BioPharmaSpec expands in-house analytical capabilities

Published: 10-May-2017

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

BioPharmaSpec, a contract research organisation (CRO) providing a full range of characterisation services for the biotechnology industry, is expanding the range of its in-house capabilities for characterising higher order protein structure.

The new in-house services allow clients access to an increased range of BioPharmaSpec’s flexible, expert characterisation 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 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 secondary and tertiary structure analysis comparisons alongside BioPharmaSpec’s usual primary structure characterisation services.

Webinar

To showcase the application of these in-house services, BioPharmaSpec scientists Mark Millichip and Christopher Ziegenfuss will be presenting a live webinar on 18 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.

Regulatory

Mark Millichip, Technical Director at BioPharmaSpec said: “Expanding our in-house capabilities means we can assist in planning regulatory-compliant characterisation 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.”

Research

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.


Chris Ziegenfuss, Laboratory Manager said: “Expanding our in-house analytical services means new scientific clients can access technical expertise in the USA and UK, with the flexibility of partnering with a more specialised CRO.”

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