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August 31, 2022

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April 4, 2022

How to be GMP Ready: A Guide

Team of pharmacists conducts drug research. Male character with magnifying glass examines dna. Group of scientists working in medical laboratory. Medicine, pharmaceutics concept.

Advanced Therapy Medicinal Products (ATMPs), such as cell and gene therapy products, are envisioned to be the therapies of the future. Good Manufacturing Practice (GMP) establishes the highest possible manufacturing standards for these innovative medical products.

GMP guidelines are followed to ensure the highest quality & safety of both the cells (starting materials), and reagents you add to grow, change and store these cells (ancillary materials). However, the world of GMP-compliant materials and when to switch from research-grade reagents is complex!

We talked to AMSBIO customer & GMP expert Dr. Erik Miljan at BIODIVIDE Ltd. to explain & unravel GMP for our customers, to ensure a streamlined clinical translation.

Why are GMP-compliant ancillary materials important in Regenerative Medicine?

GMP compliance is important for ensuring the quality & traceability of ancillary materials utilized in ATMP manufacture. The quality of these materials is crucial, as everything that touches stem cells in the manufacturing process throughout the entire lifetime of cells in effect becomes part of the final medicinal product.

Dr. Erik Miljan

Here at AMSBIO, we provide GMP-compliant cell culture media, recombinant proteins, dissociation enzymes, viral gene delivery reagents, and cryopreservation media for your ATMP manufacture!

Find out more about our range of high quality GMP-compliant AMs here!

What are the benefits of transitioning to GMP-compliant AMs early in pre-clinical research?

Pre-clinical research is any research before the clinic, including the R&D phases of a therapeutic product. The bonuses of using GMP-compliant or GMP-like materials early in pre-clinical research are numerous. It makes the transition to full GMP compliance for clinical trials much easier, saving researchers precious time & money, as there is little to no risk of having to repeat data collection completed with research-grade reagents. Therefore, the earlier you start using GMP-compliant materials, the lower risk of regulatory hurdles and delays later in your clinical research.

Dr. Erik Miljan

Advice for establishing a secure GMP supply chain for streamlined clinical translation

Here at AMSBIO, we understand the importance of reliable & approved suppliers, to ensure a secure supply of GMP-complaint AMs for your GMP manufacturing.

How to guarantee a secure GMP supply chain:

The supplier provides all necessary documentation e.g. batch-specific Certificate of Analysis (CoA), Certificate of Origin (CoO), TSE statement, & stability studies etc.
Suppliers support change control procedures.
Audits have been completed to ensure supplier facilities & practices are in compliance with GMP guidelines.
ISO certification. AMSBIO is ISO 9001 certified, meaning we follow a quality management system, which guarantees our customers recieve good quality products and services. Furthermore, our GMP-compliant cell culture media is manufactured in a certified ISO 13485 facility!
FDA-registered Drug Master File (DMF) availability. DMFs are available for our STEM-CELLBANKER® & STEM-CELLBANKER® EX cryopreservation medias!

Drug Master Files are powerful documents for streamlining clinical translation. Regulatory bodies, such as the FDA, have already reviewed the ancillary material you wish to use for your ATMP development/manufacture and have the documents on file, ready to go. DMFs are therefore a huge benefit for customers in clinical translation.

Dr. Erik Miljan

Summary

Although GMP is a complex topic, simply utilising GMP-compliant ancillary materials early in your pre-clinical research and establishing a secure supply chain reduces the risk of regulatory hurdles in later clinical phases, saving you time, money and stress!

Here at AMSBIO, we can provide our customers with GMP advice, and a secure supply of high quality and reliable GMP-complaint ancillary materials, for a streamlined clinical translation.

Collagenase and Neutral Protease Enzymes

We are a global provider of human and animal biospecimens: including frozen & FFPE tissue, DNA, RNA, total proteins, blood products and primary cells.

We are a global provider of human and animal biospecimens: including frozen & FFPE tissue, DNA, RNA, total proteins, blood products and primary cells.

We are a global provider of human and animal biospecimens: including frozen & FFPE tissue, DNA, RNA, total proteins, blood products and primary cells.

We are a global provider of human and animal biospecimens: including frozen & FFPE tissue, DNA, RNA, total proteins, blood products and primary cells.

We are a global provider of human and animal biospecimens: including frozen & FFPE tissue, DNA, RNA, total proteins, blood products and primary cells.

We are a global provider of human and animal biospecimens: including frozen & FFPE tissue, DNA, RNA, total proteins, blood products and primary cells.

We are a global provider of human and animal biospecimens: including frozen & FFPE tissue, DNA, RNA, total proteins, blood products and primary cells.

We provide the most advanced method for gene and shRNA delivery with an extensive collection of viral particles as well as a range of custom services.

We provide the most advanced method for gene and shRNA delivery with an extensive collection of viral particles as well as a range of custom services.

We provide the most advanced method for gene and shRNA delivery with an extensive collection of viral particles as well as a range of custom services.

We provide the most advanced method for gene and shRNA delivery with an extensive collection of viral particles as well as a range of custom services.

We provide the most advanced method for gene and shRNA delivery with an extensive collection of viral particles as well as a range of custom services.

We provide the most advanced method for gene and shRNA delivery with an extensive collection of viral particles as well as a range of custom services.

We provide the most advanced method for gene and shRNA delivery with an extensive collection of viral particles as well as a range of custom services.

We provide the most advanced method for gene and shRNA delivery with an extensive collection of viral particles as well as a range of custom services.

We provide the most advanced method for gene and shRNA delivery with an extensive collection of viral particles as well as a range of custom services.

