Optimizing Lyophilization for Oligonucleotides and APIs under GMP
How can a lyophilization process for oligonucleotides and APIs be optimized while remaining compliant with GMP standards?
Why choose lyophilization for these products, and why should it be performed in a cleanroom environment under laminar flow?
Eurogentec’s Expertise in Lyophilization
This is what the Eurogentec laboratory shared with us, based on their extensive experience. Eurogentec, part of KANEKA Corporation, is a Belgian biotechnology company providing life science products and personalized services to academic, medical, and industrial scientists worldwide. The company is also recognized for its expertise in developing and producing critical biopharmaceutical raw materials and therapeutic molecules.
We would like to thank Olivier Bosch and Véronique Makaire for welcoming us into their laboratory and sharing their insights and experience.
“In our laboratory, our applications involve the lyophilization of oligonucleotides (DNA, RNA, etc.), primarily APIs such as antisense oligonucleotides, siRNA, miRNA, and aptamers.”
— Olivier Bosch
Why Choose Lyophilization?
“These products are significantly more stable in a lyophilized form than in solution, and resolubilization is easier compared with drying methods such as precipitation or centrifugation.”
Why in a Cleanroom and Under Laminar Flow?
“Most of our production is intended for preclinical animal studies and Phase I/II clinical trials in humans. This is why we installed our Pilot Freeze Dryer in a classified cleanroom and perform aliquoting under laminar flow after 0.22 µm filtration, to minimize the risk of bacterial contamination and/or endotoxins.”
Why Did You Choose This Type of Equipment?
“We recently decided to work with a Martin Christ Pilot E2-10D Pilot Freeze Dryer with water cooling for our lyophilization needs, and we are extremely satisfied.
We already had an Epsilon 6-D Pilot Freeze Dryer but required a system with greater capacity. The Martin Christ Pilot E2-10D proved to be ideal because it offers sufficient ice capacity for productions of 100–200 g, which is essential for our manufacturing volumes.
We currently work with 50 mL, 5 mL, and 2 mL vials and plan to use membrane protected trays from Teclen in the future. In summary, this E2-10D Pilot Freeze dryer with water cooling perfectly meets our requirements.”
Ensuring Equipment Quality and Performance for GMP Compliance — Why Choose Martin Christ and Analis?
“Within the Pilot Freeze Dryer category, there are few suppliers, and historically we have always been satisfied with Martin Christ equipment. This experience was no exception. Christ’s reputation for quality and performance made it straightforward to approve this system for our GMP applications from a quality assurance standpoint.
We particularly appreciated the technical and application support from Christ and Analis, including precise technical guidance, clear training, and exceptional responsiveness to our questions.
At Eurogentec, Analis is recognized as a high-quality supplier and partner, providing excellent and fast application and technical support.”
Hear from our customer, JRC Geel, a Martin Christ partner since 1985, as they share their experience with the E2-65D Pilot Freeze Dryer featuring Air-CO2 Cooling
Insights From the JRC Geel Laboratory
This is what the JRC laboratory shared with us. Since 1962, the JRC (European Commission – Joint Research Centre) facility in Geel has brought together multidisciplinary expertise to develop new measurement methods and tools such as reference materials. Geel is one of the six scientific sites of the JRC, promoting standardisation and harmonisation across the European Union to foster innovation and protect consumers and citizens.
We thank Håkan Emteborg and Jean Charoud-Got for welcoming us into their laboratory and for sharing their feedback and experience.
“At JRC Geel, we freeze-dry a wide range of materials used as references in laboratories across Europe. These materials vary greatly, encompassing food, feed, and clinical batches. The final products are freeze-dried in vials ranging from 4 to 100 mL, with batch sizes of up to 5,000 vials. Additionally, we freeze-dry bulk materials (up to 600 kg of raw material) in trays as a preparatory step.”
Why Choose Lyophilization?
“The primary reason for freeze-drying is to ensure the stability of reference materials. While the speed of the freeze-drying process is not critical, the quality and homogeneity of the reference materials are paramount. JRC Geel is BELAC certified and complies with ISO 17034 standards, and our testing laboratories adhere to ISO 17025.”
Reasons for Upgrading to an Air and CO₂-Cooled System from Martin Christ
- Environmental Responsibility
As a European organization, it is essential for us to lead by example in reducing our Global Warming Potential (GWP). The lower noise level of the new system is an additional advantage.
- Suitable for Our Application
The powerful CO₂ cooling significantly improves the efficiency and speed of shelf cooling. The temperature of the liquid-controlled ice condenser is now less affected by water vapors condensing from the samples. The extra footprint required for this upgrade remains reasonable.
- Long-Lasting Relationship
Since 1985, when Mr. Kramer (JRC Geel) began the first freeze-drying experiments, several pilot and production freeze dryers have been purchased. Two pilot units (6 kg and 10 kg) are currently used for testing, and two larger production freeze dryers (65 kg and 100 kg ice condenser capacity) are used to freeze-dry final products (reference materials).
- Reputation of Martin Christ Freeze Dryers
The quality of Martin Christ freeze dryers has consistently met our high standards.
“Overall, the JRC Geel E2-65D freeze dryer with Air–CO₂ cooling has proven to be an excellent upgrade, fully aligned with our environmental goals and operational requirements.
We are proud to be a ‘happy customer’ of Martin Christ. Over the years—working with Martin Christ since 1985—we have acquired several of their systems, all of which have consistently delivered exceptional performance. Martin Christ not only meets but exceeds our expectations, providing reliable and innovative solutions that fit perfectly with our operational needs. Furthermore, as we prioritize sourcing European-made equipment whenever possible, Martin Christ has naturally remained our preferred choice.”
“We first became acquainted with Analis as a supplier of Martin Christ equipment, and from there we built an exceptional partnership with freeze-drying expert Alain Bucovaz. Alain is a trusted professional who supports us throughout the entire process—from acquisition to installation and follow-up. His expertise and application support have been invaluable to our operations.
Analis has been a steadfast partner, and Jelle Van Overloop, Field Service Engineer, is unquestionably an added value as our maintenance and repair technician.”
Once again, thank you to JRC and Eurogentec for sharing your voice of customer.
As part of our commitment to continuous improvement—for both our teams and our suppliers—client feedback is invaluable. Your insights not only help us refine our solutions but also support other users in their own workflows. Your experiences spark new ideas, drive innovation, and guide the community forward.
If you would like to share your feedback and experience, we would be delighted to hear from you. Your testimonial could make a meaningful difference for others.
Don’t hesitate to get in touch with us!