CELL AND GENE OUTSOURCING
AAV Analytics: Key Considerations When Developing A Clinical Program
Finding partners with the necessary skills to optimize AAV processes is crucial for minimizing risk. Explore key considerations for advancing your therapy from concept to commercialization.
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.
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.
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.
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.
Get To Know WuXi Advanced Therapies Testing Services
Learn how we can help you move your pipeline forward, whether you manufacture with us at WuXi Advanced Therapies, in-house, or with one of our fellow CDMOs.
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.
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.
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.
Candidate Screening And Feasibility Studies For Viral Gene Therapies
Create a simple, modular path to cGMP manufacturing that minimizes risk. Explore a strategic approach for early-stage development and how it can propel therapies to the clinic and the market.
An End-To-End Industrialization Roadmap For Autologous Cell Therapy
Explore specificities and challenges, leveraging automation for scalability with the Cocoon® Platform, and building a vein-to-vein network to achieve ‘just-in-time’ delivery of therapies.
Delivering Therapies To Patients At Scale And At Speed
Resilience is addressing a defining challenge: Biopharmaceutical manufacturing has not kept pace with scientific advancement, preventing new discoveries from reaching patients at speed or scale.
Scale-Up Allogeneic Cell Therapies To Large Patient Populations
Achieve your therapeutic and commercial goals by utilizing a tried-and-tested standardized approach combined with the latest technology and reliable analytics.
Secure And Industrialize Your CGT Process Towards cGMP Manufacturing
Learn the principles of commercialization readiness and guidance to address them in process development as well as the best time to implement automation and minimize commercialization risks.
Scalable Suspension LVV Production Platforms
Review a scalable suspension-based Lenti production platform using a proprietary HEK293T clonal cell line and improvement steps to generate commercially viable therapies from concept to patient.
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.
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.
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...
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.
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...
Mastering The Journey From Initial Method Transfer To Successful Lot Release For Cell & Gene Therapies
View the webinar and learn how efficient project management and optimized communication are cornerstones of a successful transfer process.
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.
Preparing For FDA Pre-Approval Inspection: Quality And Regulatory Topics
Consider these strategies for meeting quality and regulatory requirements in cell and gene therapies that can also help to identify issues early, reduce risks, and prevent delays and rework.
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 Viability And Standardization For Clinical Excellence
Explore how IntegriCell™ delivers high-quality, manufacture-ready cryopreserved leukopaks, vital for consistent and reliable cell therapy production.
Manufacturing Life-Saving Gene Therapies
Take a look behind the scenes and hear firsthand about the commitment to patients and clients at Andelyn Biosciences.
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.
Leveraging Platform Processes For Developing And Accelerating Novel Gene And Cancer Therapeutics
Explore how platform processes advance gene therapies, the impact of strong partnerships on patient access, and the future shaped by these collaborations.
CRISPR Genome Editing Solutions From Discovery To Clinic
Examine how a partnership leveraging expertise in production for high-quality CRISPR gRNAs as well as cGMP manufacturing is supporting the clinical translation of CRISPR genome editing technologies.
Revolutionizing How Medicines Are Made, Funded, And Scaled
Hear from site leaders and virtually tour the process and analytical development laboratory and GMP manufacturing facility which includes four additional 2,000L single-use bioreactors.