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Regulating the Shift: Quality and Compliance in Decentralized Drug Production

10 min

Explore how decentralized drug production is evolving with quality systems, FDA/MHRA guidance, and digital innovations.

Featured

All Featured insight

Video

Smarthood™ BSCA Walkthrough

1 min

In this video, Judd Baker, VP of Healthcare Innovation at Germfree, gives you a complete…

Articles

Bridging the gap: How compounding pharmacies combat drug shortages

3 min

In this article, we will explore the common causes of drug shortages and their impact…

Articles

CGT Affordability, Access at the Forefront of Germfree, Caring Cross Collaboration

2 min

Germfree announced a partnership with Caring Cross focused on providing patients with affordable access to…

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IV Workflow

All IV Workflow Software

Video

Ballad Health: The Impact of Smarthood™

Discover how Ballad Health is transforming pharmacy operations across its healthcare network with Germfree’s innovative Smarthood™ technology. Hear from their…

Video

Smarthood™ BSCA Walkthrough

In this video, Judd Baker, VP of Healthcare Innovation at Germfree, gives you a complete walkthrough of the Smarthood™ BSCA…

Video

Interview with Chris Jerry – The Emily Jerry Foundation

Chris Jerry, Founder of the Emily Jerry Foundation, shares his deep, personal story of his daughter Emily Jerry, the crucial…

Video

Smarthood™ Demo

Watch this demo of the World’s First Software Agnostic Smarthood™

Video

Smarthood™ Advisory Board

The World’s First Software Agnostic Smarthood™ is set to empower pharmacies by enhancing compounding operations, elevating accuracy, ensuring patient safety,…

Cell and Gene

All cellandgenetherapy

Video

Accelerating Access to Life-Saving Cell Therapies

In this IBTV Spotlight from Advanced Therapies Week 2025, Georgi Makin hosts a crucial conversation with Sean Bartholomew, Edwin Stone,…

Video

Considering Clinical Readiness

In this expert discussion, Josh Ludwig (ScaleReady), Carol Houts (Germfree), Heather Purvis (Title21), and Priya Baraniak (OrganaBio) explore the urgent…

Video

Decentralized vs. Centralized Manufacturing

In this roundtable discussion during Advanced Therapies Week 2025, industry leaders explore how decentralized and centralized manufacturing can work together…

Articles

Unlocking the Future of Cell & Gene Therapies: Insights from ATW2025

Explore key insights from the thought-leaders at Advanced Therapies Week 2025 on cell & gene therapy, patient access, and decentralized…

Articles

Harmonizing Regulations: Multimodal Cleanroom Design for ATMPs and Biological Safety Levels

Read this article to discover how to navigate conflicts in cleanroom standards (BSL vs. cGMP) for manufacturing advanced therapies.

Decentralized and centralized manufacturing

Video

Empowering Innovation: Women Leading the Way in Advanced Therapies

Join us for an uplifting and thought-provoking fireside chat that celebrates the remarkable contributions of women in advanced therapies. This…

Video

Leading the Way in Advanced Therapies: A Fireside Chat on Act of Hope

Join Carol Houts, Chief Commercial Officer of Germfree, and Alexander Seyf (CEO of Autolomous) for an engaging fireside chat about…

Case studies

E Tech Group and Germfree Collaborate to Design Cutting Edge Modular Cleanrooms

This collaboration is transforming modular cleanroom design with advanced building automation, data aggregation, & regulatory compliance.

Video

BioIVT x Germfree: Accelerating Cell & Gene Therapies

Learn how Germfree's partnership with BioIVT is helping them deliver smarter science and accelerate medical breakthroughs.

Articles

CGT Affordability, Access at the Forefront of Germfree, Caring Cross Collaboration

Germfree announced a partnership with Caring Cross focused on providing patients with affordable access to CGTs starting with CAR T-cell…

Point-Of-Care-Manufacturing-User-in-Gown

Articles

Leveraging Current Technology and Regulatory Frameworks to Deliver Patient Access Today

Video

Delivering on the Promise of Cell and Gene Therapy

The products Germfree manufactures are filling a critical infrastructure gap that allows patients to gain access to therapies and cures…

Articles

Considerations for the Design of Cell and Gene Therapy Cleanrooms

The rapidly evolving field of cell and gene therapies presents unique challenges and requirements, necessitating specialized cleanroom design. If you're…

Articles EQT-Pass-Through

Guidance for Cleanroom Pass Throughs in cGMP Cell and Gene Therapy Facilities

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Decentralized Manufacturing

All decentralized manufacturing

Articles

Regulating the Shift: Quality and Compliance in Decentralized Drug Production

Explore how decentralized drug production is evolving with quality systems, FDA/MHRA guidance, and digital innovations.

