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No. I will have other professionals review my work without expense to the client, however I am the only person involved in your project.

Typically, I refer creams and oral dosage issues (tableting & formulation) to other consultants that specialize in those areas.

My background is multifaceted and includes facility design and general arrangement, IQ/OQ/PQ review and analysis, and clean/dirty utility issues.

  • Inventor of mammalian cell fermentation vessel aeration system, currently the critical part of a $440 BB industry segment with 5 million patients per year under treatment.
  • Associate Director for Technical Operations for a Fill/Finish CDMO including formulation and Lyo operations development.
  • Determined failure source at vendor for stoppers, saving $16 MM per year
  • Determined design failure of a stopper processing machine, saving $6 MM per year with new design.
  • Determined software upgrade error, which when resolved generated an extra two batches per week valued at $2 MM per batch. A one keystroke error.
  • Identified potential resolution to product loss during E. Coli cell lysis that generates a 33% improvement in product yield, with a potential industry impact of $1 BB per year in increased revenue.
  • Identified Mammalian Cell Fermentation Vessel design flaw, and patented remedy with likely $40 BB per year impact.
  • Fermentation – mammalian cell, microbial, insect cell, mold, fungi
  • Bench scale to the largest commercial scales
  • Chromatography – Anion/cation exchange, affinity, Protein A, etc.
  • Tangential Flow Chromatography
  • Fill/Finish
  • Liquid, Liquid to lyo, pre-filled syringe, dual chamber

No. I will have other professionals review my work without expense to the client, however I am the only person involved in your project.

Typically, I refer creams and oral dosage issues (tableting & formulation) to other consultants that specialize in those areas.

My background is multifaceted and includes facility design and general arrangement, IQ/OQ/PQ review and analysis, and clean/dirty utility issues.

  • Inventor of mammalian cell fermentation vessel aeration system, currently the critical part of a $440 BB industry segment with 5 million patients per year under treatment.
  • Associate Director for Technical Operations for a Fill/Finish CDMO including formulation and Lyo operations development.
  • Determined failure source at vendor for stoppers, saving $16 MM per year
  • Determined design failure of a stopper processing machine, saving $6 MM per year with new design.
  • Determined software upgrade error, which when resolved generated an extra two batches per week valued at $2 MM per batch. A one keystroke error.
  • Identified potential resolution to product loss during E. Coli cell lysis that generates a 33% improvement in product yield, with a potential industry impact of $1 BB per year in increased revenue.
  • Identified Mammalian Cell Fermentation Vessel design flaw, and patented remedy with likely $40 BB per year impact.
  • Fermentation – mammalian cell, microbial, insect cell, mold, fungi
  • Bench scale to the largest commercial scales
  • Chromatography – Anion/cation exchange, affinity, Protein A, etc.
  • Tangential Flow Chromatography
  • Fill/Finish
  • Liquid, Liquid to lyo, pre-filled syringe, dual chamber