Published in the September 2014 issue of Biologicals

Adventitious agents in viral vaccines: Lessons learned from 4 case studies

Since the earliest days of biological product manufacture, there have been a number of instances where
laboratory studies provided evidence for the presence of adventitious agents in a marketed product.
Lessons learned from such events can be used to strengthen regulatory preparedness for the future.

Four case studies where an adventitious agent, or a signal suggesting the presence of an agent, was found in a viral vaccine, are presented in this paper. The lessons learned from each event are discussed.

Based in part on those experiences,certain scientific principles have been identified by WHO that should be considered in regulatory risk evaluation if an adventitious agent is found in a marketed vaccine in the future.



Invitation to Join Brighton Collaboration


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Career opportunities

The International Alliance for Biological Standardization (IABS), located in Geneva, Switzerland, is a non-profit association recognized as an NGO by WHO. The mission of IABS is to contribute to the scientific and medical advancement of biologicals by facilitating the communication among those who develop, produce and regulate biological products for human and animal health.

18-19 February, 2015, Tokyo, Japan PDF Print

International Regulatory Endeavour Towards Sound Development of Human Cell Therapy Products




Date: February 18-19, 2015

Venue: Hitotsubashi Hall

Organized by IABS with the support of Pharmaceuticals and Medical devices Agency (PMDA); Japan Science and Technology Agency (JST); National Institute of Biomedical Innovation (NIBIO); World Health Organization (WHO)

Under the auspices of Forum for Innovative Regenerative Medicine (FIRM); Japan Pharmaceutical Manufacturers Association (JPMA); The Japanese Scoiety for Regenerrative Medicine (JSRM)

Scope and objective: This meeting will bring together an outstanding and diverse group of speakers from regulatory agencies, industry, and academia, all of whom are at the forefront of the cell therapy field.The major objective of the meeting is to highlight the important regulatory considerations that are unique to human cell therapy products, as well as to promote international dialogue and exchange of information and points of view in this evolving field.The scope of the cell therapy products that will be covered in this meeting are human cell derived and substantially manipulated cell therapy products (hCTPs). The meeting will also identify special points/issues to consider for specific type of products, as well as very critical points/issues for various type of products, which have to be resolved, improved, and/or developed in terms of sound scientific regulation in order to facilitate the availability of products in a rational and timely manner, and which will be valuable globally to public health.


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22-25 March, 2015 Wilmington, Delaware PDF Print




New Technologies, New Vaccines 2015


Date: 22-25 March, 2015

Venue: Hotel DuPont, Wilmington, Delaware.

Please plan to join us in Wilmington, Delaware March 22-25, 2015 for the 10th anniversary of New Technologies, New Vaccines. Initiated in 2006, the conference has been exploring how new technologies are enhancing our ability to identify new vaccine candidates, design safe and effective vaccines using improved adjuvants and delivery mechanisms and rapidly produce these candidates using innovative manufacturing processes.

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29-30 September, 2015 - Rockville, Maryland PDF Print



2nd Statistical and Data Management Approaches for Biotechnology Drug Development


Date:29-30 September, 2015

Venue: US Pharmacopeia Conference Center, Rockville, Maryland

Co-sponsored by: IABS anad FDA

Scope and objective: This meeting is to bring together regulators, scientists, academia and industry to help resolve existing challenges in ensuring the quality of biotechnology medicinal products and to bring high quality medicines to patients. Guidance on how to use statistics for a variety of activities required during biotechnology product development such as method development, improvement and replacement, product comparability, biosimilarity exercises and stability program development. In addition, the complexity of the types of data and the volume being analysed is ever increasing and how best to manage such data will be discussed. The meeting will bring the right experts together to discuss the issues and through roundtables attempt to reach conclusions that will be valuable globally to public health.


Among the challenges that will be explored :

  • Statistical Challenges with showing Comparability and Biosimilarity (Equivalence, small data sets, tolerance intervals etc.)
  • Using statistics for Assay Methods (Statistics for development, qualification, validation and transfer of methods)
  • The use of statistics and modelling when using Quality by Design (DoE, Bayesian, partial least squares, prior knowledge data sets)
  • Managing large and/or complex data sets (Large data sets for monitoring variation, complex analytical methods – Mass Spec, NMR, historical data sets)


View the Draft Agenda

16-18 September, 2015 - The Netherlands PDF Print


The Consistency Approach and Alternative Methods: Towards Non-Animal-based Testing in Vaccine Development and QC


Date: September 16-18, 2015

Venue: Hotel Zuiderduin, Egmond aan Zee, The Netherlands


More information soon....

