The Pharma Report | Feb 2019


Save money by using bracketing and matrixing

The process of validating a stability claim can be a very costly and time-consuming exercise.  Therefore, it is important that a significant amount of thought be put into the study design.  When appropriate, one also needs to take advantage of acceptable methodologies for reducing the overall cost of these studies.  This article will summarize FDA Guidance on “Q1D Bracketing and Matrixing Designs for Stability Testing of New Drug Substances and Products”.  The of use bracketing and matrixing is an approach used by manufacturers in many industries, including the pharmaceutical industry, to reduce the costs of stability studies.

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Stability Study Services

Confirming a stability claim for a drug product is an essential, yet expensive and time-consuming exercise.  At DYNALABS, we strive to use our extensive experience and knowledge of industry guidance, to minimize the significant costs associated with this exercise.  We begin by working with our client to organize their products into families by active and formulation.  We then use Bracketing and Matrixing and our comprehensive knowledge of the inherent stability characteristics of medications, to design cost effective, yet comprehensive stability programs.  Contact us now to learn how you can start saving today.

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Deployed Enhancements

DYNALABS recently deployed many enhancements to our website, which is designed to make the sample submission process more straightforward and stream lined for sending in New Products, and overall, lead to a better experience when testing with DYNALABS.

Below are the features/updates from our latest deployment. 

  1. Changes in Rush Options—For New Compounds, only second day Rush will be available.  This is due to the extra time required to review  and accurately build your compound prior to testing.
  2. New Compound/New Product Information – In order to  further improve the process of getting your new compound/product “built” in our system, we now offer an option to upload your formula worksheet upon submission.  There is also a box in which to indicate other product specific information, such as NDC number and salt form.  This will cut down on any delays in getting your new compound set in our system.
  3. Unknown Compound/Product Information– In order to expedite the receiving process for “unknown” samples, there are several boxes available to describe what the client believes the compound to be (these types or samples are generally samples that are suspected to be diverted and therefore the final concentration is “unknown”).  The additional information given will allow  us to better determine what  to test.
  4. Volume Requirements for Labels – We are now requiring that all container labels for products sent to DYNALABS include the volume of the sample.
  5. Time Study Storage Fee – All non-quoted time studies will receive a storage fee equal to $1/day of storage per lot.
  6. Investigation Reports – Investigation Reports will be available while in process, via sample tracking.  The final investigation Reports will now be electronically signed.
  7. Password Security – The DYNALABS website will lock user accounts after 5 incorrect log-in attempts.  The client will need to contact their customer service representative to “unlock” the account.  Reset password link will be available for 24 hours.  This feature allows for increased security and compliance with 21 CFR Part 11.  Restrictions must be in place to prevent unauthorized access.

We welcome our new Southwest Regional Business Manager

Shawn Bills will manage and grow the Southwest Region. Shawn has over 20 years of experience in pharmaceutical sales and medical device sales and is a graduate with a Bachelor of Arts degree in Speech Communication from the University of St. Thomas in St. Paul, MN.

Welcome to our new Micro Manager

Justin Camillo comes to DYNALABS with 13 years experience in positions from Chemical Technician, to Forensic Scientist and spent the last 4 years working as Laboratory Director. Justin holds a Bachelor of Science Degree in Molecular and Cellular Biology from the University of Illinois, Champaign-Urbana.


Promotions to:

Sr. Manager of Chemistry Operations – Katie Lampe

Marketing Technical Services
Marketing Technical Services Supervisor – Ryan Flint
Marketing Technical Specialist I – Michael Shore

Sample Managemisent
Sample Management Supervisor – DJ Ballance-Wiechman

OOS Supervisor – Mark McCabe



notable dates

Look for us at these conferences and shows. (We’ll be adding dates through the year.)

National Home Infusion Association
03/09/19  | Orlando, FL

Kansas Council of Health-System Pharmacists

04/05/19 | Lawrence, KS

Texas Society of Health System Pharmacists

04/12/19 | Frisco, TX

International Academy of Compounding Pharmacists

05/18/19 | Washington DC HCP

Health Connect Partners Spring
05/06/19 |  Miami, FL | Booth (409)

Ohio Society of Health-System Pharmacists-
Annual Meeting • 05/06/19 | Columbus, OH

National Board of Pharmacy

05/16/19 | Minneapolis, MN FSHP

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