Category: Cell Therapy

COVID-19 Impact on Cell and Gene Therapy Manufacturing Market

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

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

Catalent’s Shopping List: Hinting Towards a One-Stop Cell & Gene Therapy CMO in Making

There appear to be no Monday blues for Catalent 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), Catalent’s recent acquisition has extended the company’s leadership in this already crowded space.

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

CARsgen anti-BCMA CAR T Therapy Receives RMAT Designation

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

Cell Therapy Manufacturing Market Update: Compal and University to set up GTP lab

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) cellular laboratory in Kaohsiung City, southern Taiwan. What are the key capabilities of Raypal: Founded in 2016, Raypal specializes in R&D of immunocyte and immunotherapy, stem cell and

Cell Therapy Pipeline Update: Talaris Therapeutics Announces Initiation of Phase 3 Clinical Trial

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 single dose of FCR001,

Cell Therapy Market Update: MaxCyte Advances Phase I Clinical Trial of Lead mRNA-based Cell Therapy

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

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

Gene Therapy Pipeline Update: AGTC Presents Promising Data of its AAV Vectors for Ocular Gene Therapy

Applied Genetic Technologies Corporation (AGTC), a clinical-stage biotechnology company, developing transformational genetic therapies for patients suffering from rare and debilitating diseases, announced new data from non-clinical studies evaluating the effect of pre-existing anti-AAV antibodies on the transduction and expression efficiency of AAV vectors. According to the company’s CSO, Preexisting immunity to AAV remains a challenge for

Cell Therapy Manufacturing Update: Merck Becomes the First to Introduce Acoustic Technology

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 allows

Growing Cell and Gene Therapy Market: Vector Manufacturers Make Merry

Cell and Gene Therapy 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 therapies.

Natural Killer Cell Therapies: Pipeline Review

Natural killer (NK) Cell Therapies , or killer (K) cells, represent an important subset of cellular mediators of the innate immune system. These cells are known to be instrumental in containing viral infections and regulating tumor development, while the adaptive immune system generates an antigen-specific response. Several studies have demonstrated the various benefits of NK

The Emergence of Encapsulated Cell Therapies and Affiliated Technologies

Extensive research on  Cell Therapies encapsulation strategies have enabled the development of a variety of technologies capable of confining therapeutic entities within biocompatible matrices / carriers. Since 2013, over 3,000 patents have been published related to the aforementioned type of therapy, indicating the rapid pace of R&D activities in this domain. I have highlighted below

Stem Cell Therapies: Upcoming Opportunities in Cardiovascular and Metabolic Disorders (CVMD)

Cardiovascular disorders and metabolic disorders are considered to be amongst the leading causes of death worldwide. In fact, approximately one-third of the annual number of deaths across the globe are attributed to cardiovascular disorders.  Likewise, a significant proportion of the global population suffers from diabetes or some form of metabolism related clinical condition. As per

Cell Therapy Manufacturing: A Niche but Rapidly Growing Multi-Billion Dollar Industry

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 therapy