Tag: Cell Therapy

Cell Therapy pipeline update, Talaris Therapeutics, a late-clinical stage biotechnology company based in Boston, MA and Louisville, KY, announced the initiation of FREEDOM-1 (NCT03995901), the company’s Phase 3 clinical trial of FCR001 in living donor kidney transplant (LDKT) recipients. What is the objective of the trial: This pivotal trial will evaluate the safety and efficacy of a

On 28 October 2019, CARsgen Therapeutics, a clinical-stage biopharma company, announced that the FDA has granted Regenerative Medicine Advanced Therapy (RMAT) designation to its investigational CT053 CAR-T cell therapy. What is CT-053: CT053 is a fully human anti-BCMA (B Cell Maturation Antigen) autologous chimeric antigen receptor (CAR) T Cell therapy for the treatment of relapsed and/or refractory multiple

The American Society of Gene and Cell Therapy (ASGCT) defines cell therapy as a therapeutic modality that involves the administration of either normal or modified cells to patients for the treatment of various diseases. In this form of therapy, patients are injected with living and intact human cells that are deemed to be capable of

Considering the vast potential of cell therapies in the treatment of rare disorders and sufficient body of evidence validating the clinical benefits / therapeutic potential of this complex class of biologic drugs, cell therapies have garnered considerable attention of players engaged in the healthcare industry, in the past few years. The focus of stakeholders has

Over the years, the pharmaceutical industry has witnessed several advancements in drug development. It has gradually shifted from a one-drug treats all model to a more personalized approach of treatment, which involves the use of personalized cell and gene therapies for various disease indications. This shift has led to an evident change in the pharmaceutical

With the success of first vaccine to reach phase I clinical trial and turning out to be safe, well-tolerated, and capable of generating an immune response against the virus in humans, a lot of hope has been created with these coronavirus preventive vaccines. However, the research is still ongoing to develop novel therapeutic treatments that

I would never have thought that a mutant flu virus could create that big panic in people at each and every corner of the world. In fact, the past few days in quarantine have really made me realize where exactly the humanity is heading. For majority of us, our lives are on a temporary hold

With close to half-million infections and the economy showing signs of the 2008 financial crisis, COVID-19 has impacted several industries. Government institutes and industry players have announced various steps to deal with the ongoing situation. In this article, we will highlight the developments in the cell and gene therapy manufacturing industry amid the ongoing COVID-19

Last week, during our weekly industry update sessions, our prime focus was to understand the recent innovations in the field of cell therapy manufacturing. We were also looking out for players that are driving these innovations. To start with, the first news that caught our attention was Novartis’ decision to sidestep Europe travel ban to

Roots Analysis has actively tracked the developments in the field of cell therapy and gene therapies. The team has focused on identifying the key challenges that are hampering the growth of these revolutionary therapies. To identify the challenges, the team has interviewed several stakeholders involved in cell therapy development and manufacturing. In addition, a recent

There appear to be no Monday blues for Catalents as the company announces the acquisition of MaSTherCell Global, a technology-focused cell and gene therapy contract development and manufacturing organization. Following its last year’s acquisition of Paragon Bioservices (a leading viral vector developer), Recent acquisition by Catalent in Gene Therapy segment has extended the company’s leadership

On 31st October 2019, Tmunity Therapeutics, a private biotherapeutics company focused on saving and improving lives by delivering the full potential of next-generation T-cell Therapies, announced the closing of $75 million Series B financing. Who were the key investors in T-cell Therapies: The financing was led by Andreessen Horowitz (also known as “a16z”). Joining the

The Compal Group’s Raypal Biomedical and Kaohsiung Medical University Chung-Ho Memorial Hospital on October 22 signed an MoU to jointly set up a GTP (good tissue practice) cell therapy manufacturing laboratory in Kaohsiung City, southern Taiwan. What are the key capabilities of Raypal in cell therapy manufacturing: Founded in 2016, Raypal specializes in R&D of

MaxCyte, the global Cell Therapy, and life sciences company, announced the initiation of dosing in the third cohort of patients of MaxCyte’s Phase I clinical trial (NCT03608618) with the next higher cell dose of MCY-M11. The dose-escalation trial is evaluating the safety and tolerability, as well as preliminary efficacy, of MCY-M11 administered intraperitoneally across a series

As per recent news coverage, United Therapeutics has received a permit for $9.5 million build-out of its cell therapy facility on the second floor of Mayo Clinic’s Discovery and Innovation Building. What is the area of the facility:  The facility will have a total of 21,843-square-foot space. What are the capabilities at the facility:  The facility will house

ReNeuron, the UK based, clinical-stage stem cell therapeutics company, announced that new data relating to its CTX stem cell platform will be presented today at the 27th Annual Congress of the European Society of Gene and Cell Therapy (ESGCT). Dr. Steve Pells, Principal Investigator at ReNeuron, will present new data showing the phenotypic stability and scalability

With its acquisition of FloDesign Sonics earlier this month, Merck/MilliporeSigma has become the first company to introduce acoustic technology in cell therapy manufacturing. The acquisition of FloDesign Sonics is a strategic fit for Merck, strengthening its ability alongside to manufacture cell-based therapies for patients. What is Acoustic Cell Processing:  Acoustic cell processing is a disruptive technology that

In the ongoing shift of biologics manufacturers to single-use systems, Cytovance®, a leading biopharmaceutical CDMO, announced the addition of an integrated single-use platform for the manufacturing of plasmid DNA (pDNA) at their facilities in Oklahoma City, OK. According to the company, two grades are available (Critical Reagent Grade™, CGMP-grade) in lot sizes from 1g to 50g,

Cell and Gene Therapy CROs are the new entrants in the pharma Superstar Club. They are selling tickets faster than a Queen’s concert in the 1980s. In fact, as per the Alliance of Regenerative Medicine’s recent findings, there has been more than 75% year on year increment in funding to support the development of various cell and gene

Cell Therapy Manufacturing market has gained significant attention in the overall biopharmaceutical industry. The personalized nature of these cell therapies options render them highly specific and, according to a number of clinical studies, safe and efficacious. Around 20 such therapies have been approved so far; recent approvals include Alofisel® (2018), YESCARTA® (2017) and Kymriah® (2017).

Post the approval of first cell-based therapy, Carticel®, in 1997 in the US, the field has rapidly advanced and a number of such therapies are currently under development. The ‘Cell Therapy Manufacturing Market, 2017-2027‘ report provides an extensive study of the rapidly growing market of cell therapy manufacturing and focuses both on contract manufacturers and cell