Microbiology Expert Witnesses

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What is a microbiology expert witness?

Microbiology expert witness candidates generally have a background in toxicology, public health, human pathogens, food microbiology, and/or a related healthcare profession. Medical microbiology, expert witnesses have education and experience with the prevention, diagnosis, and treatment of infectious diseases. The chosen expert could be a member of an industry association, such as the Microbiology Society, the American Society for Biochemistry and Molecular Biology (ASBMB), the American Society for Cell Biology (ASCB), or the American Society for Microbiology (ASM).

What types of cases require a microbiology expert witness?

Litigation support by a microbiologist often involves intellectual property matters such as a patent litigation or a trade secret dispute. A microbiology expert might also provide testimony in a case that requires toxicology or chemical exposure expertise.

Microbiology expert witness case examples

Cahn Litigation Services is often called upon by top law firm attorneys to locate an expert witness to support matters involving microbiology. Representative matter have encompassed:

• biochemistry,
• clinical microbiology malpractice,
• bacteriology,
• biotechnology,
• food microbiology,
• infectious diseases,
• vaccines in the New York education system,
• virology,
• Methicillin-resistant Staphylococcus aureus (MRSA) infection control,
• mycology,
• parasitology,
• immunology,
• environmental microbiology,
• medical microbiology, and
• cell biology.

What litigation support work might a microbiology expert witness be expected to perform?

Expert witness services can include laboratory testing, pathogen report reviews, research and authoring expert reports, providing expert opinions, and courtroom testimony. Attorney clients may also utilize an expert for pre-litigation consultant work.

Cahn Litigation Services has the experience required to turn a search for a microbiology expert witness around quickly, providing the right balance of expertise and testimony experience. History has shown that the firm consistently provides science experts and medical experts with the perfect balance of expertise and testimony to support each specific project and its nuances.

Related Disciplines

Microbiology Expert Witness - Representative Bios

Please Note: All Cahn Litigation expert witness searches are customized to attorneys' precise specifications and preferences. Attorneys are encouraged to discuss search parameters with a Cahn search specialist.

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The below expert witness bios represent a small fraction of those Microbiology experts known by Cahn Litigation Services. These bios are provided to give lawyers a sense of the Microbiology landscape.

• Expert Witness #267522

  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)
  
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