Advanced therapy medicinal products (ATMPs) are a promising source of innovation and offer a great potential for Personalized Therapies. The principle of ATMPs is the introduction of a genetic modification (e.g. viral transfer, siRNA or even cells) that becomes an active substance to cure genetic disorders. The field of Gene (GTP) and Cell Therapy (CTP) is booming with extensive evaluations of multiple diseases and technologies. ATMPs are expected to make up a significant proportion of future approval of medicinal products.
In order to cope the regulatory hurdles of these advanced technologies, specialized experience in biotherapeutical analytics is of fundamental importance. Dealing with the evaluation of samples of low amounts and short expiry dates requires fine-tuned logistical experience. Providing high quality evaluation of samples in a field without pre-defined regulatory criteria as well as the development of customized assays demands utmost analytical insight.
Protagen Protein Services GmbH can provide you a great pool of analyses for the characterization of ATMPs. Consultation along the entire product development process and preparation of comprehensive all-round care-free packages is our daily business. Outstanding knowledge and more than two decades of experience in method development will help you meet the requirements of regulatory authorities.