Biotechnology
What can we do to detect illness before the person actually becomes ill? That is medicine’s challenge for the future.
Towards predictive and individualised medicine.
agap2 Biotechnology expertise
Our agap2 team is segmented into 5 groups. Each group contributes with its knowledge and expertise to every project development stage from inception to completion. Our consultants speak english, german and french.
Areas of expertise
FIELD OF APPLICATION
- 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
FIELD OF APPLICATION
- 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
- Analytical 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
FIELD OF APPLICATION
- 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
FIELD OF APPLICATION
- 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 and site 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)
- 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
FIELD OF APPLICATION
- 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
