Articles
RSSPall Purification Technology to Speed Commercial Production of Antisense Drugs
November 12, 2003
Click here to download a datasheet on Pall's Mustang® Q Chromatography Capsule.
Pall's membrane based Mustang chromatography provides a tenfold increase in antisense drug production speeds compared to standard column chromatography, the current purification technology. Mustang chromatography also improves product purity and eliminates the need for organic solvents. Ajay Lajmi, Ph.D., Senior Research Scientist with Pall Corp., will highlight these significant processing advantages in a presentation today at the PDA 2003 Annual Meeting in Atlanta, GA.
"The momentum is growing for antisense drugs, but new chromatography technology is needed to handle production volumes once these drugs are commercialized," says Dr. Lajmi. "Mustang chromatography will play a critical role in making antisense drugs available to the people who need them the most."
Currently there is one antisense drug on the market, Vitravene® from Isis Pharmaceuticals (Nasdaq: ISIS), indicated for AIDS-related retinitis. Three drugs are currently in Phase 3 clinical trials, one of which, the anti-cancer therapy Genasense™ from Genta Incorporated (Nasdaq: GNTA), is in late stage. A significant number of other drugs are in earlier phases of clinical trials.
Dr. Lajmi's presentation will compare Mustang chromatography purification with current reverse phase chromatography steps. Utilizing Mustang chromatography, in combination with an ultrafiltration sequence, eliminates the need for organic solvents. This substantially reduces capital expenditures and disposal challenges for manufacturers.
"Mustang chromatography offers manufacturers a breakthrough in process economics to significantly reduce the cost of goods for these new therapeutics," reports Dr. Lajmi.
Antisense drugs are synthesized strands of DNA known as oligonucleotides that have been chemically modified to prevent the production of disease-causing proteins in the body. When they bind to messenger RNA (mRNA) they turn off the code sequence required to generate these proteins, thereby preventing diseases from manifesting. Antisense drugs minimize patient side effects because they are highly targeted therapies.
As antisense drugs are manufactured, they create a number of impurities that are difficult to separate because they are closely related molecules. Mustang chromatography's large pore size and configuration enable it to separate more impurities and achieve purity levels of up to ninety five percent when compared to conventional chromatography columns which typically achieve significantly lower purity levels.
Dr. Lajmi's research, entitled "Purification of Antisense Oligonucleotides by Membrane Chromatography," will be presented today at 11:15am in Grand Ballroom C as part of the meeting's Manufacturing Issues-Biotech Manufacturing breakout session.
Pall Addresses Disposability and Validation at PDA In addition to Dr. Lajmi's presentation, Pall will give two presentations on validation and disposable processing at the 2003 PDA Annual Meeting:
· "Economics of Disposable Filter Systems in Pharmaceutical Production" will highlight the benefits of using disposable products to reduce costs, save time, and increase security. Monica Cardona, BioPharm Project Manager, will give this presentation on Tuesday, November 11, 9:00am, Science and Development-Cleaning Validation breakout session, Grand Ballroom D.
· "Application of GAMP Framework to Validation and 21 CFR Part 11 Compliance of Filter Integrity Test Instruments" will detail how GAMP guidelines provide an effective framework for validating automated systems and help manufacturers streamline validation processes. Xiaohan Wei, Marketing Manager, will deliver this presentation on Tuesday, November 11, 2:00pm, Compliance Issues-Computer Systems Validation breakout session, Grand Ballrooms A and B.
Pall speakers are available to discuss these presentations and new technologies, at PDA booths # 221, 222, and 320, Hilton Atlanta, 225 Courtland Street, NE, Atlanta, Georgia, November 10-12, 2003.
