International Alliance for Biological Standardization

Dear IABS Colleagues, Stakeholders, Supporters, and Collaborators,

I am pleased to share highlights from the International Alliance for Biological Standardization’s 201^st Board of Directors meeting held this June in Ottawa Canada (and virtually).  Looking ahead, IABS is positioned well to continue  on this path of adapting the organization to the changing world and realizing our mission to increase access to vaccines and other biologicals worldwide. In summary, the Alliance is financially sound, continues to increase its recognition globally and regionally, and is celebrating a milestone with the 50^th anniversary of the publication of Biologicals.  IABS continues to lead the way on the shift to hybrid meetings, with most of our meetings now both “in person” and “virtual”.  With six conferences, meetings, or workshops on three continents since the last Board meeting, IABS continues to be recognized for its ability to provide an independent, neutral forum for the discussion of timely regulatory and scientific issues.  Thanks to the Scientific Committees for reinforcing the value of IABS as a leader and convener of parties interested in advancing contemporary biologics issues. 

Administrative announcements included the stepping aside of the Scientific Secretariat, Abbie Charlet, and the resignation of Board Member & former IABS Vice-President and IABS-EU President, Jean-Hugues Trouvin.  Resources Mobilization Director, Philippe Sabot has decided to discontinue activities with IABS and IABS-EU.  The Board recognized contributions and commitments to IABS and IABS-EU by these individuals, and they were thanked for their service and all they have done for the Alliance.  In order to cover all the work of the Alliance, activities were expanded with Madi Cox and her team at MC’Com Agency for IABS.  

Regarding the 50^th anniversary milestone for the Alliance’s journal Biologicals, Dr. Norman Baylor, Editor in Chief, provides this update:  This year, 2023, the journal BIOLOGICALS (formerly JOURNAL OF BIOLOGICAL STANDARDIZATION, JBS, until 1989) marks 50 years of advancing the development, manufacturing, quality control, safety, efficacy, and regulatory aspects of biological substances used in medicine. The JBS was established by the International Association of Biological Standardization (IABS) in 1973 to encourage advancement of the standardization of biological substances. The last 50 years have seen significant changes in product portfolios for biological substances used in medicine and in regulatory science. The journal will continue to serve as a forum for the introduction and discussion of topics which directly impact innovation and regulatory strategy in the development and lifecycle management of biological products used to improve human and animal health globally.

The Board received an update regarding the Endowment Fund (currently named Actors4Health), that was established in 2021 for donors who would become eligible for tax reduction within Europe.  Philippe Sabot, Executive Director, Actors4Health endowment fund, provides this summary:  “Resources mobilization: Following decrease of revenue from of Biologicals journal royalties and conferences income over past years, the fundraising effort initiated in 2019 is meant to address IABS needs to maintain and grow its capability, aligned with planned scientific projects. Seeking donations is an additional source of revenues, on top of sponsoring contributions from Biologics manufacturers.  An endowment fund eligible for tax reduction within Europe was created in 2021 in France under the control of IABS-EU and provides an additional tool to collect donations. This fund where donations from companies active in the Biologics industry and other contributions are mixed, also allows to manage potential conflict of interest .Together with existing US IABS 501 (c) (3) registered public charities, and IABS Swiss tax-exempt status (still on-going effort), we are looking to set an easy flow of donations revenue from various geographies to support IABS and its affiliates. In 2022 an independent projects committee selection at Endowment fund level was created. First donors are Boehringer-Ingelheim, and Ceva. Sanofi is under negotiation and other companies are targeted. In March 2023 the board decided to give a new name to the IABS endowment fund: Actors4Health.”

In addition to Board, Officer and Affiliate meetings, most participants attended the latest IABS Conference (Maintaining the Quality of Vaccines Through the Use of Standards: Current Challenges and Future Opportunities).  Congratulations to Meeting Co-Chairs, Drs. Maria Baca-Estrada and Carmen Jungbäck for a very successful event!   Presentations and conference conclusions and recommendations will be the IABS website soon. 

IABS has a celebrated history, and there are great things in the future for the Alliance. Thank you for your continued support!

