HCM is a leader in upscale process development and aseptic filling of liquid parenterals in syringes, vials and custom containers. HCM offers clients–from newly-established firms to large-scale commercial enterprises–high quality services and innovative technologies. Quality Services Quality Services Foremost among the services HCM offers are upscale process development and aseptic filling of syringes, vials, and custom containers. In addition to traditional fill and finish, HCM offers online vacuum filling and stoppering as well as lyophilization. HCM offers customers a Stability…

KBI Biopharma is a leading contract development organization for the biopharmaceutical industry. We accelerate and optimize drug development and manufacturing programs for our client partners, including global pharmaceutical and biotechnology companies and organizations in biodefense. Our clients benefit from faster time to market and lower cost of manufactured goods. Ongoing Innovation We are continually working on new technologies and new partnership opportunities to enhance biomanufacturing. Our expertise in biophysical and biochemical protein characterization makes us highly successful in delivering optimal…

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…

Figure 1. Finding optimal conditions for a downstream purification process is critical to achieving high productivity and a robust biopharmaceutical manufacturing process at large scale. In addition, the FDA’s new Quality by design initiative may increase demands on process development work because a higher degree of process understanding must be acquired. This understanding/knowledge can be obtained if a larger experimental space is considered and/or more detailed studies are performed. The introduction of high-throughput techniques for process development partially addresses these…

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…

Figure 1. At recent scientific conferences on downstream processing, there was much discussion about the need to reduce process volumes. Many manufacturing sites are space-limited and to take advantage of chromatographic process improvements, they must be made without the need to increase buffer and holding tankage. One significant opportunity to increase process throughput is to replace conventional with higher capacity ion exchange resins. Recently developed high capacity resins allow more protein to be loaded without the need to replace existing…

The increasing popularity of “single-use” or disposable bioreactors for upstream processing can be understood by considering a typical biotechnology manufacturing facility. The infrastructure required to implement traditional glass/steel bioreactors is substantial, and the time and expense required to validate it can be significant. The requirement that both the bioreactor itself and its ingress and egress tubing use inert materials such as 316-L electropolished stainless steel results in a large capital investment and long lead times for components. In addition to…

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…

Figure 1. The pharmaceutical industry has relied on laboratory testing for all of the past century. Typically, biopharmaceuticals are manufactured in batches and tested for quality using off-line laboratory test methods of samples extracted from the process line. However, taking the laboratory to the sample changes the way analyses are conducted. The FDA Guidance for industry, PAT: A Framework for Innovative Pharmaceutical Development, Manufacturing, and Quality Assurance, promulgated in final form in September 2004, encourages the use of available process…

innovatis has established a technology portfolio to assist with the implementation of process analytical technology (PAT) at pharmaceutical companies focused on manufacturing biologics. PAT is a critical component in FDA’s initiative entitled, “Pharmaceutical CGMPs for the 21st Century: A Risk-Based approach,” which was announced in August 2002. This initiative is intended to support innovation and efficiency in pharmaceutical development, manufacturing and quality assurance. PAT is a system of building into processes “quality by design” (QbD), an idea that product quality…