Lot Release 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 and testing of each lot of UPB is a regulatory requirement.
Eurofins Lancaster Laboratories offers a streamlined, cGMP approach to lot release testing. Our experienced team will help you ensure product purity in order to move your product 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 35 calendar days.
Why Choose Eurofins Lancaster Laboratories?
- Our specialized sample delivery and receipt process ensures seamless communication between our lab and yours and expedites your samples into our laboratory within a few days of receipt.
- We provide test reports within 35 calendar days and can provide interim results upon request.
- Our secure, 24/7 online data portal, LabAccess.com provides timely access to your test results.
- We can issue individual or summary Certificate of Analysis, depending on your needs.
- Our experienced project management and technical teams serve as your single-source solution for all of your cell line and production needs.
Our Recommended Testing
- Bioburden testing
- Mycoplasma Testing (Compendial or Rapid)
- In vitro viral screening
- Virus specific qPCR
Cell Lines Available for in vitro Viral Screening
- CHO K1
- NIH 3T3
- Other cell lines upon request
Interference and Testing Sample Requirements
|Test / Test Type||Sample Requirements||Storage|
|Mycoplasmastasis (28 day)||1 x 5 mL & 1 x 5 mL||≤ -60°C|
|Mycoplasma (28 day)||1 x 12 mL & 1 x 2 mL||≤ -60°C|
|Rapid Mycoplasma||1 x 15 mL||≤ -60°C|
|Interference, Rapid Mycoplasma||2 x 15 mL||≤ -60°C|
|Microbial Limits Validation||1 x 25 mL||≤ -60°C|
|Total Yeast and Mold Count Validation||1 x 25 mL||≤ -60°C|
|Total Aerobic Plate Count||1 x 10 mL||≤ -60°C|
|Total Yeast and Mold Count||1 x 10 mL||≤ -60°C|
|In Vitro Adventitious Agents
(IVAA, 14 day/28 day)
|1 x 7 mL per cell line
(i.e., for 3 cell lines, 21 mL)
|IVAA Interference||1 x 10 mL per cell line||≤ -60°C|
|Viral Testing by PCR||5 mL of spent medium||≤ -60°C|
|Viral Interference by PCR||5 mL of spent medium||≤ -60°C|
|Test / Test Type||Sample Requirements||Storage||TAT**|
|Transmission Electron Microscopy||1 x 20 mL bulk harvest||≤ -60°C||8-10 weeks|
|In Vivo Adventitious Agents (includes guinea pigs)||1 x 35 mL, 1 x 8 mL, 1 x 4 mL & 2 x 2 mL||≤ -60°C||8 weeks|
|In Vivo Adventitious Agents (without guinea pigs)||1 x 8 mL, 1 x 4 mL & 2 x 2 mL||≤ -60°C||8 weeks|
*These tests are subcontracted to approved vendors.
**These tests are not managed as a part of the Lot Release Program.
Request more information to start working with us today. Or call one of our Business Development Specialists at 717-656-2300.