Rick Hill,
IABS President  

Dear IABS Colleagues, Stakeholders, Supporters, and Collaborators, 

It was an honor to assume the presidency of this prestigious organization in 2022.  IABS has a celebrated history, and I am looking forward to more accomplishments to come!  

IABS is positioned well for the future due in large part to our outgoing President,  Dr. Joris Vandeputte.   Joris has an unending passion for the Mission of IABS and in his 6-year term as president he ensured that IABS remained on the cutting edge of biologics innovation as the world changed to meet the challenges of the pandemic.   Thanks to his vision and leadership, our organization is better prepared for future opportunities.  Please join me in congratulating Joris on a few of the accomplishments during his tenure as President:  

• Updating and modernizing IABS’ Vision for the Future:  Health Solutions for Everyone Everywhere.  
• Ensuring IABS Conferences adapted to the pandemic by switching to virtual conferences and webinars; many of which were dedicated to better understanding of SARS-CoV-2 and increased availability of vaccines. 
• Hosting  a highly success celebration of our 65 anniversary along with the corresponding scientific conference in Lyon, France 
• Highlighting IABS as partner in important global discussion around key topics such as correlates of protection and non-animal testing for batch release of vaccines
• Facilitating the participation of Low- and Middle-Income Countries in IABS events.
• Achieving broader recognition of IABS as an independent, high-level, convener among all biological stakeholders
• Providing support to all  IABS Scientific Committees:  Biotherapeutics, Cell & Gene Therapy, Human Vaccines, and Veterinary Biologics

We are very fortunate that Joris remains as Immediate Past President on the IABS Board of Directors, and continues to play an active role in all of IABS’ activities, including Presidential Representative to the IABS Fonds de dotation.  

Looking ahead, IABS is positioned well to continue  on this path of adapting the organization to the changing world and realizing our mission to increase access to vaccines and other biologicals. One of our greatest strengths is the ability to bring stakeholders together to develop innovative solutions for expanded global accessibility to biological  products and health tools.  Recent meetings on Next Generation Sequencing, Vaccination Strategies for High Pathogenicity Avian Influenza and Advancing Chemistry, Manufacturing and Control, Statistics have spotlighted this ability.  Coming meetings on correlates of protection, non-animal testing, platform technologies, reference standards, globally harmonized specifications, real world data and the application of new generation sequencing are just a few examples of future topics that will bring us together to help provide health solutions to everyone everywhere.  IABS has evolved and diversified considerably since it was founded in 1955; and the organization has continued to improve. There are great things in the future for IABS and I am honored to serve as your President during these exciting times.

Thank you for your continued support and best regards,

Rick Hill,
IABS President  

Current initiates for vector standards

Note: for the purposes of this exercise, we have not considered ‘guidelines’ as standards, because they are intentionally flexible.  This means only physical reference materials are identified, no formal written standards were identified.

AAV

ATCC: Recombinant Adeno-associated virus 8 (VR-1816™)

• The adenovirus reference standard materials can be used in the calibration of vector standards within individual laboratories and improve preclinical and clinical data comparisons using common dosages.

ATCC: Recombinant Adeno-associated virus 2 (VR-1616™)

• Use as reference material in gene therapy research. Publication: Characterization of a recombinant adeno-associated virus type 2 Reference Standard Material. (2010)

Vigene Biosciences: AAV Reference Materials

• AAV reference materials (user manual, commercially available)
  AAV1, AAV2, AAV5, AAV6, AAV8, AAV9 Empty & Full Capsids
  Also available from amsbio
  Publication: Standardized AAV manufacturing: Why are AAV reference materials needed?
  NIST/NIIMBL/USP: assess analytical methods and develop standards for adeno-associated virus (AAV)
  NIBSC: Physical Standards for Adeno-associated virus (AAV) Gene Therapy (Grant) will involve preparing an initial reference batch of a gene therapy vector based on the Adeno-associated virus (AAV) virus.

Adenovirus

ATCC: Human adenovirus 5 (VR-1516™)

• The Ad5-RM Working Group is currently working with ATCC, the National Institute of Standards and Technology, and industry partners to produce more of this material.
  Publication: Manufacturing and characterization of a recombinant adeno-associated virus type 8 reference standard material (2014)
  See ISBioTech – stocks low, planning to make more.

