Unprocessed Bulk Testing
Unprocessed bulk (UPB) is the material collected directly from the bioreactor in which genetically engineered cells grow and produce product. Low levels of adventitious agents such as bacteria, yeast, fungi, molds, mycoplasma and viruses that bypass detection during raw materials testing, may grow to detectable levels under the highly enriching conditions of the bioreactor. At this point in the manufacturing process, it is optimal to test for these adventitious agents. Testing of each lot of UPB is a regulatory requirement.
Eurofins BioPharma Product Testing’s network of experienced teams offer a streamlined, cGMP approach to unprocessed bulk testing to ensure product purity in order to move into downstream purification faster and with less risk of contamination.
While we can fully customize our approach to meet any testing needs, our recommended approach consists of a package of testing including, bioburden, mycoplasma testing, in vitro viral screening, and virus specific qPCR assays, all performed in 21 or 35 calendar days.
Why Choose Eurofins BioPharma Product Testing?
- Retroviral-like particles (RVLPs) released into the media during the manufacturing process must be quantified to help determine the log reduction value (LRV) of clearance required to obtain a safe product. Our fully validated GMP TEM service provides streamlined, reliable, and consistent unprocessed bulk testing for mAb and ADC biologics. With real-time access to experts, on-line access to raw data and images, you can feel secure moving from UPB to viral clearance in the same laboratory.
- Our specialized sample delivery and receipt process ensures seamless communication between our lab and yours and expedites your samples into our laboratory within days of receipt.
- We provide an individual or summary Certificate of Analysis within 21 or 35 calendar days.
- Our secure, 24/7 online data portal, LabAccess.com provides timely access to your test results.
- Our experienced project management and technical teams serve as your single-source solution for all of your cell line and testing needs.
Our Recommended Testing
- Bioburden testing
- Mycoplasma Testing (Harmonized Compendial or PCR)
- In vitro viral screening (Vero, MRC-5, CHO K1 for CHO-derived products. Other cell lines upon request)
- Transmission Electron Microscopy (TEM)
- Virus specific qPCR
Testing Sample Requirements
The 35-day release testing program is the traditional approach utilizing the longer test methods. The table below includes information on the test methods, turn around times, and sample requirements.
The 21-day release testing program utilizes the shorter in vitro adventitious agent test method (14-day), as well as using the molecular-based PCR approach to mycoplasma testing. The table below includes information on the test methods, turnaround times, and sample requirements. Consult with your regulatory reviewer if the shorter UPB test approach is preferred.
*TEM testing should be performed on 3 lots of UPB to assess retroviral load to help design the IND or BLA viral clearance study. After 3 lots have been tested, the TEM assay is no longer required.
The MMV interference and mycoplasmastasis test methods only need to be performed once for early stage clinical trials. For late stage/commercialization, product specific qualifications (multiple lots, multiple spike controls) should be considered.
