REGULATORY
GLP, GMP Compliant CRO
Assay Development  Assay Validation Potency
Assay Drug Release Assay
REGULATORY OVERVIEW
Marin Biologic Laboratories is a contract research organization
- CRO - performing GLP and GMP laboratory services. We have
extensive experience in assay development and validation for
new drug substances and drug products for biologics. Assay development
for GLP and GMP studies as well as GLP and GMP assay support
is performed for lot release, sample analysis, IND, BLA and
NDA submissions. The technologies described under specific headings
can be offered for assay development and validation.
ASSAY DEVELOPMENT
If you need assay development or simply to transfer an assay
to a contract research organization - CRO - to analyze samples
for FDA submissions, we will work with you to meet your long
term needs, whether or not it requires GLP, GMP compliance.
Vendors and reagent lots will be selected to ensure that your
reagents will perform consistently and provide continuity in
your assay over time. For assay development, our scientists
will perform the assay under "research level" protocols
and identify those parameters such as the limit of detection
(LOD), the limit of quantitation (LOQ) and the linear range
that will be critical for assay validation which typically will
be conducted under GLP or GMP compliance. We will write SOPs
and protocols which can be used for assay validation.
GLP, GMP ASSAY VALIDATION
Once the parameters and range are set during the assay development
or transfer, we will discuss with you the number of experiments
necessary to show linearity, accuracy, precision, specificity,
robustness, ruggedness and system suitability. Statistical data
analysis will be discussed with you, so that the relevant data
analysis tools are used to best match your system. As part of
our contract research organization - CRO - services a GLP or
GMP protocol will be generated for your sign-off and all SOPs
pertinent to your assay will be reviewed with you. Often before
we begin the assay validation, controls will be generated and
aliquoted under GLP or GMP compliance which may be used over
several years depending upon the stability of the reagents.
We will discuss these issues with you during the assay development
or transfer. Our scientist will perform the validation under
GLP or GMP compliance and a report will be submitted to your
regulatory staff for review. After your review, a GLP or GMP
final report will be issued.
POTENCY ASSAY, DRUG RELEASE ASSAY
If we have developed and validated your potency assay, whether
it be a cell-based assay, enzyme assay, ELISA assay or some
other assay, and you have accepted the final report, we can
begin to analyze your samples under GLP or GMP compliance. If
you need to submit documentation concerning potency for your
drug release assay or stability study in a cell-based assay,
we will discuss with you the parameters of your cell culture,
your frozen stocks, etc. in order to maintain the cells with
minimal variability from assay to assay over the years. If you
have an enzyme based assay or ELISA assay we will discuss with
you the storage conditions, controls, and other parameters that
may impact your assay over the years. As part of our contract
research organization - CRO - services, our scientists will
assist you in preparing your regulatory filings.
This is a partial list representing our
expertise.
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