GMP Grade Antibodies

In diagnostic manufacturing processes constant quality control and review of the production process is crucial to ensure and maintain the highest possible product quality. For this purpose, antibodies-online offers Good Manufacturing Practice (GMP) grade antibodies* for research, cell processing, and downstream manufacturing needs.

Our GMP grade antibodies are manufactured in dedicated GMP facilities, ensuring products are consistently produced and controlled according to the most recent GMP standards. They are produced in compliance with the ISO 13485:2016 Quality Management Standard, under current Good Manufacturing Practices (cGMP) guidelines. We offer GMP grade antibodies directed against human, rat and several primate species and suitable for quality control via flow cytometry in important production steps in diagnostic manufacturing.

Good Manufacturing Practices: GMP

GMP guidelines provide requirements that a manufacturer must meet to assure that their products are consistently high in quality, from batch to batch, for their intended use.

Additional tenets include ensuring the end product is free from contamination, that it is consistent in its manufacture, that its manufacture has been well documented, that personnel are well trained, and that the product has been checked for quality throughout the entire manufacturin process. GMP guidelines provide guidance for manufacturing, testing, and quality assurance in order to ensure that a manufactured product is safe for human consumption or use.

With regard to development of cell therapies applications, GMP grade antibodies are of increasing importance. One of the key factors that enable successful and safe translation of cell therapy products from bench to market is a reliable and robust manufacturing process. This includes the use of high-quality, safe raw materials needed for manufacturing, and comprehensive regulatory support. GMP grade antibodies from antibodies-online not only meet this requirement but are the ideal tool for process and quality control.

*Please note that the term "GMP grade" does not reflect the official registration status of a product