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Experimental Manufacturability Assessment Assays

Founded in 2005, Creative Biolabs is always devoted to effective drug discovery for human health improvement. We now have absolute advantages in providing comprehensive drug discovery/development services including a diversity of manufacturability assessment services through years of expansion and progression.

Why is Manufacturability Assessment Needed?

Despite the significant biological activities, therapeutic proteins are confronted with many challenges in developing into commercial products, such as active spatial structures, poor stability, susceptible physicochemical properties, and so forth. Therefore, previously biopharmaceuticals development only based on biological activities often encounters technical problems (e.g., stability, reduced activity, immunogenicity) when advanced to the later stage of production process development and failed to commercialize smoothly.

Pharmaceutical manufacturability is a measure of ease in which an active macromolecule can be manufactured and developed. Manufacturability assessment comes to light aiming to find out the possible factors or limitations affecting drug developability. It is of great significance to implement manufacturability assessment as early as possible in/before the pre-clinical stage, by which it minimizes the risks of costly late-stage failures for industrial production and develops safe, reliable, and valuable biologics.

Generally, pharmaceutical manufacturability assessment is performed by virtual computational modeling prediction and experimental/biological assays. Virtual prediction (also known as in silico method) offers useful guidance about structure, electric charge, post-translational modifications (PTMs), etc., in cost- and time-saving manners. While, manufacturability assessment by experimental assays reflects the physicochemical properties, biological activity, safety, and even developability potential of the candidate biopharmaceuticals based on analyzing data and observing phenomena.

Manufacturability Assessment Experimental Assays Provided by Creative Biolabs

Increasing research and development institutes and pharmaceutical enterprises have begun to incorporate manufacturability assessment into therapeutic proteins discovery stage in recent years in order to obtain the best pharmaceutical molecules. As a leader in the bio-drug discovery, Creative Biolabs provides a series of high-quality manufacturability assessment services by various experimental assays in vitro and in vivo, which including but not limited to:

Manufacturability Assessment Experimental Assays. Fig.1 Manufacturability Assessment Experimental Assays.

For comprehensive developability assessment, protein material of gram quantities is prepared by stable expression in a CHO expression system. And the final cell clone for clinical and commercial manufacturing is also identified in parallel. Then, candidates are compared using the same production system to directly visualize the impact of the molecule on expression and purification. Molecules with overall greater yield will be preferred for further development.

Protein unfolding can alter its functional activity and lead to aggregation, or even increase the risk of in vivo immunogenicity. During the late-stage candidate selection, the physical stability of biotherapeutic candidates is tested at different conditions of temperature, pH, mechanical stress, and diverse formulation buffers. These studies can be informative for downstream processing and help formulation function to select drug candidates that perform well in the preferred formulation platforms.

Chemical stability and PTMs of biologics are important quality attributes that should be fully investigated during the developability assessment campaign. Undesirable PTMs could cause partial or complete loss of activity, increase the tendency to aggregate, reduce the shelf life span of the product, and increase the sample heterogeneity.

The administration route and formulation are also considered by our developability assessment platform. However, these aspects are traditionally addressed in later development phases, that is, at a time point when necessary adaptation could be very expensive. The pre-formulation assessment includes determination of viscosity and solubility at a high product concentration and accelerated stability test so that these important aspects can be considered for candidate selection.

In terms of pharmaceutical manufacturability assessment, by chose Creative Biolabs, you will gain a reliable partner with extensive experience and expertise. Our scientists will anticipate in every step of the assessment service to ensure that your specific demands and the best interests are looked after. Please do not hesitate to contact us for more details.

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