CELL AND GENE THERAPY MANUFACTURING
Dr. Peter Marks Talks a Standardized Playbook for Gene Therapy Manufacturing
In this segment, Dr. Peter Marks shares developments in CMC for advanced therapies in the near future.
Perfusion: Hardware Needs
In this video, we will discuss cell retention mechanisms, pumps, and intensification challenges in the perfusion process.
Knowledge Culture Basics — Gene Therapy Education Series: Lentiviral Vectors
In this session of our ongoing education series on lentiviral vectors, we delve further into principles of lentiviral transduction and challenges in suspension-based lentivirus production.
Thermo Fisher Scientific Suzhou, China Manufacturing Site Capabilities
Watch this video to learn more about this manufacturing site capabilities, quality management systems, PPI implementation, product expansion, assurance of supply and lead times.
Supporting Development Of mRNA Therapeutics By Enabling Commercial-Scale mRNA Purification
Discover the next generation of scalable affinity capture for high-quality mRNA purification. Learn how a simple, reliable binding mechanism can maximize efficiency and simplify your manufacturing process.
What Is The DynaChrom™ Single-Use Chromatography System?
This chromatography system offers a flexible solution, paired with an advanced software platform, allowing easy integration with downstream process automation.
Leveraging dPCR r Techniques To Quantitate Lentivirus Particles
Discover how digital PCR can streamline lentiviral vector characterization to reduce variability and improve analytical sensitivity. Learn how this approach can help you comply with regulatory guidance.
Tackling Residual DNA Testing In Biotherapy Manufacturing
Controlling residual host cell DNA is critical for the safety and efficacy of biotherapeutics. Learn about robust, highly sensitive analytical methods for effective DNA clearance and process control.
Innovative Strategies For Residual DNA And Viral Titre Quantitation
Discover how digital PCR improves the accuracy of residual host cell DNA and viral titre quantification in biotherapeutic manufacturing to enhance product quality, safety, and regulatory compliance.
Aegis Film For DynaDrive Single-Use Bioreactors
PFAS-free bioreactor film technology provides proven biocompatibility and strength across workflows while simplifying validation and reducing material variability for compliant operations.
Defining The CMC / Clinical Relationship For Allogeneic Cell Therapies
During this segment, Nguyen and Wagner define why the relationship between CMC and Clinical is so critical, and they also explain what a mutually beneficial partnership between CMC and Clinical looks like.
Interview With Nico Chow And Sandi True, Field Applications Specialists
Hear Nico Chow and Sandi True, Field Applications Specialists, discuss working with customers to help them evaluate and implement Residual DNA Quantitation, Mycoplasma Detection, and Microbial Identification Assays.
Go Beyond Custom Media Screening And Prototyping
Learn about manufacturing solutions that streamline cell culture media scale-up with global production capabilities, equivalency strategies, and quality assurance for reliable supply.
DynaDrive Single-Use Bioreactors - One Reactor, Many Volumes
Single-use bioreactors with turndown ratios up to 20:1 enable facilities to operate across wide volume ranges within the same vessel, streamlining seed trains and reducing capital requirements for multi-product operations.
Focal Points for 2024: Dr. Verdun and Dr. Marks Talk Regulatory Challenges for Cell-Based Therapies
Dr. Verdun and Dr. Marks provide detailed feedback on the regulatory challenges facing cell therapy and explain the Agency’s most important focal points for 2024, patient accessibility, and more.
Key Considerations For Rapid Microbial Methods For Mycoplasma Detection
Learn the importance of demonstrating product specific suitability, defining representative sample, consistent sampling protocols, accommodating volume and turnaround time constraints, and the need to establish equivalence.
The Need for Speed: Dr. Peter Marks and Dr. Nicole Verdun Explain Meeting Unmet Need for Pediatric Patients
How can sponsor companies accelerate development in pediatric patients for genetic diseases that affect both children and adults, but where gene therapy holds the greatest promise to address unmet needs in pediatric patients?
Dr. Peter Marks on the Adoption of Novel Precision Analytics
Hear advice for developers who are worried that the FDA will not accept changes in their process that include a new analytical method.
Major Advancements In mRNA
Experts on this Cell & Gene live event discuss the major scientific biological advances in understanding the potential for mRNA-based immunotherapies vaccines for cancer over the last 2 years.
Cell And Gene Therapy Innovations
This interview with a pharmaceutical analytics expert discusses key insights into advances in cell and gene therapy and the strategies used to support customers in improving their therapeutic development.
Rethinking Sustainability In Bioprocessing
Discover how sustainability is transforming bioprocessing through innovative single-use technologies that help reduce environmental impact and support responsible, forward-thinking biomanufacturing.
Master The 2-Point Calibration Process To Maintain Data Integrity
Ensure accurate sensor readings with an innovative software by mastering the 2-point calibration process. Learn more about how and why regular calibration supports data integrity and compliance.
Safety And Efficiency Of Source Material Collection
Expert CTO's detail how automation improves safety and efficiency when collecting source material.
Understanding AI And Machine Learning's Impact On CGT with Dr. Peter Marks and Dr. Nicole Verdun
During this segment, Dr. Peter Marks and Dr. Nicole Verdun share their take on how AI and machine learning will impact FDA regulation in 2024.
Cytovance Customer Testimonial: Thermo Scientific Single-Use Technologies
Thermo Fisher Scientific has served as a key partner in the bioprocess industry, by establishing manufacturing and development capabilities, enabling Cytovance Biologics to expand offerings their product offering, to better serve clients with diverse pharmaceutical needs....
BioTitan Retention Device Overview
Learn about a retention device that provides robust fortification for single-use assemblies. Its 360-degree seal strengthens connections, reduces leak risks, and ensures process integrity for fluid transfer.
AAV Purification: Solving Downstream Challenges
In this roundtable discussion, a trio of distinguished experts in AAV purification and process development share their expertise and best practices in tackling and solving downstream challenges.
Why Clinical Requirements Change: Dr. Peter Marks on Pre-IND Meeting Pathways
Learn how clinical requirements change after the FDA and a company agree on a pathway during a pre-IND meeting and how the company might recover as a result.
Leveraging Rapid Sterility Testing To Advance Cell Therapy Production
Explore the crucial role of rapid sterility testing in cell therapy manufacturing. This presentation delves into the benefits of swift, accurate detection for product quality and patient safety.
A Successful Journey To Cell Therapy Manufacturing
Learn about the three main areas to consider when you're preparing to commercialize a cell therapy, including starting/raw material, the controlled manufacturing process, as well as testing safety and quality.