Analytical Strategies for Biosimilars

Management of cGMP facility calls for a strict monitoring all factors including analytical strategies, formulation procedures, packaging etc. For biologic products establishing comparability and interchangeability is a big hurdle. For this purpose employment of suitable analytical approach, bioassay, protein analysis, potency testing, safety assurances are highly important. LC/MS analysis for biologic products, characterization of biologics, peptide mapping, Isoelectric Focusing and Capillary Isoelectric Focusing, SDS-PAGE, Thermal Analysis, Particulate Matter Analysis, Thermogravimetric Analysis are some methods commonly used for analysis of biologics and biosimilar products.

On average, facilities outsource 32% of their analytical testing/bioassays (up from 28%) meaning that close to one-third of analytical testing is estimated to be outsourced by the industry.

Management of cGMP facility calls for a strict monitoring all factors including analytical strategies, formulation procedures, packaging etc. For biologic products establishing comparability and interchangeability is a big hurdle. For this purpose employment of suitable analytical approach, bioassay, protein analysis, potency testing, safety assurances are highly important. LC/MS analysis for biologic products, characterization of biologics, peptide mapping, Isoelectric Focusing and Capillary Isoelectric Focusing, SDS-PAGE, Thermal Analysis, Particulate Matter Analysis, Thermogravimetric Analysis are some methods commonly used for analysis of biologics and biosimilar products.

On average, facilities outsource 32% of their analytical testing/bioassays (up from 28%) meaning that close to one-third of analytical testing is estimated to be outsourced by the industry.

  • Biosimilar multimodal techniques
  • Biosimilar bioanalytical methods
  • Bioassay for comparability and potency testing
  • Biosimilar LC/MS analysis for discovery, preclinical, and clinical programs
  • Biosimilar GMP protein analysis
  • Biosimilar electrophoresis

Related Conference of Analytical Strategies for Biosimilars

Sep 25-26, 2017

12th Annual
Pharma Middle East Congress

Dubai, UAE
October 02-03, 2017

9th Annual Pharmaceutical Chemical Analysis Congress

Vienna, Austria
October 05-06, 2017 Park Inn by Radisson London Heathrow,

5th International Conference and Exhibition on Pain Research and Management

London, UK
October 16-17, 2017

16th Annual Medicinal & Pharmaceutical Sciences Congress

Seoul, South Korea
October 16-18, 2017
(10 Plenary Forums - 1 Event)

4th International Conference on Past and Present Research Systems of Green Chemistry

Atlanta, Georgia, USA
October 18-19, 2017

6th Global Congress on Mass Spectrometry

Osaka, Japan
October 19-20, 2017

9th Annual Congress on Drug Design & Drug Formulation

Seoul, South Korea
October 19-20, 2017

4th International Conference and Exhibition on Pain Medicine

(10 Plenary Forums - 1 Event)
San Francisco, California, USA
October 30-November 01, 2017
A B2B Networking & Global Knowledge Exchange Forum

Annual Congress on Emerging Orphan Drugs and  Rare Diseases

San Antonio, Texas, USA
November 13-14, 2017

Global Experts Meeting on Toxicology

Singapore
March 19-20, 2018

International Meeting on Nutraceuticals

Singapore
March 26-27, 2018

World Congress on Herbal and Chinese Medicine

Bali, Indonesia
April 20-21, 2018

4th International Conference on Antibiotics

Las Vegas, Nevada, USA
April 26-27, 2018

11th European Biosimilars Congress

Rome, Italy
May 07-09, 2018

10th Annual European Pharma Congress

Frankfurt, Germany
June 18-19, 2018

9th Global Experts Meeting on Neuropharmacology

Paris, France
June 20-22, 2018

7th World Congress on Mass Spectrometry

Rome, Italy
July 09- 10, 2018

Annual Meeting on Pharmacology

Bangkok, Thailand
July 09-10, 2018

12th Global
Pharmacovigilance & Clinical Trials Summit

Sydney, Australia
July 16-18, 2018

15th Asia-Pacific Pharma Congress

Melbourne, Australia
Jul 30-Aug 01, 2018

10th World Congress on Pharmacology

Barcelona, Spain
August 13-14, 2018

Global Experts Meeting on Case Reports

Tokyo, Japan
September 13-14, 2018

8th World Congress on Chromatography

Prague, Czech Republic
September 24-25, 2018

7th International Conference on Clinical Trials

Chicago, USA
(10 Plenary Forums - 1 Event)
Oct 29-30, 2018

3rd Global Pharma Congress

Osaka, Japan

Analytical Strategies for Biosimilars Conference Speakers

Recommended Sessions

Related Journals

Are you interested in