Video

Accelerating Access to Life-Saving Cell Therapies

In this IBTV Spotlight from Advanced Therapies Week 2025, Georgi Makin hosts a crucial conversation with Sean Bartholomew, Edwin Stone,…

Video

Considering Clinical Readiness

In this expert discussion, Josh Ludwig (ScaleReady), Carol Houts (Germfree), Heather Purvis (Title21), and Priya Baraniak (OrganaBio) explore the urgent…

Video

Decentralized vs. Centralized Manufacturing

In this roundtable discussion during Advanced Therapies Week 2025, industry leaders explore how decentralized and centralized manufacturing can work together…

Articles

Unlocking the Future of Cell & Gene Therapies: Insights from ATW2025

Explore key insights from the thought-leaders at Advanced Therapies Week 2025 on cell & gene therapy, patient access, and decentralized…

Video

Empowering Innovation: Women Leading the Way in Advanced Therapies

Join us for an uplifting and thought-provoking fireside chat that celebrates the remarkable contributions of women in advanced therapies. This…

Video

Leading the Way in Advanced Therapies: A Fireside Chat on Act of Hope

Join Carol Houts, Chief Commercial Officer of Germfree, and Alexander Seyf (CEO of Autolomous) for an engaging fireside chat about…

Fighting Medication Shortages: Expanding Global Access to On Demand Medicine Production

Video

Expanding Global Access to On Demand Medicine Production – Germfree and On Demand Pharmaceuticals

Through an innovative partnership, Germfree's Mobile Cleanroom technology and On Demand Pharmaceuticals' Pharmacy On Demand platform are bringing localized, on-site…

Video

Inside Germfree’s Groundbreaking ABSL-3 Mobile Lab

Join Mechanical Engineer Haley Gilmour for a quick tour of Germfree’s first ABSL-3 Mobile Laboratory! In this video, Haley walks…

Video

Advancing Patient Access Through Decentralized Manufacturing

In this insightful discussion, Carol Houts, Chief Strategy Officer for Germfree, addresses how decentralized manufacturing is fixing the patient access…

Case studies

On Demand Pharmaceuticals: cGMP/ USP <800> Mobile Cleanroom

Discover how Germfree and ODP developed a Mobile Compounding Pharmacy the enables local production of medicines to address drug shortages.

Articles

CGT Affordability, Access at the Forefront of Germfree, Caring Cross Collaboration

Germfree announced a partnership with Caring Cross focused on providing patients with affordable access to CGTs starting with CAR T-cell…

Video

Constructing Capabilities: Holistic Infrastructure Development in Decentralized Manufacturing

Dive into this discussion around decentralized manufacturing and the importance of designing identical and cloned processes, focusing on a copy-paste…

Articles

Leveraging Current Technology and Regulatory Frameworks to Deliver Patient Access Today

USP <797> / <800>

All USP 797/800

Articles

Navigating One Year of Compliance with USP 797 and 800

One year into the USP 797/800 updates, explore their impact on healthcare safety, success stories, and how Germfree supports compliance.

Case studies

On Demand Pharmaceuticals: cGMP/ USP <800> Mobile Cleanroom

Discover how Germfree and ODP developed a Mobile Compounding Pharmacy the enables local production of medicines to address drug shortages.

Articles

Bridging the gap: How compounding pharmacies combat drug shortages

In this article, we will explore the common causes of drug shortages and their impact on pharmacists, healthcare professionals, and…

Video

Z-Series Smoke Test

Watch our Z-Series Horizontal Laminar Flow Hood go through a unidirectional smoke test.

Video

Operating the Z-Series Horizontal Laminar Flow Hood

Learn how to operate Germfree's uniquely engineered Z-Series Horizontal Laminar Flow Hood.

Video

Maintain Compounding Capacity: Discover the Benefits of Mobile Compounding

Zach Blum, Germfree's Associate Product Manager for Mobile Trailers, walks through our standard Mobile USP 797/800 Compounding Pharmacy.

Biosafety Considerations

All biosafety considerations

Video

Inside Germfree’s Groundbreaking ABSL-3 Mobile Lab

Join Mechanical Engineer Haley Gilmour for a quick tour of Germfree’s first ABSL-3 Mobile Laboratory! In this video, Haley walks…

Containerized BSL-2 Laboratory up and running.

Case studies

Containerized BSL-2 Laboratory Hawaii

Discover how Germfree's innovative containerized BSL-2 laboratory is enhancing Hawaii's agricultural capabilities.

Articles

Understanding Biosafety Levels: Ensuring Safety in Laboratory Settings

This article provides a concise overview of biosafety levels (BSLs), essential classifications for laboratories handling hazardous pathogens. From BSL-1 to…

Video

Class 3 Glovebox Integrated in a Modular Facility

The equipment integration within BSL-3 cGMP Modular Facilities is a critical aspect of ensuring the safety and containment of the…

Jeff Serle BSL-3 cGMP Modular Facility Tour

Video

Germfree’s BSL-3 cGMP Modular Facility Tour

Germfree's BSL-3 cGMP Modular Facility was designed and built with the diverse set of requirements in mind.

Containment Isolator in cGMP/BSL3 facility

Articles

Expert Guidance on Containment Isolator Design and Facility Integration

Learn how Containment isolators are essential components in high containment environments, such as biosafety level 3 (BSL-3) laboratories, and for…

UP Series

Discover how Germfree’s UP Series Pass Through Boxes can enhance your facility’s contamination control—watch our video series on efficient operation, cleaning tips, and testing.

All up-series

Video

Operating the UP Series Cleanroom Pass Through Box

Learn how to operate Germfree's uniquely engineered UP Series cleanroom pass through box in this video.

Video

UP Series Smoke Test

Watch our Active HEPA recirculation quickly remove smoke and create an ISO 7 environment in

Video

Cleaning the UP Series Cleanroom Pass Through Box

Learn how to clean Germfree's uniquely engineered UP Series cleanroom pass through box.

Take a tour through our facilities

Step inside and explore our cutting-edge facilities with a fully immersive virtual tour. Click through each room, navigate freely, and experience every detail as if you were there in person!

All 360 Facility Tour