Biotechnologies
Comment faire pour détecter les maladies avant qu'elles ne se déclarent ? C'est le défi de la médecine de demain.
Vers une médecine prédictive et individualisée.
L'expertise agap2 dans les Biotechnologies
Notre équipe agap2 est segmentée en 5 groupes. Ils interviennent à différents niveaux avec leurs connaissances et leur expertise sur toutes les phases d'un projet de la conception à la réalisation . Nos consultants parlent anglais, allemand et français.
Pôles de compétences
Interventions
- Writing specifications and data sheets
- Basic engineering / Detail engineering
(process engineering, electricity, instrumentation, piping, boilers, etc.) / Design review - R&D: biological products
- Clinical studies: CRAs, clinical study management, biostatistics, data management
- Industrialization / Process development
- Technical inspection of materials and equipment
References and technical expertise
- Process detail engineering for new biotech plants
- Process expertise for packaging production lines
- Automation of production lines
- Clinical study management: childish pulmonary hypertension
- Detail engineering of a nanofiltration unit
- Risk analysis and PID review for the revamping of a water tank
- Process expertise for the transfer of a production line towards a CMO in Russia
- Analytical development project within the QC department
Interventions
- Quality assurance
- Quality control
- Regulatory affairs / Regulatory monitoring
- Quality Management
References and technical expertise
- Implementation of a CMC department for the clinical CMC regulatory files IND / IMPD on biosimilars and bioproducts in development
- Quality Assurance, change management for finished and packaging lines
- GMP control laboratory
- Method development for raw material identification
- Continuous improvement Quality Control Laboratory
- QA Project Management : implementation of trackwise in the stability department
- Remediation for suppliers QA
Interventions
- Supplier sourcing
- Tendering
- Technical validation of bids
- Contract management, negotiation
- Supplier expediting
- Technical inspection of equipment before delivery
- Logistics management / Industrial transport
- 5S / Kaizen / TPM continious improvement, stock management
References and technical expertise
- Support to transport validation activities for biotech products in clinical phase
- Streamline of a panel of service providers
- SCM for clinical trials
- Purchase of technical equipment for a new product line but also for the engineering and maintenance department
- Lean manufacturing TPM and 5S projects implementation
Interventions
- Site work supervision, On-site installation
- Equipment qualification, FAT/SAT/IQ/OQ/PQ (process, utilities, IT)
- Process validation (manufacturing, cleaning, sterilization)
References and technical expertise
- Support for the validation strategy on a GMP site in anticipation to a Swissmedic audit
- Qualification of QC systems
- Coordination between engineering (M.S.) and site (Novartis St Johan) for clean rooms revamping
- GMP Compliance expert in charge of the qualification of new biotech equipment / change control review
- Qualification of encapsulation equipment (IQ-OQ-PQ/FAT-SAT) – Stein
- Validation of fill and finish process
- Validation of cleaning process: washing and CIP/SIP for solid and liquid form
- Process validation at manufacturing scale (GMP – statistics studies) for biotechnology production
Interventions
- Product/Project/Program Manager (PMI or IPMA certified if needed)
- Project Management Office: Cost control/Planning/Risk Management
- Technical Project Manager
- Project Quality Management (global, QA, QC)
- Life Cycle Management
References and technical expertise
- Deployment of a Manufacturing Execution System (MES) as part of the extension of a biotech production site
- Quality management of CMO
- Regulatory affairs management for change control in biotech manufacturing
- Daily business in QA department for E-Compliance (CSV expert)
- Dossiers to register a new medicine abroad
- Project of technology transfer of the fill-finishing activities towards an American production site
- Project management in life cycle management team
- Project coordinator – automation – revamping production lines