ISBioTech: Adenovirus Reference Material Project

4^th Statistical and Data Management Approaches
for Biotechnology Drug Development
Venue: USP Pharmacopeia, Rockville, Maryland

October 30 – November 1, 2017

This meeting is to bring together regulators, and scientists, or those interested in statistics from academia and industry, who have a background in statistics, 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 will be provided by the speakers and panel members. 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.

Click here to  learn more about the meeting

Advancing Analytics for Biotechnology Products
An IABS – FDA international meeting
co-sponsored by NIST
Venue: NIST, Gathersburg, Maryland
Green Auditorium

Gathersburg, Maryland
November 6-8, 2017

This meeting is to bring together regulators, and scientists, or those interested in analytics from 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 current and novel analytics for a variety of activities required during biotechnology product development such as method development, improvement and replacement, product comparability and process development and execution will be provided by the speakers and panel members. 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.

NON U.S. CITIZENS PLEASE NOTE: All foreign national visitors must supply additional information. Failure to provide this information prior to arrival will result in significant delays in entering the facility. Authority to gather this information is derived from United States Department of Commerce Department Administrative Order (DAO) number 207-12. Please fax the following NIST 1260 form to Myesha Steadman as soon as registration is complete: fax (301) 975-4629.

 Click here to learn more about the meeting

Narcolepsy and Pandemic Influenza Vaccination
What we know and what we need to know before the next Pandemic

March 26-27, 2018
Eurostation II, Place Victor Horta
Brussels, Belgium

In partnership with
Federal Agency for Medicines and Health Products (FAMHP)
Vaccine Center of Excellence

This meeting was held under Chatham House Rule

Read the Meeting Report

Influenza Pandemics occur when an influenza strain circulates that humans have not been exposed to before. This may lead to widespread circulation and a high case fatality rate.

In 2009 pandemic, several H1N1 vaccines were developed against the new H1N1 virus and were extensively used. In Finland and Sweden an increase in narcolepsy was noted after the mass vaccination with one of these vaccines.  Disparate results were seen in other countries with other vaccines.  In addition, an increase of narcolepsy has been reported in countries in Asia following wild type influenza infection.

The goal of this meeting is to be prepared for the next pandemic:

• What are the latest data on the risk of narcolepsy following exposure to 2009 pandemic vaccines?
• What scientific data are available and what data are lacking to explain the phenomena that was seen in 2009-10?
• What additional work is needed to prepare for potential use of adjuvanted vaccines for a future pandemic ? 

5th Statistical Approaches for CMC Development and Lifecycle Management of Biotherapeutics and Vaccines

 November 26-28, 2018
Venue: US Pharmacopeia
Rockville, Maryland

Objectives

This meeting is to bring together regulators and scientists to discuss statistical approaches used to help develop and manage processes, which ensure the quality and availability of biotherapeutics and vaccines. Speakers and panel members will engage with meeting participants on challenges and solutions related to CMC development and lifecycle management of biologics.   Areas of attention will include Quality by Design in process and analytical development,  comparability and biosimilarity, stability study design and analysis, validation, and continuous process and analytical verification.  Statistical challenges related to introduction of new technologies and Big Data will be discussed.  Special emphasis will be devoted to collaboration and communication, between scientists and statisticians as well as industry and regulators.  The meeting will bring experts together to discuss the issues and through roundtables attempt to reach conclusions that will add value to global public health.

Quality Requirements for Challenge Agents

October 22, 2019
An IABS-EU Meeting

Read the Meeting Report 

Meeting Objectives
One of the proposed tools for faster development of new vaccines is CHIM: Controlled Human Infectious Models. These models can be used for early PoC (Proof of Concept) and as a basis for clinical  “Go/No Go” decisions, in particular if sporadic epidemiology impedes clinical development.
In these models researchers will use a challenge agent: a virus, bacterium or parasite. Frequently questions are raised on the quality of the agent. Should this agent be produced following GMP? What strain-related information is relevant?  Should it be attentuated or resemble the wild type?

These questions will be discussed during this symposium, more information will follow soon