Welcome to The Zlota Company
The Zlota Co., LLC provides services for rapid and robust process development using Quality by Design (QbD) methodology. We customize the use of QbD tools to the specific project objectives, whether in an early or in a late development stage, at various stages of technology transfer to pilot or manufacturing plants, in-house or at contract research organizations (CROs).
Processes that have been successfully developed include drug substance (API) and drug product, reaction and crystallization, as well as micronization projects.
Additionally, analytical method development benefits from the use of QbD tools, in particular the use of statistical design of experiments (DoE).
QbD Implementation
| QbD Method | EARLY Development | LATE Development | Technology Transfer to a Plant |
|---|---|---|---|
| TQPP (Target Quality Product Profile), CQA (Critical Quality Attribute) | As appropriate | Comprehensive | Exhaustive |
| Risk Analysis | Minimalistic | Comprehensive | Exhaustive |
| Screening DoE (Statistical Designof Experiments) | Fit for purpose | Comprehensive | Rarely |
| Optimization (RSM- Response Surface Methodology) DoE | Rarely | Comprehensive | Exhaustive |
| Scale-Up (Down) Calculations, Experiments | NA | Comprehensive | Exhaustive |
| Process Analytical Technology (PAT) | Rarely | Comprehensive | As appropriate |
| Design Space Verification | NA | Comprehensive | Exhaustive |
| Process Validation | NA | NA | Comprehensive |
| QbD Method | EARLY Development | LATE Development | Technology Transfer to a Plant |
|---|---|---|---|
| TQPP (Target Quality Product Profile), CQA (Critical Quality Attribute) | As appropriate | Comprehensive | Exhaustive |
| Risk Analysis | Minimalistic | Comprehensive | Exhaustive |
| Screening DoE (Statistical Designof Experiments) | Fit for purpose | Comprehensive | Rarely |
| Optimization (RSM- Response Surface Methodology) DoE | Rarely | Comprehensive | Exhaustive |
| Scale-Up (Down) Calculations, Experiments | NA | Comprehensive | Exhaustive |
| Process Analytical Technology (PAT) | Rarely | Comprehensive | As appropriate |
| Design Space Verification | NA | Comprehensive | Exhaustive |
| Process Validation | NA | NA | Comprehensive |
While The Zlota Company, LLC made its best efforts in preparing this document, it makes no representations or warranties with respect to the accuracy or completeness of the contents of the document, and specifically disclaims any implied warranties of merchantability or fitness for a particular purpose. The advice and strategies contained herein may not be suitable for every situation. You should consult with a professional where appropriate. The Zlota Company, LLC shall not be liable for any loss of profit or any other commercial damages, including but not limited to special, incidental, consequential or other damages. This document does not represent official guidance or policy of authorities or industry.