Manufacturing Chemist: Sebastian Joseph discusses regulatory expectations for the non-clinical development of vaccines
A client faces multiple batch rejection due to outdated Internal Release Limits (IRLs) but he has 100+ products (500+ attributes) to analyze and follow up on a regular basis
- Identified deficiencies in Change Control procedures and GMP manufacturing documentation
- Uncertainty in verifying the current registered information held with Health Authorities
- Lack of Regulatory Information Management (RIM) systems and therefore lack of oversight of product information for key stakeholders
- Small biotech US company developing a dendritic cell vaccine for the treatment of the Orphan indication glioblastoma in EU
- Timeline: long-term (8 years)
- Support in
-Preparation and conduct of the Scientific Advices (SA)
-Medical and technical Writing
-Clinical trial Phase III
-Early access medicines scheme (UK)
-Hospital exemption (DE)
-Pediatric Investigational Plan (PIP)
-Pharmacovigilance: DSUR and PSUR
Reluctance to compute tolerance intervals
- Needed support with the preparation of Module 3 and corresponding Module 2.3 documents for drug substances and drug products:
- To reflect the current status of manufacturing process and state of the scientific art analytical procedures
- To close gaps and achieve GMP compliance of regulatory documentation.
- Required on-going lifecycle management for all drug product licences needed.
Market specific CTA applications for a multi-country EU Phase III clinical trial
- Assistance required to review core documentation.
- Authoring of local documentation for country specific submissions.
- Assistance with competent authority and ethics committee communication.
- Support with handling of substantial amendments to competent authorities and ethics committees, as required.
Support for timely approval of a Phase II clinical trial in the US and UK
- Required assistance in IND authoring, eCTD publishing and FDA Agent activities for submission to FDA.
- Alongside support in authoring of IMPD and local documentation required for submission to MHRA.