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Manufacturability Assessment and Optimization

Manufacturability assessment offers the opportunity to evaluate the technical viability of a drug candidate at the industrial scale and functions as a bridge between discovery and process development stage. Creative Biolabs is able to evaluate key manufacturability parameters, including productivity and process yield, chemical stability, PTMs, physical stability, aggregation, electrostatic properties, and formulability through our virtual prediction platform and experimental manufacturability testing platform. Pilot studies conducted by our labs have suggested that these results can effectively guide the customer to the most appropriate candidate for process development. Meanwhile, we have also developed a variety of assays to improve the developability condition of potential drugs or protein therapeutics.

Introduction to Manufacturability Assessment and Optimization

Peptides, antibodies, or proteins have shown promising results in treating many kinds of diseases, but side effects still happen and are usually related to the physicochemical property of testing candidates. The safety and efficacy of candidate drugs still need to be analyzed by “manufacturability”. Manufacturability assessment and optimization play an important role in detecting the suitability of a therapeutic molecule. As a result, recent studies have revealed that high-throughput methods should be a powerful tool for eliminating the instabilities, toxicity in successful manufacturability projects. In general, comprehensive assessment and optimization are based on computational and experimental analysis strategies. In silico prediction, technologies have been widely used for modifying the structure and sequences of screened molecules to improve their stability and manufacturability in clinical use. In addition, the application of experimental approaches is an emerging area, and much progress has been made to detect the solution properties, chemical stability at different concentrations.

Manufacturability Assessment and Optimization Platform. Fig.1 Manufacturability Assessment and Optimization Platform.

Virtual Prediction of Manufacturability Assessment and Improvement

As an expert in manufacturability assessment, Creative Biolabs has generated a novel in silico analysis platform to provide a series of services to measure multiple manufacturability parameters in diverse target molecules. This platform can rapidly evaluate physical and chemical parameters, including viscosity, solubility, critical residues, aggregation, immunogenicity as well as degradation/ PTMs, in a cost-effective manner. Furthermore, we also offer a suite of predictive models for engineering the structure of protein therapeutic candidates to improve the evaluation results of manufacturability. For instance, The aggregation and stability risks of monoclonal antibodies against CD19 have been assessed by our in silico tools.

Experimental Manufacturability Assessment and Optimization

In recent years, Creative Biolabs has designed a novel experimental platform to screen and optimize the manufacturability of test materials in drug research. Up to now, we have successfully accomplished a wide collection of early assessment strategies that can be used to analyze physicochemical stability parameters, deamidation, aggregation propensity, oxidation propensity, as well as solution properties. Subsequent screens and assays are focused on binding specificity and affinity specificity. A number of high-throughput (HT) technologies, such as fluorescence spectroscopy, Nuclear magnetic resonance (NMR), high-performance liquid chromatography (HPLC), dynamic light scattering (DLS), have been proved its applicability in the screening cascade. Additionally, our customize manufacturability optimization services are designed to provide meaningful data for designing better candidates in drug discovery.

Manufacturability assessment of the drug candidates. Fig.2 Manufacturability assessment of the drug candidates.

Creative Biolabs offers a manufacturability assessment and optimization platform that is critical to improving the quality, safety, and manufacturability of potential biotherapeutic and drug candidates. If you are interested in our service, please feel free to contact us.


All listed customized services & products are for research use only, not intended for pharmaceutical, diagnostic, therapeutic or any in vivo human use.

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