Tell me about Gibraltar Labs – Microbiology services you provide, your experience, and technical capabilities.
Gibraltar Laboratories was founded by Dr. Herbert N. Prince and is currently lead by Dr. Daniel Prince. Gibraltar Laboratories has been an industry leader for over 45 years providing world class independent testing for analytical chemistry, microbiology, molecular biology, sterilization and many other services. Offered among these services are a plethora of compendial and noncompendial testing methodologies including, but not limited to, sterility, LAL/endotoxin, microbial limits, antimicrobial efficacy, bioburden, environmental monitoring, antibiotics, analytical chemistry, custom/special projects and many more. Recently, Gibraltar Laboratories launched its first product, the SteriKit®. This kit is strategically geared towards any industry that requires sterile, endotoxin and particulate free pharmaceutical grade vials, seals and stoppers in a convenient and clean room ready package.
The controversy pertaining to low recovery of purified endotoxin (CSE) and natural endotoxin (NOE) now dominate BET discussions. Does this recovery problem impact the work in your setting, and have you lost confidence in an LAL reagent being able to detect endotoxin in a pharmaceutical contamination event?
Studies confirm that some pharmaceuticals may inhibit the detection of endotoxin in an undiluted form. However, currently testing of the product final dilution is acceptable by industry standards; therefore this problem does not impact our current work settings as we have validated many of our products in a set dilution. Low endotoxin recovery phenomenon does raise a question for many of us in the industry and more research needs to be emphasized on this should spiking studies be a requirement for detecting endotoxin in an undiluted product.
Most BET labs use a kinetic LAL method and an incubating microplate reader for endotoxin testing. Do these methods have substantial limitations that warrant the development of new endotoxin test technologies?
Gel Clot, Kinetic Chromogenic and Turbidimetric are 3 of the current USP methods that are used industry wide. Endotoxin is a sensitive test and it is best detected at the optimum temperature of 37°C. New methods can be developed, keeping temperature in mind and as long as they are shown to be equivalent to current methods being used it should not have substantial limitations.
Do your routine test methods enable you to meet most or all of your BET responsibilities?
All endotoxin testing done at Gibraltar Laboratories starts with method validation, either by agreed protocols or method development to overcome any issues prior to doing routine testing. This ensures that all of the routine testing we perform meets industry standards.
Do you believe that inhibition problems in the BET are a significant limitation of LAL reagent? Is glucan enhancement a limitation in your lab?
Most of the inhibition can be overcome during product validation by using additional reagents available in the market. An appropriate reagent to be used can be determined by having detailed product information to help narrow down the source of inhibition or enhancement. Additional reagents can also help with glucan enhancement in most products and this can be determined during initial product validation.
Do LAL reagents have sufficient sensitivity to meet your BET responsibilities?
We offer both Gel Clot and Kinetic Chromogenic method for our clients testing needs each of which has different detection limit. A detection limit of <0.005 EU/mL is currently sufficient to meet our requirements.
Do you believe that BET labs should use quantitative BET, whenever possible, instead of over-the-limit testing?
Yes, a quantitative method is preferred over a qualitative method. A quantitative method is also most suitable in monitoring product performance though life cycle as this could easily detect spikes or trends in a product.
Have the FDA and other regulatory/advisory agencies provided meaningful insight and guidance to industry detailing what they need to see regarding endotoxin testing and detection studies?
Most of the research and supporting documentation data are provided from reagent manufacturers who have gone into great detail explaining the methods, issues and solutions. With evolving markets and technologies, input from the agency will be much needed.
What is the role of technology and service providers to assist in the testing and detection of endotoxins? Are they viewed as partners? Are they driving the technology forward?
As a testing lab we have to partner with our clients to meet their testing needs. Reagent manufacturers will also provide support needed to meet our needs. To keep driving the technology forward, all must move forward as partners.
What sets Gibraltar Labs apart from other providers of similar services?
Gibraltar has a lot of advantages that set us apart from our competition. Most importantly, our customers appreciate our experience, quality, turn-around-time, pricing, flexibility, attention to detail and customer service. Not only do we offer one-stop-shop testing and sterilization services, but we harbor the scientific insight and problem solving skills to offer our customers the highest scientific integrity with any test they desire. This dedication to scientific excellence is engrained within Gibraltar’s culture and is further exemplified within the leadership of the company. Gibraltar was founded by and is currently lead by PhD level and expertly trained scientists. In addition, most of our competitors do not offer sterilization services. We take pride in not only being an industry leader in microbiology and chemistry testing, but also being a leader in sterilization services. Gibraltar offers contract moist and dry heat sterilization services to support a variety of products and industries ranging from medical devices, vials, stoppers, stainless steel components and even pre-filled vials or syringes. Our sterilization services department offers full support; from method development to validation to routine processing as well as offering continuity programs and support to customers who may require redundancy.
How should potential clients evaluate suppliers of microbiology services? What are some important questions to ask, and what are some “must have” technical capabilities?
Potential clients should evaluate microbiology testing laboratories according to their particular needs. Many of the routine microbiology and chemistry tests are not novel techniques and have been well defined for many years. If a client’s primary focus is to find a testing laboratory to perform a routine sterility or endotoxin test as cheaply as possible, there are plenty of laboratories that can do it. At Gibraltar, we don’t want our clients to view us as just another testing laboratory. We want our clients to view us as partners to their manufacturing process and as an extension of their quality team. Similarly, our scientific knowledge and experience extends far beyond following a protocol and allows us to offer creative scientific and regulatory backed solutions to our clients that other laboratories may not be able to do. Our technical services, testing and quality teams often work closely with our clients to ensure their testing needs are satisfied. Occasionally, clients are unsure of certain testing requirements and or regulations and therefore rely heavily on Gibraltar’s competent and experienced staff to appropriately offer support and guidance. Gibraltar recognizes that our clients are busy and are primarily focused on manufacturing. We feel it is our duty to understand their needs and to help them figure out what testing they need performed and to execute that all as quickly and easily as possible. Our experience with this approach has ultimately lead to strong and trusted partnerships between Gibraltar and our clients and is one of the many reasons that the majority of our customers continue to do business with us year after year.
A must have technical capability for a testing laboratory like Gibraltar is the ability to be flexible and continue to offer new and updated services and support to our clients. As regulations and technology advance, so do the sponsors needs and expectations. This is why Gibraltar’s regulatory and leadership team remain on the forefront of innovation. A recent example of this is our addition of a Rapid Sterility testing system. Gibraltar is proud to announce that we are currently the first and only contract testing laboratory that is able to release compendial quality sterility testing results in as few as 5 days (compared to 14 traditionally). Gibraltar will continue to invest in our technical capabilities in order to help our clients gain a competitive edge over their competition without sacrificing product quality.
What changes do you foresee in the next decade for endotoxin testing?
Definitely the development of more rapid and better detection limits will be in the works. Research may place more emphasis on the detection of endotoxin in an undiluted pharmaceutical product.