Dalton Pharma Services Announces Completion of its GMP Oligonucleotide Manufacturing Facility
TORONTO, April 12 /PRNewswire/ -- Dalton Pharma Services, a privately owned Canadian pharmaceutical services provider to leading pharmaceutical companies, today announced the completion of its state-of-art Oligonucleotide Production Suite.
"Large-scale DNA and RNA oligonucleotide synthesis has now gained industry importance with proven therapeutic and diagnostic applications. 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," states Peter Pekos, President and CEO.
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.
About Dalton Pharma Services
Dalton Chemical Laboratories Inc. o/a Dalton Pharma Services is a contract pharmaceutical manufacturer that supplies chemistry and analytical services to the biotechnology and pharmaceutical industries in the areas of medicinal chemistry, fine chemical manufacture, custom peptides and antisense oligo production. Dalton provides cGMP manufacturing and sterile filling capabilities to its customers at any stage of the regulatory process (Phase I, II, III or commercial). In its state of the art cGMP facilities, Dalton can produce active pharmaceutical ingredients (API), at the gram or kilogram scale. Dalton can carry out sterile fills to produce batches of finished drug product in vials or syringes, either aseptically filled or terminally sterilized, under fully validated conditions.
Source: Dalton Pharma Services
CONTACT: Peter Pekos, President & CEO, Dalton Pharma Services, Tel:
(416) 661-2102, Fax: (416) 661-2108, ppekos@dalton.com
