Category: Cell Therapies

Advancements In Automation Of Manufacturing Processes: Key Value Driver For Escalated Interest In The Cell Therapy Domain

Cell therapies are based on the premise that the patient’s own cells (autologous), or those from a healthy donor (allogeneic), can be genetically re-programmed to combat various diseases. In this form of therapy, patients are injected with living and intact human cells that are deemed to be capable of providing therapeutic benefit. It is important

Cell and Gene Therapy CROs: The Next Growth Opportunity

Over the years, cell and gene therapy (CGT) and other advanced therapy medicinal products (ATMPs) have managed to capture the interest of both drug developers and healthcare investors. Their popularity can be attributed to various factors, such as minimal side effects, clinical efficacy and their personalized nature. However, there are several complexities associated with the

Cell Therapy – The Revolutionary Therapeutic Modality: All Set To Obliterate Oncological Disorders

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

Advancements in Automation of Processes: Key Value Driver for Escalated Interest in Cell Therapies Manufacturing Domain

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

CAR-T Cell Therapy: Addressing Key Unmet Needs in Oncology

Amidst the active initiatives undertaken to develop more targeted anti-cancer therapies, CAR-T therapies have emerged as a promising option, given their ability to eradicate tumor cells from the body with minimal treatment-related side effects. Further, CAR-T cell therapy, relatively recent addition to the gamut of anticancer interventions, has demonstrated significant promise. Overall, this highly specific

Treg Cell Therapy: A Hotspot in the Field of Immunotherapy

Classification of Treg Cell Therapy The Treg cell therapy (Tregs) is a therapeutic modality based on the mature subpopulation of T-cell therapy that plays a critical role in mediating immunological tolerance to self-antigens and suppress immune responses that are harmful to the host, thereby, enabling homeostasis. These mainly develop in thymus from CD4+ thymocytes and

Bioassay Services – A Prerequisite for the ATMPs Development

Bioassay Services – A Prerequisite for the Cell and Gene Therapy Development Over the past few years, investigational new drug (IND) filings by cell and gene therapy companies have significantly increased. In fact, from year 2016 to 2020 more than 300 IND filing for cell and gene therapy product have been recorded, indicating that several

Cell Line Development: An Ocean of Opportunities for Stakeholders

The growing pipeline of monoclonal antibodies, vaccines, enzymes, biosimilars and other therapeutic proteins have created an ever- increasing demand for highly- productive and stable cell lines. Many of the recombinant biotherapeutic products, produced in cellular systems, have been translated into commercial successes; these include ALPROLIX®, ELOCTATE® and ELAPRASE®.  Given their impact on the overall quality

Cell Therapy Manufacturing: Here are the Key Innovations

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

Cell Therapy and The Rise of Novel Technologies

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

CAR T Cell Therapy: Autolus Presents Data on AUT06NG

Autolus Therapeutics, a clinical-stage biologics contract manufacturing company developing next-generation programmed T cell therapies for the treatment of cancer, presented pre-clinical data on AUTO6NG, the company’s next-generation GD2-targeting CAR T cell therapy, at the 34th Annual Meeting of the Society for Immunotherapy of Cancer (SITC). What did the results highlight: The results demonstrated the utility of

CAR-T Pipeline Update: Celgene posts pivotal data ahead of FDA filing

Celgene has recently published positive data from a pivotal trial (NCT02631044) of its CAR-T therapy. As per the reports, the data look competitive against Gilead’s Yescarta and Novartis’ Kymriah, leading analysts to predict Celgene will win FDA approval next year. This is a big news for the overall CAR-T pipeline. As per the reported data, the

Cell Therapy Manufacturing Update: United Therapeutics Receives Permit

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

Cell and Gene Therapy Technology Update: ReNeuron Presents Positive Data

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

Vector Manufacturing: Growing Cell and Gene Therapy Market

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

Blockchain Genomic Data Management

It is estimated that, by 2025, around 15% of the world’s population will have had their genomes sequenced, resulting in the generation of several zettabytes of data. However, currently, there are not many reliable and secure data management resources that offer secure storage, seamless exchange of information, and a reliable transaction platform, for large volumes

The Rise of Cell and Gene Therapy CRO

Over 500 cell and gene therapy candidates are being investigated in different stages of clinical development across various geographies. In fact, in the past five years alone, more than 1,000 clinical trials, that are currently active, were initiated to evaluate the potential of these cell and gene therapies across multiple therapeutic indications. Due to several

T Cells: The Future Roadmap of The USD 15 Billion+ Opportunity

Although cancer therapeutics continue to be one of the most active areas in terms of drug development, there is still a significant unmet need in this domain. Conventional cancer treatments, such as chemotherapy, surgery and radiation therapy, have demonstrated very limited efficacy in late-stage cancers. Amidst the current initiatives to develop more targeted anti-cancer therapies,

Cell Therapy Manufacturing: The $ 8 Billion+ Growth Opportunity

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).

Cancer Stem Cell Therapies: Mapping the Future Growth Potential

The objective of the ongoing R&D in this domain is to develop novel CSC directed treatments that can combat complications, such as off-target toxicities and disease relapse, associated with the current standard of care treatments. The ‘Cancer Stem Cell Therapies Market, 2017-2030’ report examines the current landscape and the future outlook of the growing pipeline of products