Risk-Based Approach to Method Transfer

Jeffrey Staecker, PhD (jstaecker@biohpia.com)      BioPhia Consulting, Inc., November 1, 2018

An article summarizing the CMC Forum “Methods on the Move: Addressing Method Transfer Challenges for the Biopharmaceutical Industry” was recently published in BioProcess International and can be found at https://bioprocessintl.com/business/cmc-forums/methods-on-the-move-addressing-method-transfer-challenges-for-the-biopharmaceutical-industry/.   The article summarizes various ideas and approaches to test method transfer.

I was fortunate to both co-chair and present at this Forum where I focused on using a “Risk-Based Approach to Method Transfer”.  My presentation can be found on the BioPhia website (BioPhia website link inserted here).  Some key principles from my presentation include:

  • Method transfers can introduce changes in bias and/or precision.
  • The commonly employed risk tool of FMEA (Fault Mode Effect Analysis) can be utilized in evaluating the risk of method transfer.
  • The risks associated with method transfers are impacted by how “close to the edge” the process as measured by current testing is running. That is, a centered process with results far away from specifications is less at risk than a process being measured as running near a specification extreme.
  • Many companies use Cpk to monitor processes which can be leveraged to predict probability of errant results from introduction of bias and/or imprecision.
  • A statistical approach can be devised to ensure that only an acceptable level of bias/imprecision is introduced during method transfer.
  • After transfer, appropriate SPC (statistical process control) monitoring can ensure that method at receiving site continues to operate within pre-defined limits.

An alternative to method transfer is to use the identical statistical approach for all method transfers regardless of process/method performance.  The danger of this approach is to introduce a small amount of bias or imprecisions that passes method transfer criteria but results in inappropriately passing or failing material.  I personally experienced this when a method was transferred for a process running at the high end of the specification range.  The method transfer introduced a small bias (less than 2%) that resulted in inappropriately failing drug product.

21 thoughts on “Risk-Based Approach to Method Transfer

  1. I browsed through this website and there is so much handy info, bookmarked 🙂
    [url=http://college-admissionapplications.blogspot.com/2013/11/hammurabi.html]term paper help[/url]
    in essay
    basic essay structure
    [url=http://argumentativeessaysforsale.blogspot.com/2014/01/generation-of-electrical-power-using.html]education essay[/url]
    [url=http://personalstatementcollegeapplication.blogspot.com/2013/12/illegal-drugs-in-bahamas.html]english essay format[/url]
    [url=http://commonapplicationforcollege.blogspot.com/2014/01/compare-and-contrast-essay-on-babe-ruth.html]college essay help[/url]
    essay services
    mba essay writing
    [url=http://paper-write-help.blogspot.com/2013/10/the-roswell-mystery-what-was-truth.html]term paper outline[/url]
    [url=http://personalpaperforcollege.blogspot.com/2016/10/world-population-density.html]research paper topics[/url]

  2. StivenSortgaw says:

    She sent me the first draft in accordance with the deadline, but I was not satisfied with the result, so I asked her to revise the work. After a couple of unsuccessful attempts, she could provide a good draft. Fortunately, they have no limits on free revisions. Read more in Edubirdie review

  3. Thanks for helping people find the info they need. Great stuff as usual. Keep up the great work!!!
    science research paper
    sample essay
    marketing research paper
    best essay for you
    english essay topics
    a good essay
    law essay writing service
    essay writing service reviews
    simple essay format
    research paper writing service
    compare and contrast essay
    essay writing pattern
    university essay
    writing a research paper
    essay title
    essays online
    how we write essay
    buy essay online
    how to write a well written essay
    essay writing rules
    coursework help
    essay writing skills
    academic writing
    essay topics
    apa research paper
    persuasive essay samples
    writing paper
    professional essay writing services
    perfect essay
    what does essay mean
    term paper writing
    how to write an essay
    sociology research paper
    admission essay examples
    scholarship essay
    cheap essay writing service
    cheap essay writing
    effective essay writing
    essay writing structure example
    easy essay writing
    how to write a good essay
    how to right a good essay
    research term paper
    argumentative essay topics
    all essay in english
    term paper example
    do my essay
    college essays
    steps to write an essay
    essay sites
    persuasive essay examples
    essay writing
    how to make essay writing
    how to make essay writing
    pay to write essay
    how can we write an essay
    essay writers
    research papers online
    what is essay writing example
    mba essay
    university essay
    essays online
    essay writing software
    mba admission essay
    best essay writing service
    how to write a essay paper
    business essay
    argumentative research paper
    dissertation topics
    pay to write essay

  4. StivenSortgaw says:

    Maybe, I just had a bad luck, but I cannot recommend EduBirdie. I am sure there should be other writing services that can provide quality essays and research papers. So, if you need writing help, don’t lose hope and just find a better website where you can place an order.edubirdie review

  5. StivenSortgaw says:

    From my interactions with the company and the Paramount Essays paramountessays review on their site, I am convinced that you can rely on them. They give guarantees that include plagiarism-free work, qualified MA and Ph.D. writers, 24/7 customer support, no hidden charges, confidentiality, money back guarantee, and timeliness.

Leave a Reply

Your email address will not be published. Required fields are marked *

You may use these HTML tags and attributes:

<a href="" title=""> <abbr title=""> <acronym title=""> <b> <blockquote cite=""> <cite> <code> <del datetime=""> <em> <i> <q cite=""> <s> <strike> <strong>