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Biophia consultants have routinely been invited to give presentations or write articles on key issues within the biopharmaceutical field.  We contine to share many of these with our customers to help provide insight into how these concerns may affect your business and strategies for addressing them.  We invite you to utilize these resources provided and to contact us for further information on any of these areas.

Featured Articles and Presentations

Implementing a Quality by Design Program for Drug Product Development

Implementing these principles into the pharmaceutical culture can be challenging.  QbD involves a complex set of interactions, technologies and systems that are not easy to grasp.  The following presentation outlines the important concepts needed to implement a practical QbD program.



Outsourcing Manufacturing and Analytical Needs in the Biopharmaceutical Industry


    Outsourcing Manufacturing and Analytical Needs in the Biopharmaceutical Industry    S. Anne Montgomery, with Jeff Staecker
BPI’s editor in chief spoke with Jeff Staecker, principal consultant at BioPhia, about his view of current outsourcing trends. Those identified in this discussion set the stage for the articles that follow. Issues that affect decisions to outsource include cost, converging quality systems, change management, and staff training/expertise (including statistical capabilities).


Making Decisions with Probability Distributions

    Making Decisions with Probability Distributions

   An overview of 13 continuous and 5 discrete probability distributions useful for risk assessment and other applications. Includes a description of the probability density, cumulative distribution, and quantile functions of each as well as MS Excel formulae for their evaluation. Methods for generating random samples from these distributions and some additional MS Excel matrix algebra capabilities are described.



CASS Midwest Discussion Group, June 2016

   Biopharmaceutical Method Transfer as Part of the Quality System   How can a risk based approach to method transfer and integration of the method transfer process into the larger quality system allow for greater assurance that the transfer does not impact drug safety not only at the time of transfer, but also in the lifecycle management of the drug? 
                  Abstract
                  Presentation




CMC Strategy Forum Summer 2015 Highlights
  

Highlights of CASSS CMC Forum "The Evolution of the Biopharmaceutical Control Strategy through Continued Process Verification"   What are current thoughts on continuous process verification (CPV), statistical process control (SPC), and systems to monitor and respond to data monitored?  How does this relate to QbD and product specifications?


Statistical Process and Control - Background and Application
   Overview of Statistical Process and Control   An overview of statistical process and control that can be used for SPC training and Biopharmaceutical SPC training.  The presentation covers areas including Process Monitoring, Method Monitoring, Continuous Process Verification, and Quality Metrics.

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