Monday, 3 September 2018

Videos! SPR applications in protein characterization

See how fellow Biacore users are improving protein characterization with
surface plasmon resonance (SPR).

Watch these exclusive videos from the Biacore Analytical, Comparability and QC Symposium, Vienna, Nov 2017, industry luminaries share insights, tips and techniques that illuminate how SPR with Biacore system is helping advance biotherapeutics research and production.

Start off with a deep dive into a range of assays using Biacore systems to evaluate potency. Followed by Fredrik Sundberg’s insights into global industry and regulatory trends.


Mike Wilcox on compliant Fc receptor potency validation

An important step in the development of mAb biosimilars is to compare binding to Fc receptors of the new therapeutic to the reference medicine. To do this, in vitro functional testing methods are paramount, as outlined by guidelines presented in the 2005 report by the European Medical Agency.
Watch this video where Eurofins Biopharma shares how to perform an SPR assay to validate Fc receptor potency according to ICH Q2 R1 and FDA guidelines.

           Qualification of an SPR kinetics (CD64) and steady state affinity (FcRn) assay
           based on the ICHQ2 (R1) guidelines

           Presenter: Mike Wilcox, Eurofins
           Playing time: 18 minutes

Stuart Knowling explores SPR in relative potency assays

All biological products must meet prescribed safety, purity and potency requirements for BLA approval. Potency is considered a critical quality attribute (CQA) for any biological product, and the implementation of relevant assays is often at the center of many challenges and discussions among developers and regulators throughout product development.
Watch this video to get a taste of how SPR binding and affinity are being used in relative potency assays, and how that correlates with antibody-dependent cell-mediated cytotoxicity (ADCC) in work being conducted at Sartorius Stedim BioOutsource.

           Using SPR-based assays for comparability and potency assessment

           Presenter: Stuart Knowling, BioOutsource
           Playing time: 30 minutes

Veronica Fridh sheds light on SPR surrogate potency assays

The utilization of SPR in process optimization and quality control is increasing, due to the combination of robustness, high sensitivity, precision, and accuracy that Biacore SPR technology provides. This, coupled with high throughput capabilities and decreased sample preparation requirements, is why SPR is an attractive method relative to traditional analytical techniques that measure protein quantity and quality.
Watch this video on how SPR surrogate potency assays facilitate comparability biosimilar studies.

             High-resolution SPR surrogate potency assay to facilitate comparability
             and biosimilar studies

             Presenter: Veronica Fridh, GE Healthcare Life Sciences, R&D
             Playing time: 21 minutes

Fredrik Sundberg on global bioprocessing industry and regulatory trends

A thorough understanding of your drug development process and how it affects your product’s critical quality attributes is essential for decision-making, development and scale up. Are you up-to-date with new analytical platforms that can give you the edge?
Watch this video to get an overview of global industry and regulatory trends and how Biacore assays can be employed to ensure drug safety and efficacy.

           Global industry trends and health authority acceptance of SPR

           Presenter: Fredrik Sundberg, GE Healthcare Life Sciences
           Playing time: 40 minutes

Learn more! Check out the Bioanalytics in drug development
web page for a wealth of additional resources.


Christina Burtsoff Asp
Marketing manager

Monday, 23 July 2018

DiPIA 2018….where we turned back time


What does magic and science have in common?? At first glance, seemingly nothing and I could argue that they are almost antagonistic. As Neil Gaiman wrote “Science is a way of talking about the universe in words that bind it to a common reality. Magic is a method of talking to the universe in words that it cannot ignore. The two are rarely compatible."  

Then why did we have a magician at #DiPIA2018 in Boston last month????

The Great Danny Orleans in action
Ever since I was a child I found magic incredibly engaging. Magicians seem to break known physical and scientific laws, making the improbable seem, to the audience at least, possible.  At #DiPIA2018, the magician Danny Orleans (to the amazement of everyone in the audience), turned back time!!!  Who doesn’t want extra time in their day??  Attendees witnessed Danny magically turn back the time on an attendee from Sanofi’s watch 17 minutes!!  – A time selected by another audience member (and BiacoreTM user).  Clearly this was magic!!

Two hundred years ago if you saw someone fly or chat in real time to someone on the other side of the world you would have called that magic. Twenty years ago, if you asked a scientist  “could you characterize a small molecule directly binding to a kinase immobilized onto a sensor chip?”  The answer would have been “no”, but we now know you can do this easily…..is that magic?

