Public Consultation for the WHO Expert Committee on Biological Standardization (ECBS)


Read more on the Homepage


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


Read more


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.

28-30 September, 2016 - Budapest, Hungart PDF Print

Save The Date


Emerging Diseases in Animals:

Strategies in Surveillance, Control and Eradication


Budapest, Hungary

28 - 30 September 2016


Co-organized by IABS and

The National Food Chain Safety Office Directorate of Veterinary Medicinal Products, Budapest, Hungary


Emerging animal diseases challenge the health of domestic and wild animals. These highly contagious or transmissible diseases may spread easily, irrespective of political and geographic borders. This spread is fostered by the increased global movement of domestic animals and food produced from animals, as well as by vectors such as man, wild animals, intermediate hosts, and contaminated materials of all kind. This spread is also influenced by other factors such as changes in climate.

Outbreaks of diseases in livestock have a negative impact on economies, individuals’ livelihood and quality of life, as well as global safety of food produced by animals.

Although there is permanent progress in the development of new vaccines against a wide range of diseases, emerging infections and transboundary spread pose specific challenges in terms of surveillance and prophylactic interventions.

The goal of this meeting, to be held in 2016, is to update current experience in the identification, tracking, and control of these animal diseases. This includes experience thus far with licensing of vaccines required for emergency situations or scenarios. An additional area of discussion will focus on fostering rapid availability of vaccines.


More information coming soon.

October 23, 2015 - Geneva, Switzerland PDF Print



October 23, 2015

Geneva, Switzerland


Where Are We in Our Understanding of the Association Between

Narcolepsy and One of the 2009 Adjuvanted

Influenza A (H1N1) Vaccines?


In collaboration with the World Health Organization


 This meeting will be held under Chatham House Rule


The overall objective of this meeting is to exchange the latest information on research into development of narcolepsy following vaccination with one of the 2009 adjuvanted influenza A (H1N1) vaccines.


The specific meeting objectives are:

  • To discuss new data on narcolepsy and adjuvanted 2009 influenza A (H1N1) vaccines - epidemiology; pathophysiology of narcolepsy; and hypotheses on potential biological mechanism of actions;
  • To discuss possible implications for seasonal and pandemic influenza vaccines as we move forward;
  • To discuss options for collaboratively addressing vaccine rare event safety signals given availability of newer biomarkers, epidemiology, molecular biology and immunology tools and knowledge.

 The expected outcomes are:

  • A mutual understanding of a possible relationship between narcolepsy and adjuvanted 2009 influenza A (H1N1) pandemic vaccines;
  • A mutual understanding for the implications of this finding for seasonal and pandemic influenza vaccines;
  • A delineation of future research steps to be taken to expand knowledge and understanding of narcolepsy, narcolepsy and biomarkers, and inciting factors for narcolepsy;
  • A delineation of future research steps to be taken to expand knowledge and understanding of the current hypotheses between narcolepsy and vaccination with one of the 2009 adjuvanted influenza A (H1N1) vaccines;
  • A common understanding of which stakeholders are needed to develop an effective strategy and framework for addressing vaccine rare event safety signals given availability of newer biomarkers, epidemiology, molecular biology and immunology tools and knowledge.

View the Provisional Agenda



Registration fee:

for IABS members: EUR 180 (TTC / VAT inc.)

for non-IABS members: EUR 240 (TTC / VAT inc.)

16-18 September, 2015 - The Netherlands PDF Print


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


Register Here


Date: September 16-18, 2015

Venue: Hotel Zuiderduin, Egmond aan Zee, The Netherlands


Scope and objective:

Vaccine development and quality control include models based on studies in laboratory animals, substantial numbers of which are used. Increasingly, however, regulations on animal experimentation and testing now urge the use of non-animal methods, reduction of animal numbers in tests still being performed and refinement of animal procedures and animal husbandry practices; the principle which is generally known as the 3Rs.


This need for humane science aligns with a broad wish to make vaccine development and quality control more science based, more economic and less time consuming.


Substantial progress in 3Rs implementation in vaccine development and quality control has been achieved; several non-animal models are being validated and a new testing strategy which integrates analytical tools, in vitro assays and quality systems; the consistency approach, is now under study.


The IABS conference will be the focal point for well recognised experts presenting the latest developments on the most important 3Rs topics in vaccine development and quality control. The conference will be THE platform for exchange of information on the 3Rs and testing strategies with representatives from industry, academia, guideline bodies and regulatory authorities. There will be a mix of presentations and interactive sessions offering an excellent opportunity for all those who are interested in state of the art vaccine quality control in the context of improving animal welfare.


