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Creative Biolabs Released Manufacturability Assessment Service for Lab Use
SHIRLEY, IL - Apr 19, 2019 - Manufacturability assessments are designed to identify mechanical and electrical design enhancements that significantly improve manufacturability and product quality without compromising functionality. By making manufacturability assessments part of the product lifecycle process, customers can avoid costly redesigns as the product moves from prototype to manufacturing. And it can provides an opportunity to assess the feasibility of candidate drug technologies on an industrial scale and serves as a bridge between discovery and process development phases.
Creative Biolabs has developed CreDATM platform to evaluate the important manufacturability parameters, such as productivity and process yield, chemical stability, PTM, physical stability, aggregation, electrostatic properties and formulation. The comprehensive assessment results can effectively guide the client to select the most suitable process development candidate.
Featured assessment services:
For comprehensive developability assessment, Creative Biolabs is able to use stable expression in a CHO expression system for developing protein material of gram quantities, and the finial cell clone for clinical and commercial manufacturing can be identified in parallel. Then, in the same production system are candidates compared to visualize the impact of the molecule on expression and purification. Whats more, the molecules with higher yield is going to be preferred for further development.
Physical Stability Assessment
Unfolding proteins have different functional activity and and they can be aggregated, whats more, the in vivo immunogenicity may be increased. It is used to detect the physical stability of biotherapeutic candidates at different conditions of temperature, mechanical stress, pH and diverse formulation buffers during the late-stage candidate selection. These studies can offer information to downstram processing and assist formulation function to select drug candidates that perform well in the preferred formulation paltform.
Chemical Stability and PTMs Assessment
Chemical Stability and PTMs are very important for biologics, so they should be studied during the developability assessment campaign. Undesirable PTMs can lead to partial or complete loss of activity, increasing the tendency to aggregate and the sample heterogeneity, reducing the shelf life span of the product. Some items in developability assessment platform can be regulated.
Aggregation Assessment
Protein aggregation is a very important item which can appear at different stages of the manufacturing process, including but not limited to purification, formulation and storage. The yield, economics of the process and the drug potency and in vivo immunogenicity will be impacted by the aggregation.
For the process perspective, using process development and manufacturing to tackle aggregation issue may lead to be complicated and increased cost, lengthen development timelines, and result in the limited and costly formulation and delivery options. Therefore, aggregation propensity of drug candidates should be thoroughly evaluated before the process development is initiated.
Electrostatic Properties Assessment
Protein affinity for ion exchange resins will be influenced by electrostatic properties of the candidates. So our developability assessment studies will show the electrostatic properties of the protein regarding isoelectric point and charge profile.
Pre-formulation Assessment
The administration route and formulation are also included in developability assessment platform of Creative Biolabs. Determination of viscosity and solubility at a high product concentration and accelerated stability test are included in pre-formulation, which is very important for candidate selection.
About Creative Biolabs
As for drug development assessment, manufacturability assessment is an indispensable element. Creative Biolabs can offer high-quality CreDA platform and services for drug development with the most expertise and dedication.
