Silver Sponsor
MilliporeSigma
MilliporeSigma, a life science leader, is a business of Merck KGaA, Darmstadt, Germany. We offer products to safely and efficiently develop and manufacture therapeutics. Our products and services include single-use manufacturing, filtration, chromatography and purification, virus reduction, pharma and bio-pharma raw materials, drug delivery compounds, validation services and biopharmaceutical training. With the acquisition of Sigma-Aldrich, we now have the largest offering of products and services for formulations, actives and biotechnology processes.
Associated Experts
Job Title: Head of Laboratory Functional Chemistry
Job Title: Product Manager Analytics
Job Title: Viral Vector Producing Cell Lines, Gene Editing and Novel Modalities R&D, Process Solutions R&D
Job Title: Head of Customer Applications, Cell Therapy Bioprocessing.
Job Title: Process Development Scientist
Job Title: Head of Technical Operations, Viral and Gene Therapy Manufacturing
Job Title: Associate Director, EMEA Segment Development for Cell and Gene Therapy
Job Title: Global Product Manager
Job Title: Associate Director for Cell & Gene Therapy BioProcessing for the Americas
Job Title: Vice President, End-to-End Processing Solutions within Process Solutions
Associated Content
Cellvento® 4HEK Medium Provides a Comprehensive Media Solution for all Scales of AAV Production
Streamlining the adeno-associated virus (AAV) production process is a top priority for gene therapy development, as there are still issues that limit consistency and productivity. When looking at the AAV production process using human embryonic ... Continued
Gaining Real Time Bioprocess Insights Using Raman Spectroscopy
Raman spectroscopy has many advantages as a PAT tool since it is a non-invasive, non-destructive optical molecular spectroscopic method that can monitor multiple analytes simultaneously in real-time with minimal sample processing....Continued
Accelerating drug development by employing established platforms and pathways
There are many challenges faced by biopharmaceutical start-ups in navigating through the discovery, development and commercialization pipeline that can be barriers to forward progress. Backed by years of expertise and a diverse portfolio of products ... Continued
Simplifying CHO Fed-Batch and Perfusion Culture Media Evaluation from Expansion to Production
Media evaluation is critical to successful cell culture from expansion to production. However, the process of media evaluation and selection can be complex, time consuming and usually requires a large range of skills and expertise. Finding the best media for the cell line, application and culture method at each process step requires thorough assessment....Continued
Cell Therapies Require Well-defined, Optimized Media to Enable Efficient Transition Between Research, Clinical and Manufacturing Scale Culture
Our data demonstrates the utility of Stemline® XF MSC Medium for bench-scale bioreactor expansion of hMSCs in microcarrier-based cultures. High yields of functional hMSCs were generated when compared with other xeno-free alternatives....Continued
Understanding Cell Culture Media
Variability in cell culture media and associated raw materials can create variation in the upstream manufacturing process, as well as impacting final product quality. New analytical technologies have made it possible to have a better understanding of what contributes to cell culture media variability and as a result it is incumbent on cell culture media suppliers to implement control processes and a robust quality assurance program....Continued
Deciphering Continued Process Verification and Automating the Process for Straightforward Implementation
There are numerous software options that claim to do CPV reporting, but it is important to consider whether they are fit for purpose and if they encompass all the necessary operations required of CPV. Because Bio4C™ ProcessPad was designed specifically for biopharmaceutical manufacturing CPV, it provides several advantages:...Continued
The Secret Ingredient in Your Gene Therapy Success Recipe
In this podcast, Ratish Krishnan, Associate Director for Cell & Gene Therapy BioProcessing for the Americas at MilliporeSigma about the importance of 3D culture and the challenges associated with growing and maintaining culture in 3D. We also discussed using a 3D culture bioreactor system, which employs clinostat technology to culture spheroids and organoids in a way that maintains the structure and function of in vivo cells. ...Continued
Smart Data Management and Advanced Analytics to enable Bioprocessing 4.0
With the complex issues surrounding digital data collection and analysis, it is important to seek out experts in the field who can answer questions about the implementation and capabilities. For this Ask the Expert Session, we asked Hemant Garg, Product Manager Analytics, MilliporeSigma to provide his expertise and answer reader questions....Continued
Design of Experiment Principles to Optimize Benzonase® Endonuclease in Viral Gene Therapy Applications
Benzonase® endonuclease activity is strongly influenced by several factors and balancing these is a critical step during process development to maximize its benefit in the overall workflow....Continued
