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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.
Backed by a talented analytical group, our peptide and protein product development team is prepared to address all aspects of product development, including:
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Degradation studies
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Formulation development
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Assessing stability of drug in formulation
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Sterile filtration process development
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Container/closure selection
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Manufacturing process development
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Terminal sterilization
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Lyophilization
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Drug product stability testing
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Scale-up and technical transfer
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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.
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.
Our 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:
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Blending/homogenization
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Filtration
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Container/closure selection
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Terminal sterilization
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Lyophilization
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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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