In order to be operational in Q1 2020, Meissner purchased a new, existing 34,000 sq.ft. Advanced Technology Building constructed by the IDA in County Mayo, Castlebar, Ireland, expanding it to 100,000 sq.ft. Meissner has also purchased the adjacent land in order to be able to more than triple the facility’s current footprint. Meissner plans to install a substantial, state of the art cleanroom within the existing facility to be used for the manufacture of Single-Use Systems (SUS) that support their biopharmaceutical and pharmaceutical client base.
The press conference in Castlebar, Ireland, was well attended by the press and local dignitaries. Taoiseach Leo Varadkar delivered an introductory pre-recorded video welcome to kick off the event, and Michael Ring T.D., Minister for Rural and Community Development, as well as Mary Buckley, IDA Ireland Executive Director, delivered welcoming speeches. Breaking the details of Meissner’s new European facility, both Christopher Meissner, CEO, and Max Blomberg, Director of Operations, spoke at the event. Laura Meissner, Director of Quality Assurance, Rob Pearce, Project Manager, Thomas Vandromme, Director of Business Development for Europe, Christian Julien, Chief Science Officer, and Karisa Koenig, Director of Marketing, were present to represent Meissner and spoke to members of the press. This video news footage shows the RTÉ’s, Ireland’s National Television and Radio Broadcaster, coverage of the event.
Jeff Johnson, Director and New Technology Lead, Global Engineering Solutions, Merck & Co., Inc., delivers a live presentation at INTERPHEX New York on a “Large Scale Single-Use Bulk Drug Substance Freeze and Thaw Platform.” This presentation is an overview of a novel single-use end-to-end solution for freeze, thaw, handling and transport of Bulk Drug Substance. Jeff’s talk touches on design consideration, scalability, stability, and proof of concept.
Merck and Meissner Launch Next-Generation Platform for Freezing Bulk Drug Substance
TL;DR – Merck and Meissner’s New Freezing Platform
Merck & Co., Inc., in partnership with Meissner, has launched a scalable, single-use platform for freezing bulk drug substances (BDS). The system solves key challenges like cryo-concentration, container integrity, and cold chain inefficiency. It supports volumes from 30 mL to 100L, reduces capital and operating costs, enables faster freeze/thaw cycles, and ensures GMP compliance. Now commercially available through Meissner, it sets a new standard for efficient, high-integrity BDS storage and shipping.
The Problem: Limitations in Traditional Freezing
Historically, freezing BDS involved either uncontrolled methods, resulting in variability and integrity risks, or highly engineered controlled freezing systems that were capital-intensive, laborious, and often inefficient. A major issue with traditional freezing was cryo-concentration, where uneven freezing left proteins and salts highly concentrated in certain areas, risking aggregation and loss of product quality.
Merck identified a critical industry gap: the need for a low-cost, reliable freezing solution that supports modern GMP manufacturing and emerging formulations.
The Solution: A New Single-Use, Controlled-Freezing Platform
Six years in development, Merck and Meissner’s new platform features single-use containers in 100L (75L working volume) and 20L (16L working volume) sizes. The system is designed for vaccines and biologics, supports freezing, storage, shipping, thawing, and final formulation, and includes:
Custom Freezers: Accommodates up to 300L per batch with 12-hour freeze time.
Insulated Shipping Units: Maintain temperature for up to 90 hours and are airline-compatible.
Integrated Material Handling: Hoists, dollies, and Euro-pallet compatibility for operational ease.
Sampling System: An innovative “tailgate syringe” enables in-container sampling without separate bags.
Key Innovations and Advantages
Scalable, Uniform Design: The platform maintains a consistent freezing profile across container sizes (from 30 mL to 100L) using perpendicular airflow and controlled geometry. Containers freeze uniformly from outside-in, minimizing cryo-concentration.
Integrity-First Engineering: Early designs experienced cracking due to ice bridging. This was resolved through CFD modeling and two fixes:
Thicker container walls.
An insulated protective shroud reducing top-side heat loss.
Validated Performance:
50+ consecutive successful 75L runs with zero integrity issues.
No failures with the 20L system.
Tested with partial fills down to 20% without integrity risk.
