Accelerate Scalability & Smooth Regulatory Approval With Tightened QC of Oligos for Cost Efficient GMP Manufacturing
With the unprecedented growth of the oligonucleotides market, reaching $2b by 2027 and with over 250 in the clinical phase of drug development, we now seek to unlock the potential of oligonucleotides beyond rare disease to treat large patient populations for undruggable targets.
In the last 12 months alone, there have been a number of advances in the field with Switch Therapeutics advancing their first RNAi technology, Avidity turbocharging their antibody-oligo conjugate and Ansa Biotech successfully synthesising the world’s longest oligonucleotide!
Despite this, drug developers still face challenges in manufacturability and lack of concrete regulatory protocols. The 2nd annual Oligonucleotides CMC & Analytical Development Summit was a dedicated forum to CMC and Analytical experts will unite 70+ industry leaders to leverage knowledge and share thought-leadership on:
Improve analytical characterization to understand impurity profiles and ensure that quality standards are met
Effectively prepare for CMC data submission for IND filing and navigate current regulatory environment
Scale up your oligonucleotide with long-term manufacturability in mind – from cost considerations to commercial scale
Capitalize on next generation of oligonucleotides for non-rare disease indications and future growth opportunities
Our attendees joined us at the one and only industry-led dedicated forum to CMC and analytical development in oligonucleotides. With the market sky-rocketing and pipelines developing, this was the chance to be at the cutting edge!