BPI White Papers

Single-Use Automation: Unlocking the True Potential of Single-Use Technology

When single-use technology first arrived on the scene in the late nineties, the processes that it was applied to were relatively simple and low risk. These included simple filtration and storage applications of buffers and cleaning solutions. With these filtration steps typically involving lower value, non-blocking solutions of easy to dissolve salts, automation would have been seen as an unnecessary over- complication. It was thought sufficient to have an operator watch the process to make sure nothing became disconnected, a…

Isolator advantages in Cell Therapy Production

With numerous cellular and gene therapy products seeing strong initial clinical successes, investment in next-generation technologies by both large bio/pharma companies and start-up specialist firms has been significant. In fact more than 750 companies worldwide declare themselves to be in the “regenerative medicine” market space, with a high percentage of year on year increases in the number of cellular and gene therapy drugs in clinical trials. Many of these companies are eager to advance from early stage clinical trials to…

Bioprocessing in a Time of Digital Transformation

eve® is a modular software system for bioreactors and incubator shakers, rethinking bioprocess control to meet the needs of modern users: Fast, secure access to data via a web browser from anywhere, using a range of devices The move to Big Data Analytics for process data analysis A single platform for different types of information required by different users e.g. researchers, production and quality assurance A browser-based approach to accessing this information makes considerations such as operating system, size of…

Fast Trak Education and Training 2017

Gain specialist knowledge in bioprocessing With our Fast Trak education, you can access application training in specialized bioprocessing techniques. The courses provide a tangible learning experience for process development and manufacturing scientists, relevant to everyday work. Comprehensive training for your specific needs The Fast Trak courses cover various topics from upstream to downstream. These include cell culture, bioreactor scale-up, column packing, basic chromatography, as well as optimization and scale-up for both pilot and manufacturing scales. In addition to our standard…

Antibody Targeted Therapy Online Course

This online module focuses on an intensive overview of the antibody therapeutics field, enabling you to: Gain a comprehensive understanding of the antibody field and awareness of the historical aspects, current research and future direction of the development of antibodies as therapeutics. Provide an overview of the antibody fields ranging from structure and function, through to the recent development of antibodies as therapeutics including manufacture and clinical development. Gain insights to some of the issues that are required to develop…

WPI’s Biomanufacturing Education and Training Center 2018 Schedule

Now is the time to plan professional development for 2018: check out the Biomanufacturing Education and Training Center’s 2018 schedule. Download the flyer and gain access to exclusive discount opportunities for BPI subscribers. About: The Biomanufacturing Education and Training Center at Worcester Polytechnic Institute (BETC) is where biotechnology professionals gain a competitive edge. Our innovative partnership between academia and industry creates customized workforce development solutions for forward-thinking biotechnology companies across the region and around the world. Whether you’re an employee…

How to Overcome Validation Challenges in a Single-Use World

While the popularity of single-use systems (SUS) is increasing, regulation of SUS supply chains is not. With increased regulatory scrutiny on supply chain security and risk mitigation strategies throughout the development and manufacturing of a therapeutic drug product, end users are scrambling to find ways to ensure the expected level of compliance. The solution? Sharing responsibilities across the entire supply chain. Validation must begin at the component raw material level and continue to final assembly. Primary parties – including drug…

Purification of Antibody Fragments and Single Domain Antibodies With Amsphere™ A3 Protein A Resin

The standard capture purification of full-size, classical antibodies is typically performed with Protein A affinity chromatography. Binding of the Protein A affinity ligand to the “Fc” region of antibodies (Abs) (abbreviations are defined at end of paper) takes place at the juncture of the constant domains 2 and 3 of the Ab heavy chains (Lewis et al. 2008). This high affinity binding primarily involves hydrophobic interactions. Antibodies that belong to the same subclass have greater than 95% homologous Fc-regions, allowing…

Purification of Fab and scFv Using High Binding Capacity TOYOPEARL® AF-rProtein L-650F Resin

Protein L based affinity chromatography is used for the capture of antibodies and antibody fragments that do not bind to protein A. Unlike protein A and G, which bind to the Fc region of immunoglobulins (IgGs), protein L binds through interactions with the variable region of an antibody’s kappa light chain. TOYOPEARL AF-rProtein L-650F is an affinity chromatography resin that combines a rigid polymer matrix with a recombinant protein L ligand, which is derived from the B4 domain of native…

Three’s Company: Formulation Prep and Stability Screening With Grunt, Lunatic and Uncle

The stability of biologics can be highly dependent on formulation pH. The pH can be screened by buffer exchanging proteins into a variety of buffer salts and running follow-up analytics to determine stability. Current practices for buffer exchange all have limitations. Dialysis requires a large excess of buffer and time. Centrifugal filters and desalting columns are faster, but require more hands-on time. Additionally, all three methods require dilution or concentration steps to reach target protein concentrations. Automating buffer exchange eliminates…