Microdosing has been used as an investigative pharmacokinetic tool for approximately 10 years. Initial skepticism of the value of these studies was followed by investigative clinical trials to understand the circumstances when they provide useful data and this has led to routine use. When first introduced, accelerator mass spectrometry coupled with LC fractionation (LC+AMS) was the only technology that could provide the sensitivity required for these studies. Over the years, LC-MS/MS sensitivity has improved so that it is now viable to use this technique for microdosing studies, and a decision needs to be made on what technique to use.

To download a copy of this poster presented at the “7th Workshop on Recent Issues in Bioanalysis” (7th WRIB), please follow the link below.

(Germantown, MD, USA; March 19, 2013) – Xceleron, a leader in the design and use of ultra-sensitive Accelerator Mass Spectrometry (AMS) in novel clinical investigations, has announced a partnership with JCL Bioassay, a leader in the use of highly sensitive LC-MS/MS and proprietary methodologies. The new partnership will offer drug developers access to the broadest range of sensitive and robust analytical platforms in early clinical development across Asia, Europe and N. America.

Phase 0 and enriched Phase 1 studies have been used successfully in recent years to investigate a range of developmental endpoints including drug presence at the tissue or cells of interest, absolute bioavailability and human metabolism. Investigations of this type conducted early in drug development allow confident critical decision-making that offers a very cost-effective alternative when compared to later stages of clinical development.

The partnership between Xceleron and JCL Bioassay will provide access to clinical design expertise and the most appropriate analytical platform for the purpose of early clinical investigation. Xceleron and JCL Bioassay have between them developed over 100 analytical methods for Phase 0 and enriched Phase 1 investigations and both companies have recently built, equipped and staffed laboratories specifically for the purpose of ultra-low level analyses under GLP and GCP conditions.

“This partnership emphasizes the critical role of contemporary analytical platforms in driving down the cost of drug development. Whether in Phase 0 or enriched Phase I, we can confidently provide critical PK and PD information before Phase II” said Dr Michael Butler, CEO of Xceleron.

“With 27 years’ experience in providing services for bioassay work coupled with-state-of-the-art analytical instruments, our researchers are well positioned to conduct ultrasensitive bioanalyses. This has led to the continuous growth of our company as a leader in the bioanalytical field and enables our customers to make rapid and precise decisions on their drug development programs. The partnership with Xceleron further expands the geographic and technological scope of the services we can provide to our customers and promotes the use of these cutting-edge analytical platforms to detect low level analytes in early drug development” said Jenny Lin, Vice President of Operations and CSO of JCL Bioassay USA, Inc.

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About Xceleron
Xceleron provides bioanalytical AMS services for accelerated early drug development. The company pioneered human microdose and microtracer techniques using ultra-sensitive AMS to investigate the pharmacokinetics and metabolism of developmental drugs in Phase 0, Phase I and Phase II/III clinical trials. It has been providing drug development services for more than 10 years and has conducted more GLP and GCP studies than any other analytical service provider of its type. Visit Xceleron at www.xceleron.com.

About JCL Bioassay
JCL Bioassay USA, located in Hoffman Estates, IL, is a leading Japanese CRO and a global provider specialized in Bioassay services in support of TK/PK studies for pre-clinical and clinical developments. The company provides cutting-edge capabilities and sophisticated expertise in Bioanalytical method development, method validation/qualification and study sample analysis for small and large molecules. The company also pioneered microdosing analysis in Japan. As a strategic drug development partner, JCL Bioassay USA helps sponsors to overcome challenges in Bioanalysis with expertise, rapid turn-around-time and high quality services. For more detailed information, visit JCL Bioassay USA at www.jclbiousa.com.

Non-optimized or incomplete pharmacokinetic analyses commonly result in additional expenses and lost time over the course of a development program; such problems frequently become evident during expensive proof-of-concept investigations. Thoroughly understanding the pharmacokinetics of a drug or biologic in clinical Phase I studies allows investigators to make decisions earlier. Phase I pharmacokinetic investigations must be properly designed to ensure that their results will translate into proof-of-concept and must be conducted in a cost-effective manner.

The partnership between Xceleron and Kinetigen is ideally suited to provide powerful and cost-effective investigations of Phase I drug pharmacokinetics. Kinetigen specializes in complex pharmacokinetic analyses and overall clinical pharmacology strategy. Xceleron uses Accelerator Mass Spectrometry (AMS) to gain analytical insight across a broad range of asset classes and matrix types. Together, Xceleron and Kinetigen leverage a conventional Phase I approach to expand the knowledge base and value of intellectual property before the onset of expensive late-phase clinical investigations.

“At Xceleron, we believe that technology can get life-changing drugs to people who need them, sooner and at a lower cost. This partnership with Kinetigen will help our clients do that by efficiently and cost-effectively answering critical questions earlier,” said Dr. Michael Butler, CEO of Xceleron.

“Our partnership with Xceleron is very synergistic,” said Dr. Geoffrey Banks, CEO of Kinetigen.  “Matching Kinetigen’s pharmacokinetic expertise with Xceleron’s AMS technology is a ‘win-win’ situation for clients seeking more robust options for analysis and interpretation of Phase 1 PK data.”

