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Lowes S.,Quintiles | Hucker R.,A4P Consulting Ltd. | Jemal M.,931 Edinburg Road | Marini J.C.,Janssen Research and Development LLC | And 7 more authors.
AAPS Journal | Year: 2014

The A2 harmonization team, a part of the Global Bioanalysis Consortium (GBC), focused on defining possible tiers of chromatographic-based bioanalytical method performance. The need for developing bioanalytical methods suitable for the intended use is not a new proposal and is already referenced in regulatory guidance language. However, the practical implementation of approaches that differ from the well-established full validation requirements has proven challenging. Advances in technologies, the need to progress drug development more efficiently, and emerging new drug compound classes support the use of categorized tiers of bioanalytical methods. This paper incorporated the input from an international team of experienced bioanalysts to surmise the advantages and the challenges of tiered approaches and to provide recommendations on paths forward. © 2014, American Association of Pharmaceutical Scientists.


The 9th GCCClosed Forum was held just prior to the 2015 Workshop on Recent Issues in Bioanalysis (WRIB) in Miami, FL, USA on 13 April 2015. In attendance were 58 senior-level participants, from eight countries, representing 38 CRO companies offering bioanalytical services. The objective of this meeting was for CRO bioanalytical representatives to meet and discuss scientific and regulatory issues specific to bioanalysis. The issues selected at this years closed forum include CAPA, biosimilars, preclinical method validation, endogenous biomarkers, whole blood stability, and ELNs. A summary of the industrys best practices and the conclusions from the discussion of these topics is included in this meeting report.


Wu F.,Indiana University Bloomington | Chabenne J.R.,AIT Bioscience | Gelfanov V.M.,Indiana University Bloomington | Mayer J.P.,Indiana University Bloomington | DiMarchi R.D.,Indiana University Bloomington
Journal of Peptide Science | Year: 2015

This report describes the chemical synthesis and biological characterization of novel three-chain insulin analogs with a destabilized secondary structure. The analogs, obtained by chemical synthesis via a single-chain precursor and selective enzymatic digestion, were used to investigate the role of the highly conserved 'insulin fold'. Biological characterization through in vitro biochemical signaling showed extremely low activity at each insulin receptor when compared with native insulin. We conclude that the 'insulin fold' is a structural foundation that supports insulin biological action. Copyright © 2015 European Peptide Society and John Wiley & Sons, Ltd.


Shoup R.E.,AIT Bioscience | Beato B.D.,AIT Bioscience | Pisek A.,AIT Bioscience | White J.,AIT Bioscience | And 4 more authors.
Bioanalysis | Year: 2013

Electronic laboratory notebooks increase opportunities for collaboration and information exchange when compared with paper records. Depending on the degree of implementation, a laboratory- or enterprise-wide system can unify the collection, review and dissemination of data to improve laboratory efficiency and productivity. The advantages of an electronic laboratory notebook for speeding data review in bioanalysis are discussed, through the use of validated templates and organizational constructs to block errors in real-time and reduce manual audit tasks. © 2013 Future Science Ltd.


Beato B.,AIT Bioscience | Pisek A.,AIT Bioscience | White J.,AIT Bioscience | Grever T.,AIT Bioscience | And 6 more authors.
Bioanalysis | Year: 2011

AIT Bioscience, a bioanalytical CRO, implemented a highly configurable, Oracle-based electronic laboratory notebook (ELN) from IDBS called E-WorkBook Suite (EWBS). This ELN provides a high degree of connectivity with other databases, including Watson LIMS. Significant planning and training, along with considerable design effort and template validation for dozens of laboratory workflows were required prior to EWBS being viable for either R&D or regulated work. Once implemented, EWBS greatly reduced the need for traditional quality review upon experiment completion. Numerous real-time error checks occur automatically when conducting EWBS experiments, preventing the majority of laboratory errors by pointing them out while there is still time to correct any issues. Auditing and reviewing EWBS data are very efficient, because all data are forever securely (and even remotely) accessible, provided a reviewer has appropriate credentials. Use of EWBS significantly increases both data quality and laboratory efficiency. © 2011 Future Science Ltd.


