On 31 July 2019 Jamie Hall (project manager at Intertek Pharmaceutical Services) joined BPI for an “Ask the Expert†webinar to explore key applications and considerations for implementing flow cytometry (FC) methods in a GMP environment. This increasingly important technique can be applied to all stages of drug development in a range of applications, including cell-line identification, immunophenotyping, and cell-based potency assays. In a regulatory environment, such flexibility can present challenges. Hall explained how scientists can approach FC method development…
Author Archives: BPI Contributor
Gyrolab Immunoassays: Streamlining Workflows Through Automation
Immunoassays and other types of ligand-binding assays are widely used in the development of monoclonal antibody (mAb) therapeutics to measure antibody titers and support downstream purification processes by tracking impurities such as host cell proteins (HCPs) and leakage of protein A from affinity chromatography columns. While scaled down bioprocess development models and high-throughput testing generate large numbers of samples for analysis, immunoassays remain largely manual in many companies, resulting in high assay variability and low productivity. In contrast, automated immunoassays…
Automated, Closed-Loop, Inline Monitoring of CAR-T Cells in a Production Process
This webcast features: Jan Van Hauwermeiren, VP Sales and Marketing, Ovizio Imaging Systems Cell-based technology is a fundamental pillar of modern biotechnology. With the development of cell therapy products (CTPs), there is an increased need for robust and validated measurements for cell characterization to enable manufacturing control and a safe, high-quality product released to the patients. Our company has developed an inline, automated microscope that generates reliable viable cell counts (VCCs) without the need for active sampling, in real time…
Navigating Regulatory Expectations for Extractables and Leachables of Combination Products
This webcast features: Sandi Schaible, Senior Director, Analytical Chemistry and Regulatory Toxicology, WuXi AppTec The expectations for extractables and leachables of medical devices (delivery systems) are different than those of typical pharmaceutical applications such as container closure systems or single use systems. Learn about how the FDA reviews combination products and learn about testing expectations. Put these expectations to practice with a case study review complete including common pitfalls in testing. Key lessons learned: How does the FDA interact internally…
Streamlining the Antibody Discovery Workflow at ModiQuest Research
With breakthroughs in molecular engineering and antibody humanization, monoclonal antibodies (mAbs) are one of the fastest-growing classes of biopharmaceuticals for most clinical indications. In 2017, 10 therapeutic monoclonal antibodies were approved in the EU or US with nine additional candidates under regulatory review and 60 in phase III clinical trials 1. mAbs are the backbone of many treatment modalities including unconjugated therapeutic antibodies, antibody drug conjugates, bispecific antibodies and CAR-T cell therapy. Many of the approved antibody drugs engage the…
GMP Flow Cytometry: Applications, Considerations and Challenges
This webcast features: Jamie Hall, Project Manager, Center of Excellence for Biopharmaceuticals, Intertek Pharmaceutical Services Flow cytometry is a powerful technique which can be applied to all stages of the drug development pipeline including discovery, clinical development, CMC, regulatory submission and in support of production. It allows the analysis of complex mixtures of particles, from polystyrene beads to cells. Utilizing a broad spectrum of fluorescent detectors, assays can be set up to assess multiple parameters at once and ascertain otherwise…
China’s GMP Strategies: Dealing with Quality Management Issues, to Compete with the West
This webcast features: Dr. Fai Poon, President, Quacell Biotech Ltd. China’s biopharma sector faces multiple challenges in quality management, including lack of experience and talent, a rapidly changing regulatory environment, as well as cultural issues in management. In Part 3 of our series Fai Poon, President, QuaCell Biotech, Ltd., will cover China regulatory issues, a review of current challenges in biopharma quality management in China, and opportunities for progress in this field with the growing CMO platforms and the emerging…
New Approach for Qualifying Liquid Handling in Single-Use Bags
2D Flexsafe® Bags and Shells Offer Strong Validation: Complete logistical solution for handling and shipping of liquid bulk drug substance in a 2D Flexsafe® bag & shell Quality by design principles Comprehensive and innovative testing program following the guidelines like ASTM, NF and ISO The system allows for safe variable shipping volumes of 10–120% of nominal fill volume and can be leveraged by the end-users for their own process validation Fill out the form below to view the complete poster…
Reliable Supply Network with the Highest Quality Performance, the Most Stringent Change Management and Built-In Business Continuity for Single-Use Supplies
This webcast features: Claudio Catallo, Head of Global Supply Chain and Optimization Network Strategy Execution for Fluid Management Technology Operations Unit at Sartorius Stedim Biotech, and Elisabeth Vachette, Head of Product Management for Bags/Mixing/Tanks within the Single Use Fluid Management Technologies Department at Sartorius Stedim Biotech Single-use system implementation is increasing at a steady rate, recognizing the huge benefit of disposable material in biotechnology processes, providing safer, greener, cheaper and more flexible drug manufacturing processes. Our unique expertise in global…
Updates to Characterization Methods for Single Use Plastic Components Used In Pharmaceutical and Biopharmaceutical Manufacturing
This webcast features: Sandi Schaible, Senior Director, Analytical Chemistry and Regulatory Toxicology, WuXi AppTec Leachables from single use systems have the potential to impact the quality and safety of your drug product. This presentation will help you understand those risks and how to evaluate them, the current options for test methods and what the future holds so that you can prepare. Key Questions Answered: Why is characterization of Single Use Systems Important? What is the Current State of Methods used…