2010

Optimum Prefilter Selection and Filter Train Sizing for Media Filtration

          The use of 0.1-µm rated sterilizing grade filters has been increasing in cell culture media filtration due to mycoplasma contamination concerns. Currently, no standards exist for conducting mycoplasma retention testing on these 0.1-µm labeled filters. A task force has been established at PDA to publish a technical report to standardize testing. Until such guidelines are published, conducting side-by-side tests under identical conditions is the only fair way to compare different 0.1-µm rated filters. Sartorius Stedim…

Outsourcing Your Advanced Biologics GMP Manufacturing

Biotech companies appreciate the challenges involved in raising sufficient investment to support their drug development pipelines. In today’s economic conditions, it is even more critical that burn rates are minimised along with risks to achieving major product development and clinical milestones. Having reached the preclinical stage, the strategic decision whether to build in-house capability or outsource biopharmaceutical manufacturing will have been made. Limitations with investment is the main factor that will direct most companies to seek the services of a…

DNA Removal By Depth Filters in Bioprocesses

  Conclusion   The removal of DNA from cell culture broths and lysates may be required to accomplish the CBER-recommended concentration of DNA impurity of About the Author Author Details Michael Wang, PhD, is a Marketing Manager Bioprocess at 3M Purification Inc., 400 Research Parkway Meriden, CT 06450-1018; 203- 238-8795; Mwang9@mmm.com. REFERENCES 1.) Dorsey, J. 1997. The Role of Charge in the Retention of DNA By Charged Cellulose-Based Depth Filters. BioPharm 10:46-49.   2.)3MPI Application Brief: DNA Removal from Bioprocess…

Single-Use Systems from Start to Finish

          Single-use systems have become all the rage in the biotechnology industry, driven largely by the need to reduce cleaning requirements and associated time, validation, and cost factors associated with stainless vessels. A well-developed single-use system will ensure lower risk of contamination in manufacturing while eliminating the cleaning process and cleaning validation.   Providing Solutions   Advanced Scientifics provides specific solutions to process needs in fluid transfer and handling, offering flexibility in the design and componentry…

Thermo Scientific HyClone Cell Boost Process Supplements

          Major drivers in biopharmaceutical development and manufacturing include improved performance in bioprocess cell culture through increased cell viability, product quality, and yield. Success has been achieved in addressing these drivers using Thermo Scientific HyClone Cell Boost by providing solutions that include strategic supplementation of nutrients based on metabolic profiling of cells and media at various stages of the bioprocessing cell culture campaign. One of the greatest improvements is derived from increased viable cell concentration and…

Avid Bioservices

Avid Bioservices offers a fresh approach to the Contract Manufacturing organization (CMO)–client relationship: fully integrated services across the process chain, including cell line and process development, analytical methods development, cGMP manufacturing, fill/finish, regulatory submission, and commercialization of biologic drug product or drug substance. our expertise enables our clients to succeed in their ventures. As a wholly owned subsidiary of Peregrine Pharmaceuticals, a clinical-stage biotech company with a management team experienced in the commercialization of therapeutic proteins, we know what it…

Nuvia™ S Media

          Increased productivity and reduced costs continue to be the driving forces in process development. Recent advances in upstream processes have dramatically improved the productivity of cell culture fermentation. However, prolonged fermentation and high concentration of monoclonal antibodies (MAbs) at harvest may also lead to product degradation and/or aggregation. Clearing these unwanted by-products remains one of the main challenges in downstream processing of therapeutic MAbs. Media with high binding capacity for target molecules and significant resolution…

A Responsible Business

          At a time when most companies endure the effects of a global economic melt-down, ALLpaQ™ seizes the opportunity for growth on the international stage. ALLpaQ™ Packaging Ltd. develops, manufactures, and supplies standard and custom bioprocess containers for the storage, transportation, and handling of biopharmaceutical fluids on both three-dimensional (3D) and two-dimensional (2D) design platforms. During the past twelve months, ALLpaQ™ has emerged as a strong contender on the world stage in providing packaging solutions to…

Rapid Optimization of Single-Use Bioreactor Performance

          Whether evaluating conventional stainless steel or single-use bioreactors, every system must accomplish the same thing: control a bioprocess for an intended result. The result may be biomass, product titer, substrate conversion, or any number of complex, process-specific productivity measures. Each system shares the same basic elements, including a bioreactor vessel and a gas addition subsystem. The vessel uses an agitation subassembly, gas sparger, and in some cases, gas overlay elements. These must be properly engineered…

In-Process Control of pDNA Production on CIMac pDNA Analytical Column

          As the demand for plasmid DNA (pDNA)–based gene therapy and vaccines increases, large-scale, cost-effective, and reproducible pDNA production will be required. The key to success is a real-time, in-process control method that ensures a high percentage of supercoiled pDNA in the final product. CIMac pDNA Analytical Column allows the monitoring of degradation products (open circular and linear pDNA), the removal of impurities (RNA), and the assurance that each production step is yielding the amount of…