Ten years ago, if someone showed you that you could screen or characterize 100’s to 1000’s of compounds by SPR in less time, without compromising sensitivity or flexibility – would you think that was magic? Of course not, it’s just the evolution and advancement of technology. Just like the ability for humans now to “fly” on commercial airplanes or chat via Facetime (like I do) with family on the other side of the world.  Advancements in science and technology make what was previously impossible, possible.

In the words of the philosopher Ehud Benor “Science tries to make magic real” through our ideas, creativity and instruments as opposed to any mystical powers.  As a result, science turns us into magicians through the melding of mind and machine; instead of magician’s assistants to help us do tricks, we have technology.  As Faraday said, “nothing is too wonderful that it can't be true, as long as it obeys the laws of nature.”

BiacoreTM 8K+
At #DiPIA2018 my colleague Martin Teichert unveiled the next step in the evolution of SPR and the Biacore portfolio, Biacore 8K+ delivering binding data of outstanding quality with significantly higher capacity, making it possible to run unattended for over 4500 samples without changing any plates.  Giving the ability to run more samples in a day/per week, saving time.

So, to answer my opening question, what does magic and science have in common? The answer is A LOT, especially if you have the technology to makes what was once improbable now possible.  As Clarkes third law states “any sufficiently advanced technology is indistinguishable from magic

In the coming weeks you will hear from members of the Scientific committee with their thoughts and highlights of their respective sessions at #DiPIA2018

Thanks for reading,

Paul Belcher
Global Product Strategy Manager, Biacore.


Wednesday, 23 May 2018

Register for DIPIA 2018: Explore what’s on at DIPIA this Year!

The workshops planned for DiPIA are a very special section of the event, that focus more about the process of a scientific project than on results of projects and how that information is relevant as presented in main sessions. As such, each workshop is a very engaging and focused set of 3 distinguished speakers in 4 different areas, from research, discovery to quality control.

There is great excitement for the workshop “Driving forward drug discovery by utilizing binding kinetics”
The presentations in this workshop are ordered as a function of residence time. In the workshop
by Joost Uitdehaag, the residence time for drug optimization will discuss the development of the inhibitors of Threonine Tyrosine Kinase leading ultimately to new understanding of their possible use in cancer treatment.

Matthias Frech will discuss the interplay between pharmacological half-life, residence time and other biophysical parameters towards drug efficacy. Increasing the time scale for the off rate, Philip Schwartz will describe his work with irreversible inhibitors and discuss the appropriate parameters and methods that are used for their characterization. 

Additional exciting news is going to be revealed during the workshop "Small molecules as therapeutics: From structure-activity relationships to clinical trials".
Working with assay development and design can be valuable, as you will hear in a story by Veronika Fridh. The two targets: Thermolysin and Aldehyde Reductase, were kept active on the sensor chip and the binding of several drug candidates were characterized in Biacore S200. The high sensitivity data thus allowed discovery of the most potent candidates.

An inspirational talk will be given by Janice Villali, who will demonstrate how the ABA inject can be used to find small molecules disrupting a protein complex.
Göran Dahl will discuss the experimental design, in broader terms, together with opportunities and challenges of SPR in late stages pre-clinical development.

The workshops will be held twice, so no attendee needs to miss these events.
Still time to register for DiPIA 2018.


See you in Boston!
Ewa Pol and Jason Schuman, Session Chairs

Thursday, 17 May 2018

Register for DIPIA 2018: Explore what’s on at DIPIA this Year

The workshops planned for DiPIA are a very special section of the event, that focus more about the process of a scientific project than on results of projects and how that information is relevant as presented in main sessions. As such, each workshop is a very engaging and focused set of 3 distinguished speakers in 4 different areas, from research, discovery to quality control.

Quite novel application field has recently been expanding for the use of SPR in process development of biotherapeutics. This workshop has been structured to give a sample of Biacore assays related process development applications used throughout the drug development process, from purification to IND filing.

The first presentation gives insight into the development of a Biacore assay for the quantification of adenovirus, the most widely used viral vector, and how this assay was used to guide process optimization.

One more quantification assay, with calibration-free concentration analysis, in the process development of a multi-component Malaria vaccine, will be discussed by Markus Sack. He will explain how the concentration of each vaccine component could be determined independently, ultimately allowing the optimization
of the vaccine cocktail content.

Finally, Xiangdan Wang will focus on several case studies about her work with Investigational New Drugs and about how important it is to establish the binding characteristics throughout the early development of these molecules to enable the assessment of efficacy and dosing. New and stimulating insight into how SPR can be broadly applied. 