For more information, please visit

Register here

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


View the Agenda


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)


 Register here

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

Registration Now Open


2nd Progress and Challenges in Protein Particles and Immunogenicity of Biotherapeutics 2015: Filling in the Gaps in Risk Evaluation and Mitigation




 Date: 12-13 November, 2015

Venue: US Pharmacopeia Conference Cente, Rockville, Maryland

Co-sponsored by: IABS and Health Canada


View the Provisional Agenda


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.

Register Here

Public Consultation for the WHO Expert Committee on Biological Standardization (ECBS) PDF Print

Public Consultation for the WHO Expert Committee on Biological Standardization (ECBS)



Dear colleagues,


We would like to inform you that a public consultation on several documents for the WHO Expert Committee on Biological Standardization (ECBS) started at the beginning of July 2015.

Based on WHO consultations with regulators, manufacturers and other experts the following documents were prepared and have been posted on the WHO biologicals web site

for public comments: 


  1. BS.2251 Guidelines on the quality, safety and efficacy of biotherapeutic protein products prepared by recombinant DNA technology: APPENDIX 7. REGULATORY ASSESSMENT OF APPROVED rDNA-DERIVED BIOTHERAPEUTICS


Comment form: WHO / BS / 2015.2251

Comments should be sent to the Responsible Officer:  Dr Hye-Na Kang at email:

DEADLINE: 14 September 2015


  1. BS.2252 Recommendations to assure the quality, safety and efficacy of recombinant human papillomavirus virus-like particle vaccines: Proposed replacement of: TRS 962, Annex 1


Comment form: WHO / BS / 2015.2252

Comments should be sent to the Responsible Officer: Dr TieQun Zhou at email:

DEADLINE: 14 September 2015


  1. BS.2253 WHO GMP for Biological Products: Proposed replacement of: TRS 822, Annex 1


Comment form: WHO / BS / 2015.2253

Comments should be sent to the Responsible Officer: Dr Dianliang Lei at email:

DEADLINE: 14 September 2015


  1. BS.2268 Guidelines on the stability evaluation of vaccines for use under extended controlled temperature conditions


Comment form: WHO / BS / 2015.2268

Comments should be sent to the Responsible Officer: Dr Kai Gao at email:

DEADLINE: 14 September 2015


Please share this information with your colleagues who may be interested in the topics mentioned above.


All comments received by published deadlines will be considered in the preparation of the discussion at the next meeting of the Expert Committee on Biological Standardization (ECBS) to be held from 12 to 16 October 2015.


Thank you for taking action on this.

With best regards,



Dr Ivana Knezevic

Scientist, Technologies, Standards and Norms Team

Group Lead, Norms and Standards for Biologicals

Department of Essential Medicines and Health Products (EMP)

Health Systems and Innovation (HIS) Cluster

Office: L276

Phone: +41 22 791 3136

Fax: +41 22 791 4971


Biological standardization website:

Immunization website:



Joanna McMahon (Mrs)

Assistant to Group Lead


Tel. direct: +41 22 791 2427

Fax direct: +41 22 791 4167


IABS-EU - April 2015 PDF Print

IABS announces the participation of its European affiliate IABS-EU

in the IMI Call

Zoonosis anticipation and preparedness initiative (ZAPI)


IABS-EU, the European affiliate of the International Alliance for Biological Standardization (IABS) is pleased to announce its participation in the IMI call “Zoonoses Anticipation and preparedness Initiative (ZAPI)”.

This is the first time that technical platforms have been put in place. Involving different ‘actors’, these platforms will be used in the event of a pandemic or a major health threat.

The results of these technical platforms will serve to develop vaccines and antibodies, thereby allowing for optimal response should a pandemic or major threat of zoonoses occur.

This, however, creates an unforeseen regulatory situation: how to proceed in an emergency situation to ensure that these totally new tools become quickly available?

In order to respond to this question, IABS-EU will become a facilitator in the elaboration of new regulatory processes. To this end, IABS-EU has created a group of experts composed of regulatory agencies and members of the consortium who will identify as quickly as possible the specific issues that must be taken into consideration. Additionally, IABS-EU and its ZAPI partners will strive to avoid any and all regulatory hurdles that could hamper the rapid availability of vaccines and antibodies that have been developed via these new technical platforms.

IABS-EU - July 2014 PDF Print

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.


Founding Members :

Read more:


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.

Read more


Veterinary Scientific Committee

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

Read more

IABS has signed an MoU with the following organizations:

Fondation Mérieux

Brighton Collaboration


Who's Online

We have 283 guests online
International Alliance for Biological Standardization, Coordinated by Dodet Bioscience