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Free Pickup Service - MD, DC, Northern VA for all orders priced at $450 or higher.
Biotech/BioPharm Services
Clongen Laboratories, LLC offer several studies required to fulfill the FDA requirements for new investigational drugs, medical devices, chemicals and other biological products. We offer a wide range of cGMP and GLP-compliant biosafety, virology, microbiology and molecular biology services. Our scientists are prepared to design and perform custom studies to satisfy any requirements you may have for product release. Our scientists have expertise with cells of human, animal, insect and other eukaryotic origins that can be used in viral, propagation, titration, detection or other assays. Our cell lines are tested regularly for sterility and for the presence of any other contaminants.
The following services are offered:
Study Description
|
Protocol |
Turnaround Time |
Sample requirements |
In vivo Testing for Adventitious Viruses in Embryonated Hen Eggs |
CB100 |
5-6 weeks |
14 ml test article and 14 ml control |
Cell Growth and Growth Conditions Optimization |
CB101 |
2-4 Weeks |
2 X 1 ml (5 x 10(6) cells/ml) |
Cell Morphology and Growth Characteristics Studies |
CB102 |
3-4 weeks |
2 X 1 ml (10 (7) cells/ml) |
Tumor Formation in Soft Agar |
CB103 |
3-4 weeks |
2 X 1 ml (10 (7) cells/ml) |
Isoenzyme Electrophoresis for Determination of Cell Line Origin |
CB104 |
3-4 weeks |
2 X 1 ml (10 (7) cells/ml) |
Immunofluorescence for Identification of Cell line Origin |
CB105 |
3-4 weeks |
2 X 1 ml (10 (7) cells/ml) |
Generation of Master Cell Banks |
CB106 |
8-12 weeks* |
2 X 1 ml (10 (7) cells/ml) |
Cryopreservation of Cell Lines and Long Term Storage |
CB107 |
6-12 weeks* |
2 X 1 ml (10 (7) cells/ml) |
Master Virus Seed Stock Preparation |
CB108 |
4-14 weeks |
Refer to Tech Support |
In vitro Testing for Adventitious Viruses in Three Cell Lines |
CB109 |
4 weeks |
Refer to Tech Support |
Virus Titration |
CB110 |
4-5 weeks |
Refer to Tech Support |
In vitro Testing for the Presence of Retroviruses |
CB111 |
4-5 weeks |
Refer to Tech Support |
Sterility Testing - Membrane Filtration (GLP) |
CB112 |
3-4 weeks |
Refer to Tech Support |
Sterility Testing - Membrane Filtration (Non-GLP) |
CB113 |
3-4 weeks |
Refer to Tech Support |
Sterility Testing - Direct Inoculation (GLP) |
CB112a |
3-4 weeks |
Refer to Tech Support |
Sterility Testing - Direct Inoculation (Non-GLP) |
CB113a |
3-4 weeks |
Refer to Tech Support |
Mycoplasma Testing by Multiplex PCR (Non-GLP) |
131 |
1-3 days |
1 ml |
Mycoplasma Screen by Hoechst Staining (Non-GLP) |
CB114 |
1-2 weeks |
1 ml |
Mycoplasma Screen by Hoechst Staining (GLP) |
CB115 |
1-2 weeks |
1 ml |
Mycoplasma Testing by Direct Cultivation on enriched Mycoplasma Media-GLP |
CB116 |
5-6 weeks |
5 ml |
Mycoplasma Testing by Direct Cultivation on enriched Mycoplasma Media-Non-GLP |
CB117 |
5-6 weeks |
5 ml |
Mycoplasmal Testing of Biologicals in Compliance with 21CFR 610.30 |
CB118 |
5-6 weeks |
10 ml Test Article and 10 ml Control Fluid |
Mycoplasma GLP testing (9CFR113.28) for cultivable Mycoplasmas |
CB119 |
4-5 weeks |
10 ml Test Article and 10 ml Control Fluid |
Points to Consider 1993 testing for Virus Stocks, Monoclonal Antibodies and Cell Lines (Mycoplasma Testing) |
CB120 |
5-6 weeks |
10 ml Test Article and 10 ml Control Fluid |
Bioburden Testing (GLP) |
CB121 |
3-4 weeks |
Refer to Tech Support |
Bacteriostasis/Fungistasis (GLP) |
CB122 |
3-4 weeks |
Refer to Tech Support |
Cytotoxicity in Agar Overlay (L929 Cells) |
CB123 |
4-7 days |
3 ml or 300 mg |
CB124 |
2-3.5 weeks |
10 (7) cells |
|
| Endotoxin Test (Limulus Amoebocyte Lysate - LAL) - GLP - Endpoint Assay | CB125 |
2-5 days |
Any |
Endotoxin Test (Limulus Amoebocyte Lysate - LAL) - cGMP - Endpoint Assay |
CB126 |
2-5 days |
Any |
Residual Bovine Serum Albumin (BSA) Concentration by ELISA |
CB127 |
2-4 days |
1.0 ml minimum |
Residual Human Serum Albumin (BSA) Concentration by ELISA |
CB128 |
2-4 days |
1.0 ml minimum |
| Endotoxin Test (Limulus Amoebocyte Lysate - LAL) - GLP - Kinetic Assay | CB129 |
2-5 days |
Any |
Endotoxin Test (Limulus Amoebocyte Lysate - LAL) - cGMP - Kinetic Assay |
CB130 |
2-5 days |
Any |
*Turnaround time depends on cell growth properties and doubling times.
(Other custom protocols can be adapted and transferred)
Shipment Temperature:
- Cryopreserved cells: On dry ice.
- Viable cells: Ambient. If the submitted cell line is in suspension, please fill the transport container leaving some air to allow for expansion and contraction during shipping. Anchorage-dependent cells should be sent at 40-80% confluence with the flask filled almost completely with medium (leave some air space to allow for expansion and contraction during shipping).
Protocols or SOPs describing growth condition, media components and any special additives should be included with the submitted cells. Please use an additional sheet to describe growth requirements if there is not enough space in the submission form. Please provide Mycoplasma status in cell line (present or absence if you have this information for safety reasons).