GMP certified rapid molecular testing

Producers of food and pharmaceutical products need to assure that their products are of high quality and not contaminated with any type of microorganism or DNA. This quality control testing has to be performed via accurate and reliable methods that are GMP certified. ProBase Pharma, the GMP brand of BaseClear, offers several services for DNA-based quality control testing using validated methods.

An increasing number of molecular biological methods is replacing classical purification and incubation methods. BaseClear offers molecular biological testing services for raw materials, process  intermediates and finished products. BaseClear has the technology and experience to provide rapid microbial testing results to the food & pharmaceutical industry.

Bacterial and fungal identification services

Identification and typing of bacteria or fungi can be very costly and time consuming, because of growth time of the microorganisms and lab work. BaseClear offers microbial identification services using established as well as innovative techniques under GMP conditions. Our methods are much faster and more reliable than currently used phenotypic methods. BaseClear services are suitable for fast screening of even the most difficult samples.

Microbial strain typing services

To control unwanted bacteria you need to know what the contaminating organism is and how it entered your environment. For this BaseClear offers microbial strain typing services using REP-PCR in combination with 16S sequencing. These techniques use the power of DNA to not only identify the genus and species of contaminants, but also provide deeper, strain-level typing at the same time. This fine degree of resolution applies to environmental isolates, pathogens, spoilage organisms, control strains, beneficial organisms or any other bacteria that are important to the industry. Quality control labs use these strain typing techniques to track and trend microbial contaminations and environmental monitoring isolates.

GMP sequencing services

BaseClear offers a highly precise and reliable GMP sequencing service that covers all steps necessary to determine complete DNA sequences. It is commonly used for confirmation of the sequence and integrity of a gene or plasmid and prior to cloning or transfection into a cell line or viral vector. It is also the method of choice for verification that a gene of interest has been successfully introduced into a target cell or plasmid, or that a genetically modified virus has the desired genetic composition. For regulatory submission of therapeutic proteins and vaccine production, DNA sequencing of the entire plasmid or viral vector is required. In addition, DNA sequencing can be used to confirm the identity and stability of (production) cell lines and for patent submissions.

Other GMP solutions

BaseClear has the lab, technologies and expertise to offer GMP solutions for e.g., but not limited to;

  • Mycoplasma testing
  • Adventitious agent & viral testing
  • Real-time PCR (rtPCR) / quantitative PCR (qPCR)

We are happy to discuss your needs. Fill in the contact form or contact your account manager directly to discuss the possibilities.

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Testimonial Abbott Biologicals

For our production, it is important to check for microbiological contamination and to subsequently identify these on the basis of its DNA. BaseClear does excellent work and always sticks to the agreement made. I always receive a response within an hour.

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