Can you explain the difference between autologous ... - Cell …
The primary difference between allogeneic and autologous are the source of the cells for the therapy. Allogeneic therapies are manufactured in large batches from unrelated donor tissues (such as bone marrow) whereas autologous therapies are manufactured as a single lot from the patient being treated.
In-Process Analytics are Key to Successful Cell Therapy Process ...
Jul 7, 2021 · In an autologous setting, each patient’s health status and demographics translates to a unique cell population, which imparts variability to the subsequent cell therapy manufacturing process. This emphasizes the importance of in-process controls in ensuring a consistent drug product, even in the presence of such variability.
Reducing Risk of Viral Contamination in Biologics, Cell and Gene ...
Dec 16, 2020 · Implications for Cell and Gene Therapy Manufacturing. Dr. Barone explained that cell and gene therapies present unique challenges for viral contamination. Gene Therapy. For gene therapies, a human cell line, primarily HEK, is used. The production process also involves adding a helper virus that has to be removed as part of the purification process.
Part II – A Look at the State of Cell Therapy - Cell Culture Dish
Oct 21, 2015 · The supplement article, “Moving from Laboratory to Commercial Production with a Single-Use Multiplate Bioreactor,” describes the opportunity that ATMI, since acquired by Pall, had to work with a biotech company that was developing an autologous Cell Therapy to protect patients’ hearts during myocardial injury using the patients bone ...
Manufacturing and Qualification Challenges for Cell and Gene …
Mar 6, 2023 · Cell and gene therapy, or advanced therapy medicinal products (ATMPs) as they are referred to in the EU, represent intersecting categories of biotherapeutics for treating human diseases. Where cell therapy works by infusing cells into a patient to replace or repair damaged or diseased tissue, gene therapy treats the disease at the genetic level.
The Evolution of Cell Therapy Manufacturing - Cell Culture Dish
Jul 1, 2021 · The Evolution of Cell Therapy Manufacturing – Early Days and Present-Day Procedures. While often casually mentioned in a single phrase, cell therapy (CT) actually refers to quite a wide spectrum of medical treatments. In the EU, they can be referred to as cell based medicinal products (CBMP), a type of advanced therapy medicinal product (ATMP ...
Part III - Fifteen Cell Therapies/Stem Cell Therapies in Phase III ...
Apr 10, 2013 · Baxter International has developed an adult autologous stem Cell Therapy for treatment of chronic myocardial ischemia. In February 2012, Baxter announced that they were launching a Phase III clinical study for this product to evaluate safety and efficacy and according to Clinical Trials.gov it is still enrolling.
GMP Proteins for Cell Therapy Manufacturing: Top 6 Things to Know
Apr 13, 2017 · The responsibility ultimately falls on the developer of the Cell Therapy to determine whether a given supplier meets their needs. 2. Consistency from Lot-to-Lot. Consistency may be the most obvious of the characteristics to look for when choosing GMP-level proteins for clinical manufacturing. During an on-site audit, a vendor should be able to ...
Identifying Options for Stem Cell Based Therapy Scale-up
Jan 6, 2013 · At present there are three main options for scaling-up adherent cell production: Multiple or stacked 2-D surface-based systems. Microcarriers in stirred tank bioreactors. 3-D scaffold technology to hold and harvest the cells. Scale-up is not as simple as merely providing a larger surface area. Altering the surface and consequently changing the ...
Expediting cell and gene therapy workflows - Cell Culture Dish
Feb 6, 2019 · Sean described cutting edge workflow solutions. Cloudz – a novel polymer particle format acquired from Quad Technologies. Enables activation and expansion of T cells for autologous or allogeneic adoptive T cell therapy workflows such as CAR T or TCR. Ella – an automated platform for performing ELISAs developed by Protein Simple.