Eurofins Genomics US Expands Capabilities with New GMP Oligonucleotide Manufacturing Facility

Louisville, KY – [Insert Date] – Eurofins Genomics US is proud to announce the opening of its state-of-the-art Good Manufacturing Practice (GMP) oligonucleotide manufacturing facility. This new facility marks a significant milestone in our commitment to excellence and innovation in genomics, enhancing our ability to meet the growing demand for high-quality oligonucleotides for both research and therapeutic applications.

		Facility Overview The new GMP facility is designed to provide a cutting-edge environment for the production of oligonucleotides, ensuring the highest standards of quality, safety, and efficiency. One of the key features of the facility is the complete separation of Research Use Only (RUO) and GMP production streams. This separation is critical in preventing cross-contamination and ensuring compliance with stringent regulatory requirements, thereby safeguarding the integrity of our products and processes.
		Enhanced Product Quality and Safety: By fully separating RUO and GMP production, the new facility ensures that oligonucleotides intended for therapeutics, clinical, or other regulated industries are manufactured in a controlled environment that adheres to the most rigorous quality standards. This enhances the reliability and safety of our products, which is essential for clinical applications. Regulatory Compliance: The facility is designed to meet the latest regulatory requirements to ensure that our GMP oligonucleotides are manufactured in compliance with FDA and global standards, facilitating their use in commercial applications worldwide.
		Increased Production Capacity: The expansion significantly increases our manufacturing capacity and our fleet of equipment, allowing us to meet the growing global demand for RUO and GMP-grade oligonucleotides. This increased capacity ensures that our clients receive their products on time, supporting the rapid advancement of research and development in genomics. Streamlined Operations: The facility incorporates advanced automation and process controls, which enhance production efficiency and reduce the risk of human error. This leads to consistent product quality and shorter lead times, benefiting our customers across various sectors.

Questions

What is the mailing address for the new facility?

The new address is 12621 Plantside Dr. Louisville KY, 40299. It is adjacent to our current facility at 12701 Plantside Dr. Louisville KY, 40299.

When will production begin to transition to the new building?

The effective date is September 2, 2024.

How will this impact orders and deliveries?

Our current business operations will continue without interruption during the transition. Additional equipment has been purchased as part of this expansion, which will provide enough operational redundancy to ensure continuity throughout the process.  If you have any specific concerns about your orders, please contact our customer service team at GenomicsSupport@eurofins.com.

Does this require any action from my organization?

Please update your records with our new manufacturing site address. Direct any future correspondence to our new location from the effective date.

Will this impact sequencing?

No impact. The Sanger and ONT sequencing labs will remain in the current facility. Sequencing customers should continue to mail their samples to the same address, 12701 Plantside Dr. Louisville KY, 40299. No change.

Will this impact gene synthesis?

No impact. Gene synthesis orders will continue to be processed at our Seattle facility. No changes.