During the lifecycle of a biopharmaceutical, occasions arise in which the facility and support organization responsible for ensuring that it is manufactured according to schedule, demand, and quality specifications must change, either in whole or in part. The reasons for this vary: some related to scale, some related to clinical development phase, some related to internal manufacturing capacity and program ownership. The industry has adopted the term technology transfer to describe these events. Many such situations have been…
Monday, November 1, 2010 Daily Archives
Monoliths Open the Door to Key Growth Sectors
The enabling value of monoliths was strongly in evidence at the 4th International Monolith Symposium, held 29 May – 2 June in the Adriatic resort city of Portoroz, Slovenia. Forty-seven oral presentations and 34 posters highlighted important advances in vaccines, gene therapy, phage therapy for infectious disease, and monoclonal antibodies, as well as continuing advances in the performance of monoliths themselves. As these fields advance in parallel, it becomes increasingly apparent that monoliths offer industrial capabilities substantially beyond…
Working Toward Animal-Free Processing
Biological therapeutics is one of the fastest growing segments of the pharmaceutical industry — so much in fact that the overall cell culture media and supplements market used in bioprocessing applications is reportedly near $800 million (1). An increasingly important trend in cell culture is risk reduction throughout the supply chain, including a stringent focus on key raw materials. Accordingly, the industry has increasingly adopted animal-component-free materials to mitigate concerns over safety, transmissible spongiform encephalopathies, and other contaminations.…
Protein Conjugates
Methods and Materials Thanks to vendors large and small — such as Invitrogen (www.invitrogen.com), ProteoChem (www.proteochem.com), Sigma Aldrich (www.sigmaaldrich.com), Soltec Ventures (www.soltecventures.com), and Thermo Scientific Pierce (www.piercenet.com) — bioconjugation chemistry is a field of many options. For example, amine coupling of lysine amino-acid residues typically involves amine-reactive succinimidyl esters. Sulfhydryl coupling of cysteine residues uses a sulfhydryl-reactive maleimide. Photochemically initiated free-radical reactions offer broader reactivity. Most processes couple small molecules to proteins or proteins to one another (e.g., antibodies…
PEGylating Peptides (and Proteins)
Peptides should be promising drug candidates. But their small size makes delivery difficult and gives them an extremely short in vivo half-life. They are often cleared by the kidneys or reticuloendothelial system only minutes after being administered, and they are susceptible to degradation by proteolytic enzymes. These problems could be solved by linking them to polyethylene glycol (PEG). Repeating chains of ethylene oxide (CH2CH2O), PEG molecules can be long or short and straight or branched. PEG groups are linked to…
Mixing in Small-Scale Single-Use Systems
Despite the advantages of presterile, single-use technologies, mixing is one of their most complex applications. Industry has been progressing toward using single-use bag technologies rather than traditional methods of stainless steel tanks and grades A/B processing because of the positive aspects they impart to end users, including a reduced potential for contaminants, cleaning, sterilization, and capital. These technologies offer simplicity and flexibility (1). However, using them for an operation such as mixing can add processing challenges. For example,…
Implementation of Single-Use Technology in Biopharmaceutical Manufacturing
The increasing application of single-use components and systems in bioprocessing represents one of the most significant changes in biopharmaceutical manufacturing in recent times. Driven by various factors such as improved efficiency, flexibility, and economics, this trend also presents specific challenges to end users. In one industry review by Langer, extractables and leachable compounds from disposable components were considered by end users to be a major area of potential concern regarding safety, efficacy, and stability of the pharmaceutical product…
Modeling Bioprocess Cost
At every stage of biopharmaceutical development, efficient and cost-effective protein production is critically important to maintaining the economic viability of both a product and the company developing it. Biopharmaceuticals have significantly evolved through recent protein engineering advances, resulting in highly complex, novel proteins dominating the development pipeline. Such proteins are by definition very difficult to express in a soluble and active form. The success of these products depends on accessing a platform that rapidly produces high-quality, properly folded,…
Global Marketplace
Microbiological Testing Product: GeneDisc specified microorganisms assay Applications: Compendial testing Features: Pall’s GeneDisc specified microorganisms assay is part of its GeneDisc rapid microbiology system based on real-time quantitative polymerase chain reaction (qPCR) technology. Performed using a GeneDisc plate, this rapid assay detects six key indicator microorganisms used in several compendial tests. Users can simultaneously distinguish multiple organisms, obtaining results within two hours (rather than two days with traditional methods) after relevant sample preparation, depending on type of assay performed. Contact…
Biopharmaceutical Development and Production Week
Join us for the week and you will Examine the latest scientific and technical advances to overcome the critical challenges faced by bioprocessing professionals at all stages of development to help you achieve your company’s process and product development goals. Find solutions to the unique challenges of developing and manufacturing therapeutic proteins, that will help you reduce time, cost, and variability during process and product development. Learn approaches to implement the latest analytical technologies that optimize process and product development.…