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BioReliance provides quality control testing on each production lot of a biopharmaceutical to ensure its safety, purity and potency, as specified by worldwide regulatory authorities, while meeting client production schedules and streamlining processes to guarantee on-time results. Testing applies to raw materials, unprocessed bulk, purified bulk and final-filled product. As specialists in the field, BioReliance covers the full spectrum of lot release testing including adventitious agents, identity, purity, potency, concentration, residuals and excipients, moisture and sterility.
State-of-the-art instrumentation is used within
the laboratories to fully test biological products and final product
sterility assays are performed using isolator technology so clients
have absolute confidence in results. Biological and analytical lot
release assays are compliant with GLP and cGMP regulations, and
are stringently validated to meet worldwide regulatory guidelines.
The assays recommended/suggested
for use at the lot release stage are noted below. This list of assays
is not exhaustive; depending on particular characteristics of the
product, additional assays may be required.
| Antibody,
recombinant protein & blood products |
pH,
Karl Fischer titration (lyophilized samples), osmolality, appearance,
UV measurement, extractable volume, SDS PAGE, IEF, colorimetric
assay (BCA, Bradford, etc.), Western blot, HPLC, peptide mapping,
monosaccharide analysis*, biological activity/potency, host
cell DNA (quantity and size), host cell protein (quantity),
process contaminants (BSA, protein A, etc.), sterility, endotoxin,
abnormal toxicity |
| Synthetic
peptides |
pH,
Karl Fischer titration (lyophilized samples), osmolality, appearance,
UV measurement, extractable volume, colorimetric assay (BCA,
Bradford, etc.), HPLC, biological activity/potency, sterility,
endotoxin, abnormal toxicity, mass spectrometry, capillary electrophoresis |
| Viral
vaccine products |
pH,
osmolality, appearance, UV measurement, extractable volume,
SDS PAGE, colorimetric assay (BCA, Bradford, etc.), Western
blot, HPLC (cation or anion exchange+ •, RPC protein map+),
host cell DNA (quantity and size), host cell protein (quantity),
process contaminants (BSA, antibiotics, etc.), sterility, endotoxin,
light scattering, infectivity titer•, PCR with number
of primer pairs•, restriction enzyme mapping• |
| Gene
therapy viral vectors |
pH,
osmolality, appearance, UV measurement, extractable volume,
SDS PAGE, colorimetric assay (BCA, Bradford, etc.), Western
blot, HPLC, host cell DNA (quantity and size), host cell protein
(quantity), process contaminants (BSA, antibiotics, etc.), sterility,
endotoxin, light scattering, infectivity titer•, PCR with
number of primer pairs•, restriction enzyme mapping• |
* for glycoprotein products
+ method dependent on vector
• applicable to intact viral vectors
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