Regenerative medicine
Regenerative medicine aims to develop methods to regrow, repair or replace damaged or diseased cells, organs or tissues. This involves therapy treatments using stem cells or tissue engineering techniques.
We understand that transitioning from research to clinical applications requires consistent, robust and scalable procedures. AMSBIO provides a range of cell products which cover from sourcing your starting cell material, growing and storing cell lines, differentiating to specialized cell types and GMP-compliant manufacturing. To find out more visit our expanded stem cell synergy page.
Gene therapy
Gene Therapy covers both research and clinical development of novel therapeutic techniques based on a genetic engineering approaches. From identifying novel genetic targets that cause disease through to clinical studies testing the efficiency of therapeutic methods, we offer high quality products and services to support you. This includes gene delivery methods and CRISPR reagents to enable gene editing.
- Viral delivery systems - Lentivirus, Adenovirus, AAV
- Transfection reagents
- CRISPR reagents
Gene Therapy in the Real World
At the end of 2023, the first CRISPR-based gene therapy was approved by both the MHRA and the FDA for Sickel Cell Anemia
Immune Therapy
Immune Cell Therapy is a form of treatment that uses the cells of our immune system to eliminate cancer. Advancements in gene editing, synthetic biology and immunology have allowed for unprecedented progress in immune cell therapies including CAR-T cells, NK cell therapy, TCR therapy etc.
At AMSBIO we strive to support the process of producing reproducible and high quality immune cell therapies:
- CAR-T's
- Animal-free RUO and GMP proteins
- Non-viral gene delivery systems
- Immune cell culture solutions
Genetically Engineered iPSCs
Genetically engineered iPSCs enable cell therapy research with improved fidelity over cell lines and biochemical assays. This also provides an ideal model system for drug discovery with high throughput and reduced cost compared to animal model systems. Our ready-to-use genetically engineered cell lines reduce the time and materials needed for gene editing to allow human disease modelling for the development of therapies.
- Cas9-expressing iPSCs
- StemBright™ Reporter iPSCs
- Knockout iPSCs
Seamless Transition from benchside to Clinic
Transitioning from R&D to clinical manufacturing poses unique challenges, especially with the switch from RUO to GMP raw materials. To ensure a seamless transition, we offer a comprehensive range of GMP-grade products that cater to every stage of your process, ensuring a regulatory-compliant journey for cell and gene therapy manufacturing.
Our reliable, high quality GMP-compliant ancillary materials are produced under ISO 9001 certifications and are fully documented and traceable. Our meticulous approach guarantees a streamlined transition from preclinical to clinical, providing consistent supply and quality of raw materials. For more information on our GMP products which, please visit our Manufacture Page:
- StemFit® a GMP grade, animal-free, chemically defined stem cell culture media
- iMatrix-511MG is a clinical-grade recombinant laminin E8 fragment
- GMP growth factors and small molecules
- STEM-CELLBANKER - GMP freezing media
FDA Guidelines for C> Manufacture
See an overview of FDA guidelines for C>, focusing on key regulatory steps to ensure safe, efficient development and pathways to accelerate approvals.
Scaling-Up Manufacturing
Scaling up production from benchside to the clinic is a significant challenge for cell and gene therapies due to long processes, large quantities and high costs.
At AMSBIO we aim to advance innovative cell therapies by providing researchers and manufacturers with trusted products and tools, including a variety of cutting-edge culture solutions to support in scaling up production. This includes providing large scale culture systems, such as our ABLE bioreactors, custom media, microcarriers and more.
