Newsletter | December 4, 2025

12.04.25 -- Lessons In Scaling Regenerative Medicine Manufacturing With Organogenesis's Patrick Bilbo

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Webinar: Seal the Deal: Mastering Vent Integration in Medical Devices

Join W. L. Gore & Associates Application Specialist David Kunzig to explore the vital role of venting and microfiltration in life science applications—from drug delivery to diagnostics. Learn how vent orientation, welding techniques, and design choices impact system reliability. Through real-world visuals and a detailed case study, discover practical troubleshooting strategies to optimize performance and integration. Click here to learn more.

FOCUS ON MANUFACTURING CONTROLS

Lessons In Scaling Regenerative Medicine Manufacturing With Organogenesis's Patrick Bilbo

In this episode of "Better Biopharma," Tyler Menichiello is joined by Patrick Bilbo, chief operating officer at Organogenesis, a regenerative medicine company developing and manufacturing advanced wound care products.

The Continuation Of A Journey

See how one family managed to get an investigational gene replacement therapy manufactured and approved by the FDA so their daughter could be dosed just 14 months from her diagnosis.

Key Insights From A Recent Survey On BioPharma's Lab Data Management

A recent survey of over 850 biopharma professionals reveals key challenges and priorities for managing lab data, including scalability and improving research efficiency.

Seal Replacement As A Cost Avoidance Strategy

Proactive seal replacement in biopharmaceutical manufacturing prevents costly failures and downtime, ensuring product quality and process integrity.

How Software-Enabled Manual Visual Inspection Can Boost Your ROI

Learn how software-enabled manual visual inspection enhances efficiency, data integrity, and regulatory readiness without full automation's capital expense.

Why Digital Validation Is Foundational To A Pharma 4.0 Strategy

Explore how Pharma 4.0 and digital validation are revolutionizing manufacturing by driving efficiency, ensuring quality, and enabling a Zero Defect paradigm through continuous improvement.

De-Risking FDA Abbreviated New Drug Application (ANDA) Submissions

BD Physioject™ for Tirzepatide supports FDA ANDA submissions with proven usability, low error rates, and a design validated to match the reference listed autoinjector.

Navigate The Digital Transformation With A Digital Maturity Assessment

The industry is on the verge of a digital revolution. Find out how to navigate the digital revolution with a digital maturity assessment to guide digital transformation, efficiency, and sustainability.

Accelerate Process Development With Automated Aseptic Sampling

Discover how implementing automated sampling systems enabled Takeda Pharmaceuticals to achieve new efficiencies in process development.

How Automated Analytical Devices Are Driving Smarter Biomanufacturing

Precision is critical in biomanufacturing. Learn how automated analytical devices are providing real-time, high-resolution data for smarter decision-making and enhanced process control.

Unlocking Pharma Manufacturing with Contextualized Data

Context gives meaning to data, transforming raw numbers into actionable insights, with AI-driven tools that connect data across the manufacturing workflow.

Industrial DataOps: The Backbone Of AI-Ready Manufacturing Data

Manufacturers aiming for AI adoption often face data readiness challenges. Learn how Industrial DataOps helps transform raw data into usable insights, laying the groundwork for scalable operations.

Partnering With SCC To Build A Biomanufacturing Certification Program

Jubilant HollisterStier partnered with Spokane Community College (SCC) to launch a biomanufacturing program, building career pathways and community talent for Spokane’s growing life sciences sector.

Automation-Assisted Washing Of Multicellular 3D Spheroids

Automated washing of 3D spheroids improves consistency, reduces cell loss, and streamlines staining workflows. See how this approach enhances reproducibility and throughput in microplate-based assays.

MANUFACTURING CONTROLS SOLUTIONS

Enhanced Intelligent Batch Records - Aizon

Solution Brief For Life Sciences - HighByte

LabAlert Real-Time Monitoring, Notification System - PHC Corporation of North America

An Automation Platform That Drives Data Mobility - Emerson

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Live Event: How Digital Tools Are Accelerating Biopharma Development

Register today for this digital event led by Bioprocess Online’s chief editor, Tyler Menichiello, features industry experts who will share for an engaging panel discussion on how companies are deploying advanced technologies and tools to accelerate biopharmaceutical development. This event is free to attend thanks to Cytiva.

FOCUS ON FACILITIES DESIGN

The Hidden Costs Of Equipment Storage: What You're Really Paying For

Don't let idle assets drain your resources. Uncover the often-overlooked expenses of equipment storage, from rental fees to lost opportunity costs, and learn how to reclaim value.

How To Identify Optimal Materials For Biopharma Single-Use Solutions

Have you thought about how the materials chosen for the tubing, transfer sets, single-use bags, and manifolds in therapy manufacturing could enhance your processes?

Cleanroom Conceptual Design: Converting Spaces For GMP Operations

Gain insights into the nuances of cleanroom conceptual design for GMP operations and learn how an integrated approach can ensure regulatory compliance, functionality, and environmental performance.

Selecting An Aqueous Cleaning Detergent

Explore aqueous detergent selection criteria as it fits into three broad categories: function and efficacy, health and safety, and environmental.

Environmental Monitoring Handbook For Pharmaceutical Manufacturers

Acquire a thorough understanding of environmental monitoring, covering the fundamentals of particle counting and cleanroom designs, regulatory expectations regarding market release, and more.

Fundamentals Of Real-Time Viable Particle Monitoring: How Does It Work?

Real-time viable particle monitoring instruments have been available for over a decade. Learn in detail about this technology and how it is used to detect viable particles in real time.

FACILITIES DESIGN SOLUTIONS

AES Box Pharmaceutical Modular Cleanroom - AES Cleanroom Technology

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