We provide the most advanced method for gene and shRNA delivery with an extensive collection of viral particles as well as a range of custom services.

Affordable & consistent controls from 50 tumor cell lines, ideal for IHC, in situ hybridization & NGS applications.

Affordable & consistent controls from 50 tumor cell lines, ideal for IHC, in situ hybridization & NGS applications.

Affordable & consistent controls from 50 tumor cell lines, ideal for IHC, in situ hybridization & NGS applications.

ALiCE® is a radically different approach to cell-free expression and a kit unlike any others.

ALiCE® is a radically different approach to cell-free expression and a kit unlike any others.

ALiCE® is a radically different approach to cell-free expression and a kit unlike any others.

ALiCE® is a radically different approach to cell-free expression and a kit unlike any others.

ALiCE® is a radically different approach to cell-free expression and a kit unlike any others.

ALiCE® is a radically different approach to cell-free expression and a kit unlike any others.

ALiCE® is a radically different approach to cell-free expression and a kit unlike any others.

ALiCE® is a radically different approach to cell-free expression and a kit unlike any others.

The CELLBANKER® series of cryopreservation media allows for the stable long-term storage of any cell type, including sensitive cell lines.

The CELLBANKER® series of cryopreservation media allows for the stable long-term storage of any cell type, including sensitive cell lines.

The CELLBANKER® series of cryopreservation media allows for the stable long-term storage of any cell type, including sensitive cell lines.

The CELLBANKER® series of cryopreservation media allows for the stable long-term storage of any cell type, including sensitive cell lines.

The CELLBANKER® series of cryopreservation media allows for the stable long-term storage of any cell type, including sensitive cell lines.

The CELLBANKER® series of cryopreservation media allows for the stable long-term storage of any cell type, including sensitive cell lines.

The CELLBANKER® series of cryopreservation media allows for the stable long-term storage of any cell type, including sensitive cell lines.

The CELLBANKER® series of cryopreservation media allows for the stable long-term storage of any cell type, including sensitive cell lines.

The CELLBANKER® series of cryopreservation media allows for the stable long-term storage of any cell type, including sensitive cell lines.

The CELLBANKER® series of cryopreservation media allows for the stable long-term storage of any cell type, including sensitive cell lines.

Prepared from Arthrobacter luteus, Zymolyase has a highly effective lytic activity against yeast cell walls.

Prepared from Arthrobacter luteus, Zymolyase has a highly effective lytic activity against yeast cell walls.

Prepared from Arthrobacter luteus, Zymolyase has a highly effective lytic activity against yeast cell walls.

Prepared from Arthrobacter luteus, Zymolyase has a highly effective lytic activity against yeast cell walls.

Prepared from Arthrobacter luteus, Zymolyase has a highly effective lytic activity against yeast cell walls.

AMSBIO offers one of the largest selection of active recombinant enzymes and enzyme activity assays for profiling, inhibitor screening assays, and drug discovery.

AMSBIO offers one of the largest selection of active recombinant enzymes and enzyme activity assays for profiling, inhibitor screening assays, and drug discovery.

AMSBIO offers one of the largest selection of active recombinant enzymes and enzyme activity assays for profiling, inhibitor screening assays, and drug discovery.

AMSBIO offers one of the largest selection of active recombinant enzymes and enzyme activity assays for profiling, inhibitor screening assays, and drug discovery.

AMSBIO offers one of the largest selection of active recombinant enzymes and enzyme activity assays for profiling, inhibitor screening assays, and drug discovery.

AMSBIO offers one of the largest selection of active recombinant enzymes and enzyme activity assays for profiling, inhibitor screening assays, and drug discovery.

AMSBIO offers one of the largest selection of active recombinant enzymes and enzyme activity assays for profiling, inhibitor screening assays, and drug discovery.

AMSBIO offers one of the largest selection of active recombinant enzymes and enzyme activity assays for profiling, inhibitor screening assays, and drug discovery.

AMSBIO offers one of the largest selection of active recombinant enzymes and enzyme activity assays for profiling, inhibitor screening assays, and drug discovery.

AMSBIO offers one of the largest selection of active recombinant enzymes and enzyme activity assays for profiling, inhibitor screening assays, and drug discovery.

AMSBIO offers one of the largest selection of active recombinant enzymes and enzyme activity assays for profiling, inhibitor screening assays, and drug discovery.

AMSBIO offers one of the largest selection of active recombinant enzymes and enzyme activity assays for profiling, inhibitor screening assays, and drug discovery.

We supply a range of superior magnetic products each uniquely suited to specific protein purification, proteomics and genomics applications.

We supply a range of superior magnetic products each uniquely suited to specific protein purification, proteomics and genomics applications.

We supply a range of superior magnetic products each uniquely suited to specific protein purification, proteomics and genomics applications.

We supply a range of superior magnetic products each uniquely suited to specific protein purification, proteomics and genomics applications.

We supply a range of superior magnetic products each uniquely suited to specific protein purification, proteomics and genomics applications.

iPS Cell Based Therapies for Genetic Skin Disease

Muscular Dystrophy Research – Challenges and Breakthroughs

How to be GMP Ready: A Guide

Why are GMP-compliant ancillary materials important in Regenerative Medicine?

What are the benefits of transitioning to GMP-compliant AMs early in pre-clinical research?

Advice for establishing a secure GMP supply chain for streamlined clinical translation

Summary

Further Reading & Guidance

Collagenase and Neutral Protease Enzymes

Lentivirus & Adenovirus & AAV

STEM-CELLBANKER® Stem Cell Freezing Media

StemFit Purotein® Recombinant Proteins

StemFit® Feeder-Free Stem Cell Culture Media

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