Solving Tech Transfer Challenges for Complex Pharmaceutical Products

Transcription

1 Solving Tech Transfer Challenges for Complex Pharmaceutical Products Edwin HOPPENBROUWERS Director New Product Introduction Catalent Pharma Solutions

2 PROJECT

3 Product information Natural protein released in the blood stream by host cells in response to the presence of pathogens (viruses, bacteria, or tumour cells) Biotechnologically changed protein to mask the agent from the host s immunity system, increase the blood circulation time and decrease renal clearance Indication Reduction of viral load in the blood stream Therapeutic treatment of chronic infections 11/2/2011 UNICORN PROJECT 2

4 New syringe platform Current syringe presentation 11/2/2011 UNICORN PROJECT 3

5 Product forecast UNITS AIN PFS 11/2/2011 UNICORN PROJECT 4

6 Supply chain set up ROW Excipients & API Primary Components Customer SITE 1 Catalent Customer SITE 2 EUROPE USA 11/2/2011 UNICORN PROJECT 5

7 Process description Formulation Filtration into a sterile holding tank Storage of the solution Sterile filtration Filling & plunger insertion activities Storage between 2 C and 8 C Cosmetic and particulate inspection Packaging and shipment Dedicated equipment requirement by the customer 2 different batch sizes 11/2/2011 UNICORN PROJECT 6

8 Project = a piece of cake! 11/2/2011 UNICORN PROJECT 7

9 Project road blocks Every project has its road blocks! They can be divided in Product related issues Process & equipment related issues Process management and organizational issues They do not occur individually but are intertwined 11/2/2011 UNICORN PROJECT 8

10 Project overview FORMULATION VERIFICATION COMPONENT STERILIZATION MACHINABILITY CAPABILITY EQUIPMENT CLEANING MEDIA VESSEL CLEANING MEDIA EQUIPMENT CLEANING API VESSEL CLEANING API EQUIPMENT STERILIZATION TECHNICAL BATCHES SPECIFIC MEDIA FILL TESTS VALIDATION & REGISTRATION BATCHES ANALYTICAL TRANSFER VALIDATION SA-VISUAL INSPECTION VALIDATION AUT-VISUAL INSPECTION 11/2/2011 UNICORN PROJECT 9

11 Project issues overview FORMULATION VERIFICATION COMPONENT STERILIZATION MACHINABILITY CAPABILITY EQUIPMENT CLEANING MEDIA VESSEL CLEANING MEDIA EQUIPMENT CLEANING API VESSEL CLEANING API EQUIPMENT STERILIZATION TECHNICAL BATCHES SPECIFIC MEDIA FILL TESTS VALIDATION & REGISTRATION BATCHES ANALYTICAL TRANSFER VALIDATION SA-VISUAL INSPECTION VALIDATION AUT-VISUAL INSPECTION 11/2/2011 UNICORN PROJECT 10

12 Process issues Machinability issues Customer specific procedure for tub introduction Change of standard system required incl documentation Modification of equipment required! Plunger machinability issues Freshly sterilized / non siliconized stoppers do not run Modification of the equipment is required! Component deformation issue Deformation of the nest resulting in OOS on stopper height Modification of the equipment required! 11/2/2011 UNICORN PROJECT 11

13 Product issues Technical batch issues API availability for technical batches Change of quantities including all batch related documentation 1 day before filling After thawing of the API only limited holding time for processing Major formulation issues Impurity problem during analytical testing Particles originating from glue of the stacked needle Possible major impact on total timeline of the project Very high reject rate on the automated visual inspection Parameter setting re evaluated and new recipe developed Revalidation of the new settings required 11/2/2011 UNICORN PROJECT 12

14 Project management issues Organizational issues Short project time line committed Time to market priority fast track project Customer taken over by another pharmaceutical company Increased project management workload, new concepts New requirements on documentation, finished documents to be modified and to be adapted to the new standards Decision making process becomes more difficult Customer project team doubles in number 11/2/2011 UNICORN PROJECT 13

15 Keys to success How did we cope? Very flexible project management team Multidisciplinary team with members of all departments involved NPI, manufacturing, quality control, quality assurance, regulatory, supply chain, engineering, purchasing & finance Quality single point of contact assigned at project start Back ups guaranteed for all project team members at all times Full time scheduler to track all in house and customer activities Customer project management set up Full involvement of customer project management team Customer representatives on site for all activities Quality single point of contact function also created at the customer s side 11/2/2011 UNICORN PROJECT 14

16 Keys to success How did we cope? Strict governance structure Governance structure including higher management in place All roles and responsibilities defined up front Escalation procedures in place if required Cross functional teamwork No difference between Catalent & customer team members All are part of the same team Problems are tackled together The team effort & creativity concentrated on providing solutions! 11/2/2011 UNICORN PROJECT 15

17 Project outcome Project outcome Project delivered with an acceptable delay, due to component issues Original filing date has been met! New product received EU & FDA approval! Product successfully launched in EU & US 11/2/2011 UNICORN PROJECT 16

18 Quote We can't solve problems by using the same kind of thinking we used when we created them A. Einstein 11/2/2011 UNICORN PROJECT 17

19 Questions? Provider of solutions 11/2/2011 UNICORN PROJECT 18

20 discover more CATALENT PHARMA SOLUTIONS 14 SCHOOLHOUSE ROAD SOMERSET, NJ