Pronalyse is a new division of Creative Proteomics, which is an integrated CRO company with rich experience in providing drug development services. The product manager of the company is excited to launch the Gene Therapy Products Characterization service to help clients overcome the challenges of gene therapy analytical development, which include characterization, quality control, and the need to meet increasingly demanding regulatory expectations.
Gene therapy aims to treat or prevent diseases by delivering modified genes into target cells, thereby replacing mutated genes in patients with corresponding healthy gene copies. Compared with traditional drug therapy, gene therapy is to fundamentally control the disease, so it has a very good development prospect, and has received more and more attention and investment from the pharmaceutical industry worldwide. Gene therapy drugs are in clinical trials with demonstrated efficacy in ophthalmology, neurological disorders, muscular tissue disorders, hematological disorders, metabolic disorders, and oncological diseases.
Regulatory requirements for gene therapy products are evolving in the EU and US currently, with some key guidance already published such as recommendations regarding chemistry, manufacturing, and control (CMC) information to be submitted in human gene therapy Investigational New Drug Applications (INDs). There is an expectation for orthogonal analytical techniques to be applied to characterization, stability and release testing and also to assess the quality of all components of the product including all materials and components used for the manufacture of a gene therapy product such as vectors, reagents, and excipients.
“Gene therapy products represent a novel and complex class of products. Ensuring product safety, identity, purity and potency following a manufacturing change extends not only to assessing the final formulated product but also to all the components used during product manufacturing. It is important that product characterization be performed early in product development because, without full product characterization, it will be difficult to determine the impact of the manufacturing process on the product as well as the impact any manufacturing change will have on the product. To demonstrate product comparability a thorough understanding of the manufacturing process, including product characterization, is necessary so that the impact of a manufacturing change can be accurately assessed,” said the product manager of Creative Proteomics. “With a heritage of supporting advanced pharmaceutical product development, coupled with a comprehensive range of analytical techniques, our experts offer Total Quality Assurance expertise to help you to confirm identity and ensure the product safety, quality, purity, potency and strength of your gene therapy product.”
To find out more about Creative Proteomics’s biopharmaceutical solutions, please browse the complete portfolio on the website.
About Pronalyse 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 checks, and pharmacokinetics analysis, etc.
Contact:
Address: Shirley, NY 11967, USA
Email: contact@creative-proteomics.com