Biotech-BioPharm Services » In - Vitro - Studies :
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.
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.