Pharma and Biotechnology

Towards predictive and individualised medicine.

What we can do to detect illness before the person actually becomes ill? That is medicine’s challenge for the future.

Areas of expertise

Interventions

  • Writing specifications and data sheets
  • Basic engineering / Detail engineering (process engineering, electricity, instrumentation, piping, boilers, etc.) / Design review
  • R&D: biology / chemistry / biological products
  • Clinical studies: CRAs, clinical study management, biostatistics, data management
  • Analytical method development
  • Process development / industrialization

References and technical expertise

  • Detailed engineering for clean utilities (Water For Injection, Purified Water, Clean Steam) for a new biotech plant
  • Process expertise for the improvement of secondary packaging production lines
  • Automation of liquid production lines with Siemens S7
  • Detail engineering of a nano-filtration unit for a recombinant protein production unit
  • Feasibility studies / Basic design phases for a new vitamins production line
  • Creation of Master Batch Records during the implementation of a new MES (Werum PAS-X 3)
  • HPLC Methods development for raw materials characterization

Interventions

  • Quality assurance
  • Quality control
  • Quality Management System
  • Regulatory affairs

References and technical expertise

  • Quality Assurance on the floor in a biotech factory : deviations, change control, CAPA management
  • QA release : batch record review for the release of OTC products
  • Creation of SOPs for a new production unit
  • Quality E-compliance project for a large IS migration project
  • Supplier quality audits
  • Implementation of Quality EDMS (Electronic Documentation Management System) and archiving system
  • Analytical method development for raw material identification
  • Regulatory compliance remediation project before a Russian authorities inspection
  • Regulatory CMC for bio-products in clinical phase I & II (IND, IMPD)

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 continuous improvement, stock management
  • Lean Management/ Manufacturing 6s

References and technical expertise

  • Support to transport validation activities for biotech products in clinical phase
  • Streamline of a panel of service providers
  • Negotiation with suppliers and contract writing for pharmaceutical developments
  • 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, Maintenance, SHE
  • Equipment qualification, FAT/SAT/IQ/OQ/PQ (manufacturing, packaging, laboratory, clean and black utilities)
  • Manufacturing process validation
  • Special process validation (cleaning CIP, sterilization SIP)
  • Information and automation system validation (CSV): automates, MES, LIMS, Serialisation & Aggregation

References and technical expertise

  • Qualification of QC systems
  • SHE Management before and during a shutdown (SHE Plan, PPE, SHE onsite supervision)
  • Work supervision for the installation of USP and DSP manufacturing lines
  • Qualification of encapsulation equipment (IQ-OQ-PQ/FAT-SAT)
  • Validation of cleaning process: washing and CIP/SIP for solid and liquid form
  • Process validation PQ at manufacturing scale for a biotechnology factory
  • Project Leader for the revamping of solid dosage production lines
  • Qualification and validation of automated machines for the assembly of medical devices (inhalators and insulin pens)
  • New clean room installation and validation

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

  • Project management for the technology transfer of a fill & finish line to a US location
  • Quality management of CMO
  • Project Quality management for multi-site implementation of a T&T solution
  • Management of a process risk analysis (FMECA) for chemical operation PU
  • Shutdown management for the capacity increase of a biotech factory
  • Cost controlling and Planning for a EPCM project ~50M€
  • Project Management (cost, quality deadline) for the industrialization of a new auto-injector not approved by the FDA