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 contributs with its knowledge and expertise to every project development stage from inception to completion. Our consultants speak english, german and french.

Areas of expertise

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

They trust us

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