Laboratory Equipment

This expert has many years of microbiology experience including practical proficiencies in pharmaceutical, biotech, medical device research and development, manufacturing quality and business development.  This expert also brings to the table practical experience as a microbiology expert witness in patent litigation and product liability cases. This expert has successfully served as a microbiology expert witness on numerous cases, representing branded and generic drug companies, corporations and individuals, plaintiffs and defendants. This expert has supported clients during fact finding/expert discovery and claim construction in addition to providing consultation, patent review, expert opinion, deposition and trial testimony. This expert has also provided technical guidance to counsel in preparation of taking depositions.

This expert has significant education, training, skill sets and experience, and has provided legal support as a consultant and expert witness in many areas, including:

• Pharmaceutical microbiology
• Sterility assurance
• Good Manufacturing Practices (GMPs)
• FDA regulatory compliance
• Contamination control
• Sterilization
• Preservative and antimicrobial effectiveness
• Compounding pharmacy microbiology
• United States Pharmacopoeia (USP) testing
• Laboratory operations
• Ophthalmic formulations and contact lens care

This expert’s capabilities span a wide range of applications and functions, including, but not limited to:

• Manufacturing
  • Sterility assurance and aseptic processing
  • cGMP compliance
  • Investigations of microbial excursions, presence of objectionable organisms and out-of specification findings
  • Contamination control and bioburden reduction strategies for sterile and non-sterile fill-finish facilities
  • Manufacturing isolator and RABS design, cycle development and microbiological validation
  • Process development
  • Manufacturing facility design and qualification
  • Process Analytical Technology (PAT)
  • Environmental monitoring (sterile and nonsterile)
  • Fermentation, recovery and purification microbiological control (API, bulk drug)
  • Process water monitoring and maintenance
  • Disinfection and sterilization
  • Cleaning validation
  • Audit readiness
  • Rapid microbiological method (RMM) validation and implementation

• Microbiology Laboratory
  • Laboratory audits, optimization and management
  • Laboratory design, qualification, optimization and automation
  • Sterility test isolator design, cycle development and microbiological validation
  • cGMP compliance
  • Microbiology method suitability testing, including the harmonized Sterility Test and Microbial Limits Test, Antimicrobial Effectiveness testing, USP 1223 and1227
  • Sterility testing (harmonized)
  • Antimicrobial and preservative effectiveness testing
  • Environmental monitoring
  • Pharmaceutical-grade water analysis
  • Bioburden and microbiological examination of nonsterile products (harmonized Microbial Limits Test)
  • Disinfectant effectiveness validation
  • Microbial identification strategies and instrument/method validation, including gene sequencing and MALDI
  • Endotoxin analysis and method validation
  • SOP and protocol development
  • Method validation and technology transfer
  • Pharmacopoeia (e.g., USP, Ph. Eur., JP) interpretation and compliance
  • Risk assessments (e.g., objectionable organisms, microbial data deviation, bioburden excursions)
  • Documentation and data management
  • Rapid microbiological method (RMM) validation and implementation

• Quality, Regulatory and Product Development
• Failure investigations and root cause analysis
• Microbial data deviation investigations
• Audit response (e.g., FDA 483, warning letters, consent decree)
• Regulatory submission support associated with microbiological processes (e.g., NDA, ANDA, IND, BLA, marketing authorization)
• Pharmacopoeia (e.g., USP, Ph. Eur., JP) compliance
• Contact lens care and ophthalmic formulation development, manufacturing, stability testing and product release
• USP 797 compliance, pharmaceutical compounding of sterile preparations (compounding pharmacies)