CONSULTING and INTERIM-MANAGEMENT for BIOPHARMA and MEDTECH:COVID-19 VACCINE PROJECT:• Tech Transfer Lead for sterile Fill & Finish operations with Key Accountability (FPOC) for CMO • Cross functional multinational Project Management within large teams• Close collaborations with big European pharma companies • Tech Transfer documentation, Risk analysis, identification of gaps, scientific studies, Root Cause Investigation (RCI), Process Performance Qualification (PPQ), Comparability Planning, Change Management, Equipment Qualification, Transport study (-80 °C cold supply chain)• Support for Analytical Method Transfer, Quality Agreement, Release Process, Labelling and Packaging activities• Support for Regulatory Affairs: Data and information collection, preparation of packages for dossier• GMP Compliance for DS productionPrevious BIOPHARMA PROJECTS with focus on QUALITY ASPECTS, FDA REMEDIATION:• CELL CULTURE UPSTREAM & DOWNSTREAM PROCESSING following Quality by Design (QbD), A-Mab-Case Study from CMC Biotech Working Group• MONOCLONAL ANTIBODIES – Manufacturing Science and Technology (MS&T): Validation for USP, DSP, Cleaning, Risk Assessments• STERILE FILL & FINISH OPERATIONS - Multi-factory/site FDA Data Integrity project: Risk-Assessment, GAP-Analysis, CAPA Management, Quality supporting processesMEDICAL TECHNOLOGY PROJECTS:• CANCER DIAGNOSTICS – HERCEP TEST: IMPROVEMENT and VALIDATION OF PRODUCTION PROCESSES (Mixing, Dilution, Filtration)• CARDIOVASCULAR DEVICES / HEART-LUNG-MACHINES - QUALITY CONTROL for Oxygenators, Arterial Filters, Cardioplegic Devices, Centrifugal Pumps, Catheders: Development and implementation of NEW TEST METHOD FOR MICROPARTICULATE CONTAMINATION according to requirements of UNITED STATES PHARMACOPEIA and INTERNATIONAL STANDARDS SELECTED CUSTOMERS: Novartis Pharma (Basel), Boehringer-Ingelheim (Ulm area), AbbVie (Ludwigshafen), Dako-Agilent (Copenhagen), Getinge Group: Maquet Cardiopulmonary (Stuttgart area)

ADVANCED BIOPROCESS TECHNOLOGIES Customer-specific Pharma-projects covering Upstream and Downstream of Biopharmaceuticals, including Formulation TechnologyIntegrated solutions reflecting Quality by Design (ICH) and Process Analytical Technology (PAT) from US-FDA

Focus: Biopharmaceuticals and Process Analytical Technologies (PAT)

Collaborative building-up of the ETH-Zurich spin-off company biospectra AG since early launch-phase,Bioprocess Optimization implementing process analytical tools and systems from lab scale to production scale, with priority on CHO cell cultures,Evaluation and implementation of new analytical methods,Product development and realisation up to small scale series:• Online Process Analysers HPLC, GC, UV/VIS-Spectrophotometry, incl. sterile sampling technology• Enzymatic bench-top analysers (Novartis, Swiss Technology Award)• High-precision-parallel-bioreactor system for R&D (Roche, DSM)• Online-microscope for mammalian cell culture process (Novartis)• Development of Bioreactor control and automation systems• Acquisition of new customers from Pharma- and Biotech-Industries in Europe and in the USA

INSTITUE of BIOTECHNOLOGY, Prof. Dr. A. Fiechter: Swiss KTI-funded Research-Project: HIGHLY PRODUCTIVE MAMMALIAN CELL CULTURES“Intense project collaboration and technology transfer with Ciba-Geigy AG (later Novartis Pharma AG), Basel