Advanced Therapeutic Medicinal Products (ATMPs) hold the promise to change the ways through which we address vaccine and therapeutic treatments for complex diseases and conditions. ATMPs include 4 discrete modalities as listed below:
Advanced Therapeutics
While the 4 modalities listed share the category of ATMPs, the analytical platforms are quite different from one another. Each associated analytical platform presents its own set of analytical challenges and requires a varied set of analytical approaches to accurately characterize the Identity, Purity, Potency, and Safety of the drug candidate. BA Sciences has extensive experience testing and characterizing ATMPs. We also have a proven track record of supporting the development of these novel products and generating supporting test data that meets regulatory requirements to ensure patient safety. The analytical services offerings are designed to provide a “One Stop Shop,” for our sponsor companies to ensure that regulatory-tested comprehensive analytical characterization is achieved. Our ATMP service offerings include:
- Microbiome – Live Biotherapeutic Products (LBPs) – BA Sciences is considered world class pioneers for IND-enabling analytics associated with LBPs with over 7 years or experience developing and qualifying the analytics regulators have come to expect. The expertise includes development or purity (including safety) and potency of viable anaerobic production strains in complex multistrain consortia Drug Products.
- mRNA – BA sciences offers comprehensive analytical testing services for Drug Substance (DS) and final formulated Lipid Nanoparticle (LNP) Drug Product (DP). Testing methodologies employed include pre-qualified platform methods for residual testing ( coli DNA, Protein, and dsRNA).
- Plasmid DNA (pDNA) – Plasmid DNA is often utilized in the mRNA manufacturing process as a template for the construct of interest during In Vitro Transcription (IVT) manufacturing efforts. BA Sciences offers a comprehensive analytical platform to characterize the ID, Purity Potency and Safety of cGMP pDNA.
- Gene Therapy – Gene therapy applications are varied and complex. Utilization of the analytical platforms at BA Sciences ensures comprehensive characterization of Gene Therapy DS and DP with a targeted approach. BA specializes in many of these analytical approaches and has a cell culture dedicated space to execute gene therapy potency considerations.
- Process Development (PD) Support – While ATMP testing at BA Sciences is designed to meet the cGMP regulatory requires expected when submitting a candidate for clinical administration, we understand the value of getting FIO results for Process Development scale up that don’t require the complexity and timing associated with QA-reviewed data. BA Sciences strives to offer non-GMP testing of PD samples with enhanced turnaround times.
- Stability Testing – BA Sciences offers full service stability management and testing. Specific ATMP stability considerations are in place at BA sciences to ensure product specific considerations are encompassed, including freeze-thaw studies and forced degradation evaluations.