The Changing World of Bioanalysis: Summary of Panel Discussions

Spooner, Neil; Anderson, Melanie; Dillen, Lieve; Ferrari, Luca; Hilhorst, Henk W. M.; Lam, Zamas; Michi, Marco; Munday, James D.; Smeraglia, John; Summerfield, Scott; Zimmer, Dieter

doi:10.4155/bio-2017-4993

Cited by 6 publications

(4 citation statements)

References 1 publication

(1 reference statement)

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“…Due to constrained resources, to build flexibility and avoid setting up internal GLP/GCP laboratories, pharmaceutical companies engage with CRO partners to expand their large molecule LC-MS capability and capacity in a fashion that has been well established for small molecules [28,29]. Different strategies have been implemented based on the individual company's capabilities and capacity, as well as the availability of CROs [30].…”

Section: Industry Outsourcing Considerations and Challengesmentioning

confidence: 99%

IQ Consortium Perspective: Complementary LBA and LC–MS in Protein Therapeutics Bioanalysis and Biotransformation Assessment

Kaur¹,

Bateman

Glick

et al. 2020

Bioanalysis

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Increasingly diverse large molecule modalities have driven the need for complex bioanalysis and biotransformation assessment involving both traditional ligand-binding assays (LBA) and more recent hybrid immunoaffinity LC–MS platforms. Given the scientific expertise in LBA and LC–MS typically resides in different functions within the industry, this has presented operational challenges for an integrated approach for bioanalysis and biotransformation assessment. Encouragingly, over time, the industry has recognized the complementary value of the two platforms. This has not been an easy transition as organizational structures vary widely within the industry. However, there are tremendous benefits in adopting fully integrated strategies for biopharma. This IQ consortium paper presents current perspectives across the biopharma industry. It highlights the technical and operational challenges in current large molecule bioanalysis, the value of collaborations across LBA and LC–MS, and scientific expertise for fully integrated strategies for bioanalysis and biotransformation.

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Section: Industry Outsourcing Considerations and Challengesmentioning

confidence: 99%

IQ Consortium Perspective: Complementary LBA and LC–MS in Protein Therapeutics Bioanalysis and Biotransformation Assessment

Kaur¹,

Bateman

Glick

et al. 2020

Bioanalysis

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show abstract

“…One of the successful collaborations of 2017 included the publication of the Panel Discussions that we organized together, in which experts from leading CROs, consultancies and pharmaceutical companies conversed about the 'Changing World of Bioanalysis'. The Panel Discussion Report was one of our top read articles of the year [24], while the videos of the discussions remain some of the most viewed content on the site [25].…”

Section: Bioanalysis Zone If You Have Not Yet Visited Bioanalysis Zonmentioning

confidence: 99%

Welcome to Volume 10 of Bioanalysis

Nadarajah

Makin

2017

Bioanalysis

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“…Scientific conferences offer a venue for stakeholders in the bioanalytical community to converge and discuss current and emerging trends affecting the discipline. In recent years, panel discussions with key opinion leaders, have become a complementary medium to reflect on the direction of travel faced by the business of bioanalysis [1][2][3]. These discussions have been filmed and then shared with the bioanalytical community via dual media formats; video access through the Bioanalysis Zone website and an accompanying publication [4].…”

mentioning

confidence: 99%