Our experienced team will help with all aspects of CMC including, but not limited to, interim CxO leadership support, strategy, risk analysis, process development and optimization, raw materials, analytics, and regulatory writing for Interact, Pre-IND, IND, BLA and other forms of agency meetings. Our experts will help you analyze your business processes, identify areas for improvement, and develop strategies to achieve your business goals.
Let us help you design or optimize your manufacturing platform, find a manufacturing partner, oversee your CDMO, be your person-in-plant, or provide advice and strategy for your busy organization.
Our experts have years of experience providing technical diligence on assets and companies in and around the Cell and Gene Therapy space and have performed technical diligence for some of the largest acquisitions in the space. Whether it's cell or gene therapy, our team has the technical knowledge and experience to evaluate programs in early and late stage, and assess upstream, downstream, and fill finish processes for plasmids, viral vectors and cell therapies.
With over 25+ years' experience developing, optimizing and manufacturing Cell and Gene Therapy products, we are best suited to help you develop the best product possible in your timeframe and within your budget. Our experience lies with in vivo and ex vivo platforms such as Adeno Associated Virus (AAV), Adenovirus (Ad), Lentivirus (LV), Retrovirus (RV), and other vector systems including oncolytic viruses, so let us help you develop, optimize and troubleshoot your plasmid and vector manufacturing processes. Whether you're just getting started with an academic process or moving into commercial manufacturing, our team's experience with upstream, downstream and fill finish processes such as adherent and suspension platforms, cell growth, transfection, DNase digestion, affinity and anion exchange (AEX) chromatography, ultracentrifugation (UC) and ultrafiltration diafiltration (UFDF or TFF) processes, fill finish, analytics, process characterization / validation, and PPQ. We can help get your process where it needs to be.
Our team has designed and built Cell and Gene Therapy facilities. We have the experience necessary to ensure your design is appropriate and fit for purpose. We also provide customer representative oversight during the design and build process, helping to ensure that your needs are met during the processes.