Mariann Neverovitch, Bristol Myers Squibb - Qepler Summits And Conferences

Mariann Neverovitch

Research Scientist
Bristol Myers Squibb
New York, USA
Bristol-Myers Squibb - Global Biopharmaceutical Company

MS Pharmacy.

Research Scientist at Bristol-Myers Squibb with about 20 years of experience in HPLC method development and validation for drug product, API and intermediates. Areas of interest include but not limited to column technology, trace analysis, high speed separations, and method optimization.

Cleaning Validation Subject Matter Expert with over 15 years of experience in cleaning verification method development and support. Since 2010 leading cleaning verification program in Support of Clinical Supply Operations.

Presented a number of papers on method development and analytical support, challenges in determination of residual API on the equipment (cleaning verification), assessment of on-column degradation, evaluation of narrow - bore vs. conventional columns for method optimization, implementation of Ultra High speed LC, and using integrated approach in methods development.

Member of Eastern Analytical Symposium Governing Board.

Member of USP Expert Committee.

Member of BPOG.

Related Sessions:

Highly Potent APIs
Summit 2019

Assess and reduce manufacturing and handling challenges for highly potent active pharmaceutical ingredients.
  • 20 Feb 2019
  • Berlin, DE
  • Pharma
Day 1: Wednesday, 20 February 2019
BLOCK: CLEANING VALIDATION.
CASE STUDY: Analytical Approach for Implementation of Visual Inspection.

Visual inspection following equipment cleaning is a mandatory step in the cleaning verification workflow for pharmaceutical equipment. Equipment must pass visual inspection before swab sampling for analysis can be performed. However, since a significant number of low risk compounds are visible well below established safety levels, it is possible to justify equipment as “visually clean” without performing swabbing analysis. Internal studies performed at BMS showed that over 90% of participants could identify residual product at a level of ~2 ppm without preliminary training. The implementation of a robust visual inspection qualification program and clear “Visually Clean” inspection parameters can enable visual inspection to be used to qualify equipment in lieu of swab analysis for low risk products.

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