Parallel Cultivation of Microorganisms Using Rigid Wall Single-Use Bioreactors

This webcast features: Dr. Sebastian Kleebank, development and application lab manager, DASGIP GmbH (part of Eppendorf AG) Single-use bioreactor solutions have been successfully established in animal and human cell culture in the last years. Currently this technology is investigated for microbial applications, especially for high cell density fermentations. Dr. Sebastian Kleebank demonstrates that reproducible process control could be achieved using single-use bioreactors operated in parallel. You can view the webcast here. (Registration required)

Dual-Chamber Syringes vs. Vials

Is there a clear choice between dual-chamber syringes and vials in today’s competitive drug development market? That’s the topic of this recorded webcast. During the webcast, the speakers address the following questions: What are the causative factors that have resulted in the rapid increase in prefilled syringes over the last several years? Do dual-chamber syringes offer distinct advantages over vials in drug development? How can dual-chamber technology help differentiate products in a highly competitive environment? What are the main differences…

Clinical Syringe Development Webinar

Clinical Syringe Development: An Innovative Approach to Gain an Early Advantage

Do ever-rising drug development costs, highly competitive markets, and increasing regulatory demands sound familiar? This webcast addresses the benefits of starting syringe work earlier in the development process of injectables. This webcast will: Provide an overview of the many development challenges faced by pharmaceutical and biotechnology companies Discuss the benefits of clinical syringe development including time savings and package attractiveness Offer a case study with a live question and answer session Feature thought leaders Dr. David Brett and Dr. Sabine…

Use and Optimization of Chemically Defined Media Supplements in Mammalian Cell Culture Processes

The manufacture of biological therapeutics requires a recombinant cell line, a media system and process to produce the therapeutic, and a purification process. BD Advanced Bioprocessing specializes in the media system to produce the therapeutic, including cell culture media and a variety of different types of supplementation.There are many types of supplementation, from animal-origin and animal-free hydrolysates to chemically defined, and each biopharma needs to find the best supplementation for their systems’ requirements.

Chemically defined media supplementation has many benefits such as lot-to-lot consistency and reduction/elimination of the risk of animal-origin materials. However, to get optimal performance these supplements are not always as forgiving as a full-bodied hydrolysate.

This webinar will use the newly commercialized BD CD Resurge™ supplements as a case example on how to use and optimize CD supplements in mammalian cell culture processes.

Reducing the Host Cell DNA Quantitation Bottleneck: Approaches for Improved Sample Preparation and Throughput

The removal of impurities arising from host cells used for the production of biopharmaceutical products is a crucial step in the purification process. Regulatory guidance for products produced in cell culture specifies that residual host cell DNA content in the final product should be as low as possible. Because of the low sample throughput typical of most quantitative DNA assays, host-cell DNA quantitation can become an analytical bottleneck during process characterization.

In this webcast, speakers will discuss a qPCR-based system for highly sensitive, accurate quantitation of residual host-cell DNA from a variety of cellular production systems, including Chinese Hamster Ovary (CHO), E. coli and Vero cells. Case studies will be presented that demonstrate DNA recovery from highly complex test sample matrices, typical of those in biopharmaceutical manufacturing environments. Options for automated sample preparation, testing results from samples typical of a monoclonal antibody purification process and results from an external validation study, executed according to ICH guidelines, will also be reviewed.

One Billion Mesenchymal Stem Cells in Eppendorf BioBLU 5c Single-Use Bioreactor at 3L Scale

This webcast features: Ma Sha This Ask the Expert webcast features Dr. Ma Sha, Director of Technical Applications for Eppendorf, Inc. In this webcast, presented to a live audience on May 6, 2014, he demonstrated the success of large clinical-scale culture of human adipose-derived mesenchymal stem cells (AdMSCs) in a BioBLU 5c single-use bioreactor at 3L scale. You can view the webcast here (Registration Required) Link to paper mentioned in presentation: A Novel Method for the Expansion of Mesenchymal Stem…

KrosFlo® Research IIi Tangential Flow Filtration System

Spectrum Laboratories’s the KrosFlo ®Research IIi Tangential Flow Filtration System (KRIIi) is the only commercially available system with hold up volumes as low as 1 milliliter. Spectrum’s innovative, semi-automated TFF System, is ideal for small volume, R&D scale microfiltration and ultrafiltration. The KRIIi system can be used to concentrate and wash, viruses, proteins, nano-particles, and cells, at low volumes, with remarkable recovery rates. Hollow Fiber Tangential Flow Filtration is fast becoming the preferred method of large and small scale processing, due to outstanding efficiency and easy scalability compared to cassette or centrifugal devices.

Driving Optimal Cell-Level “Observability” and Data-Driven Process “Guidance”

In the spirit of implementing PAT (Process Analytical Technology), biopharmaceutical companies are striving to gain a more fundamental understanding of what is happening to the cells within their bioreactors. Implementation of online tools like Raman and Dielectric Spectroscopy are helping to provide insight, yet there is still a gap integrating this data with off-line measurements such as cell density, viability, metabolite levels and titer. Bend Research, in collaboration with major biopharmaceutical companies, is working to advance MAST, a modular, automated sampling platform that can provide samples directly from bioreactors to analytical devices, while maintaining process sterility. In this webcast, Clint Pepper, Ph.D. and Lisa Graham Ph.D., P.E. of Bend Research focus on this overall cell-level “observability” concept and illustrate how the MAST platform is incorporated.

Bioreactor Monitoring – Best Practices for Cell Counting, Sizing, and Viability

Manufacturers utilizing bioprocesses for production need accurate and reliable tools for monitoring bioreactors. The key parameter that many bioprocess engineers rely on is viable cell density. This is a compound parameter arising from knowledge of the cellular concentration and the total cellular viability. Viable cell density is the mathematical product of these two primary pieces of information. In order to minimize variability, the detection technique of each of the primary measurements (concentration and viability) must be understood separately.

In this educational webcast, Matthew N Rhyner, PhD., Global Analytical Marketing Manager at Beckman Coulter Inc, discusses two of the most powerful techniques for assessing concentration and viability: the Coulter Principle and flow-based imaging. Join Dr. Rhyner as he compares the strengths and weaknesses of these techniques and discusses competing technologies. The webcast concludes with some recommendations for best practices in monitoring cell count, size, and viability.

Mirus TransIT-PRO® Transfection Kit for Biotherapeutic Protein Production

Decrease time to produce usable protein by maximizing target protein yields through transient transfection. The TransIT-PRO® Transfection Kit uses animal origin free components designed for high and reproducible nucleic acid delivery into suspension CHO and 293 derived cells. Since it is compatible with varied media formulations, the same media can be used for both transient and stable expression. The TransIT-PRO outperforms linear PEI in protein yield, while providing a cost-effective alternative to FreeStyle™ MAX and 293Fectin™ Transfection Reagents.