March 2018 - In This Issue:
Celebrating 20 years with 20% off

2018 marks the 20th anniversary of ARL Bio Pharma. Over the last 20 years, ARL has developed and maintained healthy and strong collaborations with hospitals, pharmacies, academic institutions, non-profit entities, for-profit organizations, and government entities. 

To thank you for making our success possible, beginning March 26, 2018, ARL is offering customers:
  • 20% off USP <71> Sterility Tests method suitability
  • 20% off USP <61> Microbial Enumeration Tests method suitability
  • 20% off USP <51> Antimicrobial Effectiveness Testing method suitability
This discount is good through December 31, 2018. 

To take advantage of these savings, visit  arlokapps.com to submit samples online or  download ARL's sample submission form. 

Contact ARL for more information 405-271-1144 or  [email protected]  to request a quote. 
ARL Bio Pharma 20th Anniversary
This milestone anniversary celebrates ARL's achievements and incredible culture of our company. "The people are ARL's greatest achievement," stated Dr. Thomas C. Kupiec, President and CEO. " It's an exciting culture.   I am very fortunate to have great leaders. We hire very bright women and men of integrity. We have great employees."

ARL Bio Pharma built its reputation on the same paramount values that still exist today: quality and customer service. Dr. Kupiec said, "When I began the company in 1998, the thought process was return the phone calls and treat people how you want to be treated. Quality and customer service are the values we base our success on. If you treat people how you want to be treated, provide incredible quality service, based on scientific merit, and combine that with great customer service, you'll be successful."
 
ARL started in a 1,500 square foot lab with three employees in Edmond, Oklahoma. Our company relocated to the Research Park in Oklahoma City in 2000. ARL has grown every year and our four laboratory divisions occupy approximately 30,000 square feet of laboratory space with over 130 employees.

We continue to celebrate long-term business partnerships with our valued customers.  We say "Thank you!" and look forward to another 20 years.
Q&A with Dr. Kupiec
Dr. Thomas C. Kupiec, President and CEO

Over the next few months, we will sit down with Dr. Thomas C. Kupiec, President and CEO, for a Q&A to learn more about the evolution of ARL Bio Pharma over the past 20 years.
  1. This year we celebrate ARL's 20th Anniversary, what thoughts come to mind when you think about that? "Wow! Who would have thought?!"
     
  2. What made you start ARL Bio Pharma? "It was serendipitous. We just kind of fell into it. Dr. Loyd Allen indicated there might be an opportunity here so I explored it and sure enough BAM!"
     
  3. Where did you draw inspiration to start and build this business? "Well actually, I'd love to get the credit, but I can't, it's really a God thing. I have been very fortunate to have great leaders. It's exciting to have great people around you. Dr. Nicole Vu, our scientific director, brilliant mind; Vince Bobin came from Pfizer, he's just as sharp as a tack and a great head of operations; and, Brian Kelley that heads up our business development. We have very good people. Tommy Means has been with me for over a decade. He heads up our quality and does an incredible job dealing with external and internal audits that includes all regulatory entities such as the FDA and DEA."
     
  4. In what ways has ARL Bio Pharma grown over the past 20 years? "The diversification of the offerings. We started doing testing of compounded products and very quickly we transitioned into work with innovation, pre-clinical, and pre-formulation. The nice thing about ARL is we've acquired a team of experts that can plug in at different aspects of the drug development process whether it's pre-formulation, formulation, quality control, or even assessment of an issue that may come up after that. That's both for big pharma as well as pharmacy and compounding pharmacies."
     
  5. What is your favorite part about the job? "Every day is different. It's not the same thing any one day."
Join us next month as we continue our Q&A with Dr. Kupiec and dive into what the pharmaceutical and compounding industry looked like 20 years ago.   
Endotoxin Essentials
 Andrew Taylor, Microbiology Supervisor
Gram Negative Bacteria Cell


Pyrogens are a group of fever causing substances.  The most widely known pyrogen is bacterial endotoxins. 

Bacterial endotoxins are:
  • Remnants of bacterial cells that can cause fever, diarrhea, or septic shock in patients  
  • Not removed during filter sterilization
  • Not removed during steam sterilization
  • Not detected by a sterility test
USP <797> requires a Bacterial Endotoxin Test (BET) for:
  • High Risk products prepared in groups greater than 25, except those for inhalation and ophthalmic administration
  • Multiple dose vials prepared for administration to multiple patients
  • Preparations exposed to longer than 12 hours at 2°C to 8°C before sterilization or longer than 6 hours at warmer than 8°C before sterilization
The Food and Drug Administration (FDA) requires a BET for all 503B outsourcing facility drug products reported to be non-pyrogenic. 

Even if it is not mentioned specifically in the regulatory documents, it is important to check for the presence of endotoxins in raw materials, at various points in the compounding process, and in finished products before administering drug to the patient. 

The  limit for the maximum amount of endotoxin allowed to be present in drug substances or drug products can be found in USP monographs, or calculated using the route of administration, patient weight, and maximum bolus dose. Once the limit has been established, the primary test method used to determine the amount of bacterial endotoxins in drug substances and drug products is described in USP <85>.  

Click here to learn more about ARL's BET process. 

Contact ARL for more information 405-271-1144 or [email protected] to request a quote.  

$25 off
Submit this coupon with your next sample for $25 off your next test with ARL. Cannot be combined with discounts or special offers. 
Offer Expires 4/30/2018. (March Newsletter)