AbbVie says payors will look to consistent global supply as a key differentiator among the many Humira biosimilar makers poised to enter the US market. AbbVie’s autoimmune monoclonal antibody (mAb) Humira (adalimumab) is the bestselling drug of all time, clocking in over $193 billion for AbbVie (and previously Abbott) since its launch in 2003 to the end of 2021. Last year alone it pulled in $20.7 billion (though lost out to the industry’s top seller spot due to $36.9 billion…
Bristol Myers Squibb will apply the same strategy used to increase Abecma supply to increase capacity for Breyanzi as it pushes back projected timelines into next year. Bristol Myers Squibb (BMS) has with its chimeric antigen receptor (CAR) T-cell therapy Breyanzi (liso-cel) “a best-in-class profile,” Christopher Boerner, EVP & chief commercialization officer told stakeholders at the Morgan Stanley Global Healthcare Conference last week. Having been approved in February 2021 for Large B-cell Lymphoma, the therapy won second-line approval for relapsed…
Adeno-associated virus (AAV) vectors are a widely-used, versatile, and appealing gene therapy delivery platform because of their high safety profile and ability to target many different cell types and transport healthy gene copies into a patient’s cells. The recent clinical successes of AAV-mediated gene therapies have ignited much interest in solutions for the scalable, good manufacturing practice (GMP) production of AAVs, and high demand for outsourced development and manufacturing capabilities. Yet, significant challenges remain, particularly around product quality, productivity, and…
The International Society for Cell & Gene Therapy (ISCT) has slammed the decision of a federal judge in California who ruled surgical procedure using a patients’ stem cells does not fall under the FDA’s regulatory jurisdiction. In 2017, the US Food and Drug Administration (FDA) took a series of actions “to remove unproven, potentially harmful treatment used in ‘stem cell’ centers targeting vulnerable patients.” This included the issuing of Form 483s and warning letters, the seizing of vials of materials…
A standardized approach to collecting, processing, and storing cell therapy starting materials can reduce variations in manufacturing outcomes and simplify supply chain management, says Cryoport’s CEO. Temperature-controlled supply chain services firm Cryoport has partnered with Takeda’s plasma donation and collection business BioLife Plasma Services to offer standardized cell therapy collection, processing, and storage services for cell therapy products across the US and Europe. The collaboration, of which no financial details have been divulged, aims to establish an integrated GMP-compliant supply…
“It’s important we maintain control over the process to ensure we are meeting the highest standards of quality,” says cell therapy developer Orca as it announces a 100,000 square-foot plant. Orca Bio’s lead product, the cell therapy Orca-T, is in Phase III clinical trials for several of the most prevalent blood cancers. As such, the firm is looking beyond its clinical manufacturing site in Sacramento, California and is constructing a 100,000 square-foot commercial facility nearby with the capacity to manufacture…
Shanghai, China-based Neukio Biotherapeutics has completed a $50 million Series A-1 funding to support development of its cell therapy molecules, especially off-the-shelf allogenic CAR-T therapies. After raising $40 million in an Angel round last year, the company will use these latest funds to accelerate preclinical/clinical validation of induced pluripotent stem cell (iPSC)-derived off-the-shelf CAR-NK cell therapy products, while also expanding its team and operations. This latest funding was led by CD Capital, with participation from Alwin Capital and Surplus Capital…
Ilya Pharma has secured the IP position for ILP100 – a candidate immunotherapy for various skin and mucosal disease – with patents in India, China, Australia, and the US. The patents mean the company’s method for using modified bacteria for treatment of both mucosal and cutaneous wounds in humans and animals has patent protection in all major markets according to CEO Evelina Vågesjö. She told BioProcess Insider “all commercial activities are covered,” explaining that the patents cover the general use…
Advanced Therapies Europe (#ATE22) took place in London, UK, last week. BioProcess Insider was there, as were biopharma’s social media army. We present the best from the Twittersphere. Before we consider and celebrate #CGT in a #EuropeanMarket at out #AdvancedTherapiesEurope event next month, take a look at this handy infographic with 5 Disruptive Strategies for Market & Patient Access in Europe. Do you agree with them? Take a look 👇https://t.co/EvBfHAFRvs — Phacilitate (@Phacilitate) July 13, 2022 Honoured to be…
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…