Dalton Pharma Services Announces Completion of its GMP Oligonucleotide Manufacturing Facility
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Dalton Pharma Services has announced the completion of its Oligonucleotide Production Suite.
"Large-scale DNA and RNA oligonucleotide synthesis has now gained industry importance with proven therapeutic and diagnostic applications," states Peter Pekos, President and CEO.
"Building on our 17 year history in oligonucleotide manufacture and analysis, Dalton can now use its expertise in synthesis and manufacturing of antisense oligonucleotides and their analogs to produce cGMP grade oligonucleotides as required for human clinical testing."
"With the expansion of our capabilities for the controlled synthesis of multigram quantities of oligonucleotides, Dalton will be able to play a greater role in both diagnostic oligonucleotide manufacturing and antisense therapeutics."
"Combining GMP synthesis of oligonucleotides and sterile fill puts us at the forefront of providing drug development solutions that accelerate our client's discovery, pre-clinical and clinical programs."
"Dalton's capabilities in small molecule and therapeutic peptide manufacture, combined with this expansion into antisense therapeutic synthesis and oligonucleotides for diagnostic applications, allows us to extend our reach and participate in the success of more companies and products."
The Oligonucleotide Production Suite is equipped with the latest technology that allows small to large scale Oligo production and purification capabilities.
Special controls, including environmental (e.g. HEPA filtered air) and manufacturing controls have been implemented.
New equipment includes 4 AKTA OligoPilots each capable of producing oligos from 500 umole to 50g scale of oligo per run.
Purification is achieved using Waters preparative HPLC's utilizing either reverse phase or ion-exchange chromatographic techniques.