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

They trust us

  • agap2_logos-clients_shire_680x628.png
  • agap2_clients_novartis_680x628.jpg
  • agap2_logos-clients_csl-behring_680x628.png
  • agap2_clients_novartis_680x628.jpg
  • agap2_clients_roche_680x628.jpg
  • agap2_logos-clients_jj_680x628.png