2020 White Paper on Recent Issues in Bioanalysis: BAV Guidance, CLSI H62, Biotherapeutics Stability, Parallelism Testing, CyTOF and Regulatory Feedback (Part 2A – Recommendations on Biotherapeutics Stability, PK LBA Regulated Bioanalysis, Biomarkers Assays, Cytometry Validation & Innovation Part 2B – Regulatory Agencies’ Inputs on Bioanalysis, Biomarkers, Immunogenicity, Gene & Cell Therapy and Vaccine)

The 14th edition of the Workshop on Recent Issues in Bioanalysis (14th WRIB) was held virtually on June 15-29, 2020 with an attendance of over 1000 representatives from pharmaceutical/biopharmaceutical companies, biotechnology companies, contract research organizations, and regulatory agencies worldwide. The 14th WRIB included three Main Workshops, seven Specialized Workshops that together spanned 11 days in order to allow exhaustive and thorough coverage of all major issues in bioanalysis, biomarkers, immunogenicity, gene therapy and vaccine. Moreover, a comprehensive vaccine assays track; an enhanced cytometry track and updated Industry/Regulators consensus on BMV of biotherapeutics by LCMS were special features in 2020. As in previous years, this year's WRIB continued to gather a wide diversity of international industry opinion leaders and regulatory authority experts working on both small and large molecules to facilitate sharing and discussions focused on improving quality, increasing regulatory compliance and achieving scientific excellence on bioanalytical issues. This 2020 White Paper encompasses recommendations emerging from the extensive discussions held during the workshop, and is aimed to provide the Global Bioanalytical Community with key information and practical solutions on topics and issues addressed, in an effort to enable advances in scientific excellence, improved quality and better regulatory compliance. Due to its length, the 2020 edition of this comprehensive White Paper has been divided into three parts for editorial reasons. This publication covers the recommendations on (Part 2A) BAV, PK LBA, Flow Cytometry Validation and Cytometry Innovation and (Part 2B) Regulatory Input. Part 1 (Innovation in Small Molecules, Hybrid LBA/LCMS & Regulated Bioanalysis), Part 3 (Vaccine, Gene/Cell Therapy, NAb Harmonization and Immunogenicity) are published in volume 13 of Bioanalysis, issues 4, and 6 (2021), respectively.

Download Full-text

2020 White Paper on Recent Issues in Bioanalysis: BMV of Hybrid Assays, Acoustic MS, HRMS, Data Integrity, Endogenous Compounds, Microsampling and Microbiome (Part 1 – Recommendations on Industry/Regulators Consensus on BMV of Biotherapeutics by LCMS, Advanced Application in Hybrid Assays, Regulatory Challenges in Mass Spec, Innovation in Small Molecules, Peptides and Oligos)

Bioanalysis ◽

10.4155/bio-2020-0324 ◽

2021 ◽

Vol 13 (4) ◽

pp. 203-238

Author(s):

Hendrik Neubert ◽

Stephen C Alley ◽

Anita Lee ◽

Wenying Jian ◽

Michael Buonarati ◽

...

Keyword(s):

Cell Therapy ◽

Small Molecules ◽

Regulatory Compliance ◽

White Paper ◽

Scientific Excellence ◽

Research Organizations ◽

Mass Spec ◽

International Industry ◽

Regulatory Input ◽

Biotechnology Companies

The 14th edition of the Workshop on Recent Issues in Bioanalysis (14th WRIB) was held virtually on June 15–29, 2020 with an attendance of over 1000 representatives from pharmaceutical/biopharmaceutical companies, biotechnology companies, contract research organizations, and regulatory agencies worldwide. The 14th WRIB included three Main Workshops, seven Specialized Workshops that together spanned 11 days in order to allow exhaustive and thorough coverage of all major issues in bioanalysis, biomarkers, immunogenicity, gene therapy, cell therapy and vaccine. Moreover, a comprehensive vaccine assays track; an enhanced cytometry track and updated Industry/Regulators consensus on BMV of biotherapeutics by Mass Spectrometry (hybrid assays, LCMS and HRMS) were special features in 2020. As in previous years, this year's WRIB continued to gather a wide diversity of international industry opinion leaders and regulatory authority experts working on both small and large molecules to facilitate sharing and discussions focused on improving quality, increasing regulatory compliance and achieving scientific excellence on bioanalytical issues. This 2020 White Paper encompasses recommendations emerging from the extensive discussions held during the workshop and is aimed to provide the Global Bioanalytical Community with key information and practical solutions on topics and issues addressed, in an effort to enable advances in scientific excellence, improved quality and better regulatory compliance. Due to its length, the 2020 edition of this comprehensive White Paper has been divided into three parts for editorial reasons. This publication covers the recommendations on (Part 1) Hybrid Assays, Innovation in Small Molecules, & Regulated Bioanalysis. Part 2A (BAV, PK LBA, Flow Cytometry Validation and Cytometry Innovation), Part 2B (Regulatory Input) and Part 3 (Vaccine, Gene/Cell Therapy, NAb Harmonization and Immunogenicity) are published in volume 13 of Bioanalysis, issues 5, and 6 (2021), respectively.

