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.