Advanced Therapeutics

• Microbiome – Live Biotherapeutic Products (LBPs) – BA Sciences has over seven years of experience supporting IND-enabling work for Live Biotherapeutic Products (LBPs), including the development and qualification of methods aligned with regulatory expectations. We develop and qualify methods to assess purity (including safety) and potency for viable anaerobic strains used in complex, multistrain consortia drug products.
  mRNA
• BA Sciences supports mRNA – based therapeutics by testing both drug substance (DS) and final formulated Lipid Nanoparticle (LNP) drug products (DP)Testing includes pre-qualified methods for residuals such as E. coli DNA, host cell protein, and double-stranded RNA (dsRNA).
• Plasmid DNA (pDNA) – Plasmid DNA (pDNA) is frequently used in the production of mRNA, serving as the template during in vitro transcription (IVT). We provide full analytical characterization of cGMP-grade pDNA, evaluating its identity, purity, potency, and safety.
• Gene Therapy – Gene therapy programs often involve complex product configurations. Our analytical platforms enable targeted characterization of gene therapy drug substance (DS) and drug product (DP). We maintain dedicated cell culture facilities to support potency assays for gene therapy applications.
• Process Development (PD) Support – While our ATMP services support cGMP requirements for clinical submissions, we also recognize the need for flexibility during early-stage process development. We offer non-GMP testing for development-stage samples to help accelerate scale-up decisions and process refinement.
• Stability Testing – We provide full-service stability management and testing for ATMPs, with protocols tailored to product-specific needs. Studies include freeze-thaw evaluations, forced degradation testing, and other stress condition analyses.

ATMPs require diverse analytical approaches and a detailed understanding of product-specific regulatory expectations. Our team has direct experience supporting IND submissions and method development across the full spectrum of ATMP platforms.

What we provide:

• Specialized scientific staff focused on ATMP assay development, validation, and execution
• Platform-specific methods for Live Biotherapeutics, mRNA, plasmid DNA, and gene therapies
• Fit-for-purpose workflows that align with regulatory guidance and development timelines
• Transparent communication and project coordination from early-phase studies through submission

Our ATMP analytical services are structured to adapt to the complexity of each program while helping teams move confidently toward clinical milestones.

To request a quote or discuss method selection, contact us. Our team can support ATMP analytical needs across development, submission, and commercialization.