Download Full-text

2020 White Paper on Recent Issues in Bioanalysis: Vaccine Assay Validation, qPCR Assay Validation, QC for CAR-T Flow Cytometry, NAb Assay Harmonization and ELISpot Validation (Part 3 – Recommendations on Immunogenicity Assay Strategies, NAb Assays, Biosimilars and FDA/EMA Immunogenicity Guidance/Guideline, Gene & Cell Therapy and Vaccine Assays)

Bioanalysis ◽

10.4155/bio-2021-0007 ◽

2021 ◽

Vol 13 (6) ◽

pp. 415-463

Author(s):

Bart Corsaro ◽

Tong-yuan Yang ◽

Rocio Murphy ◽

Ivo Sonderegger ◽

Andrew Exley ◽

...

Keyword(s):

Flow Cytometry ◽

Cell Therapy ◽

Regulatory Compliance ◽

White Paper ◽

Scientific Excellence ◽

Assay Validation ◽

Research Organizations ◽

International Industry ◽

Regulatory Input ◽

Biotechnology Companies

The 14th edition of the Workshop on Recent Issues in Bioanalysis (14th WRIB) was held virtually on June 15-29, 2020 with an attendance of over 1000 representatives from pharmaceutical/biopharmaceutical companies, biotechnology companies, contract research organizations, and regulatory agencies worldwide. The 14th WRIB included three Main Workshops, seven Specialized Workshops that together spanned 11 days in order to allow exhaustive and thorough coverage of all major issues in bioanalysis, biomarkers, immunogenicity, gene therapy and vaccine. Moreover, a comprehensive vaccine assays track; an enhanced cytometry track and updated Industry/Regulators consensus on BMV of biotherapeutics by LCMS were special features in 2020. As in previous years, this year's WRIB continued to gather a wide diversity of international industry opinion leaders and regulatory authority experts working on both small and large molecules to facilitate sharing and discussions focused on improving quality, increasing regulatory compliance and achieving scientific excellence on bioanalytical issues. This 2020 White Paper encompasses recommendations emerging from the extensive discussions held during the workshop and is aimed to provide the Global Bioanalytical Community with key information and practical solutions on topics and issues addressed, in an effort to enable advances in scientific excellence, improved quality and better regulatory compliance. Due to its length, the 2020 edition of this comprehensive White Paper has been divided into three parts for editorial reasons. This publication (Part 3) covers the recommendations on Vaccine, Gene/Cell Therapy, NAb Harmonization and Immunogenicity). Part 1 (Innovation in Small Molecules, Hybrid LBA/LCMS & Regulated Bioanalysis), Part 2A (BAV, PK LBA, Flow Cytometry Validation and Cytometry Innovation) and Part 2B (Regulatory Input) are published in volume 13 of Bioanalysis, issues 4 and 5 (2020), respectively.

Download Full-text

2019 White Paper On Recent Issues in Bioanalysis: FDA BMV Guidance, ICH M10 BMV Guideline and Regulatory Inputs (Part 2 – Recommendations on 2018 FDA BMV Guidance, 2019 ICH M10 BMV Draft Guideline and Regulatory Agencies' Input on Bioanalysis, Biomarkers and Immunogenicity)

Bioanalysis ◽

10.4155/bio-2019-0270 ◽

2019 ◽

Vol 11 (23) ◽

pp. 2099-2132 ◽

Cited By ~ 3

Author(s):

Brian Booth ◽

Lauren Stevenson ◽

Renuka Pillutla ◽

Michael Buonarati ◽

Chris Beaver ◽

...

