PRODUCT RELEASE & QUALITY CONTROL
For the product release of new drugs or biologics, several tests are required from regulatory guidelines to ensure their quality. Cell lines must be authenticated, gene sequences must be confirmed, the identity of the plasmids used should be verified, and raw materials, cell lines and final products should be checked for mycoplasma and viral contaminations. BaseClear can help you perform these tests in compliance with your quality system. Services mentioned below can be either ISO or GMP compliant. We can assist you in designing an optimal testing strategy for your production process.
GENE SEQUENCE OR PLASMID IDENTITY VERIFICATION
Before a new drug or other biologic can be released, it is necessary to confirm the quality of the encoding gene sequence and to verify the identity of the plasmids that are used. This can be easily done via Sanger sequencing. BaseClear offers an all-inclusive Sanger sequencing service, which can be either ISO or GMP compliant. BaseClear can help you design the optimal sequencing strategy. In some cases this is even possible with a delivery time of only 24 hours! GMP Sanger sequencing can be done through our daughter company Probase Pharma.
Mycoplasma contamination of cell cultures and other cell-derived chemicals is a widespread problem in biological laboratories and production facilities. Since they are relatively small and resistant to common antibiotics, they often escape notice. However, their presence can have mild to severe consequences, including changes in membrane composition, cell metabolism, RNA, DNA and protein synthesis and even chromosomal aberrations. Nowadays, mycoplasma testing is required for meeting quality control standards for laboratories concerning research, production and maintenance of cell lines. BaseClear offers a mycoplasma testing service using a validated PCR test. In addition, we offer the possibility to further characterize the positive Mycoplasma samples with our MicroSEQ® system, using 16S sequencing. This system allows us to identify the exact Mycoplasma strains that are present, giving you the possibility to conduct a root cause investigation.
Viral contaminations only rarely occur in the biopharmaceutical industry. However, they present a serious threat since they are difficult to detect and there is a lack of effective methods of treating infected cell cultures. Therefore, viral contaminations should be prevented as much as possible and raw materials, cell banks and products should be regularly checked for the presence of viruses. BaseClear has developed a special service for viral testing. We can detect and characterize not only known viral pathogens, but also novel ones from a wide spectrum of sample types. Therefor we will isolate the viral RNA or DNA from your samples, and sequence it using next generation sequencing (NGS) technology.