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Protein Characterization
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Creative BioMart
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Introductions Proteins are complex molecular entities derived from
B
biological processes. Their size, molecular structure and physical and chemical properties are different from each
other. These differences allow the analysis and characterization of proteins through separation and identification. Creative BioMart has more than 20 years of experience in protein characterization. We have extensive experience in developing and establishing protein identification methods to help our customers generate the data they need to obtain
the level of product identification required for regulatory submission. These characterization services are also part of our stability and product launch support services, where we provide critical identity, purity, and performance measurements.
Protein modification One of the important fields of protein characterization is to identify those proteins and their modification sites that are post-translationally modified, and to characterize the modified functions. Almost all proteins, whether produced and purified as recombinant proteins or isolated from natural sources, will carry modified amino acids to some extent. At Creative BioMart , we use a mass spectrometer to detect the smallest and most annoying modifications. Usually, we combine electrophoresis, HPLC, and peptide mapping methods for analysis. Generally, mass spectrometry data is qualitative rather than quantitative. However, we will provide you with data assessments-that is, real numbers about the degree of modification that occurs in the protein-so that you can clearly understand how the protein works.
Protein analysis Creative BioMart focuses on a wide range of analytical testing technologies to support the characterization and development of recombinant protein and peptide therapeutics. Our team of experts, coupled with advanced technology, supports customers while maintaining the highest standards of quality, technical analysis and reporting. In the production process, they are almost always not completely purified and homogeneous molecules, but show a certain degree of structural heterogeneity. This means that the characterization of proteins always has three aspects: • Identification of main protein components • Identification of minor ingredients • Quantification of minor ingredients
Amino acid analysis
The amino acids can be derivatized with ninhydrin or o ‐phthalaldehyde to make fluorescent derivatives that are easy to detect. These are chromatographed by reverse‐phase HPLC (high pressure liquid chromatography). The characteristic retention times are used to identify the a mino acids. The fluorescence level can be quantified to determine the amount of that amino acid.
Determination of Primary Structure B
Hydrolyze peptides with hot 6M HCl. – Usually done by chromatography Identify the N‐term and C‐term Aas
– C‐term via carboxypeptidase – N‐term via Sanger’s Reagent (DNFB)
•
Fluoro‐2,4‐dinitrobenzene and dansyl c hloride
•
Phenylisothiocyanate (Edman degradati on)
Characterization of proteins and peptides involves three different processes:
1
Determining the amino acid composition. Involves finding out the amin o acids that make up the pro tein and their number.
2
3
Determining the molecular mass Determining the amino acid sequence Involves finding out the sequence of amino of the protein. acids of the proteins in their order.
Platform and Analytical Techniques
Our services Creative BioMart performs a number of routine protein analyses throughout all project stages to understand the heterogeneity, impurity profile, and potency of a recombinant protein destined for pharmaceutical use. We have developed the platforms and analytical methods to pursue a 01 comprehensive chemical, physical, and conformational characterization. 02
Creative BioMart provide comprehensive, highquality detection methods for the characterization and analysis of protein drugs. Whether it is characterizing reference products at different stages, evaluating different batches of products, or used for comparative research on biosimilars or modified biopharmaceuticals, our services can meet scientific standards and international regulatory requirements.
Our advantages
01
03 Complete service portfolio. Many
Great flexibility. We focus on
other chemical, microbiological and
small projects and provide all
ancillary services are provided in
the flexibility you need.
GMP certification, WHO prequalification and FDA approved
02
laboratories.
04 Single point of contact. Due to the large number of services provided internally, all communications are centralized.
Standard and customized solutions. If our
standard solutions do not meet your requirements, our skilled technicians will be
able to develop specialized solutions.
Contact Us creativebiomart.net
Address: 45-1 Ramsey Road, Shirley, NY 11967, USA Email: contact@creative-biomart.com
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