Keyword(s):

Gene Therapy ◽

Flow Cytometry ◽

Method Development ◽

Regulatory Compliance ◽

White Paper ◽

Regulatory Agencies ◽

Draft Guideline ◽

Effective Strategies ◽

Biotechnology Companies ◽

Management Flow

The 2019 13th Workshop on Recent Issues in Bioanalysis (WRIB) took place in New Orleans, LA on 1–5 April 2019 with an attendance of over 1000 representatives from pharmaceutical/biopharmaceutical companies, biotechnology companies, contract research organizations and regulatory agencies worldwide. WRIB was once again a 5-day, week-long event – a full immersion week of bioanalysis, biomarkers, immunogenicity and gene therapy. As usual, it was specifically designed to facilitate sharing, reviewing, discussing and agreeing on approaches to address the most current issues of interest including both small- and large-molecule bioanalysis involving LCMS, hybrid LBA/LCMS, LBA cell-based/flow cytometry assays and qPCR approaches. This 2019 White Paper encompasses recommendations emerging from the extensive discussions held during the workshop, and is aimed to provide the bioanalytical community with key information and practical solutions on topics and issues addressed, in an effort to enable advances in scientific excellence, improved quality and better regulatory compliance. Due to its length, the 2019 edition of this comprehensive White Paper has been divided into three parts for editorial reasons. This publication (Part 2) covers the recommendations on the 2018 FDA BMV guidance, 2019 ICH M10 BMV draft guideline and regulatory agencies' input on bioanalysis, biomarkers, immunogenicity and gene therapy. Part 1 (Innovation in small molecules and oligonucleotides and mass spectrometry method development strategies for large molecules bioanalysis) and Part 3 (New insights in biomarker assay validation, current and effective strategies for critical reagent management, flow cytometry validation in drug discovery and development and CLSI H62, interpretation of the 2019 FDA immunogenicity guidance and gene therapy bioanalytical challenges) are published in volume 10 of Bioanalysis, issues 22 and 24 (2019), respectively.

Download Full-text

2019 White Paper on Recent Issues in Bioanalysis: FDA Immunogenicity Guidance, Gene Therapy, Critical Reagents, Biomarkers and Flow Cytometry Validation (Part 3 – Recommendations on 2019 FDA Immunogenicity Guidance, Gene Therapy Bioanalytical Challenges, Strategies for Critical Reagent Management, Biomarker Assay Validation, Flow Cytometry Validation & CLSI H62)

Bioanalysis ◽

10.4155/bio-2019-0271 ◽

2019 ◽

Vol 11 (24) ◽

pp. 2207-2244 ◽

Cited By ~ 4

Author(s):

Steven Piccoli ◽

Devangi Mehta ◽

Alessandra Vitaliti ◽

John Allinson ◽

Shashi Amur ◽

...

Keyword(s):

Gene Therapy ◽

Flow Cytometry ◽

Method Development ◽

Regulatory Compliance ◽

White Paper ◽

Large Molecule ◽

Regulatory Agencies ◽

Assay Validation ◽

Biotechnology Companies ◽

Management Flow

The 2019 13th Workshop on Recent Issues in Bioanalysis (WRIB) took place in New Orleans, LA, USA on April 1–5, 2019 with an attendance of over 1000 representatives from pharmaceutical/biopharmaceutical companies, biotechnology companies, contract research organizations and regulatory agencies worldwide. WRIB was once again a 5-day, week-long event – a full immersion week of bioanalysis, biomarkers, immunogenicity and gene therapy. As usual, it was specifically designed to facilitate sharing, reviewing, discussing and agreeing on approaches to address the most current issues of interest including both small- and large-molecule bioanalysis involving LCMS, hybrid LBA/LCMS, LBA cell-based/flow cytometry assays and qPCR approaches. This 2019 White Paper encompasses recommendations emerging from the extensive discussions held during the workshop and is aimed to provide the bioanalytical community with key information and practical solutions on topics and issues addressed, in an effort to enable advances in scientific excellence, improved quality and better regulatory compliance. Due to its length, the 2019 edition of this comprehensive White Paper has been divided into three parts for editorial reasons. This publication (Part 3) covers New Insights in Biomarker Assay Validation, Current & Effective Strategies for Critical Reagent Management, Flow Cytometry Validation in Drug Discovery & Development & CLSI H62, Interpretation of the 2019 FDA Immunogenicity Guidance and Gene Therapy Bioanalytical Challenges. Part 1 (Innovation in Small Molecules and Oligonucleotides & Mass Spectrometry Method Development Strategies for Large Molecule Bioanalysis) and Part 2 (Recommendations on the 2018 FDA BMV Guidance, 2019 ICH M10 BMV Draft Guideline and regulatory agencies' input on bioanalysis, biomarkers, immunogenicity and gene therapy) are published in volume 11 of Bioanalysis, issues 22 and 23 (2019), respectively.

