Covance provides analytical solutions and expertise for vaccines throughout the product lifecycle. This includes assay development, validation, stability testing, characterization, and release testing according to regulatory standards. Using Covance's centralized laboratory allows clients to obtain higher quality data more efficiently compared to using multiple providers. Covance has experience supporting over 12 vaccines in the last three years and offers various analytical techniques and BSL-2 and BSL-3 containment.
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Vaccines CMC Analytical Solutions for Every Stage of Product Lifecycle
1. KEY ANALYTICAL
CHALLENGES
COVANCE SOLUTIONS
Regulatory compliant
analytical strategies for
cell banks, virus seeds,
adjuvants, intermediates,
drug substance and drug
product
Vaccine subject matter
expertise and regulatory
consultation to align
your Analytical Control
Strategy and Plan with
product CQAs
Analytical and stability
assay development for
testing of the broad range
of vaccine types to ICH,
WHO guidance and
regulatory standards
Broad range of fit-
for-purpose analytical
capabilities for most
vaccine types
Assay progression
to global GMP
expectations
Qualification and testing
to global cGMP quality
standards including
ICH specified stability
chambers
Subunit, toxoid and
conjugate vaccine structural
characterization, including
characterization of process
and analytical anomalies
Expertise, experience
and equipment to
understand peptide,
protein, polysaccharide,
and conjugate structure
and structural anomalies
Management of
reference standards
and antibody reagents
supply and qualification
Robust characterization
and control of reference
standards and antibodies
SPECIALTY EXPERTISE
• Biopharmaceutical development
• Platform and custom assays, most biochem and cell-based
assay platforms (physicochemical, in vivo and in vitro potency)
• Biosafety testing, including Next Generation Sequencing for
adventitious virus detection
• High-resolution MS, Edman sequence analysis, AAA, CD
• Polyclonal and monoclonal antibody reagent manufacturing
IND/IMPD/CTA
PRECLINICAL
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VACCINES HAVE MANY CMC ANALYTICAL CHALLENGES THROUGHOUT
THE PRODUCT LIFECYCLE. COVANCE HAS THE SOLUTIONS.
KEY ANALYTICAL
CHALLENGES
COVANCE SOLUTIONS
Establishment of product
specifications that
demonstrate control of
product
Refinement of the
Analytical Control
Strategy by determining
the list of assays to
address QQAs and
defining acceptance
criteria
Demonstration of
process control
Process validation
testing and linkage to
product CQAs
Assay validation
Validation to ICH
requirements and
cGMP standards
Manufacturing lot
comparability
Expertise, experience
and equipment to
establish lot-to-lot
comparability
Expiration dating
Accelerated and long-
term stability testing
to cGMP and ICH
standards
SPECIALTY EXPERTISE
• In-process analytical support
• Viral clearance
• cGMP change control
• Global quality standards
CLINICAL DEVELOPMENT
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BLA/NDA/MAA
KEY ANALYTICAL
CHALLENGES
COVANCE SOLUTIONS
Routine, global lot
release and
stability testing
under commercial
GMP conditions
GMP testing labs located
in North America and
Europe
Monitoring and
identification of
data trends
Lead Scientist oversight
of molecule data to
trigger OOT/OOS alerts
SPECIALTY EXPERTISE
• Global project management
• Global GMP quality systems
• Control charting and review of all analytical data
COMMERCIALIZATION
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