Advanced therapy medicinal products (ATMPs) are medicines for human use that are based on genes, tissues or cells. More and more cell and gene therapies have been approved and are available globally. The approach to biopharmaceutical end-to-end solutions shows an even greater advantage moving forward.
Based on using human cells this type of regenerative medicine targets cancer cells and genetic diseases. Stem cells that are taken either by the patient or from a suitable donor are modified and (re-) injected intravenously into the patient.
Single-use applications for fluid management in Cell Therapies.
Under gene therapies fall in-vivo viral vector production, such as AAV or lentivirus, plasmid DNA production and ex-vivo gene modified cell therapy. The latter is in turn distinguished from autologous and allogeneic therapies.
Blood cells are taken from a donor to be modified, grown, and harvested for the same donor (autologous) or multiple recipients (allogeneic). DNA is extracted to be genetically modified ex vivo. It is then re-infused in the patient’s system to target cancer cells.
Single-use applications for fluid management in Gene Therapies.
With the use of Single Use Support’s technology, biopharmaceutical companies in the area of Cell and Gene Therapy (CGT) and Regenerative Medicine can minimize the risk of bio contamination, manipulation or product loss towards 0%. Mostly small batches of either t-cells, buffer, primary cells or media are supplied and delivered between biopharmaceutical companies, biotech companies, CMOs and CDMOs, hospitals and other suppliers.
Single-use technologies that perform fast operations accelerate time-critical process for cell & gene therapies. Integrated and scalable process solutions around single-use bioprocess containers that include automated aseptic filling and controlled freezing and thawing optimize and standardize logistic process steps for ATMPs.
