The nature of biopharmaceuticals requires growth media to support the functionality of the cell growth and production of the desired biological expression. As with higher trophic organisms, micronutrients are necessary for optimal growth and viability of cells, whether the biopharmaceutical production uses animal or plant-based cell lines. This includes mAb, CAR-T, viral vector, and future pharmaceutical drug opportunities. Each one having its own special demands and concerns.
Improper micronutrient controls in biopharmaceutical production can result in out of specifications (OOSs), lower yield, decreased profitability, and worst of all, interruptions in availability of life saving drugs for patients. Thus, it is of paramount importance for the biopharmaceutical industry, as a whole, to implement appropriate quality practices associated with their delivery and control.
Learn about the variables associated with micronutrient quality assurance and how they can be integrated into your systems.
Greater yield equated to increased profits. Learn more about how statistics coupled with high quality analytical results will impact your bottom line.
Micronutrients are dietary components, often referred to as vitamins and minerals, which although only required by organisms in small amounts, are vital to development, activity, and viability. Minute changes to micronutrient levels during all phases of biopharmaceutical investigations and production stages can have significant impacts driving OOS and R&D concerns. The quantitation of micronutrients, specifically minerals and metal bearing vitamins, as well contaminants that are known to be relevant to all aspects of the biopharmaceutical industry is what Brooks Applied Labs specializes in.
The quantitation of micronutrients, specifically minerals and metal bearing vitamins, as well contaminants that are known to be relevant to all aspects of the biopharmaceutical industry, is what Brooks Applied Labs specializes in.
Micronutrients are a small component of chemically defined media but play a key role in optimization and control of bioreactors. Unfortunately, due to the relatively low concentrations of certain minerals in the chemically defined media, the contribution from all sources of the process must be taken into consideration. Thus, a holistic approach to micronutrients is necessary for controlling the process, whether the project is in the R&D phase, FDA filing, or final CGMP production phase.
Many of our methods are validated in accordance with the International Conference of Harmonization (ICH) and Code of Federal Regulations (CFR). This not only lends confidence in our quality systems but also ensures our clients can apply analytical results in a standardized basis throughout their processes.
Brooks Applied Labs has been audited by our pharmaceutical clients, third party accreditation services, as well as the FDA, which play an invaluable role in our desire to continue to improve our quality systems and support our clients’ needs.
Brooks Applied Labs has been audited by our pharmaceutical clients, third party accreditation services, as well as the FDA, which play an invaluable role in our desire to continue to improve our quality systems and support our clients’ needs. Our approach to quality is dynamic with the understanding that the regulatory environment can, and will, change necessitating a proactive approach by both our clients and Brooks Applied Labs.
Contact us to find out how your quality and process objectives can be met more efficiently than ever or read more about our services by clicking on any of our brochures below.