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CELL AND GENE OUTSOURCING

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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.

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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.

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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.

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De-Risk Your Path To Clinic With An AAV Suspension Platform

Build a reliable, de-risked path to the clinic while avoiding unforeseen costs and compliance-related delays with advice from Suparna Sanyal, PhD, Head of Viral Vectors Commercial Development.

1:00:05 Resilience
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.

22:19 Lonza1
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...

1:00:36 Comprehensive Cell Solutions CDMO Governance Splash
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.

11:20 Northway
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...

50:05 West
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.

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Early Preclinical Development: A Successful Transition To cGMP Manufacturing

Explore the development steps that lead to an mRNA construct optimized for your requirements and that meets future-proof cGMP manufacturing requirements, thereby de-risking the development.

1:00:20 Andelyn - AAV Bucket
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.

1:19 Expertise In Commercial Fill-Finish For More Than 30 Years
Expertise In Commercial Fill-Finish For More Than 30 Years

Examine how a new high-speed aseptic filling line can help bring your product to market with speed and efficiency while ensuring safety and high product quality.

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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.

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Future-Proof Your Aseptic Filling

Using the Cytiva SA25 Aseptic Filling Workcell, a standardized system designed with flexibility built in, ensures that companies can pivot between products quickly and adapt as manufacturing needs change.

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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.

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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.

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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.

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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.

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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.

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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.

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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.

0:44 Meeting Needs And Exceeding Expectations Worldwide
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.

1:16:51 West-PFS SYRG-018
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.

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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.

6:08 Get To Know WuXi Advanced Therapies Testing Services
Get To Know Minaris Advanced Therapies Testing Services

Learn how we can help you move your pipeline forward, whether you manufacture with us at Minaris Advanced Therapies, in-house, or with one of our fellow CDMOs.

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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.

4:16 WuXi Advanced Therapies Philadelphia Campus Overview
Minaris Advanced Therapies Philadelphia Campus Overview

Our Philadelphia Campus serves as a centralized hub for collaborative efforts, supporting numerous companies throughout the CGT pipeline, from initial research to commercial-scale manufacturing.

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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.

52:26 Mastering The Art Of Developing A Successful Bispecific Antibody
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.

30:41 Advancing viral vector mfg
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.