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 Quality Solutions can help you perform these tests in compliance with your quality system. These services 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 easily be done via Sanger sequencing. BaseClear Quality Solutions offers an all-inclusive Sanger sequencing service, which can be either ISO or GMP compliant. BaseClear Quality Solutions can help you design the optimal sequencing strategy. This is also possible with a delivery time of only 24 hours! GMP Sanger sequencing can be done through our subsidiary company Probase Pharma.

BaseClear Quality Solutions also provides a second pipeline to sequence and assemble your plasmids using Next Gen Sequencing and BaseClear’s bioinformatics services. This newer technology is widely used for (meta)genome and amplicon sequencing and is more cost effective for larger datasets. The delivery time of this service can vary, but could be as fast as one week. Please contact our professionals for the most suitable strategy for your sequencing project.

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MYCOPLASMA TESTING

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, mycoplasma infections often escape notice. However, the presence of mycoplasma 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 Quality Solutions offers a mycoplasma infection 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, enabling you to conduct a root cause investigation.

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VIRAL TESTING

Viral contaminations only rarely occur in the biopharmaceutical industry. However, they present a serious threat as 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 Quality Solutions 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. Therefore, we will isolate the viral RNA or DNA from your samples, and sequence it using next generation sequencing (NGS) technology.

Meet Richard de Winter!

Richard is director of our Quality Solutions business unit. In addition he is site-manager of ProBase Pharma, the daughter company of BaseClear for GMP certified rapid molecular testing.

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