Cell And Gene Articles, App Notes, Case Studies, & White Papers

1. Efficient Expansion of Suspension CHO Cells in Corning® 5 Liter Erlenmeyer Flasks 8/4/2021

   Erlenmeyer flasks are commonly used for expansion of a variety of suspension cell lines for bioprocessing applications. In this study, we describe a protocol to scale up suspension CHO cells from 40 mL to 15L of total volume in just 12 days using Corning 5L Erlenmeyer flasks. Furthermore, we demonstrate that Corning 5L Erlenmeyer flasks provide a more favorable culture environment (higher oxygenation and lower lactate metabolite accumulation) and support a higher yield of viable CHO cells when compared to competitor 5L Erlenmeyer flasks.

2. China’s Changing Pharmaceutical Landscape 8/24/2021

   China’s National Medical Products Administration (NMPA) continues to bring its regulatory policies for drug manufacturing into closer alignment with global Good Manufacturing Practice (GMP) regulations. These evolving regulatory guidelines are profoundly influencing the way China-focused life sciences companies establish and use computerized systems in their manufacturing operations. This white paper provides an overview of the essential aspects of recent regulatory guidelines that the NMPA has issued to advise companies in the use of electronic systems for quality management, traceability and product serialization as they do business in China’s life sciences marketplace.

3. Factoring The “What Ifs” Into Supply Forecasting 8/24/2020

   Growing urgency in the biopharmaceutical industry to speed new products to market leads to greater appreciation for supply forecasting as a strategic and highly complex success factor. Review considerations for developing a supply plan, the influence of early decisions and their impact on outcomes as a trial progresses, and how decisions can put patients and the trial at risk.

4. Advantages Of Single-Layer Film Vs. Multilayer Film In Bioprocessing 12/17/2019

   Speed and flexibility are critical to succeed in the bioprocessing market. Plastics technology enables small-batch, single-use packaging solutions for customized drugs to serve a smaller patient population.

5. Purification Of mRNA By Affinity Chromatography On CIMmultus® Oligo dT Column 6/7/2021

   Increasing demand for messenger RNA (mRNA) as therapeutic product requires efficient and scalable purification methods. In this application note a CIMmultus® Oligo dT, a monolithic stationary phase is used for purification of mRNA from a capping mix of Luc2 RNA. The large channels and convective mass transfer within the stationary phase eliminate shear forces and allow high flow rates, which leads to very short purification times and high recoveries.

6. Transforming Your Biopharma Automation Capabilities 6/24/2021

   The seamless functionality of single-use technology equipped with a scalable distributed control system (DCS) empowers you to capture the benefits of collecting and sharing data while simultaneously creating a connected enterprise that grows with the pace of your business.

7. Pre-Banking And Avoiding Manufacturing Challenges For GMP Plasmids Containing Unstable Sequence Regions 4/21/2021

   Ensuring consistent replication and proper retention of plasmid DNA sequence is vital to the economics and efficiency in generating starting materials used for production of adeno-associated virus (AAV) delivered gene therapy and messenger RNA (mRNA) vaccines and therapeutics. Plasmid DNA sequences often present challenges with certain notorious regions, such as inverted terminal repeats (ITRs) in constructs containing transgene sequences and long poly-A tail contents in mRNA template plasmids.

8. Best Practices For CDMO Evaluation, Selection, And Management 3/16/2021

   When executed properly, outsourcing manufacturing scaleup to a CDMO can be an expeditious way to further mobilize the science and drug products. To provide a smooth transition from the lab to CDMO, there are important factors you must first understand and steps to take prior to searching for and engaging with an external partner. If this process is not executed properly, there is a risk of wasting valuable time, resources, and the potential to not have the requirements for success.

9. Reliable Osmolality Testing Of High Concentration mAb Formulations 12/17/2020

   Osmolality testing has several bioprocessing applications, and new use cases are constantly emerging. This paper evaluates two osmometers for measuring concentrated protein formulations. 

10. Groundbreaking Work Leads To First Gene Therapy Ever Approved In Europe 1/14/2021

    Veristat was brought in to create and manage a full development program for a gene therapy for a very rare inherited disorder. The work involved charting the course in completely uncharted waters – our team had to create industry best practices that didn’t exist before, anywhere. With no classic route to market, Veristat’s experts wrote the map on patient recruitment, regulatory and health agency engagement, natural history studies and the Central Site Model.