Transcript Jacinta Wyeth Presentation

IDA Ireland / PharmaChemical Ireland
Symposium
The Road to Integrated Development and
Manufacturing
Jacintha Griffin
Wyeth Newbridge
September 23rd 2009
Overview
The Road to Integrated Development & Manufacturing
•
From technical transfer to Co-development
•
Pharmaceutical Development Centre (PDC) business case
•
PDC Newbridge – Capability, facility and approach to integrated development &
manufacturing
•
Development and Manufacturing Model - Future Opportunities and Challenges
Wyeth Newbridge
The Road to Integrated Development & Manufacturing
Newbridge PDC
Newbridge PDC
Construction Start
2009
New products
organization & PDCs in
Operation
PDC Concept Approval
Co-Development &
Clinical Trial Supplies
Technical Transfers
& Process
Optimisation
1992 - 2003
2004
2008
2007
2005
Opens
Pharmaceutical Development Centre (PDC)
Integrated Development and Manufacturing
Business Case and Fiscal Supports
Critical Supports in Justifying Business Case for Development centre:
•
Proven technical capability of supporting a large portfolio of solid dosage products
•
Demonstrated capability in collaborating with corporate R&D - Co-development
•
Collaboration with the IMB for rapid application, audit and receipt of IMP licence
•
Process optimization for marketed product portfolio - “Quality by re-Design”
•
Changing regulatory environment – impact of ICH Q8, 9, 10
Government, IDA mandate and support
• R&D Tax Credit System & capability grants
• 12.5% Corporation Tax
• IP Royalty Scheme
PDC Charter and value proposition
PDC Newbridge
Multi-Purpose Multi- Product cGMP Module
Pilot Scale 5-50kg
•
1/10th the commercial scale of pipeline products
Small Scale (<5kg Suite)
•
‘Smart Development’
Smaller Batches - Higher Velocity / Throughput
• Supports API Cost and Supply Constraints
Full Scalability to pilot and commercial scales
•
Process Characterisation Laboratory
•
•
Active and Excipient Functional Characterisation
Dedicated Analytical Development Laboratory
Flexible and Modular Design
•
•
•
Multiple Product Capability
Flexible Containment to handle potent compounds
“Future Proofed” for Next Generation Technologies
PAT/Data Management Infrastructure
•
Process Analytical Infrastructure for Real Time Acquisition,
Aggregation, Analysis of Data
Focus on Capability – Process Characterisation
Molecular
Spectroscopic:
NIR
Other chemical:
Analysis to support
physical
characterisation
(GQAD)
Particulate
Crystallographic: XRay Powder
Diffraction (with
Controlled Humidity
Chamber)
Microscopic:
Scanning Electron
Microscopy, Optical
Microscopy, Image
Analysis
Thermal: Differential
Scanning Calorimetry,
Thermogravimetric
Analysis
Micromeritic: Specific
Surface Area,
Dynamic Vapour
Sorption, Particle Size
Analysis
Bulk powder
Final dosage
form
Mechanical: Texture
Analysis
Coating Layer
Thickness: Terahertz
Pulsed Imaging
Flow: Powder
Rheometry
Agglomeration: Air Jet
Sieving
Moisture: Loss on
Drying, Water Activity
Density: Bulk and
Tapped Density, Helium
Pycnometry, Envelope
Density
Tablet Dimensions:
Tablet Autotester
PAT & Data Management Infrastructure
Process Char.
Lab
LIMS
SAP ERP
PAT Tools
1 – 5kg & 5 – 50kg Equipment
BMS
Newbridge PDC Competencies
Cross Functional Team with Qualifications, Subject Matter Expertise and Practical
Experience in:
• Material Science
• Powder Properties, Spectroscopic Techniques
• Formulation Design
• Pharmaceutics, Drug development, Pharmacokinetics
• Process Design & Process Engineering
• Process development
• Analytical Method Design and Development
• Spectroscopic Techniques, QbD for methods
• Scale-up Expertise, Operational excellence and Lean manufacturing methodologies
• Process Analytical Technology and Chemometrics expertise
• IT, Automation and Data Management
• Software Programming, Automation and Control Systems
• Quality and Compliance
• Regulatory understanding and application of CFR, GMP and ICH Q8, Q9 and Q10
Organisational structure to deliver success
New Products and Process Development (NPPD)
•
Accountable for all new product activities from Proof of Concept (PoC)
Key operating principles:
• “Quality by Design” and “Quality Risk Management” principles embedded
•
API and Drug product accountabilities
•
Broad scope – clinical relevance and manufacturing optimization
•
Smart Development - Do more with less API using QbD and DoEs
•
Drive Finished Product dosage to support standardized technology platforms
•
PDC network part of NPPD
New Products & Process Development (NPPD) and PDC Network
Newbridge
PDC
Pipeline
Newbridge, Ireland
Corporate
R&D
New York
PDC
Process Knowledge
3rd Party
Pipeline
Puerto Rico
PDC
Phase 0, 1
Phase 2
Phase 3
Puerto Rico
Commercial
Building blocks for integrated Development & Manufacturing

Using Quality Risk Management techniques to drive the level of development activities required
to yield the highest level of scientific knowledge

Understand inputs - physical characterisation techniques

Structured development programme - Understand Design space and interdependencies through
DOEs
Data management infrastructure - design allows for the ability to Acquire,
Analyse, Archive and Report Product and Process Data

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Advanced chemometrics and statistical modelling to interrogate and understand data

Process Analytical Technology (PAT) for real time monitoring, prediction and control of quality
attributes
Elimination of science of scale through knowledge management, model creation &
Management
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Regulatory filing (Design & Control space) and elimination of post approval changes
PDC – Co-location with Manufacturing
A Win - Win
Development co-located with manufacturing at commercial site •
Enhanced technical expertise to support both marketed and pipeline portfolios
•
Seamless knowledge transfer from late stage development through to commercial
•
Manufacturing requirements and input earlier into development programme
•
Influences standardized technology platform selection
•
Technical training and site upskilling
•
Reduction in regulatory complexity – Learn before filing
•
Deployment of PAT “with a purpose” – Pull not Push
Looking to the future
Future Opportunities
• Leverage from Competence Centres/Clusters – Solid state Pharmaceutical cluster
(SSPC) etc
•
Build RD&I reputation – IP, publications, conferences
•
Business Process Innovation
•
RTR & Continuous Manufacturing
Industry Challenges
• Availability of personnel with cross functional skills
•
Alignment and harmonisation of regulatory requirements of EMEA / Japan / FDA &
other global markets
Summary
Build on manufacturing expertise and proven track record
 Tech, transfers, scale up, operational excellence
Build and deliver on business case
o Drive an integrated & innovative approach to development and
manufacturing
o Focus on smart development and manufacturing excellence
o Science driving compliance
o Simple PAT solutions
Grow a highly skilled, cross functional Team
 Diverse backgrounds –formulation & process development, automation,
statistics, chemometrics, analytics & engineering
Overall result:
 Enhanced process knowledge -Defined targets & ranges for CPP and CQA
o Enhanced robustness, reduced COGs, elimination of scale up issues
Thank You
Questions?