12-13 November, 2015, Rockville, Maryland PDF Print



Progress and Challenges in Protein Particles and Immunogenicity of Biotherapeutics 2015: Filling in the Gaps in Risk Evaluation and Mitigation II


Date: 12-13 November, 2015

Venue: US Pharmacopeia Conference Cente, rRockville, Maryland

Scope and objective:

The efficacy of therapeutic proteins can be compromised by patients' immune response to the proteins, resulting in antibody-mediated alteration of the proteins' activity or bioavailability. It is well established that highly repetitive motifs, such as those that would occur in large protein aggregates in therapeutic protein products, can enhance immunogenicity and can be produced during the pharmaceutical manufacturing process. While particles greater than 10 µm in size are monitored by light obstruction test in combination with the visible appearance test, the presence of sub visible particles (0.1-10 µm), large assemblies containing thousands to millions of protein molecules, in therapeutic protein products is not routinely monitored or controlled.

In 2009, IABS and FDA cosponsored a conference which focused on

a) The mechanism of protein folding

b) The characteristics of sub visible and visible protein particles that may influence immunogenicity including the size, type (reversible, protein class), composition, amount, and conformational status);

c) The risks associated with the propensity to generate immune responses including the route of administration, dose, and frequency, duration of administration and indication;

d) The factors that influence the formation of large protein aggregates and methods to reduce protein aggregation (approaches in formulation, and protein design) including case studies of occurrence of these particulates in manufacturing;

e) Analytical methods that are useful in quantifying these particles and approaches to the design of suitable control strategies that mitigate the risk to product quality.

One key outcome of that meeting was the realization that further study was required to improve our knowledge of how sub visible protein particles form, how they are accurately quantitated and characterized, and how they evolve over the shelf life of the drug product. There was consensus that standardization of quantitation technology was needed. While there was evidence that some types of particles might relate to immunogenicity, there were also clear gaps in understanding how this happened and whether this applied to all types of protein particles in all biotherapeutics. It was also unclear how this information related to developing a control strategy for each product during development.

It is now better understood that virtually all protein drug products possess some level of sub visible particles. IABS will cosponsor another meeting on 12-13November 2015 at the USP, Rockville, Maryland, USA to revisit these topics in light of what has been learned in the past 6 years. Progress in understanding the science of protein particle formation, the evolution of the analytical technologies for characterization and measurement of sub-visible protein particles, the advances in standardization of protein particle measurements, and their possible relationship of protein particle attributes to safety and efficacy of biotherapeutics will be highlighted. The goal of the meeting is to assess the progress of the past half-decade, and its implications for risk management during biotherapeutic product development.


IABS launches its European affiliate: IABS-EU

This is a landmark event in the history of IABS and will open the way for greater participation with EU partners in scientific activities. The objective of the Association IABS-EU is to support the mission and projects of the International Alliance for Biological Standardization and to enhance its image and develop its outreach within the European Union. The Association will contribute to scientific and medical advancement of biologicals, by facilitating communication among those who develop, produce and regulate biological products for human and animal health. More specifically, it will focus on issues concerning the regulation and standardization of biological products that are intended for market use.

A unique feature of IABS is that it acts as a neutral meeting point for the major stakeholders - regulators, academia, and industry- to consider the impact of regulatory requirements on innovation, with the objective of identifying sections that may require modification.

IABS-EU is officially recognized by French authorities as a nonprofit organization.

You will be hearing more about IABS-EU in the months ahead.

Founding Members :

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A few words from the President


As we start the new year, I’d like to review our 2014 accomplishments and hi-lite what we have planned for 2015.

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Veterinary Scientific Committee

Read more about Alternatives to Antibiotics, Challenges and Solutions in Animal Production

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Now available !

Vaccines and Diagnostics for Transboundary Animal Diseases

International Symposium, Ames, Iowa, September 2012: Proceedings

Editor(s): Roth J.A. (Ames, Iowa) ; Richt J.A. (Manhattan, Kansas); Morozov I.A. (Manhattan, Kansas)

Please use this link to order the book:

IABS has signed an MoU with the following organizations:

Fondation Mérieux

Brighton Collaboration


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