Corporate Banner
Satellite Banner
Technology
Networks
Scientific Communities
 
Become a Member | Sign in
Home>News>This Article
  News
Return

Merck Millipore Publishes White Paper

Published: Wednesday, February 27, 2013
Last Updated: Wednesday, February 27, 2013
Bookmark and Share
Details use of flow cytometry and surface plasmon resonance to quantify binding of therapeutic monoclonal antibodies to molecules mediating cytotoxicity.

Merck Millipore has announced the publication of a white paper, "Effective In Vitro Bioanalytical Assays for Comparing Pharmacodynamics of Biosimilar Monoclonal Antibodies", which describes both regulatory and technical aspects of comparability studies for the development of biosimilars.

The white paper describes two bioanalytical approaches involving measurements of ligand binding to compare pharmacodynamics of biosimilars.

Specifically, surface plasmon resonance (SPR) and flow cytometry were used to quantify the binding of two therapeutic mAbs, alemtuzumab and infliximab, to molecules mediating cytotoxicity. Data generated from these comparability studies are highlighted.

The biosimilar therapeutics industry, estimated to be greater than $90 billion, is rapidly expanding and poised to see dramatic growth in the next five years in the United States, Europe and other international markets.

This explosion is being driven by the large size of the biologics industry, upcoming patent expirations on many major branded biologics and the issue of new or updated regulatory guidelines by the FDA, EMA and DBT of India.

While the industry is growing rapidly, developing a biosimilar therapeutic can be expensive, as each new biosimilar must prove that variances from the innovator drug are not clinically significant.

Therefore, there is a critical need for accurate and precise nonclinical, in vitro assays to measure drug potency.

"Although our regulatory bioanalytical services were founded on supporting the development of innovator biologics, we have also helped lead the development of both simple peptide and complex monoclonal antibody biosimilars," says James Hulse, Ph.D., Managing Scientific Director of Discovery and Development Solutions.

Hulse continued, "The regulatory guidelines governing the development of biosimilars are relatively new, and this white paper describes new approaches for development of preclinical data about drug properties and their physiological interactions without the need for animal experiments."


Further Information

Join For Free

Access to this exclusive content is for Technology Networks Premium members only.

Join Technology Networks Premium for free access to:

  • Exclusive articles
  • Presentations from international conferences
  • Over 4,000+ scientific posters on ePosters
  • More Than 5,300+ scientific videos on LabTube
  • 35 community eNewsletters


Sign In



Forgotten your details? Click Here
If you are not a member you can join here

*Please note: By logging into TechnologyNetworks.com you agree to accept the use of cookies. To find out more about the cookies we use and how to delete them, see our privacy policy.

Related Content

Merck Millipore Enters Into Strategic Alliance with Turgut Ilaç
Company to provide Provantage® End-to-End solution for development and manufacture of biosimilars.
Friday, October 23, 2015
Merck Millipore Introduces Enhancements to its EMPROVE® Program
Instant, online access to regulatory and technical information on portfolio of 400 products.
Thursday, September 17, 2015
Merck Millipore Enters Into Agreement with Singulex
Acquiring exclusive worldwide rights to Singulex’s SMC™ technology - instruments, assays and services - for research applications.
Thursday, May 28, 2015
Merck Millipore Announces Agreement with Precision Biologics
Merck Millipore services include design and development of cost-effective process to deliver high yield and productivity.
Thursday, February 05, 2015
Merck Millipore Expands Biomanufacturing Sciences and Training Center in Japan
Facility expansion and relocation of existing operations from Yokohama, Kanagawa Prefecture to Tokyo.
Thursday, August 28, 2014
Merck Millipore Invests €12M in France Facility
The investments will expand ready-to-use media manufacturing at company's Molshiem facility.
Tuesday, August 12, 2014
Princeton’s Dr Bonnie Bassler Receives 2014 Alice C. Evans Award
Merck Millipore congratulates winner of the Alice C. Evans award for leadership in clinical microbiology.
Thursday, May 22, 2014
Merck Millipore Announces Incoming CEO and President
Udit Batra, Ph.D. will be responsible for the organization’s strategic direction to drive growth and product innovation as well as oversight of the worldwide operations.
Tuesday, April 15, 2014
Merck Millipore, VWR Extend Western European Distribution Agreement
Provides VWR access to more Merck Millipore products and reagents for chemical and microbiological analysis.
Wednesday, April 09, 2014
Merck Millipore Introduces the Lab Solutions Virtual Conference: “Complete Solutions for Food Safety Analysis.”
Merck Millipore, the Life Science division of Merck KGaA has announced the first Lab Solutions Virtual Conference on November 19 and 20, 2013.
Tuesday, November 05, 2013
Merck Millipore Announces Co-marketing Agreement with groninger
Offering combines industry-leading single-use assemblies, sterility assurance solutions and stainless steel filling equipment.
Tuesday, August 13, 2013
Merck KGaA Passes EXCiPACT Audit for Certification as Provider of Pharmaceutical Excipients
Ensures current GMP and GDP requirements applied to pharmaceutical excipients through a recognized auditing and certification process.
Friday, August 02, 2013
Merck Millipore Partners with Gyros
Partnership to develop, manufacture and commercialize kits on the Gyrolab™ immunoassay platform.
Tuesday, July 16, 2013
Merck Millipore Opens New R&D Center
Facility fosters company's focus on Bioavailability Enhancement.
Monday, July 15, 2013
Merck Millipore Introduces the Lab Water Virtual Conference
“The Lab of Tomorrow, Bringing the Future to Life Today”.
Wednesday, May 22, 2013
Scientific News
Big Genetics in BC: The American Society for Human Genetics 2016 Meeting
Themes at this year's meeting ranged from the verification, validation, and sharing of data, to the translation of laboratory findings into actionable clinical results.
Stem Cells in Drug Discovery
Potential Source of Unlimited Human Test Cells, but Roadblocks Remain.
Cancer Genetics: Key to Diagnosis, Therapy
When applied judiciously, cancer genetics directs caregivers to the right drug at the right time, while sparing patients of unnecessary or harmful treatments.
Transporting Microscopic Cargo Between Human Cells
Scientists have developed a virus-inspired delivery system for material transport between cells.
Tissue Damage Is Key for Cell Reprogramming
Researchers have shown tissue damage is important for cells to return to an embryonic state for cell reprogramming.
Metabolite Promotes Cancer Cell Transformation
Researchers have identified a metabolite that promotes cancer cell transformation and colorectal cancer spread.
Improving Drug Production with Computer Model
A model has been developed that can be used to improve and accelerate the production of biotherapeutics, cancer drugs, and vaccines.
Bird Flu Confirmed in the Netherlands
An outbreak of H5 avian influenza was confirmed in the Flevoland province of the Netherlands.
Pasteurised Bacterium Reduces Obesity and Diabetes
Researchers have discovered that an intestinal bacterium provides a lasting effect on the intestinal barrier.
Turning Off Asthma Attacks
Researchers discover a critical cellular “off” switch for the inflammatory immune response that causes asthma attacks.
Scroll Up
Scroll Down
Skyscraper Banner

SELECTBIO Market Reports
Go to LabTube
Go to eposters
 
Access to the latest scientific news
Exclusive articles
Upload and share your posters on ePosters
Latest presentations and webinars
View a library of 1,800+ scientific and medical posters
4,000+ scientific and medical posters
A library of 2,500+ scientific videos on LabTube
5,300+ scientific videos
Close
Premium CrownJOIN TECHNOLOGY NETWORKS PREMIUM FOR FREE!