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Technology-Ready Processes for Gene Therapy Manufacturing 2.0

Course Orientation and Objectives for Technology-Ready Gene Therapy Manufacturing

Structured Roadmap of Topics and Learning Flow

Why manufacturing must evolve

Comparative Analysis: Manufacturing 1.0 Constraints vs. 2.0 Capabilities Across Quality, Cost, Scalability, and Speed-to-Patient

Quiz: Drivers for Evolution from Manufacturing 1.0 to 2.0

From Manufacturing 1.0 to Manufacturing 2.0

Enabling Technologies: Digital, Single-Use, and Modular Facilities for Gene Therapy 2.0

Control Strategy by Design: Linking Critical Quality Attributes to Process Parameters with Real-Time Analytics

Quiz: Mapping CQAs, CPPs, and Analytics in a 2.0 Control Strategy

Upstream: suspension culture and perfusion

Platform Selection: Suspension, Fixed-Bed, and Perfusion Trade-Offs for Diverse Gene Therapy Modalities

Facility Fit and Process Economics: Scale-Up/Scale-Out, Single-Use vs. Stainless, and Tech Transfer Readiness

Quiz: Upstream Platform Decision-Making and Impact on Yield and Quality

Quiz: Facility and Economics Considerations for Upstream Technologies

Quiz: Case Scenarios on Perfusion vs. Fed-Batch Selection

Survey: Confidence and Readiness to Implement Manufacturing 2.0 Practices

Badge Card

Gene therapy is scaling from bespoke batches to global supply—and manufacturing must keep pace. Technology-Ready Gene Therapy Manufacturing: Platforms, QbD, and Scale-Up is a practical, industry-aligned course that shows you how to design, control, and scale next‑generation processes from bench to commercial readiness. You will learn how Manufacturing 2.0 transforms cost, quality, and speed-to-patient through digital enablement, single-use platforms, modular facilities, and real-time analytics. Using a structured roadmap, we map Critical Quality Attributes (CQAs) to process parameters, develop control strategies by design, and evaluate upstream platform choices including suspension, fixed-bed, and perfusion for AAV, LV, and emerging modalities. You’ll compare scale-up versus scale-out pathways, weigh single-use against stainless options, and stress-test tech transfer readiness and facility fit. Quizzes and decision scenarios reinforce trade-offs affecting yield, purity, cost of goods, and batch release timelines. Whether you’re optimizing a clinical program or preparing for commercial launch, this course equips you with the frameworks, tools, and confidence to architect robust, scalable, and regulatory-ready manufacturing—without sacrificing agility. Build a futureproof process now, so your therapy can reach more patients, faster.

Technology-Ready Gene Therapy Manufacturing: Platforms, QbD, and Scale-Up

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            <p>Gene therapy is transitioning from artisanal, program-specific processes to scalable, platform-driven operations that can reliably deliver quality, speed, and cost-effectiveness. This course, Technology-Ready Gene Therapy Manufacturing: Platforms, QbD, and Scale-Up, equips engineers, scientists, QA/QC, validation, safety, and process development professionals to design and operate Manufacturing 2.0 systems. You will examine how digital infrastructures, single-use technologies, and modular facilities enable robust, tech-transferable processes, while Quality by Design (QbD) frameworks connect critical quality attributes (CQAs) to critical process parameters (CPPs) using real-time analytics. The structured roadmap emphasizes decision-making discipline—from upstream platform selection to facility fit and economics—so that organizations can move beyond one-off solutions toward reproducible, regulatory-aligned manufacturing platforms.</p>

<p>The learning flow begins with a clear orientation on objectives and outcomes, followed by a comparative analysis of Manufacturing 1.0 constraints versus 2.0 capabilities across quality, cost, scalability, and speed-to-patient. You will then dive into enabling technologies and control strategies by design, mapping CQAs, CPPs, and analytics to build closed-loop control and release-readiness. The upstream section provides a rigorous evaluation of suspension, fixed-bed, and perfusion choices, including trade-offs for different modalities, as well as scale-up/scale-out strategies, single-use versus stainless design, and technology transfer readiness. Each knowledge block is reinforced through targeted quizzes and a capstone survey to assess confidence and implementation readiness. By the end of the course, participants will possess a practical, technology-ready blueprint to modernize gene therapy manufacturing with platform thinking, QbD rigor, and economically viable scale-up.</p>
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