CELL & GENE ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS

• Amplification-Free Analysis Of Lentiviral Vector Genome Integrity

  We review an amplification-free workflow has been developed for the genome integrity analysis of lentiviral vectors (LV) using capillary electrophoresis with laser induced  fluorescence detection (CE-LIF).

• Upstream Platform For Continuous Lentiviral Vector Production

  Here, we demonstrate a high-yield LV production process, using animal-derived component-free media and reagents, where multiple or continuous vector harvests could be obtained from a single batch.

• Patient-Centric Approach And FDA Expertise Lead To Orphan Approval

  An international company developing an orphan drug product needed a partner experienced in FDA interactions to help it navigate the U.S. regulatory process from beginning formulation to NDA approval. Find out how this was done in the available case study.

• A Platform Standard For Viral Vector Manufacturing And Commercialization

  Learn more about platform technologies that are being developed and implemented to support large-scale production of viral vectors.

• Superior Biopharmaceutical Manufacturing Facilities Prioritize Cleaning & Disinfection During Design

  Thorough consideration of cleaning/disinfection during facility design eases maintenance across the facility lifecycle, optimizes workspace utility, and contributes to efficient facility operation.

• First Clinical Trial Using Stem Cell Therapy To Treat Septic Shock

   An Ottawa Hospital Research Institute’s Cell Manufacturing Facility successfully conducted a Phase I clinical trial examining the safety and efficacy of allogeneic bone marrow-derived MSCs as a treatment for patients experiencing septic shock. Before initiating clinical Phase II studies, the protocol for generating large quantities of MSCs had to be established to reduce end-product variability, minimize production costs, and to ensure sufficient yield to treat multiple patients. Maximizing the yield of viable cells proved challenging in a limited footprint.

• Choose The Right FDA Program To Expedite Your Rare Oncology Trial

  With their poorly understood natural histories, phenotypic heterogeneity, and diverse clinical manifestations, rare cancers pose challenges to drug development and represent a significant unmet need in oncology. Faced with limited treatment options, researchers, clinicians, and patients may be seeking approaches to accelerate the development and approval of novel therapies. In this blog post, we review the regulatory programs available to expedite treatments for rare disorders and serious diseases.

• Successfully Achieve High Numbers Of Peptide And Protein Identifications

  Collecting quality MS/MS at high acquisition rates is key to achieving high numbers of peptide and protein identifications. This study investigates the impact of large sensitivity gain on identification rates.

• Fundamentals Of Size Exclusion Chromatography

  SEC, also known as gel filtration, can be used for preparative and analytical studies of your protein. But how do you know which parameters give you the best resolution of your protein mixture?

• Bioprocessing And Scaleup Of HEK293 Cells For AAV Production

  MilliporeSigma has developed the VirusExpress®️ AAV Production Platform as a scalable upstream AAV production solution for viral gene therapies.