July 2008

Single-Use Solutions for Complex Processes

While industry is rapidly shifting from stainless steel vessels and hard-plumbed processes to single-use bioreactors and TFF filters, the transition between the multiple process steps remains complicated and time-consuming, often requiring fluid transfers, disrupting sterile barriers, and cleaning protocols. The simple solution to a complex process is connectivity: a continuous flow-path that interconnects all the process steps by means of a sterile singleuse process manifold. Spectrum Laboratories incorporates process filters, reservoir bags, flexible tubing, and other critical elements into a…

Designed for Advanced Application

Emerging lifestyle diseases and an aging population are creating a number of major health challenges. Over the past few years, the food industry has been more focused on functional foods, those intended to be consumed within the normal diet but containing biologically active components with physiological benefits intended to reduce certain chronic diseases. This US$35 billion market has been steadily growing at 8-14% per year, as estimated by the Food and Agriculture Organization of the United States (FAO). Although the…

Process Control in Single-Use Bioreactors

The development of single-use bioreactor technologies is focused on bringing new designs onto the market for effective oxygen transfer and cultivation of not only cell culture processes, but also microbial cultures. The advantages of disposable technologies are: ease of use, prevention of cross-contamination, labor and capital investment savings, reduced qualification and validation, and increased flexibility. The costs of disposables are lower compared with conventional stainless-steel bioreactors because the capital investment is lower. Therefore, the need is reduced for qualification and…

Protein Projects Integrated Development

Founded in 2000 in Grenoble, France, Protein’eXpert is an expanding contract research organization devoted to recombinant protein engineering and production. Our 50-member staff offers custom-designed services focusing on the discovery, optimization, and production of valuable target or therapeutic proteins. Since 2004, Protein’eXpert has extended its offering to the biomanufacturing of therapeutic protein and recombinant vaccines for early clinical trials through its integrated subsidiary PX’Pharma. PX’Pharma provides dedicated contract services for process development and scale-up optimization as well as preclinical and…

Supply Chain Risk Mitigation

SAFC Biosciences views supply chain management as a structured process that seeks to evaluate, monitor and control supply chain risk, safeguarding continuity while maximizing profitability for its supply chain partners. Successful supply chain management in the biopharmaceutical industry is no longer simply a case of having the right material in the right place at the right time to guard against production delays. Today, the basis of our supply chain offering includes risk mitigation, robust supplier relationship management and critical raw…

In Line Buffer Dilution

Biopharmaceutical companies continue to wrestle with how to approach the implementation of process analytical technology (PAT). The accelerated adoption of many new technologies has benefited from the identification of a “killer app,” an early application that enables a readily achieved breakthrough in capability. This can be a totally new capability (e.g., e-mail on the internet) or a major step-change (e.g., 10× or more) in an existing capability. Flashes of inspiration cannot be achieved at will, but we can identify elements…

Chromatography on Tecan Freedom EVO® Robotic Workstations

Figure 1. The demand for biopharmaceutical products is increasing rapidly; however, development timelines of about 12 years leave little time for return on investment before a patent expires. Fast process development is therefore crucial to speed up the market entrance of new biopharmaceuticals. Until recently, chromatographic process development was restricted to a sequential regime. However, new innovative methods have been developed to perform up to 96 parallel chromatographic experiments on a Tecan Freedom EVO® robotic workstation (pictured, right), allowing for…

Quality Key to Risk Mitigation

Whether applied to business security, product specification, financial exposure or personnel safety, quality is a key element underpinning any biopharmaceutical risk mitigation strategy. A quality system should not be inherently dependent upon personnel, nor should it rely solely on people to ensure the quality of the products manufactured. Irrespective of human resources, the system itself should provide consistency, addressing risk from design inception through to product delivery, ensuring that robust processes are in place that minimize risk to the product…

Flexible, Cooperative, Midsized Miltenyi Biotec, a CMO for Biopharmaceuticals

Trust, competence, and motivation are the major characteristics of a reliable contract manufacturer for clinical projects. At Miltenyi Biotec, customers have more than just projects: they have goals that Miltenyi Biotec helps them to achieve. Miltenyi Biotec is a midsized biotechnology company, focused on medical devices, equipment, and therapeutics for R&D and clinical applications. The product expertise includes GMP-grade antibodies, peptides, growth factors, cytokines, aphaeresis materials, and cellular products, resulting in a broad and significant understanding of different manufacturing challenges.…

Process Supplements for Optimized Fed-Batch Culture Systems

Figure 1. Fed-batch versions of stirred-tank cell culture have become most popular at large scales. The primary driver of a mid-run addition of nutrients to batch cultures is to increase the quantity of product harvested. The prevalence of fed-batch over other modes is attributable to many practical factors such as reliability, scalability, and application latitude. Increases in the integral of viable cell concentration and volumetric productivity are commonly the greatest improvements obtained (1). Factors determining optimum feeding of cultures include…