Thawing Optimization: A gentle mechanical rocker reduced thaw time from 12 to 8 hours while preventing aggregation.
Reduced Cold Chain Footprint:
300L fits on one Euro pallet vs. 100L in traditional systems.
One-third the storage volume required.
Operational Efficiency:
One-tenth the capital cost.
Simplified material handling.
Rapid deployment—one operator loaded four containers in five minutes.
Regulatory Compliance:
Gamma irradiated.
Fully validated CCI and ASTM shipping testing (including frozen drop and vibration).
Manufactured in a clean room using medical-grade HDPE (fully recyclable and low particulate).
Strategic Impact: Redefining the Future of Drug Substance Freezing
This next-generation freeze and thaw platform from Merck and Meissner solves critical industry pain points around cost, scale, and product integrity. With a decade-long net present cost savings projected at over $10 million per product, this system represents a new standard for bulk drug substance freezing—efficient, reproducible, and ready for global deployment.
There are many requirements (quality, regulatory, technical) that have to be met when designing new single-use systems. Following industry standards, such as ASTM E3051, BioPhorum and BPSA have created templates to walk end-users and suppliers through the SU design process. Templates for download as part of the Toolkit cover Single-Use User Requirements (SUUR), Technical Diligence and Supply Chain.
User Requirements Template: Facilitates clear communication of process/application needs and supplier capabilities.
Supply Chain Template: Enhances transparency and risk management of the SUS supply chain.
Technical Diligence Template: Provides detailed, pre-populated forms for assessing supplier responses.
Benefits
The SUUR Toolkit offers benefits in terms of quality, cost, and delivery:
Reduction in Full-Time Equivalent (FTE) hours.
Decrease in churn and waiting times.
Reduction in rework and time to production.
Error reduction and risk mitigation.
Standardized workflow and faster decision-making.
Integration of industry standards.
Industry Feedback
Feedback from industry professionals emphasizes:
Reduced compliance risks and project timelines.
Accelerated delivery and cost savings.
Standardized and structured communication between users and suppliers.
The SUUR Toolkit offers a transformative approach to the design and implementation of single-use systems, enabling improved communication, risk mitigation, and efficiency. By standardizing workflows and aligning user requirements with supplier capabilities, it reduces compliance risks, saves time, and minimizes resource use. The collaboration between industry experts ensures the toolkit’s credibility and adaptability, making it a vital resource for streamlining processes and achieving better outcomes in single-use system projects.
Our application engineers have been involved in the design and implementation of single-use filling systems for years. During INTERPHEX New York, Max takes a look at some of the inherent challenges in terms of system complexity, dosing accuracy and sterility assurance.
The CryoVault® Freeze & Thaw Platform for Biopharmaceuticals
The CryoVault® Platform provides an end-to-end solution for your entire freeze-thaw process, from fill to dispense. The modular platform is composed of four components: single-use assemblies, freeze-thaw equipment, distribution options, and material handling infrastructure.
FOR IMMEDIATE RELEASE Meissner Acquires PDC Aseptic Filling Systems
Meissner Filtration Products announced that it has acquired PDC Aseptic Filling Systems, a supplier of advanced aseptic filling systems and sealers to the pharmaceutical industry.
“PDC’s technology is a natural extension of our current portfolio and fits with our trajectory as pertains to providing automated platforms that enable robust pharmaceutical processing operations” stated Chris Meissner, CEO of Meissner. “We are committed to providing our clients with process solutions that reduce risk, while at the same time enhance productivity, and this makes PDC a great fit for our organization.”
PDC Aseptic Filling Systems products will complement Meissner’s current process solutions portfolio which include filtration, single-use systems fluid handling and unit processing offerings. The filling systems enable automated aseptic filing of pharmaceutical process liquids, which are essential to drug manufacturing processes, while the innovative sealing equipment reduces cycle times associated with aseptic disconnections.
About Meissner Filtration Products – Meissner develops, manufactures, supplies and services advanced microfiltration and single-use systems worldwide. Meissner’s product portfolios are built upon a solid foundation of quality, operational excellence and technical expertise that allows them to deliver high performance products and technical support services for their clients’ critical applications.
