Piramal launches integrated approach to Taking ADCs to IND
ADCelerate delivers Phase I appropriate antibody-drug conjugate (ADC) drug substance and drug product for Investigational New Drug (IND) submissionADCelerate delivers Phase I appropriate antibody-drug conjugate (ADC) drug substance and drug product for Investigational New Drug (IND) submission
Piramal Pharma Solutions, a market-leading, patient-centric Contract Development and Manufacturing Organisation (CDMO), announced the launch of ADCelerate, a new, branded solution for antibody-drug conjugate drug development that accelerates timelines for developing the initial clinical supply of both drug substance and drug product.
With ADCelerate, Piramal Pharma Solutions (PPS) delivers fully developed manufacturing processes for antibody-drug conjugate drug substance and lyophilised drug product, all within as few as twelve months. The program includes qualified, Phase I appropriate analytical methods to support batch release and stability studies for both drug substance and drug product, as well as initial stability data on drug substance (six months) and drug product (one month).
Peter DeYoung, Chief Executive Officer, Piramal Pharma Solutions said: “As a CDMO serving the biopharma industry, we recognise that speed matters. Getting our clients into the clinic as quickly as possible without compromising quality supports our ethos of patient centricity. ADCelerate is a strong example of this principle brought to life. By leveraging our capabilities and expertise in ADCs and sterile fill/finish, we are able to shorten timelines while maintaining the highest standards of quality.”
The accelerated timelines that ADCelerate delivers are made possible by PPS’s vast experience in antibody-drug conjugate problem solving, as well as the company’s expertise in manufacturing lyophilised drug product. While based on a standard process, all ADCelerate programs are customised to the scope of each client’s project.
