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Presented by Troy Logan at the Advisory Committee for Pharmaceutical Science meeting on April 13, 2004

Presented by Troy Logan at the Advisory Committee for Pharmaceutical Science meeting on April 13, 2004. Siemens – PAT solution in pharmaceutical industry. for internal use only. PAT opportunities (FDA’s PAT Draft Guidance). Reducing production cycle times

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Presented by Troy Logan at the Advisory Committee for Pharmaceutical Science meeting on April 13, 2004

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  1. Presented by Troy Logan at the Advisory Committee for Pharmaceutical Science meeting on April 13, 2004

  2. Siemens – PAT solution in pharmaceutical industry for internal use only

  3. PAT opportunities (FDA’s PAT Draft Guidance) • Reducing production cycle times • Right first time quality (RFT)Preventing rejects, scrap, re-processing • Managing variability (improving energy and material use and increasing capacity) • Facilitating continuous processing (improve efficiency) • Increasing automation to improve operator safety and reduce human errors • Real time release

  4. Ultimate step – Real Time Product Release • Production and release of pharmaceuticals, without final tests • Quality is based only on review of process characteristics

  5. Standardized over the complete unit Buffer + Medium Bioreactor Harvest & separation Purification Formulation Finishing Packaging

  6. Multidisciplinary approach MES regulatory (advanced) Controls Modelling Process development Chemometrics/ MVDA Process under-standing ProcessAnalytics

  7. IT / MES INFRASTRUCTURE 1101001001 1001000100 100101111 1001110101 electronic batch record batch optimization real-timeproduct release Process Monitoring (process) knowledge pharma modules Control iterative learning control equipment modules monitoring process Specif. verification control modules Process Analytics PROCESS PAT concept

  8. M Transform to quality data Bio-reactor Lab based review of product quality Product hold release Real Time Product Release On line Off line Iterative Learning Control Monitoring Qualitative Quantitative Fingerprint Close loop control (physical / chemical parameters only) PAT Temperature, pH, pO2, pressure Temperature, pH, pO2pressure Required Process information Process feed Process output

  9. Infected (102 CFU/ml) Non infected Infection detection with PAT on yeast based fermentation and substrate samples: B. subtilis, C. albicans, S. aureus, E. coli, Ps. Aeruginosa, A. niger and L. Brevis Biological contamination

  10. Bioreactor process monitoring In-situ NIR Probe

  11. Use of PAT as qualitative tool Example vaccine production Process track monitoring and early detection of disturbances Process pattern : processfingerprint / signature (multidimensional profile) Comparing “fingerprints” of different batches Start Disturbance End Scores plot for the two main principal components on collected spectra during the batch process Change in process status

  12. PAT implementation Road Map 1.     Measure (Monitoring + Process understanding) Time Product Q assessment Risk assessment analyzer assessement Knowledge + Change management People & organizatio-nal Managm. Validation Plan Process assessment Process Path definition Data analysis 2.      Control Process control definition (ideal process runs) Process control for process corrections 3.      Optimization Continuous optimization & improvement

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