How can one optimize a lyophilization process for oligonucleotides and APIs while adhering to GMP standards? Why choose lyophilization? Why in a cleanroom and under laminar flow?
This is what the Eurogentec laboratory explains, sharing their experience with us. Eurogentec, part of KANEKA Corporation, is a Belgian biotechnology company that provides life science products and personalized services to academic, medical, and industrial scientists worldwide. Eurogentec is also renowned for the development and production of biopharmaceutical critical raw materials and therapeutic molecules.
Thank you to Olivier Bosch and Véronique Makaire for hosting us in their laboratory and sharing their feedback 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?
“Because these products are much more stable in a lyophilized form than in solution, and their resolubilization is easier compared to drying methods such as precipitation or centrifugation.”
Why in a cleanroom and under laminar flow?
“Most of our production is intended for preclinical animal testing and Phase I/II clinical trials in humans. That’s why we’ve 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 opted 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 needed a device with greater capacity. The choice of the Martin Christ Pilot E2-10D Pilot Freeze dryer proved to be ideal for our needs because it offers sufficient ice capacity for productions of 100–200 g, which is essential for our production 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 is crucial for GMP compliance – Why choose Martin Christ and Analis as partners?
“In the Pilot Freeze dryer range, there aren’t many supplier options, and historically, we’ve always been satisfied with Martin Christ equipment. This experience was no exception. Christ’s reputation for quality and equipment performance made it easy to approve this device for our GMP applications from a quality assurance perspective. We particularly appreciated the technical and application support from Christ and Analis, including precise technical advice, clear training, and exemplary responsiveness to our questions. Analis is recognized at Eurogentec as a high-quality supplier and partner, offering excellent and rapid application and technical support.”
Once again, thank you to Eurogentec for sharing your voice of customer.
As part of our commitment to continuous improvement for both us and our suppliers, feedback from our clients is not only extremely valuable to us but also to other users. Your insights and experiences inspire new ideas, enhance our solutions, and guide others in their journey.
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