Assistance to new Biotech facility establishment

•cGMP assessment of facility concept
Flow reviews (raw material, product, equipment, clean/dirty segregation, people, viral segregation); waste flow and treatment; Air locks, pressure cascade; Air breaks; Risk Analysis (HACCP)...
•  Engineering review
Concept and philosophy assessment; P§ID review; Contract review; Global planning review, HVAC requirements...
•  Dimensioning
Sizing of manufacturing equipment, Water for Injection production, Steam production...
•  Documentation review
Review of FAT and SAT protocols; IQ/OQ protocols; Validation Matrix
•  Equipment qualification
Acceptance criteria review
•  Process validation
PQ philosophy; protocol review; Cleaning validation
•  System validation
PQ WFI, PQ gas, Air treatment; Risk assessment review

Manufacturing Assistance

• Technology Transfer Assistance
Protocol and acceptance criteria review; Equipment suitability; Batch record review; Report review
• Technology licensing assistance
Value analysis; Intellectual property assessment; Negotiation
• Continuous improvement implementation
Target definition; Performance assessment; Project definition and follow-up
• Capital usage optimization
Switch to multi-products operations; Automation versus manpower; Scale –up and/or bottleneck elimination

Process development assistance

• Strategy for Upstream and Downstream processes optimization
Process Flow diagram; Bottleneck identification; Medium and chromato optimization; Continuous or Batch process rational; Wave bags implementation; Cell separation approaches; Buffer consumption; Cleaning issues; Pre-formulation at bulk level; Fill and Finish anticipation; Freeze-drying elimination; Quality attributes
Process and analytical evolution as a function of clinical phase.
• Viral clearance strategy
Risk analysis; Animal free components; Viral clearance strategy; Validation approach.
• Clinical trial production strategy
Internal production or Outsourcing? Final Dosage anticipation; Associated devices; Quality progress as a function of clinical trial

Project Assessment

• Strategic consistency
Rational for the project; Risk/benefit ratio assessment; Integration in the company strategy
• Economical assessment
 Internal Rentability rate; Return on invest time; Net Present Value
• Implementation strategy
People acceptance; Key milestone definition; Detailed planning

Start-up assessment for investors

· Platform technology assessment
Patent position; Competitors; Added value; Product or technology portfolio, publications.
· Cost for development estimates
Pipeline; Investment needs; Cost to Market
· Staff management, scientific board, partnership and alliances
CEO profile; Strength and weakness of the company; Threats and opportunities;
· Business plan assessment
Market growth reality; Environnement impact; Regulatory pitfalls

Executive Search for Biotech Managers

· Top managers
Directors, Members of scientific /advisory boards, Site managers, Corporate level Managers,
· Scientific managers
Development directors, Discovery heads, Research directors
· Scientists
Project managers, Post Doc, Head of laboratory
· Technical staff
Production technical support, production specialist, manufacturing managers,
· Quality / Regulatory Affairs
Quality control, Quality assurance, Validation managers, Regulatory affairs specialists
· Technicians
Lab technician, Support technician, Production supervisor

Training

· Biotech Process Development Strategy
Coordination Research/development. Main steps in process development. Upstream/Downstream coordination. Which process for which clinical phase ?. Viral clearance strategy. Optimization approach. Smooth validation. Quality attributes. Global view including stability requirement, and tox.studies. Technology transfer
· Upstream processing: the E. Coli case
From the MCB to the first extract. Fermentation parameters. Medium optimization. Inclusion bodies collection
· Downstream processing
Module 1: Protein characteristics - Separation methods review (precipitation-partition –chromatography)- Bases of chromatographic principles- Packing control-Membranes separation- Understanding of a purification sequence- Viral clearance

Module 2: Optimization of a purification process- Buffer preparation- Automation- Chromatographic optimization: column design and qualification- different types of columns- new supports- Design of affinity ligands- Modern processes.
· Project management
Definition of a project - Different types of projects - Project planning-Critical path - Resources and Costs - Specificity of biotech projects (process development, pharmaceutical development).

Partner Search

· To sell or to buy
Do you want to sell your company, or to grow through external acquisition? We can help you to identify the right partner.