CELL AND GENE OUTSOURCING
Level Up With Product Characterization
In the race to bring a new biotherapeutic to market, unexpected obstacles can slow you down or even knock you back a few steps. But with the right information at the right time, and an experienced partner to provide scientific, regulatory, and bioprocessing guidance and s...
MilliporeSigma Large Scale Capabilities Tour
A detailed look at MilliporeSigma’s new BioReliance® viral vector manufacturing facility and how we have employed the latest innovations and quality systems to deliver best-in-class gene therapy services.
The Journey To Safety Through Viral Clearance
Discover a simple yet powerful solution for getting viral clearance studies done safely, thoroughly, efficiently, and on your timelines. Learn how to free your teams and trust your project.
How Molecular Structure Influences Potency Of A Therapeutic Biologic
Gain an understanding of how an antibody’s molecular structure and its many measurable properties influences its binding and affects potency of a therapeutic biologic.
A Faster, More Sensitive Approach To Virus Detection
Discover a faster, more sensitive approach to rodent virus detection that offers a targeted NGS workflow to help uncover contaminants traditional assays may miss.
Streamlining Viral Vector Development And Gene Therapy Manufacturing
Explore solutions for gene therapy production from experts, as they highlight the key features of a GMP manufacturing facility, including its technologies and infrastructure, through a virtual tour.
An Early Formulation Screening Service
Gain insights into overcoming the challenges in lipid nanoparticle (LNP) formulation, explore critical aspects of the process and analytical development of LNPs, and much more.
Optimizing Viability And Standardization For Clinical Excellence
Explore how IntegriCell™ delivers high-quality, manufacture-ready cryopreserved leukopaks, vital for consistent and reliable cell therapy production.
Innovating Upstream Manufacturing For The Next Wave Of Gene Therapies
Explore a streamlined approach to transient AAV production, including yield improvements across serotypes, key transfection parameters, and practical guidance for scaling processes.
Industry-Leading Lentiviral Titers Through Optimized Production Technology
See how VirusExpress' technology was optimized to provide industry-leading lentiviral titer and a streamlined approach to accelerate development timelines and de-risk manufacturing.
A Transformative Journey From Research To Large-Scale Production
Learn about MilliporeSigma's journey to becoming a leader in clinical and commercial viral vector manufacturing and their support of cell and gene therapy innovators since the industry’s beginnings.
Optimization-By-Design — A Critical Factor In Viral Vector Scale Up
Learn how leveraging the expertise and capabilities of an experienced partner is a key factor in optimizing AAV processes using Design of Experiment (DoE), thereby reducing variability and risk.
BioPhorum Raw Materials Risk Assessments
Torsten Schaderdorf provides an in-depth exploration of current regulations related to Raw Materials Risk Assessment, highlighting the risk criteria and raw material scope outlined in the BioPhorum guidelines.
Eliminate Risk From Your Viral Vector Tech Transfers
Explore strategies to simplify viral vector tech transfers, reduce risk, and maintain quality under tight timelines, as well as a case study that demonstrates how to streamline this critical process.
Characterizing AAV Encapsidated Nucleic Acid Sequences Using NGS
Here, we discuss the characterization of several representative AAV molecules using next-generation sequencing (NGS), including the sequencing process, bioinformatic analysis, and representative results.
Cryopreservation Best Practices For Cell & Gene Therapy Source Material
Industry experts share their experiences, including why and how cellular source materials are cryopreserved and why experience across cell types and methods matters.
Tailored CMC Solutions That Meet Needs Of Novel Molecular Biologic Formats
Explore an integrated drug substance/drug product CMC strategy and technical case studies that provide insight into delivering product-specific solutions and enabling the acceleration of novel molecular formats.
GLP And The Impact To Start Up Companies
Good Laboratory Practice is often used in laboratories and is necessary for specific investigations. What does it mean? And how can it help start-up companies? Watch this video to learn more.
Meet The Experts: Part 1 - Process Analytical Technology (PAT)
Watch part 1 of this 4-part interview series to learn about process analytical technology (PAT) from expert Stacy Shollenberger.
Early Preclinical Development: A Successful Transition To cGMP Manufacturing
Explore the development steps that lead to an mRNA construct optimized for your requirements and that meets future-proof cGMP manufacturing requirements, thereby de-risking the development.
Integrated Technologies And Glycosylation Tuning In Upstream Bioprocessing
Optimize mAb production with innovative cell culture media and feed designs. Explore integrated technologies, intensified fed-batch approaches, and methods to modulate glycosylation profiles in upstream bioprocessing.
Similar Enough Product Characterization To Support Process Changes And Biosimilar Development
Characterization is essential to understand the impact following process changes and successful biosimilar development. Here, we provide best approaches for comparability studies.
Make More Lentivirus And Make It Right The First Time
Discover how you can achieve higher titers and robust yield with an optimized, end-to-end lentivirus platform, designed to maximize production and quality for the success of your cell or gene therapy.
Biotherapy Characterization: Binding Assays
MilliporeSigma Senior Scientist Helen Hsu, Ph.D. describes how, with our custom binding assays, and supported with our comprehensive off-the-shelf Fc gamma receptor binding assays, we can help you optimize your mAb production, from clone development through upstream and d...
Meet The Experts: Part 3 - Chemometrics And Model Building
Watch part 3 of this 4-part interview series to learn about chemometrics and model building from expert Johan Cailletaud.
How To Boost AAV Titer With Feed Supplementation In Both HEK293 And Sf-9 Platforms
Explore how optimizing post-transfection or post-infection feeding in HEK293 and Sf-9 cells significantly boosts AAV titers, enhancing production efficiency for gene therapy applications.
CRISPR Genome Editing Solutions From Discovery To Clinic
Examine how a partnership leveraging expertise in production for high-quality CRISPR gRNAs as well as cGMP manufacturing is supporting the clinical translation of CRISPR genome editing technologies.
Selecting Containers For Sensitive And Costly Cell & Gene Therapies
Explore the challenges related to packaging of cell and gene therapy products and proven solutions to enable speed to market and compatibility, performance of packaging materials.
Cell & Gene Therapy Development: Characterization Of Cellular Starting Material
Watch to gain valuable insights into the characterization of cellular source material for the development and manufacture of cell and gene therapy-based products.
Accelerate Your AAV Journey To IND And Beyond
Explore essential QC strategies in AAV gene therapy and learn how to address rcAAV detection, viral clearance per ICH Q5A, and impurity profiling using NGS to meet evolving regulatory demands.