Lot Release Testing - Clongen Labs

(877) CLONGEN (256-6436)

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7 July, 2008

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Clongen Laboratories, LLC

12321 Middlebrook Road,
Suite 120 Germantown, MD 20874

Phone: (301) 916-0173
Fax: (301) 916-0175

Email: akil@clongen.com

Customer Support
cs@clongen.com

Web Master
webmaster@clongen.com

Biotech-BioPharm Services » Lot Release Testing :

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 Retro viruses	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
Mycoplasma Elimination from Contaminated Cell Lines	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

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     Turnaround time depends on cell growth properties
        and doubling times.(Other custom protocols can be
        adapted and transferred) (Other custom protocols
        can be adapted andtransferred)

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).

Please send us your submission form either by e-mail, Fax or mail and include a copy with your submitted test article(s). Forms can be downloaded from the "Forms" link to the left.