Nav: Home

New cell lines produce NIST monoclonal antibody for improved biologic drugs

July 31, 2018

When the National Institute of Standards and Technology (NIST) issued the world's first standardized monoclonal antibody (mAb) in July 2016, the exhaustively analyzed protein known as NISTmAb (NIST Reference Material 8671) was intended as a valuable tool for biopharmaceutical companies. Its purpose: to help ensure the quality of measurement techniques used in the development and manufacture of biologic drug therapies for a wide range of health conditions, including cancers, autoimmune disorders and infectious diseases. Although the molecule has been precisely characterized, the current proprietary method for its production has not.

In a new paper in the journal mAbs, researchers at the Institute for Bioscience and Biotechnology Research (IBBR), a joint institute of NIST and the University of Maryland, describe how they have taken the first step to solve this dilemma: engineering three mouse cell lines to produce nonproprietary versions of NISTmAb that closely resemble the characteristics of the original reference material.

"By creating the means to produce our already well-characterized monoclonal antibody, the NISTmAb, we can now make the measurements that will define the production process as well as the product," said NIST research biologist Zvi Kelman who co-authored the mAbs paper. "From that, we can develop a standardized model for monoclonal antibody biomanufacturing that will give researchers and manufacturers a second valuable reference tool."

Monoclonal antibodies are proteins manufactured in the laboratory that can target specific disease cells, viruses and other antigens (agents that trigger an immune response) for removal from the body or can be used to deliver therapeutic chemicals or radiation to select sites. Since the first commercial mAb was approved in 1986, their impact on medicine has been astounding. Today, five of the 10 top-selling drugs are mAbs with annual sales currently at $100 billion and expected to rise to $150 billion within three years.

As the patents on the original mAb biologics expire or near expiration over the next few years, many biopharmaceutical companies will seek to enter the market with generic versions known as biosimilars.

"Both the manufacturers seeking legal and public approval for their biosimilars and regulators at the Food and Drug Administration must verify that the new drugs match the originals with regard to efficacy, quality and safety," said John Marino, leader of the Biomolecular Structure and Function Group in NIST's Material Measurement Laboratory and another author on the mAbs paper. "Having a rigorously characterized mAb production process, along with our standard NISTmAb protein, will serve as powerful benchmarking tools that should help manufacturers and regulators release new mAb therapeutics and biosimilars with greater confidence."

Quality control is not the only way that the NISTmAb cell lines will make a difference, Marino added.

"Understanding how the NISTmAb is derived will enable investigators to look for ways to optimize the production of other mAbs or overcome commonly shared problems such as contamination or aggregation [protein clumping]," he said.

Equally important, Kelman said, the knowledge and benefits gained from study of the nonproprietary NISTmAb bioprocessing system will be freely available and widely shared.

"Researchers will be able to look at the broad issues currently facing manufacturers of mAb therapeutics with a system that is not proprietary; the NIST cell lines will encourage innovation and exploration that isn't related to specific product development," he explained.
-end-
Paper: L. Kashi, K. Yandrofski, R.J. Preston, L.W. Arbogast, J.P. Giddens, J.P. Marino, J.E. Schiel and Z. Kelman. Heterologous Recombinant Expression of Non-Originator NISTmAb. mAbs. Published online 30 July 2018. DOI: 10.1080/19420862.2018.1486355

National Institute of Standards and Technology (NIST)

Related Infectious Diseases Articles:

Critical gaps in our knowledge of where infectious diseases occur
Today Scientists have called for action. The scientific journal Nature Ecology & Evolution have published a joint statement from scientists at Center for Macroecology, Evolution and Climate, University of Copenhagen and North Carolina State University.
'Flying syringes' could detect emerging infectious diseases
Blood-sucking flies can act as 'flying syringes' to detect emerging infectious diseases in wild animals before they spread to humans, according to research published in the journal eLife.
27th European Congress of Clinical Microbiology & Infectious Diseases
Media can register now for the 27th European Congress of Clinical Microbiology and Infectious Diseases (ECCMID) in Vienna, Saturday 22 April to Tuesday 25 April 2017.
Young doctors working in infectious diseases suffering burnout and bullying
One in five physicians working in medical microbiology and infectious diseases is suffering from burnout, bullying and poor work-life balance.
Gut cells are gatekeepers of infectious brain diseases, study finds
Fresh insights into infectious brain conditions help to explain why some people -- and animals -- are more at risk than others.
More than 3 million children under 5 years old will die from infectious diseases next year
A new report outlines the alarming burden of pediatric infectious diseases across the world.
New global migration mapping to help fight against infectious diseases
Geographers at the University of Southampton have completed a large scale data and mapping project to track the flow of internal human migration in low and middle income countries.
More research is needed on how climate change affects infectious diseases
It is time we act proactively to minimize the effect of climate change on our health, say the researchers behind a new review published in Environment International.
A global early warning system for infectious diseases
In the recent issue of EMBO reports, Barbara Han of the Cary Institute of Ecosystem Studies and John Drake of the University of Georgia Odum School of Ecology call for the creation of a global early warning system for infectious diseases.
Ways of reducing the transmission of infectious diseases in transport hubs
Transport plays a major role in the spread of transmissible diseases.

Related Infectious Diseases Reading:

Best Science Podcasts 2019

We have hand picked the best science podcasts for 2019. Sit back and enjoy new science podcasts updated daily from your favorite science news services and scientists.
Now Playing: TED Radio Hour

Don't Fear Math
Why do many of us hate, even fear math? Why are we convinced we're bad at it? This hour, TED speakers explore the myths we tell ourselves and how changing our approach can unlock the beauty of math. Guests include budgeting specialist Phylecia Jones, mathematician and educator Dan Finkel, math teacher Eddie Woo, educator Masha Gershman, and radio personality and eternal math nerd Adam Spencer.
Now Playing: Science for the People

#518 With Genetic Knowledge Comes the Need for Counselling
This week we delve into genetic testing - for yourself and your future children. We speak with Jane Tiller, lawyer and genetic counsellor, about genetic tests that are available to the public, and what to do with the results of these tests. And we talk with Noam Shomron, associate professor at the Sackler School of Medicine at Tel Aviv University, about technological advancements his lab has made in the genetic testing of fetuses.