CELL AND GENE OUTSOURCING
From Platform To Patient: Streamlining Gene Therapy Development
Explore how platform processes advance gene therapies, the impact of strong partnerships on patient access, and the future shaped by these collaborations.
Identify And Quantify AAV Fill States Using Analytical Ultracentrifugation
Explore how to implement analysis using sedimentation velocity analytical ultracentrifugation to characterize AAV size distributions and multiple detection wavelengths to identify various fill states in AAV preparation.
Quantifying Cell Response With Duplex RT-qPCR
Discover a new potency bioassay using RT-qPCR to assess relative transcription activity, and learn more about the advantages and limitations of transcriptional assays versus reporter gene assays.
Critical Supply Chain And Logistics Considerations For Cell And Gene Therapy Management
Explore the unique challenges and complexities involved in key CGT logistics areas like donor and patient accessibility, critical raw materials management, and innovative temperature control equipment.
Viral Vector Manufacturing: Improve Efficiency With A Platform Approach
Learn more about the platform-based scalable suspension process for LVV production and how it is impacting CGTs advancing toward commercialization.
Tailored CMC Solutions That Meet Needs Of Novel Molecular Biologic Formats
Explore an integrated drug substance/drug product CMC strategy and technical case studies that provide insight into delivering product-specific solutions and enabling the acceleration of novel molecular formats.
Keys To A Successful cGMP Manufacturing Operation Delivering CGTs
Uncover the secrets behind successes in commercializing and producing commercial cell and gene therapies, including establishing standards of every day, manufacturing operational excellence.
Pioneering Solutions That Turn Hope Into Reality
The number of AAV-mediated therapies in clinical trials continues to rise, increasing demand for doses. A scalable platform is crucial to ensure a seamless transfer from pre-clinical to commercial.
Early Developability And Analytical Toolbox For The Production Of Multi-Chain Biotherapeutics
In recent years, the number of biotherapeutic molecules requiring more complex assemblies has greatly increased. Typically, these multi-chain molecules are no longer compatible with platform approaches and require a more agile approach to early developability and method d...
Building A Strong Safety Culture In The Biopharmaceutical Industry
Explore how fostering a strong safety culture — rooted in accountability, collaboration, and proactive risk management — can drive operational excellence and long-term success in biopharmaceuticals.
Cell & Gene Therapy Development: Characterization Of Cellular Starting Material
Watch to gain valuable insights into the characterization of cellular source material for the development and manufacture of cell and gene therapy-based products.
Selecting Containers For Sensitive And Costly Cell & Gene Therapies
Explore the challenges related to packaging of cell and gene therapy products and proven solutions to enable speed to market and compatibility, performance of packaging materials.
Cryopreservation Best Practices For Cell & Gene Therapy Source Material
Industry experts share their experiences, including why and how cellular source materials are cryopreserved and why experience across cell types and methods matters.
Mastering The Art Of Developing A Successful Bispecific Antibody
Learn innovative strategies to overcome the complexities of bispecific antibody development, from intelligent design to efficient purification techniques.
Manufacturing Life-Saving Gene Therapies
Take a look behind the scenes and hear firsthand about the commitment to patients and clients at Andelyn Biosciences.
Managing Risks In Injectable Drug Delivery
Gain insights pertinent to efficient and effective drug development. Understand and execute a risked-based critical thinking approach related to injectable drug packaging and delivery.
Quality Agreements: Defining Governance In CDMO Partnerships
Quality agreements serve a critical role within a CDMO-Sponsor partnership. Review the importance of aligning objectives, quality standards, and compliance frameworks to establish a robust foundation.
Sustainable Approaches To Oligonucleotide Manufacturing
An industry expert shares about sustainable Oligo manufacturing approaches that can save time, cost, and resources – while improving purity, quality, and scalability of these promising therapeutics.
A Robust And Scalable Suspension Platform For AAV Manufacturing
Review the demands for AAV manufacturing using a suspension process and the DOE-based strategy used to achieve a scalable process both in terms production and quality of AAV purified.
Optimizing Monoclonal Antibody Manufacturing For Commercial Success
Strategically optimize your upstream and downstream processes and decrease the timeline from optimization to commercial manufacturing.
Biopharmaceuticals Development And Manufacturing: Wide-Ranging Expertise And Vertically Integrated Service
The company’s wide-ranging expertise and vertically integrated service offering translate to the ability to rapidly execute multiple projects from its state-of-the-art cGMP facilities while ensuring full process and product compliance at all stages of research, deve...
Advancing Viral Vector Manufacturing: The Importance Of The Cell Line
Explore the pivotal role of cell lines in viral vector manufacturing, a complex, multi-step process that has traditionally been both time-consuming and labor-intensive.
Accelerating Your Gene Therapy: Not All Platforms Are Created Equal
Standardized methods, materials, and analytics are critical for overcoming hurdles in the gene therapy space. Explore how a platform approach to fast-track AAVs can enhance quality and efficiency.
How To Apply Quality By Design Principles To Cell And Gene Therapy Release Testing
Review how to develop and use QC assays that can facilitate both product and process understanding and control.
Meeting Needs And Exceeding Expectations Worldwide
Whether you are looking to optimize your existing formulations or require full-scale manufacturing solutions, Boehringer Ingelheim BioXcellence™ is dedicated to helping you realize your vision and deliver impactful therapies.
Improved And Rebalanced Plasmids To Ramp Up Your AAV Productivity
Growth in rAAV-based therapies is creating a need for dramatically increased production. Learn how AAV productivity can be optimized using platform technologies capable of affording significantly higher titers.
The CDMO Value Proposition For Your Autologous Cell Therapy
This panel session features a decade-long story of partnership in bringing two life-changing gene therapies to market successfully in 2022.
Optimization-By-Design — A Critical Factor In Viral Vector Scale Up
Learn how leveraging the expertise and capabilities of an experienced partner is a key factor in optimizing AAV processes using Design of Experiment (DoE), thereby reducing variability and risk.
Combining An MVA Technology Platform With Innovative Analytical Methods
Learn how this process development platform for MVA impacts vaccine manufacturing and supports the drug life cycle from process and analytical development through trials and commercialization.
Optimizing Viability And Standardization For Clinical Excellence
Explore how IntegriCell™ delivers high-quality, manufacture-ready cryopreserved leukopaks, vital for consistent and reliable cell therapy production.