With an ever-increasing number of countries involved in the collection, processing and marketing of serum, it is necessary to understand the relevance and rules relating to geographic region of origin. This article reviews and discusses the safety and quality of FBS, rules of origin, consumer market-motivated misinformation, and how mislabeled serum can be detected. The article concludes that high-quality serum needed for scientific research and biopharmaceutical products can originate from any country, as long as it is collected, imported, and processed following all the applicable regulatory and industry requirements…
Tag: <span>quality</span>
Growth performance testing in cell culture is an effective approach to making serum suitability and purchase decisions. An independent commercial testing lab conducted two separate and sequential growth promotion studies to underscore the need for pre-purchase lot performance testing with: (1) FBS; and (2) FBS alternatives. Results from both studies are presented here to compare and contrast:
• FBS lots to each other
• FBS alternatives lots to each other
• FBS alternatives lots to FBS
FBS alternatives are included because they are often overlooked as a cost-effective substitute for FBS, providing, in many cases, equivalent performance. It is advisable to avoid preconceived notions concerning the quality or performance of a serum product without considering the culture system, culture conditions, and the subject cells, which can all have a material impact on its performance in cell culture.
Test – then decide…
As pharmaceutical and biopharmaceutical companies become more global in nature with products that have the potential to reach into the worldwide marketplace, a special understanding is needed of the requirements that are specific to varying geographical areas. Specifically, the regions for worldwide pharmaceutical distribution can be broken into America, Europe, and Asia-Pacific, with each region presenting its own regulation and technical challenges. There are many issues that are common among these regions, but each region’s focus may be different. Typically, an issue arises in one region and then migrates to another as people become aware of the issues and concerns. For example, the use of prefilled syringe systems in Europe and Asia has migrated to the American marketplace, amounting to a more significant volume…
With the advent of whole cell-based therapeutics has come a growing standardized quality control and quality assurance of the processes employed for developing and manufacturing cellular materials, similar to the controls over traditional drugs and biologicals. Cellular therapeutics present unique process and quality control challenges due to the innate complexities of living cells, making it important to use whole cell assays to provide detailed pictures of the status and consistency of cell preparations that will be used to treat patients. This article illustrates how a cellular assay from Guava Technologies addresses these issues…
Cell culture was first devised at the beginning of the 20th century as a method for studying the behavior of animal cells free of systemic variations that might arise in the animal both during normal homeostasis and under the stress of an experiment. During the past thirty, thousands of academic and for-profit organizations have come to rely on cultivation of animal cells as the basic foundation to perform biomedical research and large-scale biomanufacturing. Their success is directly dependent upon the reproducible production of high quality cell culture products. The complexity of the mammalian cell, its growth and storage requirements, and the need to maintain pure and uncontaminated cultures is a constant challenge to those involved with in vitro cell culture…
Long-term growth of the biopharmaceutical industry is increasingly relying on outsourcing to overcome the current capacity constraints, especially for monoclonal antibody production. Companies are often reluctant to commit to building multimillion dollar manufacturing facilities for potential products with no guarantee of approval. Therefore to offset risks, companies will enter into contract manufacturing arrangements…
Risk management deals with planning for, and reacting to, hazard or loss. The regulatory authorities are focusing on the issues associated with establishing alternative sources of raw materials, especially as they are noticing a number of related quality problems in biopharmaceutical manufacturing. Supply chain management for critical raw materials used in biopharmaceutical manufacturing is an appropriate subject for risk management. This paper analyzes five important areas in risk management as it applies to the supply chain for critical raw materials…