Download Full-text

Workshop on Recent Issues in Bioanalysis (WRIB) Poster Award winners 2019

Bioanalysis ◽

10.4155/bio-2019-0263 ◽

2019 ◽

Vol 11 (24) ◽

pp. 2245-2249

Author(s):

Ryan Darling ◽

Eric Bonner ◽

Pei Li

Keyword(s):

Gene Therapy ◽

New Orleans ◽

Regulatory Agencies ◽

High Quality ◽

Scientific Excellence ◽

Contract Research ◽

Research Organizations ◽

Poster Award ◽

The World

The 13th WRIB was held in New Orleans, LA, USA in April 2019. It drew over 1000 professionals representing large pharmas, biotechs, contract research organizations and multiple regulatory agencies from around the world. The Global Bioanalytical Community convened in New Orleans to discuss current topics of interest in bioanalysis, biomarkers, immunogenicity and gene therapy. High quality, better compliance to regulations and scientific excellence are always the foundations of this workshop. Bioanalysis and Bioanalysis Zone are very proud to be supporting the WRIB Poster Awards again this year, and we feature the profiles of the authors of the winning posters. Visit www.bioanalysis-zone.com to see the winning posters in full.

Download Full-text

Mission Accomplished: The ACVP/STP Coalition for Veterinary Pathology Fellows Completes Its Objectives, but Its Legacy and Spirit Live On

Veterinary Pathology ◽

10.1177/0300985820918314 ◽

2020 ◽

Vol 57 (4) ◽

pp. 472-475

Author(s):

Rick Adler ◽

Elizabeth Clark ◽

Mark Cline ◽

Michael Conner ◽

Torrie Crabbs ◽

...

Keyword(s):

Support Groups ◽

Contract Research ◽

Research Organizations ◽

Veterinary Pathology ◽

Biotechnology Companies ◽

Training Position

After 15 years of existence, the ACVP/STP Coalition for Veterinary Pathology Fellows will dissolve, primarily due to lack of renewed financial sponsorship. While in operation, the Coalition organized 32 new training position for veterinary pathologists, supported by $7.4 M from sponsors, including pharmaceutical and biotechnology companies, contract research organizations, private individuals and allied veterinary pathology support groups. All residual funds will be donated to ACVP and STP with the understanding that the two organizations will use these funds to enhance training by collaborating on outreach efforts, thus maintaining the legacy and spirit of the Coalition.

Download Full-text

Use of Multiple Temperature Logger Models Can Alter Conclusions

Water ◽

10.3390/w12030668 ◽

2020 ◽

Vol 12 (3) ◽

pp. 668

Author(s):

Joanna B. Whittier ◽

Jacob T. Westhoff ◽

Craig P. Paukert ◽

Robin M. Rotman

Keyword(s):

Water Quality ◽

Regulatory Compliance ◽

Effect Of Temperature ◽

Regulatory Agencies ◽

Water Quality Standards ◽

Temperature Logger ◽

Combined Model ◽

Combining Data ◽

Ecological Implications ◽

Similar Accuracy

Remote temperature loggers are often used to measure water temperatures for ecological studies and by regulatory agencies to determine whether water quality standards are being maintained. Equipment specifications are often given a cursory review in the methods; however, the effect of temperature logger model is rarely addressed in the discussion. In a laboratory environment, we compared measurements from three models of temperature loggers at 5 to 40 °C to better understand the utility of these devices. Mean water temperatures recorded by logger models differed statistically even for those with similar accuracy specifications, but were still within manufacturer accuracy specifications. Maximum mean temperature difference between models was 0.4 °C which could have regulatory and ecological implications, such as when a 0.3 °C temperature change triggers a water quality violation or increases species mortality rates. Additionally, precision should be reported as the overall precision (including a consideration of significant digits) for combined model types which in our experiment was 0.7 °C, not the ≤0.4 °C for individual models. Our results affirm that analyzing data collected by different logger models can result in potentially erroneous conclusions when <1 °C difference has regulatory compliance or ecological implications and that combining data from multiple logger models can reduce the overall precision of results.

