Plasmid Platform Facilitates Transition to Clinic
Summary: Securing the supply of this critical raw material will help biotech and pharma companies throughout the drug development lifecycle of their advanced therapies.
Platform Processes for Streamlined Regulatory Filing and Decreased Time to Market for Gene Therapies
Summary: In this podcast, we will discuss how Catalent is working to simplify the supply chain, develop processes scalable for late-stage and commercial needs, and accelerate timelines for production of clinical materials.
Accelerating Advances in Cell and Gene Therapy Production
Summary: During this webinar, we reviewed progress in several areas of advanced development and their impact on readiness for large scale manufacturing.
Plasmid DNA: Integrated Solutions for Cell and Gene Therapies
Summary: Plasmid DNA is a critical raw material for cell and gene therapies. Discover the importance of having an integrated partner like Catalent Cell & Gene, and how we can keep your development and manufacturing on track and on schedule.
Plasmid DNA Manufacturing
Summary: The Catalent team has broad expertise in developing customized plasmid DNA manufacturing solutions, from plasmid engineering to large-scale GMP plasmid production.
Overcoming the Raw Material Hurdle: Plasmids for Viral Vector-Based Gene Therapies
Summary: Learn how Catalent Cell & Gene Therapy recognizes the challenges faced when obtaining raw materials, and how our investments in pDNA manufacturing secure our integrated supply chain.
Readiness through Planning and Alignment: Guiding Gene Therapies from Clinic to Market
Summary: Learn how integrated service providers can streamline manufacturing, development and commercialization for optimal regulatory and process outcomes for gene therapy programs.
Are Real-Time Gene Therapy Test Results Possible?
Summary: Along with the complexities of vaccine and viral-based gene therapy process development comes the need for analytical techniques that can help assess quality parameters, in real-time.
Formulation Strategies for AAV-Based Gene Therapies
Summary: In this executive summary, our expert discusses how Catalent Cell & Gene Therapy continues to learn about formulating gene therapies by adapting methods used for other biologics.
Formulation and Characterization Strategies for Gene Therapies
Summary: In this on-demand webinar, our expert discusses how Catalent Cell and Gene Therapy is working towards an approach for gathering product knowledge and establishing formulation selection criteria using traditional/routine techniques as well as evaluating novel methodologies for gene therapy products.
Measuring Quality Attributes for Gene Therapies: Empty vs Full Viral Vector Capsids
Summary: Catalent offers tools to measure the ratio and help assess the safety and efficacy of viral vector-based therapies.
Navigating the Path to the Clinic and Beyond for Gene Therapies
Summary: In this webinar, hear from Catalent panelists as they discuss navigating the path from research lab to the clinic.
Are Real-Time Gene Therapy Test Results Possible?
Summary: Radiance® data is presented on rapid and low error adenovirus and baculovirus infectivity measurements as well as AAV transfection monitoring.
Manufacturing Innovation Across New Modalities
Summary: The successful outcomes delivered by cell and gene therapies coupled with emergence of modalities across nucleic acid therapeutics and microbiomes pose the next challenge for innovators to make these new modalities…
Pharma Predictions for 2021
Summary: Catalent CEO John Chiminski to talks about the year ahead, offering projections for what 2021 holds in store for the biopharma industry.
Cell and Gene Therapy Brochure
Summary: Catalent Cell & Gene Therapy is a premier partner for innovators across the entire field of advanced biotherapeutics. Explore our development and manufacturing capabilities for allogeneic and autologous cell therapies, viral vector-based…
CPhI Festival of Pharma Roundtable: Cell & Gene Technology
Summary: In this on-demand webinar from the 2020 CPhI Festival of Pharma, panelists discuss innovative technologies and their adoption for cell and gene therapies.
Technology Integrators in Cell and Gene Therapy: Powering Innovation
Summary: Julien Meissonnier, Catalent’s Vice President and Chief Scientific Officer, discusses innovative approaches, technology disrupters, and more in this webinar.
Creating Commercial-ready & Scalable Solutions for Gene Therapy Development & Manufacturing
Summary: Learn about the complexities from raw material supply through drug product manufacturing, including planning early for a commercial-ready process.
Overcoming Commercialization Challenges for Cell & Gene Therapies
Summary: This panel discussion highlights technical and regulatory hurdles associated with development and manufacturing steps, and strategies and solutions to facilitate development through commercialization.
Clinical Readiness – Practical and Innovative Solutions for AAV Development and Manufacturing
Summary: Learn about specific case studies for neuromuscular degenerative indications, AAV technology and manufacturing, strategies for navigating the current regulatory environments.
Catalent Cell & Gene Therapy, the Journey
Summary: Learn about Catalent’s journey into the Cell and Gene therapy space, overcoming challenges, and the company’s commitment to its partners.
Endpoints Cancer R&D Summit: The Outlook for Cancer Gene Therapies
Summary: What hurdles need to be overcome before gene therapy is the new modality in the cancer therapy arsenal? We’ll look at manufacturing, viral vectors, and the most promising approaches coming to the clinic.
Radiance® Label-Free Monitoring of AAV Transfection in HEK293 Cells Using Laser Force Cytology™
Summary: Catalent and LumaCyte experts collaborate to compare AAV production with three different transfection reagents.
Re-engineered Tubing Assembly for iCELLis® Nano Bioreactor
Summary: To minimize off-line manipulations with aseptically-closed bioreactor system, iCELLis® Nano tubing assemblies were designed to use on-line bio-welding technology for each step from…
Comparison Oxygen Mass Transfer Coefficient (kLa) of iCELLis® Nano and iCELLis® 500 Bioreactors
Summary: kLa estimations were performed for the iCELLis® Nano and iCELLis® 500 bioreactors with equivalent packed-bed size and compaction (4m2 and 500m2).
Gene Therapy – Unprecedented Growth and Challenges
Summary: Gene therapy is a rapidly growing area in healthcare but, now the promise has been shown, we must focus on improving the manufacturing process and reducing…
The Do’s and Don’ts of Managing a Pivotal Gene Therapy Trial
Summary: Gene therapies have been exploding in popularity and lining up new programs looking to create a new standard of care models for a wide variety of diseases.