PEPTIDE AND PROTEIN FORMULATION
& CHARACTERIZATION
Our scientific staff has the expertise and
instrumentation to carry out full development programs for
protein-based or derived pharmaceuticals. Capabilities include
peptide or protein characterization, stability evaluation,
formulation and process development of molecules as sterile
liquids and lyophilized cakes for parenteral and alternative
delivery routes. Our biotechnology team has the combined expertise
to tackle all aspects of development and the experience to
surmount the unique challenges of working with macromolecular
drugs.
Peptide and Protein Product Development
Backed by a talented analytical group, our
peptide and protein product development team is prepared to
address all aspects of product development, including:
- Degradation studies
- Formulation development
- Assessing stability of drug in formulation
- Sterile filtration process development
- Container/closure selection
- Manufacturing process development
- Terminal sterilization
- Lyophilization
- Drug product stability testing
- Scale-up and technical transfer
Peptide and Protein Stability Assessment
Chemical Stability is typically assessed
by studying degradation rates, degradation pathways, identifying
degradation products and by generating pH-rate profiles. Physical
Stability is typically assessed through studying aggregation,
unfolding/denaturation, adsorption and interaction with surfaces.
pH-solubility profiles are usually generated to provide information
about compound solubility during the formulation development
process.
A variety of tests and services are offered
to characterize degradation. To study chemical instability
(degradation rate, degradation pathways and degradation product
identification) we use LC-MS and HPLC (UV and fluorescence).
To study physical instability (aggregation, unfolding, denaturation,
disulfide scrambling and solubility) we use circular dichroism,
electrophoresis (by Bioanalyzer), size exclusion chromatography,
UV and DSC.
Services include compatibility studies of
active ingredients with excipients and with delivery components.
Formulation selection and optimization are aided by the extensive
use of statistical experimental design. Short-term and accelerated
stability studies are typically employed to challenge the
drug formulations.
Peptide and Protein Analysis
Cirrus provides all method development and
validation for regulatory submission-required tests. Full
release testing, as well as short- and long-term stability
testing, are available. We can provide services to meet all
testing requirements for regulatory submission of peptide
and protein products. Submission-ready documents will be generated.
Peptide and Protein Formulation
Our scientists have expertise in formulating
peptides and proteins for a various routes of administration
including pareneteral, oral, inhaled and nasal. Formulation
scientists and process engineers collaborate to develop a
manufacturing process which can be optimized for robustness
and efficiency then scaled up through careful evaluation of
manufacturing parameters. To facilitate the transfer process,
Cirrus typically writes the manufacturing monograph. Elements
of the process may include:
- Blending/homogenization
- Filtration
- Container/closure selection
- Terminal sterilization
- Lyophilization
If requested, Cirrus can work with
the sponsor to select a manufacturing site for full-scale
batch production, transfer the manufacturing process, and
oversee batch manufacture.
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