Biochemistry and Biopharmaceutical Development

SSCI offers state-of-the-art cGMP techniques and analytical method development for the isolation, identification, and characterization of proteins and other large molecules. We aim to provide clients with knowledge of how to utilize the crystalline state to stabilize proteins in formulations. Additionally, exploration of the solid-state properties of biomolecules can not only lead to faster development and improved products, but also greater control and reproducibility. Rely on SSCI for your solid state biopharmaceutical development.

Regulatory Aspects of Biological Pharmaceuticals

With the growing number of biological products advancing to the market, the demand for thorough characterization has been increasing. Unlike traditional small molecule drugs, biological products are inherently heterogeneous; thus small differences in the molecular structure or low levels of impurities can dramatically change efficacy, immunogenicity or toxicity. Development activities related to biological products are covered by ICH guidelines. Of particular importance are the guidelines relating to quality [1,2], specifications [3], stability [4,5], comparability [6,7,8], and method validation [9,10,11].

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Biochemical and Biosimilar Characterization

ICH Q6B guidelines [3] specify the characterization of a biotechnological or biological product (which includes the determination of physicochemical properties, purity and impurities, biological activity, immunochemical properties) by appropriate techniques. SSCI provides full range of support services to determine the purity, identity, and potency of biological products and biosimilars including but not limited to protein, peptide, and oligonucleotide based drug substance or drug product.

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Product-Related Impurity Characterization

According to ICH Q6B guidelines [3], impurities in biological products can be classified as process-related and product-related. Process-related impurities include those that are derived from the manufacturing process (e.g., cell substrates, cell culture media components, or downstream processing); product-related impurities in the drug substance are molecular variants with properties different from those of the desired product formed during manufacture and/or storage. The general approach to the characterization of these impurities is to isolate sufficient quantity and then apply commonly used techniques for characterization. SSCI offers a full complement of analytical techniques for the isolation and characterization of process and product-related impurities:

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Aggregation State Characterization

Protein aggregation has been a critical quality attribute and is considered an important factor that may increase the risk of immune response. Protein aggregates can form during production, storage, or shipment. Many environmental conditions (i.e., mechanical stress, pH, ionic strength, temperature, light, and oxidation) lead to protein unfolding, misfolding, and subsequently to aggregation either by physical interaction or by covalent bonding. SSCI has extensive experience in characterization of aggregates in solution including proteins/peptides, oligonucleotides, and other polymers using the advanced analytical techniques:

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Structure Elucidation

SSCI provides expertise for structure elucidation of proteins, peptides, oligonucleotides, PEGylated proteins and small molecule drugs, antibody-drug conjugates (ADCs), and other polymers using various techniques.

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Protein Formulation Development

Physical and chemical instabilities are the most challenging tasks in the development of protein therapeutics. The molecular structure of protein is delicate in nature compared to small molecule drugs and is highly sensitive to environmental changes and stresses. Ensuring native-like higher order structure in a biologic drug is essential because the overall conformation not only defines the stability and biological activity, but also the efficacy and safety.

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Comparability

Comparability protocols for biologics [6-8] are based on the realization that changes in a manufacturing process, equipment, or facilities could result in changes in a biological product that would affect the products safety and efficacy. Comparability protocols are aimed at reducing the risk of such changes by outlining strategies for comparing the properties of pre- and post- change materials.

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Analytical Method Development and Validation

SSCI specializes in biochemical method development, transfer, and validation for the analyses of biological products and biosimilars by HPLC, UPLC, LC-MS, MALDI-TOF MS, NMR, and assays. All methods are developed and validated according to ICH guidelines [9-11] for accuracy, precision (repeatability and intermediate precision), specificity, limit of detection, limit of quantitation, linearity, range, and robustness.

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Protein and Peptide Crystallization

SSCI offers crystallization screening using a variety of crystallization techniques from vapor diffusion to microbatch screening. Initial screening is conducted on a small scale using various vapor diffusion techniques (sitting drop, hanging drop, sandwich drop, and capillary) and batch crystallization techniques (slow evaporation, fast evaporation, and anti-solvent precipitation). The conditions in which crystallization occurs will be further optimized and scaled up. The batch crystallization process can also be applied to large scale purification.

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