Case Studies

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  1. Design of Experiments Improves Peptide Bond Yield from 20% to 76%

    February 2018

    Researchers worked to fine-tune the conditions that best promote peptide bond formation in an uncatalyzed aqueous phase reaction. We felt that we should be able to obtain a better yield than our initial 20% and had a hunch that one or more interactions between variables might be playing a role that was obscured by the OFAT method.

    Authors: Professor Palwinder Singh & Dr. Manpreet Singh Bhatti
    Publication: Laboratory Focus
  2. Design of Experiments Improves Throughput of Key Intermediate

    December 2017
    This article explains how Codexis developed the manufacturing process for (2S, 3R)-Epoxide (1), a key intermediate used in the production of Atazanavir (marketed as Reyataz), an antiretroviral drug used to treat human immunodeficiency virus (HIV).
    Authors: Jerry Fireman
    Publication: Express Pharma
  3. DOE Reduces Bioequivalent Generic Development Time to 4 Months

    July 2016

    A generic pharmaceutical manufacturer recently hired VerGo Pharma Research Laboratories Pvt. Ltd to develop a bioequivalent with different polymorphic forms for an anti-depressant drug that had previously been patented in crystalline form only. Bioequivalence requires that a drug be pharmaceutically equivalent and that it be delivered at the same rate and same level of bioavailability so that its efficacy and safety can be expected to be the same as the original product. By using design of experiments (DOE) to reduce the number of tests required (to determine the effects of inactive ingredients on bioavailability in both fed and fasting conditions), VerGo was able to cut the development process from several years to only four months.

    A variation of this case study was also printed in R&D magazine, July 2016, as Scientists Develop Bioequivalent Drug in Months instead of Years.

    See also How Design of Experiments Can Improve Formulation Development by Jerry Fireman, March 2016, Scientific Computing magazine.

    Authors: Subrata Kundu
    Publication: Pharmaceutical Manufacturing
  4. How to Properly Size Response Surface Method Experiment (RSM) Designs for System Optimization

    March 2016
    By sizing experiment designs properly, test and evaluation (T&E) engineers can assure they specify a sufficient number of runs to reveal any important effects on the system. For factorial designs laid out in an orthogonal matrix this can be done by calculating statistical power (Anderson and Whitcomb, 2014). However, when a defense system behaves in a nonlinear fashion, then response surface method experiment (RSM) designs must be employed (Anderson and Whitcomb, 2005). The test matrices for RSM generally do not exhibit orthogonality, thus the effect calculations become correlated and degrade the statistical power. This in turn leads to inflation in the number of test runs needed to detect important performance differences that may be generated by the experiment. A generally acceptable alternative to sizing designs makes use of fraction of design space (FDS) plots. This article details the FDS approach and explains why it works best to serve the purpose of RSM experiments done for T&E.
    Authors: Mark J. Anderson, Wayne F. Adams, Pat J. Whitcomb
    Publication: ITEA Journal
  5. DOE Improves Throughput in Manufacturing of Key Intermediate

    July 2013

    Researchers improved the performance of an isolated ketoreductase (KRED) enzyme using directed evolution, and also performed two stages of design of experiments (DOE) to identify and optimize key process variables.

    Authors: Collier, Ph.D., Steve
    Publication: Pharmaceutical Manufacturing
  6. Design of Experiments Helps Increase Yield of Pharmaceutical Intermediate from 70% to 88%

    May 2012

    Researchers at Codexis Laboratories Singapore performed a full-factorial designed experiment with 20 runs to determine the impact of four independent variables on product selectivity during a silylation reaction. The result was a process that delivered 95% selectivity along with an 88% yield

    Authors: Collier, Wilson
    Publication: Pharmaceutical Manufacturing
  7. Framing a QbD Design Space with Tolerance Intervals

    May 2012

    Given the push for Quality by Design by FDA and agencies worldwide, statistical methods are becoming increasingly vital for pharmaceutical manufacturers. DOE is used to determine the impact of multiple factors and their interaction.

    Authors: Anderson, Mark J.
    Publication: Pharma Qbd
  8. Using DOE with Tolerance Intervals to Verify Specifications

    March 2012

    Statistical methods are becoming increasingly vital for pharmaceutical manufacturers. Design of experiments (DOE) is a primary tool for determining the relationship between the factors that have an effect on a process and the response of that process.

    Authors: Whitcomb, Patrick J., Anderson, Mark J.
    Publication: Stat-Ease, Inc.
  9. Design-Expert Diagnostics Saves Experiment (and Post-Grad Student)

    August 2011

    Design-Expert's features for checking design properties including diagnostics helped a student achieve a valid analysis

    Authors: Mullenix, Paul
  10. What to look for in Statistical Software for the Pharmaceutical Industry

    January 2011

    This article discusses what to look for in DOE software in the pharmaceutical industry.

    Authors: Anderson, Mark J.
    Publication: Pharmaceutical Manufacturing
  11. Using Design of Experiments to Optimize Chiral Separation

    September 2010

    This article discusses what to look for in DOE software in the pharmaceutical industry.

    Authors: Roche
    Publication: Pharmaceutical Manufacturing
  12. Switch to a Double-Sided Tablet Press Solves Powder Sticking Problem

    July 2010

    Schiff Nutrition used DOE to solve an intermittent problem with a multimineral tablet sticking inside the dies of a high-speed rotary tablet press

    Authors: Schiff National
    Publication: Healthcare Packaging
  13. Practical Considerations for DoE Implementation in Quality By Design

    June 2010

    This article takes a look at the different things that should be considered when implementing DOE in Quality By Design.

    Authors: Shivhare, Mahesh and McCreath, Graham
    Publication: BioProcess International
  14. The Application of Statistical Design of Experiments for Mathematical Modeling of a Bacterial Cell Culture Process

    September 2009

    DOE was used to determine the statistically significant factors affecting the growth of an E. coli cell line in shaker flasks.

    Authors: Elhanafi, Drissand and Carey, Jim
    Publication: NCSU Bioprocessing and Process Development Symposium
  15. Design of Experiments Helps Optimize Cell Culture Bioproduction System

    August 2009

    To handle numerous variables Invitrogen Corporation utilized design of experiments (DOE) methods to reveal a complicated array of multi-factor interactions involved in bioprocess development.

    Authors: Invitrogen
    Publication: BioProcess International

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