Dalton invests big in oligos

By Gregory Roumeliotis

- Last updated on GMT

Related tags Oligonucleotide

Contract manufacturer Dalton has announced the completion of its
oligonucleotide (oligos) manufacturing facility, in a $500,000
(€400,000) investment drive to dominate pilot and large-scale DNA
and RNA oligo synthesis.

The company has spent approximately $10m since 1999 at its Toronto site, where it already had a full service facility for small molecule synthesis, peptides and oligos.

But the growth in the oligo market, which is set to reach $776m by 2010 driven by demand from researchers working in basic research, drug target screening and therapeutic development, has lured Dalton further into this lucrative sector.

Dalton's new oligonucleotide production suite has small to large-scale current good manufacturing practice (cGMP) oligo production and purification capabilities.

The Canadian firm hopes its years of experience in this area of technology as well as the combination of synthesis, stability programmes and sterile filling services will give it an edge in managing the supply chain for its clients.

"The cost of the manufacturing service we provide depends greatly on the particular backbone, stage of the programme, quantity and purity,"​ Dalton's CEO Peter Pekos told In-PharmaTechnologist.com​.

"We plan to be competitive within the marketplace."

New equipment at the facility includes 4 AKTA OligoPilots, each capable of producing oligos from 500 umole to 50g scale per run.

Purification is achieved using Waters preparative high performance liquid chromatographs (HPLCs) utilising either reverse phase or ion-exchange chromatographic techniques.

However, there are several manufacturing challenges, ranging from issues around scale up, the final purification and yield of the oligos.

In particular, validation and cleaning after product changes are some of the major issues for manufacturers in multi-product facilities.

"Where possible we use product dedicated equipment to save time and money as we switch products,"​ Pekos said.

"There have also been tremendous challenges in the development of appropriate analytical tools for the final analysis of the products."

In this area, Pekos points out that the advancement of ion pairing methods to show oligo impurities has led to a much better understanding of the impurities found in the final products.

Apart from making cGMP grade oligos for human clinical testing, Dalton also produces active pharmaceutical ingredients (APIs), at a gramme or kilogramme scale, and 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.

The manufacturer can also make liposomes, both batch and extruded, allowing it to develop new delivery forms for its client's products.

The entire facility is covered by a back-up generator to protect processes from power fluctuations and special checks, including environmental - for example high efficiency particulate absorbing (HEPA) filtered air - and manufacturing controls have been implemented.

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