Pronalyse, a division of Creative Proteomics, is an integrated CRO company with rich experience in providing drug development services. To ensure drug identity, strength, potency, purity, and safety, Creative Proteomics Pronalyse recently announced the launch of therapeutic enzyme characterization services.
Enzymes play a major role in the pharmaceutical industry today due to their ability to efficiently and selectively catalyze biochemical reactions in living systems. Because enzymes have such a significant impact on human health, research on enzyme-based drugs has emerged as a focus in recent times.
Most of these therapeutic enzymes are produced industrially by employing various types of fermentation techniques using suitable expression systems. These expression systems include microbial strains (bacteria, yeast, fungi, etc.), plant or animal cell cultures, and genetically engineered organisms. Recombinant DNA technology, protein engineering, materials science, enzyme immobilization, and nanotechnology provide an astounding platform for the development of enzyme-enzyme drugs, which have multiple applications in the treatment of various diseases.
“Regulatory agencies strictly govern the testing and production of therapeutic enzymes worldwide, and batch-to-batch consistency is crucially important. Batch manufacturing begins at the fermentation or cell culturing stage. Subsequently, therapeutic enzymes are expressed in a cell culture bioreactor to robust the reproducible protein purification or downstream processing (DSP) of the target product. Thus, it is critical to ensure the safe delivery of these medicines throughout the whole process. QC is highly crucial in therapeutic enzyme production to ensure the drug's identity, strength, potency, purity, and safety. This is why we need to characterize therapeutic enzymes,” said the Senior Scientist of Creative Proteomics.
Creative Proteomics's comprehensive suite of protein analysis services brings together a variety of methods, including amino acid analysis, concentration/yield assays, cell potential and in vitro cell culture, glycosylation assays, post-translational modifications, etc.
“Creative Proteomics strictly complies with the FDA and ICH guidelines to provide you with the most comprehensive antibody-related analysis services. We provide a one-stop solution tailored for your programs and are confident in providing the most helpful technical support for drug discovery, manufacturing processes, and other special requirements,” commented the Pronalyse’s project manager.
About Pronalyse division of Creative Proteomics
Pronalyse is supported by specialists who are professional and skilled in protein chemistry, NMR, HPLC, mass spectrometry and bioinformatics. Currently, Pronalyse is dedicated to providing protein-oriented analysis services to support manufacturers and researchers in biopharmaceutical development, mainly including antibodies, PEGylated proteins, peptide and protein drugs, vaccines, amino acids and their derivatives. The services provided include in vitro characterization, purity analysis, protein structure modification, in vivo safety check, and pharmacokinetics analysis, etc.
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