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American Preclinical Services: Extractables and Leachables Program

November 12, 2018

APS is a State of the Art, AAALAC and ISO17025 accredited, USDA registered and GLP compliant Contract Research Organization (CRO) located in Minneapolis, MN specializing in medical device and pharmaceutical testing. In addition to biocompatibility testing, interventional, surgical, toxicology, pharmacology, pain, physician training, bioskills, animal model development, and complete pathology services, APS has expended its services to include analytical services. The analytical laboratory is equipped with state-of-the art instrumentations and exceptional personnel expertise. It provides a full range of analytical services to facilitate integration and overlapping of various study components such as pharmacokinetic, toxicology, biocompatibility, quality control, stability studies, purity and impurity characterization and profiling, leachables and extractable from raw materials, in process and finished products, container closure, implantable medical devices, drug carriers, drug delivery systems, manufacturing process, packaging materials, particulate characterization, etc.

One of the main area of expertise of the Analytical Services is the characterization of Extractables and leachables following recognized industry and FDA guidelines. A recent market survey conducted by rootanalysis.com has recognized APS as a leader in extractables and leachables per the link and excerpts as shown: https://www.rootsanalysis.com/reports/view_document/extractables-and-leachables-testing-services-market-2018-2028/220.html

“Extractables and Leachables Testing Services Market, 2018-2028

The research and insights presented in this report are backed by a deep understanding of key insights captured from both secondary and primary research. The experts in this domain whom we interviewed include Cheryl Johnson (Commercial Development Manager of Biotechnology, Alcami), Mike Ludlow (Technical Study Manager Drug Development Services, LGC), Mourad Rahi (Director of Analytical Services, American Preclinical Services) and Roger Pearson (President of Analytical Services, Aspen Research).

During our research. We identified over 100 players offering a wide range of extractables and leachables testing services for a variety of pharmaceutical products (such as parenteral formulations, ophthalmic formulations, inhalation drugs, oral solutions and topical or transdermal products), medical devices (such as single use systems, combination products, implants and electronic nicotine delivery systems) and container closure systems. Some players claim to offer services for majority of the products listed above. Examples of such players include (in alphabetical order) American Preclinical Services, Bibra Toxicology Advice & Consulting, Sterigenics, Pine Lake Laboratories, Smithers Rapra and Vimta. It is also worth mentioning that the market is highly fragmented, featuring the presence of several large companies (33%), mid-sized companies (26%) and small-sized companies (41%).

The report features inputs from a number of eminent industry stakeholders. Nanda remarked, “Most of the experts we spoke to mentioned that extractables and leachables testing is one of the relatively faster growing fields in the pharmaceutical industry and is primarily being driven by companies that are making new devices, new drugs, or new packaging systems.” The report features detailed transcripts of discussions held with the following experts:

  • Cheryl Johnson (Commercial Development Manager of Biotechnology, Alcami)
  • Mike Ludlow (Technical Study Manager Drug Development Services, LGC)
  • Mourad Rahi (Director of Analytical Services, American Preclinical Services)
  • Roger Pearson (President of Analytical Services, Aspen Research).”

 

Whether your company is a startup or an established industry leader, our experienced scientific staff has the expertise to meet your research needs and timelines.  Pilot and screening evaluations, feasibility and efficacy testing or ultimately GLP safety studies of the finished product, you will have industry experts to rely on every step of the way.

We strive to deliver comprehensive, yet rapid service with the understanding that in product development, the only constant is change. We’ve tailored our processes, capacity, and customer service to keep up with today’s fast paced business cycles. APS will go from a quote to a ready to implement study design with your time lines in full focus.