Walk us through recent developments in your LAL product offerings.
Associates of Cape Cod, Inc.’s (ACC) fourth generation tube reader, the Pyros® Kinetix Flex, offers the most sensitive bacterial endotoxin test (BET) available for both turbidimetric and chromogenic kinetic methods. In addition to flexibility of test method, ACC offers a choice of 32, 64 and 96 well readers. All of these readers provide the flexibility to add tubes at any time. Unlike a microplate reader, additional samples can be added after a test has been started.
I am also pleased to announce that ACC has recently received US FDA approval for a supplement adding Pyrosate®, our Rapid Endotoxin Detection Kit to our biologics license for Limulus amebocyte lysate reagent for the detection of bacterial endotoxin in sensitivities of 0.03, 0.125 and 0.25 EU/mL.
Discuss techniques for overcoming inhibition and enhancement.
There are a range of strategies for overcoming interference. The most common technique is dilution. The test method is usually substantially more sensitive than is necessary to detect the endotoxin limit, which allows the sample to be diluted to overcome interference. For example, if the sensitivity is 100 times greater than the endotoxin limit (i.e. the maximum valid dilution is 100), the sample can be diluted by a factor of up to 100. In some cases, a particular test method may be less susceptible to interference by a particular product. ACC’s Contract Test Service can develop and validate a test method.
What are the benefits of attending one of your BET workshops?
Our workshops are attended by people ranging from those who have never performed an endotoxin test to those with many years of experience. The workshops are educational, interactive and give hands-on experience conducting LAL tests and learning to read and interpret results.
The benefits of attending our BET workshops include:
- A better understanding of endotoxin and the BET through detailed demonstrations of the test methods including a discussion of laboratory set-up, materials, aseptic techniques, and sample handling/preparation, which can assist in developing a strategy to overcome interference.
- A clear understanding of the regulations and standards applicable to endotoxin testing and the rationale behind them. This helps assure that the appropriate procedures and controls are in place for compliant testing.
ACC also offers a Bioburden, Endotoxin and Sterility Testing (BEST) training program in collaboration with EMD Millipore.
Associates of Cape Cod celebrates its 40th anniversary this year. Discuss some major milestones you’ve achieved since inception.
There have been many milestones over the past 40 years. Obviously the founding of the company in 1974 by Dr. Stanley Watson is the event we are celebrating. Then becoming the first LAL manufacturer to be licensed by the FDA in 1977 was the next important step. Other major events were:
- 1979 – Contract Testing Services are established
- 1985 – Introduced first LAL instrumentation
- 1993 – Became the first LAL manufacturer to offer licensed reagent for all three major test methods
- 2003 – Transitioned global headquarters and manufacturing to our new 80,000 sq. ft. facility
- 2004 – Established Beacon Diagnostics® Laboratory
- 2004 – Fungitell® is cleared by the FDA as an aid in the detection of Invasive Fungal Disease
- 2008 – Offered Pyros® EQS Endotoxin Quantitation Software
- 2010 – Introduced the Pyros Kinetix® Flex Endotoxin Detection Instrument
- 2011 – Launch of enhanced Pyrochrome® chromogenic reagent
- 2014 – FDA license issued for ACC’s Pyrosate® Rapid Endotoxin Detection Kit
Other milestones are listed on our website.
In 1985 Associates of Cape Cod introduced the first LAL instrumentation. How has instrumentation developed since then?
The instrumentation has changed enormously. Firstly, capacity of our tube reader has increased from 20 to 96 wells. Also, reducing the diameter of the reaction tubes increases testing flexibility by allowing for economical tests at a 1:1 reagent to sample volume ratio and an even more economical 1:4 ratio using only 50 μL, as opposed to the usual 100 μL. Our most recent instrument, the Pyros Kinetix® Flex offers dual wavelength capability and can be used with chromogenic as well as tubidimetric reagents. From the start the sensitivity of 0.001 EU/mL has been unbeaten by any other instrument. In addition to the instrumentation, the software used with it has improved beyond recognition. We started with a simple MS-DOS based application and have progressed to the sophisticated database system that we offer today.
So, we have seen an impressive growth in the range of and quality of our products and in the systems used to manufacture them. I think Dr. Watson would be proud. I wish he could see how far we’ve come since our beginnings in his garage.