Creative Biolabs have established a platform for a full cascade of protein physic-chemical characterization, ranging from a series of structural and molecular approaches to biochemical analysis to obtain the requested physico-chemical characteristics, strictly following the ICH Topic Q6b guideline. In-depth physico-chemical characterization of therapeutic proteins is indispensable during all phases of drug development to ensure drug safety and efficacy.
Physico-chemical properties, such as molecular weight, size, solubility, partition coefficient and acid dissociation constant greatly impact on pharmacokinetics of traditional small molecule drugs and substantially utilized in the discovery and development of small drugs. However, it is extremely difficult to predict pharmacokinetic fate (absorption, distribution, metabolism and elimination) of protein therapeutics from their physicochemical parameters due to the macromolecular nature of therapeutic proteins and peptides. Their structural complexity and immunogenicity are other involved factors that determine their biological functions. Therefore, it is highly challenging to develop generalized strategies during the discovery of therapeutic proteins and peptides. However, Creative Biolabs, as a leading service supplier in the biotechnology and biopharmaceutical fields, offer comprehensive and state-of-art physico-chemical characterization platforms for your target protein or peptide candidate including the following scopes:Physico-chemical characterization
The amount of protein-based therapeutics has increased exponentially over the past few years due to better efficacy in treatment and rising incidences of life-threatening diseases. Nowadays therapeutic proteins are prescribed to patients under various disease conditions, sometimes in high milligram quantities per dose. They contribute greatly in the treatment of lethal disease like autoimmune diseases, a variety of cancer types and replacement therapies such as enzyme and hormone substitutes. Creative Biolabs platforms have already been widely utilized in a set of therapeutic products to avoid risks, reduce attrition and improve the quality and safety during production and storage. We also address the challenges and accelerate the design and evolution of promising therapeutic drug candidates. By screening physico-chemical characterizations of therapeutic drug candidates to evaluate their performance in the manufacturing process, as well as in long-term storage, an outstanding candidate can be selected that abstains from typical issues. These services offer you a complete portfolio for your therapeutic drug discovery and early development in an efficient timeline.