BPI White Papers

Automated PBMC Isolation and T Cell Wash and Concentration by the CTS Rotea System

Successful processing and manufacturing in cell and gene therapy workflows are essential to the efficacy of the product. Autologous cell and gene therapy workflows involve isolating cells from an individual, engineering the cells, expanding and concentrating them, and infusing them back into the patient. Certain steps in these workflows could benefit from optimized automation to decrease hands-on time and the cost of the cell manufacturing process. In this application note, we present the Gibco™ Cell Therapy Systems™ (CTS™) Rotea™ Counterflow…

Do Not Let HCPs Delay Your Biologics Route to Market

The stakes are high in biologics development, especially in host cell protein (HCP) analysis. Regulatory bodies have rules and suggested strategies for HCP analysis and reporting, and it is likely that removing HCPs is a key concern in your process development. Ultimately, the accuracy of monitoring and success of purifying your biologic of these HCPs can make or break your product. Get it wrong and it could delay your development cycle. In this blog, we outline strategies to optimize your…

Ensuring Everything is A-OK at AKBA

Accurately and reliably producing pharmaceuticals and biotherapeutics is one of the most important – and challenging – tasks in the world of manufacturing. Any misstep in the production process will lead to the creation of a substandard end product that can do substantial harm to the user. That’s why the processes used in these production chains – things like inline buffer formulation (IBF) and virus filtration – must be completed with no deviation from accepted norms. For Asahi Kasei Bioprocess…

Antibody Internalization: Advanced Flow Cytometry and Live-Cell Analysis Give Rich Insights During Antibody Profiling

The natural characteristics of antibodies, such as high binding affinity, specificity to a wide variety of targets, and good stability, make them ideal therapeutic candidates for many diseases. Therapeutic antibodies, in particular monoclonal antibodies (mAbs), deliver promising therapeutic results in several different disease areas, such as autoimmunity, oncology, and chronic inflammation. Researchers’ abilities to improve the breadth of antibodies have been aided by innovative technologies for antibody discovery, for instance, through humanization of mouse antibodies and phage display. However, advanced…

Integrated Generation and Characterization of CAR T Cells

Chimeric antigen receptor (CAR) T cell therapies have been approved by the FDA and other global public health agencies to treat B cell leukemias and have seen great clinical success. Autologous CAR T cell manufacturing involves isolating T cells from a patient, activating these cells, introducing an engineered CAR construct, and expanding the cells to a scale appropriate for therapeutic dosing. Patient samples from multiple sources result in inconsistent clinical outcomes and overall product quality. To ensure patient safety and…

Three Ways to Successfully Scale-Up Your Bioprocessing Production

When developing a biopharmaceutical manufacturing process, an R&D or process development team may fall into the trap of developing a process in the lab which is difficult to scale to work with larger volumes in production, leading to delays and costly additional development later on. It is therefore crucial that, where possible, technology is used at small-scale which can be scaled alongside the process in a consistent manner. Taking a thoughtful and strategic approach can help biopharmaceutical products get to…

A Smart Path for Novel Biologics

Roche Pharma Research and Early Development (pRED) was faced with a challenge: double the number of projects in process development without significantly increasing headcount. Pawel Linke, a pRED lab automation specialist, tells the story of how the group approached this challenge with a focus on obtaining high quality data through automation and by integrating independent lab systems and devices to streamline their workflow. Implementation of high-throughput process development systems requires an orchestrated approach of both hardware and software solutions, so…

Embedding Your Drug Strategy Within a Solid Foundation for Success

Demand for drugs and therapeutics is growing thanks to the globalization of pharmaceutical-based medicine. Manufacturing new drugs and getting them to market faster, more economically and safely demands development strategies and business models that support successful outcomes for both investors and patients. Outsourcing has become an increasingly attractive business model for pharma as companies seek partners who can deliver comprehensive end-to-end drug substance and drug product development. It has prompted contract manufacturing organizations (CMOs) to consolidate and expand to create…

Writing the Future of Biologics to Discover and Optimize Antibodies

With our unique DNA writing technology, Twist Biopharma is accelerating the way our partners discover and optimize antibody therapeutics. We have decades of synthetic antibody library design and selection expertise and have the ability to write any DNA sequence to enable faster, better discovery and development. Using our precise, rational, expertise in library fabrication, we can create libraries in a fundamentally different way that allow us to address tough targets, e.g. GPCRs. Since we are a DNA product company, we…

Confidence in Host Cell Protein (HCP) Coverage Assays with Differential Gel Approaches

Enzyme-linked immunosorbent assays (ELISAs) are critical to detecting and removing host cell proteins (HCPs), a primary source of impurities in biologics development. Scientists must validate HCP ELISAs to ensure patient safety and meet regulatory guidelines – but different coverage assays come with different challenges, limitations, and benefits. The US Pharmacopeia recommends 2D differential gel electrophoresis (DIGE) combined with Western blot or immunoaffinity approaches, and labs might not be able to gain the full benefits of DIGE without significantly altering current…