PubMed | AIT Bioscience
Type: Journal Article | Journal: Bioanalysis | Year: 2011

AIT Bioscience, a bioanalytical CRO, implemented a highly configurable, Oracle-based electronic laboratory notebook (ELN) from IDBS called E-WorkBook Suite (EWBS). This ELN provides a high degree of connectivity with other databases, including Watson LIMS. Significant planning and training, along with considerable design effort and template validation for dozens of laboratory workflows were required prior to EWBS being viable for either R&D or regulated work. Once implemented, EWBS greatly reduced the need for traditional quality review upon experiment completion. Numerous real-time error checks occur automatically when conducting EWBS experiments, preventing the majority of laboratory errors by pointing them out while there is still time to correct any issues. Auditing and reviewing EWBS data are very efficient, because all data are forever securely (and even remotely) accessible, provided a reviewer has appropriate credentials. Use of EWBS significantly increases both data quality and laboratory efficiency.


PubMed | AIT Bioscience
Type: Journal Article | Journal: Bioanalysis | Year: 2013

Electronic laboratory notebooks increase opportunities for collaboration and information exchange when compared with paper records. Depending on the degree of implementation, a laboratory- or enterprise-wide system can unify the collection, review and dissemination of data to improve laboratory efficiency and productivity. The advantages of an electronic laboratory notebook for speeding data review in bioanalysis are discussed, through the use of validated templates and organizational constructs to block errors in real-time and reduce manual audit tasks.


FOR IMMEDIATE RELEASE Contact: Bo Kowalczyk Bo@aitbioscience.com 1-708-698-1090 INDIANAPOLIS, September 30, 2015 AIT Bioscience, LLC, ranked No ...


INDIANAPOLIS--(BUSINESS WIRE)--AIT Bioscience, LLC announced today that Franklin P. Spriggs, BS, MS, will join the company as the group leader of the Ligand Binding Assays (LBA) department. Spriggs’ appointment further strengthens AIT Bioscience’s expertise in molecular biology analytical techniques in the LBA service line. As LBA group leader, Spriggs will head all pharmacokinetic and biomarker research services for large molecule studies in clinical and pre-clinical stages. His immunochemistry expertise will further support the company’s immunogenicity research portfolio. His position oversees a significant proportion of AIT Biosciences’ throughput, running parallel to LC/MS-MS services for small molecules and serving directly under Chief Scientific Officer, Ron Shoup, PhD. His team is supported by the industry’s only fully integrated electronic laboratory environment. “AIT Bioscience continues to build the Ligand Binding Assay department through continued execution of great science and implementation of innovation tools and platforms,” stated CEO Terri Pascarelli. “Frank’s expertise and leadership will drive that innovation and delivery of exceptional scientific consultation on LBA studies.” AIT Bioscience clients include US and international biopharma and animal health companies engaged in drug development of novel medical therapies. Spriggs joins AIT Bioscience from Pfizer, where he held positions of increasing responsibility in the Pharmacokinetics, Dynamics and Metabolism department. Previously he worked at Amgen where he oversaw GLP bioanalysis and implemented automation projects for pharmacokinetics and drug metabolism. His expertise in biotech and pharmaceuticals includes extensive method development, validation, and analysis of protein therapeutics in pre-clinical and clinical phases of regulated drug development. His scientific focus includes pharmacokinetics, biomarkers, immunogenicity, quality assurance, clinical trial management and experimental design. Additionally, Spriggs has held leadership roles within the BIOTEC section of American Association of Pharmaceutical Scientists (AAPS). Spriggs earned his BS in Microbiology from Ohio University and an MS in Quality Assurance and Regulatory Affairs from Temple University. AIT Bioscience, LLC, headquartered in Indianapolis, Indiana, is an integrated contract research laboratory that provides continuous process monitoring and real-time quality control processes in Ligand Binding Assay (LBA) analytics for large molecule development alongside LC-MS/MS analytics for small molecules in pre-clinical and phase I – III clinical trials. The integration of these services, supported by a state-of-the-art smart electronic laboratory environment, allows AIT Bioscience to devise the best solution for its clients, across all bioanalytical methods. AIT Bioscience delivers robust analytical methods, highly skilled client consultation, efficient sample logistics and rapid sample analysis from pre-IND through investigational new drug (IND) and new drug application (NDA). For more information, visit www.aitbioscience.com.

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