Platform Approach to Accelerating Cell Line and Process Development
Improve the efficiency of cell line and process development by employing a platform approach, which includes all materials needed to advance from protein sequence to production cell line....Continued
Plasmid DNA Production for Cell and Gene Therapy
For this Ask the Expert Session, we assembled a team of experts to answer questions on plasmid DNA production for cell and gene therapy applications....Continued
Viral Vector Manufacturing
For this Ask the Expert Session, we assembled a team of experts to answer questions on viral vector manufacturing and process improvement....Continued
Viral Vector Process Intensification: Stepwise Model for Efficient Scale-up
Overall, the VirusExpress™ 293T Lentiviral Production Platform consistently achieved high functional titers at a large scale, which addresses the industry’s current challenges for lentiviral production process intensification....Continued
GMP-Compliant Benzonase® Endonuclease Safety Plus Emprove® Expert Provides Enhanced Risk Mitigation
Benzonase® endonuclease Safety Plus Emprove® Expert is ideally suited for manufacturing of cell and gene therapy agents such as adeno-associated and lentiviruses, oncolytic viruses, and viral vector vaccines....Continued
Efficient DNA Clearance Enables Better, Faster Virus Production
Video highlights the effectiveness of adding Benzonase® endonuclease for downstream virus purification process intensification improving the speed of purification, reducing cost, improving product purity, and yield while also meeting regulatory requirements....Continued
Balancing Risk, Cost and Speed During Clinical Development While Still Maintaining Quality
In this podcast, we talked with Thierry Cournez Vice President, BioReliance® End-to-End Solutions, MilliporeSigma. We discussed effective ways for emerging biotechs to collect material quickly and cost-effectively for pre-clinical and clinical studies. We also discussed managing the need to move quickly with cost and quality....Continued
Non-Animal Origin cell culture supplements and manufacturing aids for biologics manufacturing
In this podcast, we talked with Dr. Tobias Hertzig, Regulatory Affairs Manager and Dr. Ulrich Tillmann, Global Product Manager, Supplements and Manufacturing Aids both representing Merck KGaA, Darmstadt, Germany. We discussed non-animal origin cell culture media supplements, including regulatory advantages, performance metrics and their use in biologics manufacturing....Continued
Optimizing Fed Batch Culture – Developing New Tools and Methods to Improve Production
In this podcast and accompanying article, we interviewed Dr. Aline Zimmer, Head of R&D, Advanced Cell Culture Technologies at Merck about the importance of optimizing fed batch cell culture for successful biomanufacturing. Aline discussed how her team has developing new tools and methods for optimizing fed batch culture and the impact this has had on productivity and product quality....Continued
Chemically modified amino acids enable the evolution of fed-batch processes from multiple feeds to single feed strategies
Cell culture optimization is critical to good biomanufacturing. In particular fed-batch cultures require optimization of feed strategies to ensure that cultures are not becoming nutrient depleted, to extend the growth phase and increase product concentration. ... Continued
New Chemical Modification of L-Tyrosine and L-Cysteine Increase Solubility and Stability and Permit Single Feed Strategies
Moving to one single, neutral pH feed is a very innovative approach and has many associated benefits. It increases the efficiency of your fed-batch process by reducing the number of necessary feeds and corresponding materials, while also reducing pH spikes. It also allows formulations that are stable at room temperature....Continued
Addressing Shear Stress in Bioreactors
Introduction Introduction of oxygen to cell culture media via sparging is critical for efficient bioreactor operation. Since oxygen is sparingly soluble in culture media, efficient sparging methods are important to ensure cells have enough oxygen for ... Continued
Improved, High Quality Poloxamer 188 Produces Consistent Performance in Cell Culture
Hydrodynamic stress in bioreactors and specifically shear caused by sparging can present a challenging issue in commercial biopharmaceutical manufacturing. A solution was found in the use of Poloxamer 188, a surface-active, non-ionic polymer that when added to cell culture media acted as a shear protectant. Poloxamer 188 became a standard ingredient in cell culture media for commercial production....Continued
Lynx CDR Connectors to Improve Sterile Fluid Transfer in Biomanufacturing
Lynx® CDR Connectors are multi-use disposable sterile connectors that can connect, reconnect and disconnect even when the flow path is wet and pressurized....Continued
PureFlex Plus – A Robust Single Use Fluid Management Film for High Volume/Value Applications
At the BioProcess International Conference (BPI) in October, EMD Millipore launched their new PureFlex™ Plus single use fluid management film as an addition to their existing PureFlex™ film. The PureFlex™ Plus film provides a more ... Continued