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Experimental Manufacturability Assessment and Optimization

As a senior leader in drug discovery, Creative Biolabs has long been concentrated on therapeutic biomolecules discovery and development. Based on our abundant experience and solid technical strength, we currently provide our valued clients with a full range of manufacturability assessment and optimization services by means of in vitro and in vivo assays.

Manufacturability Assessment and Optimization

In recent years, biopharmaceuticals like monoclonal antibodies and therapeutic proteins have accounted for a major component of the Food and Drug Administration (FDA) approved new drugs, and still maintained a growth trend. Accordingly, since the first therapeutic monoclonal antibody was introduced in the early 1980s, over 5,000 therapeutic antibody molecules are in clinical studies for the treatment of a wide range of indications covering tumors, autoimmunity, infections, and some rare diseases.

Generally, a therapeutic protein that can be successfully developed into a commercial drug in industrial-scale should have several characteristics as follows:

All these characteristics are essential factors for the technical requirements of easy manufacture which also referred to manufacturability or developability of therapeutic biomolecules. Definitely, manufacturability assessment and optimization by computational or experimental methods are the necessary processes for evaluation of potential developability of therapeutic molecules with minimizing waste of resources.

Creative Biolabs is the best service provider in drug development with abundant experience, who offers quantities of experimental assays both in vivo and in vitro for manufacturability assessment and optimization.

Experimental Manufacturability Assessment Assays

The stability and physicochemical properties of antibodies or proteins are significantly lower than chemical drugs and tend to non-desired modification, fragmentation, aggregation, or immunogenicity during the production, storage, and administration, which result in challenges in the yield, efficiency, and manufacturability of drugs. Therefore, manufacturability assessment is needed to evaluate the feasibility and cost of developing therapeutic candidates into commercially valuable drugs. Creative Biolabs can provide customized manufacturability assessment services by a series of experimental assays, such as physical and chemical stability assessment in vitro and in vivo, translation modifications assessment, and pre-formulation evaluation.

Experimental Manufacturability Optimization Assays

As known to all that each factor and process of biopharmaceuticals manufacturing affects final bio-drug products and increase costs. Proper optimizations for the specific deficient characteristics or imperfect processes can increase the developability of biopharmaceuticals, which are beneficial for manufacturing the most efficient biological drugs in the most cost-saving manner. In addition to assessment services, Creative Biolabs also using a diversity of experimental assays offers specific manufacturability optimization services to facilitate developability of these biological drug candidates.

Supported by our advanced CreDA™ platform, scientists at Creative Biolabs are professional in designing custom-specific manufacturability assessment and optimization services to meet all kinds of project expectations and requirements. We are happy to work with you step by step so as to ensure that the most satisfactory outcome can be acquired. If you are interested in our services, contact us to discuss your requirements.

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