From process evaluation, through technology transfer , process improvements to dmf submission.

Contract manufacturing for the development and manufacturing of New Chemical Entities in early clinical phases is based on confidentiality and full trust in Helsinn by the chosen partner.

Helsinn’s R&D is fully involved in the implementation history of the process within Helsinn from the very beginning, after confidentiality agreement signed through process and analytical transfer, process improvements’ and finally in the preparation of the documentation required for a successful NCE registration.

For more details click on one of items below:

Process Evaluation

Technology Transfer (TT)

Continuous process improvements

Regulatory Support

Process Evaluation

After the signing of a Confidentiality Agreement, and the RFP and technical packages have been received , Helsinn’s R&D Group together with Business Development makes a project assessment in order to confirm the feasibility of the same at Helsinn facilities. Before submitting the first proposal, discussions with Helsinn’s partner will clarify the possible registration strategy with the support of Helsinn’s regulatory expert. This expert input and discussion prior to starting the Technology Transfer of the process and analysis to Helsinn has been consistently recognized to be of high value to our medium-to-small pharma companies with a fine-tuning of the timelines and optimizing global project cost.

The quotation submitted to the partner therefore not only includes a pure time/cost consideration but also a mix of several parameters to be considered in order to successfully support the critical clinical phases as forecasted with high quality material and documentation.

Technology Transfer (TT)

nowadays is no longer a quick lab trial to prove that the process can make some grams of material as it was in the past. It forms a crucial part of the execution of any project involving transfer of know-how and the process and analytical TT procedures and documentation are carefully reviewed by FDA inspectors during a Pre-approval-inspection. Helsinn’s long-term R&D experience with over 50 projects successfully transferred over the past 15 years (28 active projects at the beginning of 2007) and the procedures in place together with a professional project management will ensure a smooth transfer from the lab that developed and manufactured the first clinical batches to the late clinical and commercial manufacturing at Helsinn.

laboratory R&D
• technology transfer from the partner to Helsinn
• synthetic route fine-tuning
• process development & optimization
• analytical development & validation
• powder characterization for solving flowability issues

project management
• dedicated project manager
• technology transfer team & plan
• cost and price control & optimization
• logistics for raw materials and key starting materials

Continuos Process Improvements

A process has never reached the optimum. The operators and supervisors experience while making routine production together with the R&D .gives further and additional ideas on how to improve the process, being solvent recovery or operations changes (regulated by programmed change controls agreed with the partners). In addition to that, the identification of alternate sources of key starting materials or yields improvements during routine production is also supporting the continuous cost-of-goods (COGS) optimization process that is more than welcome from Helsinn’s partners.

Regulatory Support

After the succesfull TT, production of clinical batches and/or registration and/or validation batches, the documentation is ready to be collated for several purposes such as : filing an IND, end of Phase II meeting, NDA submissions, DMF’s to CTD format, etc. Helsinn’s Chemical Operations regulatory group has supported Helsinn Healthcare Regulatory Affairs in relation to several Group product registrations including Palonosetron (ALOXI®), Nimesulide, Oxaprozin, and Netupitant thus possessing an expertise and know-how that few of our competitors possess and which is available to our third party clients also.

The successful 5-day pre-approval inspection of the FDA in 2003 with no 483 and subsequently having DMF’s for our contract manufacturing partners approved within 4-6 months after submission with few if any questions confirms the high standards of our regulatory group activities. This is often highly valuable to our partners who recognize and appreciate this very often “free-of-charge” regulatory consultancy in terms of smooth review and approval of submissions saving time and money.

regulatory & cGMP services
• preparation & support of the CMC part (Chemistry Manufacturing and Controls)
• DMF (Drug Master Files) and CTD (Common Technical Document) , qualified in Japan...
• process validation
• stability testing
• vendor assessments
• inspections from the FDA and European authorities