHPXV) that it claims…

Lilly working ‘around the clock’ to ensure Mounjaro supply

by Dan Stanton

Two US drug substance and two drug product manufacturing plants are in the works to support the rollout of Eli Lilly’s recently approved type 2 diabetes GLP-1 receptor Mounjaro (tirzepatide). In May, the US Food and Drug Administration (FDA) approved Mounjaro, a once-weekly GIP (glucose-dependent insulinotropic polypeptide) and GLP-1 (glucagon-like peptide-1) receptor. Mounjaro represents the first new class of type 2 diabetes medication introduced in almost a decade, and a boost for developer Eli Lilly, which has begun rolling out…

Regenxbio: Inhouse facility a driving force in ‘5×25’ gene therapy ambition

by Dan Stanton

A newly opened inhouse facility gives Regenxbio not just capacity but quality and operations continuity, the firm says as it aims to bring five gene therapies to market by 2025. Earlier this year, gene therapy developer Regenxbio launched a strategy called ‘5×25’ aimed at progressing five adeno-associated virus (AAV) vector-based therapeutics from its internal pipeline and licensed programs into pivotal stage or commercial products by 2025. Around the same time, the firm began operations at a 132,000 square-foot facility in…

Astellas eyes AMD cell therapy trial restart after manufacturing tweaks

by Dan Stanton

Astellas is set to restart trials for its age-related macular degeneration (AMD) program ASP7317 after improving production and analytical process for the embryonic stem cell-derived candidate. Astellas added ASP7317 to its pipeline through the acquisition of Ocata Therapeutics in 2015. The cell therapy, derived from pluripotent human stem cells, is being investigated as a potential treatment for people with dry AMD. But a Phase I trial enrolment was voluntarily put on hold by Astellas last year “due to the time…

Charles River looks to CGT growth to offset ‘bumpiness’ in CDMO biz

by Dan Stanton

Stabilizing acquired CDMO businesses is proving “elusive and expensive” say analysts, but Charles River is confident cell and gene therapies entering the clinic will be the foundation of future growth. For the second quarter 2022, Charles River Laboratories reported revenue from its manufacturing segment of $195 million, down 1.5% on the same quarter last year. Furthermore, the company is reducing its 2022 financial guidance from revenue growth of 13.5-15.5% to 9-11% in part due to “headwinds associated with the CDMO…

Plasmid production a plus for Polyplus

by Millie Nelson

Polyplus has added transgene plasmid engineering services for viral vector manufacturing, which it says allows customers to get their gene therapies to market quicker. The French biotech claims that since acquiring DNA design and production services firm e-Zyvec in February, it has focused on providing more advanced levels of solutions to support its client base. By using e-Zyvec’s technology “the plasmids are assembled de novo, from a library of DNA bricks, removing the use of standard plasmid backbones that contain…