BioAnalysis LLC is an agile, non-clinical CRO (Contract Research Organization) that provides answers to the toughest questions with scientifically in-depth analyses. Our customers receive the most rigorous investigations and recommendations possible for gene therapy and other biotherapeutics candidates.
With our deep experience in Analytical Method Development, GMP Validation, CMC Strategy, and Quality Control, we help improve science at every stage of the product lifecycle. We specialize in Biophysics and Mass Spectrometry applications for Gene Therapy, mAbs, Therapeutic Proteins, ADCs, and Nanoparticles.
Our biophysical and mass spectrometric methods produce a meticulous understanding of your biotherapeutics — from viral capsid quantitation, assessment of PTMs, peptide mapping, and HCP to robust structure-function relationships. We go the extra mile, deep into the data, interpreting it, and producing customized reports that are clear and actionable.
We have built from the ground up a robust cGMP Biophysical Lab. We specialize in cGMP Analytical Ultracentrifugation (SV-AUC), starting from robust Methods Development to cGMP Release Tests. We are bringing online other techniques into the cGMP space: Reverse Phase (RP), Size Exclusion Chromatography (SEC) , HILIC (Hydrophobic) and AEX (Anion Exchange) HPLC.
We offer a variety of biophysical and mass spectrometric solutions that are tailored to your questions. These analytical solutions range from size distributions, peptide mapping, PTM identification and quantitation, impurity profiles (HCP) to interaction studies (binding constants.)
Utilizing extensive experience with pre-IND, IND, and BLA/MAA, we provide comprehensive CMC strategies, guidance, and analytics in product development: experimental design and method development/ cGMP qualification.
We teach biophysics and mass spectrometric techniques, including how to develop robust assays that can last through the life cycle of the product.
Our solutions are carefully designed to support your unique product. With our team of subject matter expects, BioAnalysis is focused on providing the most comprehensive and scientifically robust analysis available. Our experience ensures the highest standards of scientific rigor are applied to every project while our thorough investigation ensures complete results without unnecessary experiments.
From initial contact, through preliminary updates and delivery of final reports, our effective and concise communication with our clients is the gold standard. We are able to responsively adapt to our clients’ needs. We quickly shift experimental focuses to ensure your objectives are met. We take great pride in our ability to exceed your expectations in experimentation, responsiveness, and problem solving.
Our deep scientific expertise differentiates BioAnalysis from other CROs. With over 100 years of Biophysics and Mass Spectrometric experience and over 70 peer reviewed publications, our team is made up of subject matter experts in Method Development and cGMP Validation. We have supported numerous IND, BLA, and MAA applications and submissions in Gene Therapy and Biotherapeutics. This wealth of expertise is observed in our analytical reports and translates into successful FDA/EMEA Applications.
Small-to-large biopharmaceutical companies who want more than the cookie-cutter, form-template, analytics, value our personalized service, scientific expertise, and customized results. We partner with labs and organizations who are in the R&D to the cGMP release stages.