Since its inception in 2006, the International Serum Industry Association (ISIA) has been focused on providing a more informative characterization standard for animal sera. A fundamental aspect of this effort has been the development of a program focused on product traceability from abattoir to end-user. This goal has been achieved in part by implementing the ISIA-sponsored audit program. Serum vendors determined to be compliant with all audit requirements are awarded ISIA Traceability Certifications. In conjunction with Oritain Global Ltd, ISIA has developed and implemented a method for establishing geographical origin of serum products. The method and its capability of determining geographical origin are described in this paper…
Tag: <span>standards</span>
This article examines two interrelated animal welfare topics: the transportation of pregnant cattle, and the collection of fetal bovine serum (FBS). The occurrence of pregnant cattle at slaughter is unavoidable because of health, management, and economic reasons, or because farmers may be unaware of their pregnancy status. Since cattle are often sold to slaughterhouses through intermediaries, the pregnancy status of the cow is usually unknown until after it has been slaughtered and the uterus exposed. In slaughterhouses where fetal blood is collected, technicians are responsible for the detection and proper handling of fetuses, making sure they remain inside the uterus until dead, or are immediately euthanized. The harvesting of fetal blood also provides a possible source of information, which upon request, may help farmers improve the management of their livestock operations. The serum industry endorses the animal welfare standards set forth by the World Organization for Animal Health (OIE), as well as all existing local and national standards relating to the transportation of pregnant cattle and the collection of fetal blood. This article concludes that there is nothing negative or unethical about collecting blood from a dead fetus. Rather it would be unethical not to utilize available fetal tissues obtained from the slaughter of pregnant cattle, especially since FBS, used as an ingredient in cell culture media, contributes greatly to the advancement of the life sciences industry, as well as the replacement and reduction of live animals used in research and testing…
Today, many if not all of the major pharmaceutical companies have specific budgets for large research and development pipelines for new biologics including vaccines, monoclonal antibodies, recombinant proteins and even gene therapy projects. In addition, small innovative companies are continually presenting us with novel treatment opportunities which hold great promise for the future. The reason for such huge optimism in the field of biologics is that there are now a number of “blockbuster” drugs for which the safety profile has been very successfully managed. This success has been achieved following a considerable amount of time and financial investment by both the innovators and the regulators…
The analytical characterization of recombinant protein therapeutic drug products has broadened to include the use of more sophisticated technologies. The expansion of technical abilities has translated into increasing the depth and breadth of our knowledge and understanding of the drug product intended for commercialization. With the availability of more precise methods, the regulatory expectations for understanding the characteristics of a protein therapeutic drug product are increasing. A thorough understanding of a therapeutic protein’s biochemical and biophysical characteristics is necessary to support investigational new drug (IND) applications and other drug regulatory filings…
Three types of heart valves are employed for replacement in patients: mechanical, xenogeneic tissue, and allogeneic human valves derived from donors post-mortem. The intention of this article is two-fold: 1) to place issues associated with the preservation of allogeneic human heart valves in perspective relative to the AATB Standards for Tissue Banking and current practices in US cardiovascular tissue-processing facilities; and 2) present potential opportunities for improvements with appropriate validation. Most patients receive either xenogeneic tissue or mechanical valves; however, the use of cryopreserved human valve allografts became established during the 1970s and 1980s for certain patient subsets…
The “Lean” manufacturing process management methodology is derived largely from Toyota Motor Corporation’s automotive production system, implemented as a response to the problems they observed within their production facilities over 50 years ago. The principle of reducing costs by eliminating waste—also known as “Lean Thinking”—has been gaining momentum as a continuous improvement philosophy for all sorts of industries outside of its automotive industry origins. In recent years, we have seen several examples of successful Lean implementations in the pharmaceutical and biotech companies. Multinational corporations such as Merck, Pfizer, and GlaxoSmithKline have reported significant gains by applying Lean not only to manufacturing, but also in critical areas like quality control, regulatory adherence, and administration management…
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…
The enzyme-linked immunospot (ELISpot) assay is one of the most useful techniques for the immunological monitoring of vaccine trials and has increasing application as a measure of specific T-cell activation. Recently, we developed, optimized, and validated a customized ELISpot kit for the detection of interferon gamma (IFNγ) positive cells. The precision of the ELISpot was good and it varied over the range of the assay values, independent of the stimulus. Here we describe the development of a library of donors with characterized responses to the CEF peptide pool: cytomegalovirus (CMV), Epstein-Barr virus (EBV), and influenza (Flu); pool of 32 peptides which can be used as controls for IFNγ ELISpot and multiple immune monitoring assay validations for use in clinical trials…
The United States Pharmacopeia (USP) is a not-for-profit nongovernmental organization founded in 1820 that develops public standards for drug substances and products; these standards are enforceable by FDA and have been adopted by many nations around the world. USP General Chapters provide industrial and academic researchers alike with crucial guidance, particularly in areas where there is a regulatory void. A good recent example is the proposed USP general information chapter…