For characterizing higher order protein structure and accurately defining CQAs of biopharmaceuticals

Malvern, PA, USA and Jersey, UK. May 9, 2017 – BioPharmaSpec, a leading contract research organization (CRO) providing a full range of characterization services for the biotechnology industry, today announced it is expanding the range of its in-house capabilities for characterizing higher order protein structure. The new in-house services allow Clients access to an increased range of BioPharmaSpec’s flexible, expert characterization methods to accurately and cost-effectively define Critical Quality Attributes (CQAs) of their biopharmaceuticals.

With the addition of new scientific expertise to the BioPharmaSpec leadership team and further investment in state-of-the-art equipment in the US Laboratory, BioPharmaSpec has expanded its in-house services to include: Circular Dichroism (CD), Fourier Transform Infrared Spectroscopy (FT-IR), and Intrinsic Fluorescence (IF). These capabilities allow rapid secondary and tertiary structure analysis comparisons alongside BioPharmaSpec’s long-standing and widely-acclaimed primary structure characterization services, providing clients with reliable data that fulfil regulatory requirements.

To showcase the application of these in-house services, BioPharmaSpec scientists Dr. Mark Millichip and Christopher Ziegenfuss will be presenting a live webinar on 18th May 2017 entitled: “Understanding the Importance of Higher Order Protein Structure”. The webinar will feature case studies of antibody therapeutic candidates’ higher order protein structures using data derived from the new in-house analytical services.

Scientists can register for this free webinar here.

Dr Mark Millichip, Technical Director at BioPharmaSpec commented: “Expanding our in-house capabilities to assess higher order protein structure provides Clients with access to a full range of analytical expertise and means we can assist in planning comprehensive, regulatory compliant characterization strategies. This will support formulation and process development, as well as biosimilar comparability and stability studies, thus helping our Clients to reduce development timelines of their biopharmaceuticals.”

Demonstrating higher order protein structure capabilities, BioPharmaSpec’s scientists have co-authored a research study with academia in the peer-reviewed journal ‘Analytical Methods’ to define the molecular structure of different insulin samples as a function of pH, temperature, and the presence or absence of zinc. The article can be requested here.

Chris Ziegenfuss, Laboratory Manager stated: “We are delighted to be investing in expanding our in-house analytical services because this means new and existing scientific clients have the unique opportunity of accessing comprehensive technical expertise in both the USA and the UK together with the speed and flexibility that partnering with a more specialized CRO provides.”

Chris Ziegenfuss continued, “We look forward to hearing from Clients who want to discover how BioPharmaSpec’s new comprehensive in-house protein structure characterization services can deliver quality analytical data, as well as a competitive advantage for their biopharmaceutical product development.”