Sterile suspension failed to meet specifications and 1+ year's work had not secured root cause. Used process understanding with data driven development and optimisation to define and eliminate/control root causes. Data closely matching to specifications and no failed lots in 6 month follow up.
Inhaled product which could not be scaled up now made at x200 scale following design of process, experimental design and process optimisation. Filed and approved in EU and US.
Drug control and processing steps re-engineered and upgraded to meet EU requirements for combination products. Design File submitted and EU Notified Body inspections achieved with successful data bridge and rationale for clinical to upgraded commercial process changes without added clinical work.
Device with major foreign particulates contamination complaints from patient/customers required root cause and process, equipment and personnel skills/training improvements to be defined and implemented in moulding and assembly plants.
Optimised process and methods to improve MDI with poor dose uniformity, failing to meet specification and impacting supply capability. Specifications updated to control uniformity and tool/assembly process changes also made to required timeline. Approval of changes now achieved in over 50 countries.
Root cause defined and solutions proven for variability in fine particle doses of two drug combination, manufactured by different companies for APIs, device and product where 2 years' work had not succeeded.
Developed new process for viral and prion removal from animal material for biologic product based on regulatory authorities request. Approved in EU and US and filed in other countries.
Selected CMO and led transfer of product from original CMO with poor quality/compliance and reliability/delivery for complex combination product through filing/approval in EU and US.
Reorganised >120 staff in R&D departments to fewer layers, clarity of responsibilities, with project/portfolio management introduced to drive project implementation, including change programs. Reduced non-project work by >40% by streamlining lab, GMP /QA processes and rationalised lab design and equipment use. Project tracking showed delivery near much improved target after 6 months.
Improved process by structured monthly review of progress/resource consumption/requirements for four sites in Europe. Resource forecasting tool for people and major plant introduced and refined over 3 months, highlighted bottlenecks in lab and pilot plant with solutions implemented.
Centre of Excellence Set Up with technology transfer from R&D to manufacturing for novel technology. Recruited/training plan aligned with new equipment and facility delivery and first 3 experts recruited.
Device Industrialisation plan and 2 key expert roles set up for over 10x increase in scale for device, integrated with product manufacture scale-up. Procurement and risk mitigation plans developed and maintained over prolonged project execution.
Led change program from functional to project organisation across 7 manufacturing sites, for product transfer and industrialisation. Recruited four key Programme Managers and coached multiple Functional managers during change program.
Let Claidmhor Pharma review your program with a “fresh pair of eyes”.
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