Disposables Technology Trends, drivers & practices. Gordon Farquharson July 2017

Transcription

1 Disposables Technology Trends, drivers & practices Gordon Farquharson July 2017

2 Agenda 1. Business drivers 2. Technical trends 3. Systems in practice 4. Comparison with fixed systems & justifications Slide 2 PharmOut 2017

3 The basic decision Slide 3 PharmOut 2017

4 Basis for analysis Paper reference: November 2008 BioPharm International paper "The environmental impact of disposable technologies Can disposables reduce your facility's environmental footprint? (Sinclair, Leveen, Monge, Lim and Cox) Process Cost Models Analyse the impact of a specific technology within a given process Disposables vs. stainless Technology performance can be modelled in computer programmes like BioSolve Impact on Cost of Goods Process throughput Impact on facility: utilities, waste streams, etc. Slide 4 PharmOut 2017

5 Challenges in Bio-pharma 1. Compared to chemical pharmaceuticals Drugs are complex products. Sophisticated manufacturing facilities. 2. Product development is expensive & slow 3. Products are expensive to make (on a per treatment basis) Especially current generation MABs 4. Production facilities have traditionally been very expensive and inflexible 5. Rapid response is often required Biodefense Epidemics (Pandemic flu) 6. Competition from Bio-similars Slide 5 PharmOut 2017

6 Manufacturing trends Trends Success rates & yields increased Titres have greatly increased Titre improvements continue & will reduce the volume of bioreactor capacity. Titres and Yields of Licensed Antibodies will gradually increase over time' There will be more Antibodies with smaller market penetration/sales and lower Product Mass (50-500kg) requirements'. Implications Plant size decreasing Need for more flexible facilities Disposable technologies will have greater application for commercial supply However Cost is an issue Maturity and supply chain security Slide 6 PharmOut 2017

7 Key challenges Business analysis When & where is it cost effective to implement disposable technologies into a given process. Impact on design logistics Need for better understanding of the possibilities Facilities that can be rapidly expanded with minimum effort. Environmental impact of disposables. Procurement and supply chain dependency. Slide 7 PharmOut 2017

8 Disposable Risk/Benefit Assessment Risks Nature Mitigation Technology maturity Economics Supplier and application dependent Depends on degree of novelty and extent of available competition Formal assessment Evaluate full life-cyle costs capital & operation Supplier dependency Available competition Design system to maximise choice. Validation The environment Dependent on the defined approach Extent and method of waste treatment Risk based approach to current industry practice Assess, mitigate impact, treat waste stream Slide 8 PharmOut 2017

9 Disposable Key positive effects Feature Effect Outcome Remove or reduce CIP & SIP requirements Faster product/batch change-over Ease of reconfiguration Reduce complex pipework. Reduce automation systems requirements. Reduced activity for washing, cleaning, and preparing reused equipment. Can set up new process trails easily. Can be developed and validated off-line. Reduced periodic qualification. De-couple building and process systems. Lass labour. Less water and energy. Less labour. Better utilisation. Supports lean manufacturing. Easily reconfigured in response to new products and improved yield as process matures. Note: Facility design has to be completely changed in concept = loose fit solution. Slide 9 PharmOut 2017

10 Result = Less complexity, smaller (1000 L scale) Slide 10 PharmOut 2017

11 Disposable examples Reactors & vessels Slide 11 PharmOut 2017

12 Disposable examples Connectors Slide 12 PharmOut 2017

13 Layout of a Complete Disposable Aseptic Processing mixer Disposable formulation, Filtration system Grade A Pump Slide 13 PharmOut 2017

14 Disposable Final Fill and Finish Acerta Dispensing System (Millipore) Novel patented disposable liquid dispensing Volumetric Fill - Gravity Driven Matches Conventional Filling Systems Fill Reproducibility: < 0.5% at 1.0 ml Set-up Time: 30 min. Fill Volume Range: 0.5 to 20 ml Fill Rates: up to 40 / minute per head at 1.0 ml All product contact parts are disposable The set-up is pre-assembled, integrity tested and gamma sterilized up to 45 kilograys Components are: Platinum-cured silicon and C-flex tubing LDPE reservoir Polycarbonate sight tubes and needles All materials are USP Class VI Slide 14 PharmOut 2017

15 Conclusions Biological medicines are very significant business going forward Pressure to reduce price of medicines to patients, and maintain margins for inventors and manufacturers Disposables have a key role to play as a platform technology: Driving out cost in biologics manufacturing Reducing complexity Rapid expansion & contraction of capacity Many challenges remain for disposables: Supply chain security Manufacturing standards and capacity Varying quality standards Disposable system standardization Slide 15 PharmOut 2017

16 Conclusions- a structured apprach Single-use technology analysis and feasibility assessments Rapidly changing area need to keep current Identify the added value technologies Fully" disposable manufacturing plant design Use the appropriate amount don't go fully disposable for disposables sake Use structured evaluation methodology Cost Technologies Design options Vendor Supply chain security Integrated disposable and stainless steel manufacturing plant design Slide 16 PharmOut 2017

17 Thank you for your time. Questions? Gordon Farquharson Executive Consultant Slide 17 PharmOut 2017