2008

Specialists in Purification and Analysis

Figure 1. As a leading provider of process and analytical solutions for the biotechnology and pharmaceutical industries, Applied Biosystems offers an extensive portfolio of tools to help optimize every stage of biopharmaceutical production — from characterization to purification to pharmaceutical manufacturing. These solutions provide pharmaceutical manufacturers with the tools they require to maximize throughput and yield and ensure product quality. Purification High Performance on a Large Scale: Applied Biosystems POROS Perfusion Chromatography products are today’s best-performing chromatographic media for process-scale…

Boehringer Ingelheim: From Mind to Market Our Services in Biopharmaceutical Contract Development and Manufacturing

The Boehringer Ingelheim group is one of the world’s 20 leading pharmaceutical companies. Headquartered in Ingelheim, Germany, it operates globally with 135 affiliates in 47 countries and nearly 39,800 employees. Since its foundation in 1885, the family-owned company has been committed to researching, developing, manufacturing, and marketing innovative products of high therapeutic value for human and veterinary medicine. Our therapeutic areas are respiratory, cardiovascular, central nervous system, urology, virology, rheumatology, metabolism, immunology, and oncology. Boehringer ingelheim is one of the…

Octet RED System

Figure 1. Select promising leads earlier in the development process with the Octet RED system’s rapid, highly sensitive detection and label-free analysis of small peptides and small molecules. The Octet RED system’s rapid data acquisition and high sensitivity means that even the fastest reactions and smallest binders will be easily characterized. The Octet RED system shares the advantages of the Octet QK system: BLI technology, no microfluidics, eight-channel parallel processing, walk-away automation of up to 96 samples, and affordability —…

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…

Robust Small Virus Removal with Planova® Virus-Removal Filters: No Effect from Varying Virus-Spike Quality and Concentration in a Validation Model

Figure 1. A virus validation study is required for virus-removal filters prior to employing them in a biopharmaceutical purification process. Validation conditions are determined on a case-by-case basis by each filter user. Optimizing conditions for removal of parvovirus is important to achieve LRV = 4. However, the optimal conditions are often unclear for validation studies, because each product may behave differently. We attempt to establish optimal conditions for human IgG and show the effects of varying IgG concentration, purity of the virus…

Providing Process Solutions for the Biopharmaceutical Industry Worldwide

Figure 1. Integrating production processes within a complete facility does not always lead to a costly execution and long time to market for end users. This is what a specialist company such as Boccard can offer thanks to its expertise in process design and construction of pharmaceutical GMP systems, and thanks to a different project implementation strategy that focuses on the client’s core business, production needs, and operating methodologies. Case Study: Alpha Biologics Facility Project in Malaysia Present in 20…

Expertise in Fluoropolymer Engineering Provides Unique Products for Biopharmaceutical Processing

Throughout its 50-year history, WL Gore & Associates has earned its reputation for providing innovative, high-value products such as GORE-TEX® outerwear, Elixir® guitar strings, and GORE-TEX® vascular grafts. Having invented expanded polytetrafluoroethylene (ePTFE), Gore offers an unparalleled level of technical knowledge and experience with this versatile material. This know-how starts with a deep scientific understanding of fluoropolymers, particularly PTFE processing and fluoropolymer development. Gore’s unique technical agility enables the development of a wide range of processes, products, and creative, reliable…

The Next Step in Implementing Disposables

Biopharmaceutical manufacturers face increased pressure to commercialize new drugs faster and at a lower cost. As a result, production demand is outpacing available manufacturing capacity. To meet existing and future demand and maintain a competitive advantage, many manufacturers are striving to develop increased efficiencies within their manufacturing processes. This is where single-use systems — particularly single-use transfer lines — can deliver significant value, including added flexibility, improved production yields, and increased cost savings. The trend today is toward transfer lines…

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…

DAISOGEL C4-Modified Phases for Protein Purification

Figure 1. Recently, purification of biomolecules, such as peptides and proteins, by process scale HPLC using reversed phase silica gel media has become increasingly important in biopharmaceutical production. DAISOGEL SP-300-C4-BIO is the newest product using this technology, a butylsilyl(C4)-modified silica gel with 30-nm pore diameter for applications involving peptides, proteins, and other large molecules. Besides selectivity, several other aspects influence the performance of chromatography in preparative processes and consequently have a crucial effect on the total process cost. Therefore, when…