BBG Advanced Therapies provides a comprehensive suite of RUO and cGMP-qualified assays to support the development and biomanufacturing of cell- and tissue-based products.
Experienced scientists collaborate closely with biopharma and research partners to develop, transfer, and validate custom assays that confirm the safety, purity, and potency of advanced therapies. From early research through cGMP release, testing services ensure your data withstands regulatory and scientific scrutiny.
BBG Advanced Therapies offers integrated testing solutions designed to support the safety, quality and potency of advanced therapy products. Our laboratory provides comprehensive safety, characterization and potency testing under rigorous quality systems and regulatory standards.
From custom assay development and qualification to technology transfer and commercial testing, our scientists deliver reliable, reproducible results throughout the product lifecycle.
Test | Sample Requirements |
|---|---|
CD45/105 Single and Dual Stain | Recommend 2e6 live cells/mL, minimum of 1e6 live cells/mL |
MSC Panel (CD73, CD90, CD105, CD106, CD11b, CD14, CD34, CD45, HLA-DR) | Recommend 2e6 live cells/mL, minimum of 1e6 live cells/mL |
Mini-MSC Panel (CD90, CD166, CD34, CD45) | Recommend 2e6 live cells/mL, minimum of 1e6 live cells/mL |
CD44 | Recommend 2e6 live cells/mL, minimum of 1e6 live cells/mL |
CD276 | Recommend 2e6 live cells/mL, minimum of 1e6 live cells/mL |
CD133 | Recommend 2e6 live cells/mL, minimum of 1e6 live cells/mL |
HLA-ABC | Recommend 2e6 live cells/mL, minimum of 1e6 live cells/mL |
CD13 | Recommend 2e6 live cells/mL, minimum of 1e6 live cells/mL |
CD29 | Recommend 2e6 live cells/mL, minimum of 1e6 live cells/mL |
CD31 | Recommend 2e6 live cells/mL, minimum of 1e6 live cells/mL |
CD106 | Recommend 2e6 live cells/mL, minimum of 1e6 live cells/mL |
SSEA1 | Recommend 2e6 live cells/mL, minimum of 1e6 live cells/mL |
SSEA4 | Recommend 2e6 live cells/mL, minimum of 1e6 live cells/mL |
Tra-1-60 | Recommend 2e6 live cells/mL, minimum of 1e6 live cells/mL |
Nanog | Recommend 2e6 live cells/mL, minimum of 1e6 live cells/mL |
2-Marker Panel (SSEA5, Tra-1-60) | Recommend 2e6 live cells/mL, minimum of 1e6 live cells/mL |
Leukopak Marker CD3 | Recommend 2e6 live cells/mL, minimum of 1e6 live cells/mL |
Leukopak Marker CD4 | Recommend 2e6 live cells/mL, minimum of 1e6 live cells/mL |
Leukopak Marker CD8 | Recommend 2e6 live cells/mL, minimum of 1e6 live cells/mL |
Leukopak Marker CD14 | Recommend 2e6 live cells/mL, minimum of 1e6 live cells/mL |
Leukopak Marker CD19 | Recommend 2e6 live cells/mL, minimum of 1e6 live cells/mL |
Leukopak Marker CD34 | Recommend 2e6 live cells/mL, minimum of 1e6 live cells/mL |
Leukopak Marker CD45 | Recommend 2e6 live cells/mL, minimum of 1e6 live cells/mL |
Leukopak Marker CD56 | Recommend 2e6 live cells/mL, minimum of 1e6 live cells/mL |
Test | Sample Requirements* |
|---|---|
* Cell Suspensions are normalized to 20,000 cells for testing | |
CMV | 1 mL EDTA Plasma / CPD Plasma / BM-MSC cell Suspension |
EBV | 1 mL EDTA Plasma / BM-MSC cell suspension |
HEV | 1 mL EDTA Plasma |
HHV 6/7/8 | 1 mL BM-MSC cell suspension |
HAV | 1 mL BM-MSC cell suspension |
HTLV 1 | 1 mL BM-MSC cell suspension |
HTLV 2 | 1 mL BM-MSC cell suspension |
HIV/HBV/HCV | 1 mL BM-MSC cell suspension |
B19 | 1 mL BM-MSC cell suspension |
Test | Sample Requirements* |
|---|---|
*Cell suspensions are normalized to 5.00e5 cells/mL | |
Rapid Myco PCR | mL client sample (cell suspension, media, plasma)1 |
Test | Sample Requirements* |
|---|---|
Rapid Endotoxin (Kinetic Chromogenic LAL) | 1 mL client sample (liquid or solid product) |
Test | Sample Requirements* |
|---|---|
TIMP-1, HGF | 1 mL Cell Culture Supernatant |
Adiponectin | 1 mL Cell Culture Supernatant |
IL-1b, IL-6, TNF-a | 1 mL Cell Culture Supernatant |
Test | Sample Requirements* |
|---|---|
Pierce BCA | 1 mL client sample |
Micro BCA | 1 mL client sample |
Test | Sample Requirements* |
|---|---|
pH | Minimum 100uL liquid sample |
Osmolality | Minimum 100uL liquid sample |
Connect with our team to discuss your testing needs, request assay information or explore custom testing solutions.
The integrated collaboration between BBG Advanced Therapies’ testing and quality teams accelerates the introduction of new assays and products. Phase-appropriate, risk-based testing solutions are designed to assure the safety, purity, identity, and potency of cell- and tissue-based products.
This has been our guiding principle for more than 50 years—ensuring quality by advancing laboratory excellence through validated methods, controlled environments, and a continuous focus on process improvement.