The workshops will be held twice, so no attendee needs to miss these events.
Still time to register for DiPIA 2018

See you in Boston!
Ewa Pol and Jason Schuman, Session Chairs

Friday, 27 April 2018

Register for DIPIA 2018: Explore what’s on at DIPIA this year

DIPIA 2018: SPR-based Assays for Comparability and Potency Assessment

The workshops planned for DiPIA are a very special section of the event, that focus more about
the process of a scientific project than on results of projects and how that information is relevant
as presented in main sessions.

As such, each workshop is a very engaging and focused set of 3 distinguished speakers in 4 different
areas, from research, discovery to quality control. 
In the workshop “SPR-based Assays for Comparability
and Potency Assessment”, 
you will be able to hear some proposals for handling complex interactions
occurring for instance 
in receptor-to-antibody binding. 

Two scientists, Giordana Bruni and Mike Willcox, will share their experiences 
with the validation of kinetic assays of biotherapeutic agents and biosimilars, 
as recommended by Health Authorities, for use in a regulated environment. 

In the same session, one of the “co-founders” of Biacore™ systems, 
Robert Karlsson, will demonstrate how SPR can be used to investigate 
several critical quality attributes and determine relative potency of 
biotherapeutics in a single assay. During his presentation, you will get a deeper 
understanding of the importance of binding kinetics to potency determinations.  
Very exciting!!

The workshops will be held twice, so no attendee needs to miss these events.
Still time to register for DiPIA 2018. See you in Boston!

 Ewa Pol and Jason Schuman, Session Chairs

Wednesday, 18 April 2018

Countdown to DIPIA: Diversity of SPR research applications

Diversity of SPR research applications


Out of all the scientific sessions at DiPIA, the Basic Research to Advanced Applications session is always the most diverse and to many the most interesting. This session highlights why biophysical tools like SPR are so important in research and discovery, and provides an opportunity to examine intrinsically interesting research outside the realm of classic biotherapeutic and small molecule SPR assays which many of us do on a daily basis.


This will be a wide-ranging session, with lively discussions that will take you outside the world of biotherapeutics and give you broad view of some cutting edge SPR applications.
  • Learn how SPR assays are being applied to protein-lipid binding in the context of viral infectivity from Robert Stahelin of Purdue University
  • Frantz Jean-Francois will discuss oncogene function research at the U.S. NIH National Cancer Institute
  • Hear about the assembly/stability/inhibition of complement system factors from Claire Harris of the University of Newcastle
  • Betsy Yakes of the U.S. Food and Drug Administration will discuss quantification of biotoxin levels in seafood.

Each presentation will address challenging assay components such as atypical ligand surfaces, complex sample matrices, and function of multi-subunit protein complexes.



There’s still time to register for DiPIA 2018. See you in Boston!

Eric Roush and Emeric Gueneau, Chairs Basic Research and Advanced Applications Session

Tuesday, 10 April 2018

Countdown to DIPIA: SPR in LMW drug discovery

SPR - integral part of LMW discovery, even for complex targets

Surface Plasmon Resonance is an integral part of modern small molecule drug discovery and 
research efforts. For DiPIA 2018, we have been working to put together a thought-provoking session, 
with topics ranging from fragment-based drug discovery (FBDD) screening, to hit to lead projects, 
to detailed characterization and mechanism of action for challenging assays, and novel approaches.

We are excited to have Sanjay Panchal from AbbVie Inc. 
as our keynote speaker discussing the hit to lead process, 
with EED protein as an example, to highlight the benefits and 
challenges of using kinetic and thermodynamic data 
in drug discovery and development. 

Antibacterial drug resistance is emerging as a serious threat to the
world population. Peter Coombs from LifeArc will present results from
the work they have done on fragment screening for anti-bacterial targets. 



Hyun Lee from University of Illinois will address the use of SPR in tackling the Zika virus,
another global health threat, by identifying protease inhibitors.
Kristin Hamman from Syros Pharmaceuticals will present a challenging project on a sensitive assay 
to measure inhibition of CDK7 in its active heterodimer form, with the goal of disrupting cancer 
cell proliferation. 
Bhamini Vaidialingam from Agios Pharmaceuticals will share work probing the molecular 
mechanisms of metabolic enzymes.  Her work probes conformational changes by allosteric regulators, 
with an elegant use of the A-B-A inject.

Finally, Göran Dahl will focus on how researchers at AstraZeneca use SPR to understand mechanism 
of binding and mode of action, in addition to affinity and kinetic data, to guide drug discovery.
This session will illustrate why SPR has emerged as one of the major biophysical techniques 
used in drug discovery.

There is still time to register for DiPIA 2018. We hope to see you there!

Cynthia Shuman and John Sinfield, Session Chairs