Download Full-text

Come from away: Best practices in mini-sabbaticals for the development of young investigators: a White Paper by the SEQUIN (mini-Sabbatical Evaluation and QUality ImprovemeNt) Group

Journal of Clinical and Translational Science ◽

10.1017/cts.2019.369 ◽

2019 ◽

Vol 3 (1) ◽

pp. 37-44 ◽

Cited By ~ 1

Author(s):

Michael H. Pillinger ◽

Stephenie C. Lemon ◽

Martin S. Zand ◽

P. Jeffrey Foster ◽

Jeanne S. Merchant ◽

...

Keyword(s):

Best Practice ◽

Research Unit ◽

White Paper ◽

National Institutes Of Health ◽

Regulatory Agencies ◽

Limited Data ◽

Non Profit ◽

History Of ◽

Training Institutions ◽

And Training

AbstractMini-sabbaticals are formal short-term training and educational experiences away from an investigator’s home research unit. These may include rotations with other research units and externships at government research or regulatory agencies, industry and non-profit programs, and training and/or intensive educational programs. The National Institutes of Health have been encouraging training institutions to consider offering mini-sabbaticals, but given the newness of the concept, limited data are available to guide the implementation of mini-sabbatical programs. In this paper, we review the history of sabbaticals and mini-sabbaticals, report the results of surveys we performed to ascertain the use of mini-sabbaticals at Clinical and Translational Science Award hubs, and consider best practice recommendations for institutions seeking to establish formal mini-sabbatical programs.

Download Full-text

The pollution prevention partnership: a Colorado voluntary private/public environmental initiative

Water Science & Technology ◽

10.2166/wst.1994.0240 ◽

1994 ◽

Vol 30 (5) ◽

pp. 215-221 ◽

Cited By ~ 1

Author(s):

Paul Ferraro

Keyword(s):

Public Interest ◽

Technical Assistance ◽

Pollution Prevention ◽

Regulatory Compliance ◽

Early Morning ◽

Regulatory Agencies ◽

Medium Size ◽

Non Profit ◽

Colorado State University ◽

Corporate Executives

It started with breakfast. In 1989 representatives from industry, regulatory agencies and public interest groups began to meet over early morning coffee. At first they sought a better dialogue between industries and regulatory agencies-turning potential adversaries into team-mates. Later, this “breakfast club” evolved into the Pollution Prevention Partnership, a Colorado voluntary environmental initiative. The goal: working together to prevent pollution at its source. By 1991, the Pollution Prevention Partnership (PPP) formed a non-profit organization. The Partnership set new standards for reducing pollution in Colorado's industries by making it easier for regulatory officials, public interest spokespeople and industry representatives to meet and forge new solutions to environmental problems. The first major project, “SolvNet I,” focused on reducing the use of 1,1,1-trichloroethane (TCA). TCA poses both health and environmental hazards. PPP set a goal for each company in the Partnership to reduce its use and release of this industrial “solvent-of-choice” by 70%. Partnership members methodically searched for more acceptable alternatives, testing over 50 compounds. By making changes in processes, products and business methods, they exceeded their goal. Pollution prevention-by reducing solvent use-reduces burdensome regulatory compliance, taxes and surcharges. The work has not stopped there. The Partnership is reaching beyond its membership to other Colorado businesses. Members conducted technical workshops for other industry representatives. The Partnership hosted a luncheon for Colorado's top corporate executives. They worked with the Waste Minimization Assessment Center, of Colorado State University, to perform waste assessments at small and medium size industries in Colorado. Work is also under way on SolvNet II, an expanded program designed to reduce hazardous industrial waste by the Partnership's industrial members. This paper presents the purpose and goals of the Pollution Prevention Partnership. It discusses the SolvNet I and SolvNet II projects, gives perspectives on how companies succeeded in preventing pollution, and outlines the Partnerships technical assistance activities.

Download Full-text