About Xceleron

Xceleron provides bioanalytical AMS services for accelerated early drug development. The company pioneered human microdose and microtracer techniques using ultra-sensitive AMS to investigate the pharmacokinetics and metabolism of developmental drugs in Phase 0, Phase I and Phase II/III clinical trials. It has been providing drug development services for more than 10 years and has conducted more GLP and GCP studies than any other analytical service provider of its type. Visit Xceleron at www.xceleron.com.

About Kinetigen, Inc.

Kinetigen, Inc. is a clinical pharmacology consulting firm specializing in pharmacokinetics. Fast becoming the pharmaceutical industry’s go-to resource for pharmacokinetics, Kinetigen gives pharmaceutical companies and CROs rare access to a hands-on team of leading clinical pharmacology and pharmacokinetics professionals experienced in many different therapeutic areas. We embrace the notion that simplicity and clarity lead to good decisions by taking complex pharmacokinetic principals and making them understandable and usable for common sense drug development. Kinetigen’s flexible business structure enables us to integrate with our clients and help them maximize the potential of clinical pharmacology studies and pharmacokinetics analyses to pave the way toward marketing approval. For more information visit www.kinetigen.com.

Email us now or call us at +1 240 361 1900

Xceleron’s use of Accelerator Mass Spectrometry (AMS) technology delivers solutions and insight for a range of pharmaceutical and biobased challenges.

“At Xceleron, we believe that technology can improve the lives of people by bringing them better products faster and cheaper. We recently became ISO17025 accredited and certified to ASTM D6866. Now our technology is made available to Intertek’s international client base” said Dr. Michael Butler, CEO of Xceleron.
Dr. Ruud Overbeek, Vice President, Global Health, Environmental and Regulatory Services for Intertek said “Xceleron’s technology is an excellent addition to the suite of services Intertek supplies to manufacturers of bio-based, renewable products. Adding this special technology to our complementary services portfolio will address our customer’s demand for ensuring their products are truly eco-friendly and sustainable”.
About Xceleron
Xceleron is an A2LA ISO/IEC 17025:2005 (Certificate # 3411.01) Accredited ASTM D6866 Testing Laboratory. Xceleron provides biobased Accelerator Mass Spectrometry (AMS) testing services to determine the renewable carbon content in a wide range of biobased products for the consumer, household, plastics and biological fuels industries. Xceleron also provides bioanalytical AMS services for the pharmaceutical and biotechnology industries. The company pioneered human microdose and microtracer techniques using ultra-sensitive AMS to investigate the metabolism and pharmacokinetics of developmental drugs in human clinical trials, and has been a leading AMS service provider for more than 10 years. Visit www.xceleron.com
About Intertek
Intertek (ITRK.L) is a leading provider of quality and safety solutions serving a wide range of industries around the world. From auditing and inspection, to testing, quality assurance and certification, Intertek people are dedicated to adding value to customers’ products and processes, supporting their success in the global marketplace. With a network of more than 1,000 laboratories and offices and over 33,000 people in more than 100 countries, Intertek helps its clients to meet end users’ expectations across increasingly diverse quality, health, environmental, safety and social accountability aspects in virtually any market around the world. Visit www.intertek.com

(Germantown, MD, USA; January 22, 2013) — Xceleron, a U.S.-based leader in the application of ultra-sensitive analytical technology to novel clinical designs, has announced a partnership that will offer drug developers early bioavailability data that will lead to optimized solid-state forms and formulations. The partnership with Crystal Pharmatech, a China-based, technology-driven, solid-state research CRO, will enable sponsors to make faster decisions in the early stages of development.

Contemporary small molecules represent a challenge in translational development due to their physicochemical properties and the low predictivity of traditional nonclinical biological models. Too frequently, drug efficacy suffers because of poor pharmacokinetic properties.
The partnership between Xceleron and Crystal Pharmatech provides a solution. They combine the accelerator mass spectrometry (AMS) technology with the expertise to cost-effectively remove pharmacokinetic uncertainty by providing better early clinical and solid state information. This enables their customers to make better decisions sooner about a candidate’s later-stage readiness.

“At Xceleron, we believe that technology can get life-changing drugs to people who need them, sooner and at a lower cost. This partnership will help our clients do that by efficiently and cost-effectively answering critical questions earlier,” said Dr. Michael Butler, CEO of Xceleron.

“Having robust bioavailability and pharmacokinetic data at the outset provides a strong foundation for determining the best solid form and formulation,” added Dr. Alex Chen, CEO of Crystal Pharmatech. “Each company brings significant expertise to the discussion of novel clinical outcomes.”

About Xceleron

Xceleron provides bioanalytical AMS services for accelerated early drug development. The company pioneered human microdose and microtracer techniques using ultra-sensitive AMS to investigate the pharmacokinetics and metabolism of developmental drugs in Phase 0, Phase I and Phase II/III clinical trials. It has been providing drug development services for more than 10 years and has conducted more GLP and GCP studies than any other analytical service provider of its type.

The presentation addresses questions on scaleability of microdose study designs, as well as demonstrating how the approach, used in conjunction with AMS, can be used to address questions about a drug’s efficacy by investigating disposition to target tissues and cell types.

Presenters / Speakers

Dr Graham Lappin