Viral vectors are an essential part of gene therapy treatments. They are essential for delivering corrected genetic information to faulty genes within affected cells, and are at the heart of the gene therapy process. At Andelyn Biosciences, we specialize in viral vector manufacturing for gene therapy.
Current Good Manufacturing Processes (cGMP) are outlined by the FDA. Together, cGMPs help ensure consumers get a product that’s safe to use, and that it has the ingredients, strength, and other elements that it claims to have. At Andelyn Biosciences, we always follow all cGMPs required by the FDA to maintain product safety. In this blog, we cover the basic elements of cGMP, also known as the or “5 Ps” of CGMP.
Gene therapy is the process of replacing damaged or unhealthy genetic material with new material for treating various diseases and conditions. At Andelyn Biosciences, we’re a leading provider of this service. This blog post breaks down the details of the gene therapy manufacturing process.