Today, there is much discussion regarding the promise of improved insight into bioprocess industry processes. Look to the pages of industry publications such as this one, and you’ll see that industry leaders in process measurement and control have begun to discuss openly the potential for simulating and modeling bioprocesses. “Important opportunities such as the application of mass spectrometers, dissolved carbon dioxide probes, and inferential measurements of metabolic processes have come to fruition today opening the door to more advanced process…
Analytical
Validation of Adventitious Virus Removal By Virus Filtration
Regulatory bodies around the world expect downstream purification processes to demonstrate robust clearance of model adventitious viruses in time for execution of phase 3 clinical trials and product licensure (1,2,3). Model viruses selected for these studies should represent a diversity of viral physicochemical properties, and the clearance methods applied should include orthogonal mechanisms such as clearance based on size alongside chemical inactivation. Virus filtration is a critical unit operation used in numerous purification processes of monoclonal antibodies (MAbs), recombinant proteins,…
Emerging Analytical Technologies for Biotherapeutics Development
A major goal of pharmaceutical development is to characterize pathways of chemical and physical instability and then to develop strategies to minimize them. Deamidation and oxidation are examples of the former, aggregation a result of the latter. The potential for the presence of multiple variants in protein-based pharmaceuticals highlights a need for analytical methods capable of reliably and accurately identifying and measuring those variants. The ideal analytical method would be sensitive, accurate, linear over a broad range, resistant to sample-matrix…
Guide to Irradiation and Sterilization Validation of Single-Use Bioprocess Systems
Single-use bioprocess manufacturing systems increasingly are being implemented by the biopharmaceutical industry based on safety, time, and cost-reduction benefits. These disposable systems are used to process or contain fluids ranging from culture media, additives, and buffers, to bulk intermediates and final formulations. In many cases microbial control or sterility is required to ensure product purity and safety. Radiation sterilization is a common means of microbial control and sterilization applied to single-use systems. The standard methods for validating radiation sterilization are…
Secrets to a Successful Validation Project
Three major elements comprise validation projects in the biopharmaceutical industry: cost, schedule, and quality. If you can work within a budget, complete activities on time, and maintain regulatory-compliant documentation, then you significantly increase your chances for a successful validation project. Here we suggest ways you can improve these essential measurements with the help of a third-party validation team to achieve favorable outcomes. Team Selection The first key is building a validation team. Cohesion is critical for successful project management. All…
Understanding Analytical Methods
As biosimilars move into the forefront of consciousness in the biopharmaceutical industry, analytical methods, especially comparability studies, have an increasingly important role to play. Additionally, as more products progress from phase 1 to 2–3 studies and require production-scale manufacturing, analytical methods are an important component of technology transfer or in-house scale-up efforts. The Analytical Methods for Biologics track will elucidate these challenges, and will include discussions about the latest changes in immunogenicity guidance, posttranslational modifications, analytical strategies, comparability testing, and…
Moving On in Cell Culture
Record-breaking titer outputs in mammalian cell culture systems in the past few years have pushed the industry to a new crisis of sorts: resolving the downstream bottleneck. However, the cell culture and fermentation groups at biopharmaceutical companies aren’t yet ready to sit back and rest on their laurels. Instead, they are moving forward, tackling the downstream issue with upstream modifications and continuing their drive for more cost-efficient processing. The Cell Culture and Upstream Processing track will focus on cell culture…
In the Laboratory Automation Zone
When you hear the phrase “laboratory analysis” on a TV commercial, maybe you imagine a technician in a white coat and safety goggles pouring a chemical from one test tube to another. Technicians still wear white coats and goggles, but today, in many labs, they’re not the ones pouring the chemicals. Instead, tiny trays carrying minuscule dabs of samples are whisked by robots from one analytical workstation to another. The workstations are equipped with ultraprecise instrument systems to prepare the…
Cutting Down Process Time and Costs
Because the biopharmaceutical industry operates as an industry rather than a nonprofit, the bottom line is an important consideration in every aspect of product design. From laboratory automation methods that speed discovery to streamlined manufacturing processes that incorporate the themes of operational excellence, Lean manufacturing, and quality by design, the industry is undeniably focused on minimizing cost and maximizing revenue. At the BioProcess International European Conference and Exhibition, the Scale-Up and Manufacturing track will focus on economic strategy and technology…
High-Throughput Process Development
Increasing pipelines, shorter timelines, talent scarcity, reduced budgets — all these are issues faced by companies working in today’s biotechnology environment. The ultimate goal of a process development team is to stay off the “critical path” to drug approval. But how do they complete the necessary work to create a robust manufacturing process in light of such pressures? To increase the effectiveness of development, many companies are turning to high-throughput technologies within their development platforms. Such technologies promise that scientists…