Newsletter | July 16, 2026

07.16.26 -- The Facility Master Planning Playbook With Herman Bozenhardt

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Webinar: Enhancing AAV Manufacturing Yield Through a Promoter-Optimized Mini-Helper Plasmid

Discover how Samsung Biologics is advancing AAV manufacturing with a promoter-optimized mini-helper plasmid platform designed to improve productivity and reduce costs. This webinar explores the plasmid design strategy, transfection optimization, and scalability from flask to bioreactor production. Learn how the approach delivers higher AAV titers, lowers DNA input requirements, maintains particle quality, and supports future gene therapy manufacturing innovations. Click here to learn more.

FOCUS ON FACILITIES DESIGN

The Facility Master Planning Playbook With Herman Bozenhardt

In this episode of “Better Biopharma,” host Tyler Menichiello is joined by friend-of-the-show Herman Bozenhardt, a consultant and industry veteran who has spent decades advancing the fields of biopharmaceutical manufacturing, engineering, and regulatory compliance.

The Future Of Modular Life Science Infrastructures

As biopharma shifts toward personalized and smaller‑batch therapies, modular infrastructure is redefining how facilities are built and scaled to enable faster deployment and greater flexibility.

How Integration Is Redefining Speed, Scale, And Sustainability

Integrated manufacturing ecosystems help biologics programs adapt to changing demand across the product lifecycle. Discover flexible scaling strategies that improve speed, efficiency, and sustainability.

The Framework For Containment In A Cleanroom

ISO classification decisions shape cleanroom design. Learn how early alignment between process needs, biosafety, and classification can reduce redesign risk while supporting scalable environments.

Performance Characteristics Of The Mobius® ADC Reactor For Conjugation

Explore results from a series of studies evaluating the mixing performance of an innovative ADC reactor during the conjugation step utilizing a model fluid.

FACILITIES DESIGN SOLUTIONS

3D Modeling Of Facilities With Digital Twin Technology - CAI

Engineered For Purity: Water For Injection (WFI) Quality Water - ILC Dover, An Ingersoll Rand Business

Single-Use Product Selection Guide Solutions For Monoclonal Antibody (mAb) Processes - Thermo Fisher Scientific Bioproduction

FOCUS ON MANUFACTURING CONTROLS

How GMP And Clinical Rules Shape Upstream Discovery And Development

Early collaboration between R&D and manufacturing ensures regulatory readiness. See how automation and robust panel design enable clinical translation for advanced cell therapy development.

The Future Of Compliance, Efficiency, And Data Integrity

Examine how eValidation revolutionizes the pharmaceutical industry by enhancing compliance, efficiency, and data integrity, as well as its indispensable role in modernizing traditional validation methods.

Traditional Vs. Digital: A Side-By-Side Look At CPV

Manual CPV processes often delay insights and increase compliance risk. Real-time analytics and automated reporting enable earlier interventions and stronger data integrity.

Implementing AI Systems In Regulated Pharma Environments

Find out how AI can be safely and effectively deployed in regulated pharma environments, with practical guidance on risk, governance, and lifecycle management rooted in GAMP 5 principles.

Ingenuity And Instrumentation: Creating A Novel 4D Microscopy Method

A team of researchers sought to uncover the viral infection process before the virus has bonded to tissue, understanding how viruses navigate the epithelial space, through mucus and the periciliary layer.

Middlesex County, NJ: A Diverse Talent Pool And Rich Resource Base

Middlesex County, NJ, offers life sciences organizations a deep talent pool, an extensive R&D presence, and dedicated backing by local government investment.

How Integrated Data Systems Enhance Clinical Development

Delve into how cloud-based systems and unified data platforms are transforming biomanufacturing by enhancing efficiency, ensuring quality, and accelerating the delivery of complex therapies to market.

MANUFACTURING CONTROLS SOLUTIONS

Control Software For Industrial Applications - Cytiva

Evolve From Paper To Digital Operations Quickly And Simply - Aizon

Recipe Importer Tool - Emerson

Zero Time To Master: Uniform Seals For Simplified Setup - Nordson MEDICAL

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