The Path to Protein Concentration Measurement

8th May 2018

Category: Bioanalytical

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By: Stuart Wright - Scientist,

Protein Concentration Analysis Quick and accurate measurement of protein concentration is very important within the biopharmaceutical industry. This must be carried out on a large number of samples prior to performing the various physicochemical analysis involved in protein characterization or protein structural analysis, since many assays depend on knowledge of the biotherapeutic protein concentration. However, More

Orthogonal Chromatographic Techniques for Therapeutic Protein Characterization

1st March 2018

Category: Bioanalytical

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By: Stuart Wright - Scientist,

Development of biotherapeutics, for example monoclonal antibodies (mAbs), requires a wide range of physicochemical and structural analysis to be undertaken in accordance with ICH Q6B guidelines. Each technique will assess different critical quality attributes (CQAs) which form part of the analytical characterization of the biotherapeutic. CQAs are properties or characteristics relating to physical, chemical, biological More

Characterization of Protein Structure: The Value of Intact Mass Analysis

26th February 2018

Category: Bioanalytical

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By: Dr Martin De Cecco - Senior Scientist,

Intact mass analysis is the assessment of a protein’s total molecular weight  by mass spectrometry (MS) without prior digestion or fragmentation of the molecule of interest. Molecular weight determination forms part of the ICH Q6B guidelines for physicochemical analysis of biological products: what use is this information in the analytical characterization of biopharmaceuticals? High resolution More

Why Glycan Analysis is an Essential Part of Therapeutic Protein Characterization

4th January 2018

Category: Bioanalytical

By: Dr Martin De Cecco - Senior Scientist,

A recent report on the growth of the glycan analysis market¹ highlighted the importance of assessing the glycosylation of biotherapeutics. The carbohydrate structures attached to the crystallizable fragment (Fc) of monoclonal antibodies can influence efficacy and safety and so they are often classed as critical quality attributes. For this reason the analytical characterization of glycosylation More

Improved Product Quality of Biosimilars in the Cellca CHO Expression Platform

15th December 2017

Category: Biosimilars

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By: Cornelia Lindner - Team Leader, Dr Christoph Zehe - Lead Scientist, Johannes Wirth - Scientist, Marina Putanko - Scientist,

Due to the high number of patent expirations for first generation biopharmaceuticals, the production of biosimilars is a fast growing market. Biosimilars require finger-print like similarity to their originator drug with respect to product quality.  One important aspect of product quality is a comparable glycosylation pattern, as glycosylation influences serum clearance, immunogenicity, as well as More

Promoter Evaluation in the Cellca CHO DG44 Expression System

4th December 2017

Category: Cell Line Development

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By: Ann-Catherin Leroux - Scientist, Dr Christoph Zehe - Lead Scientist,

One key component of the powerful Cellca Expression Platform is the expression vector. We have carefully selected its genetic elements to allow: freedom to operate high level expression of monomeric and dimeric products (e.g. IgG-type antibodies, Fc-Fusion, bispecifics) enhanced, stable expression by optimized S/MAR elements increased secretion by optimized signal peptide As a next step More

Improved Speed to Clinic by Increasing Automation in Cell Line Development

14th November 2017

Category: Cell Line Development

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By: Dr Christoph Zehe - Lead Scientist, Dr Monika Holeiter - Senior Scientist, Technology Development,

“Speed to Clinic” is a crucial measure for successful drug development. As a leading provider of stable cell lines, Sartorius Stedim Cellca strives to contribute to this goal by increasing the degree of automation in its Cell Line Development (CLD) technology. While maintaining consistently high quality of the recombinant products, we develop an automation strategy More

Delivering Scientific and Service Excellence for 10 Years

28th September 2017

Category: General

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By:

In 2007, a team of experienced industry professionals founded BioOutsource Ltd. in Glasgow, UK. This year we are celebrating our 10 year anniversary, and taking a look back at our key milestones and achievements. Follow our story about how we began as a small start-up business to becoming one of the global leaders in contract testing. August More

Proving Clonality of Cell Lines with 99.9% Probability

21st September 2017

Category: Cell Line Development

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By: Dr Christoph Zehe - Lead Scientist,

Proving clonality of production cell lines is an important topic in the field of cell line development. The main regulatory authorities and organizations, such as the Food and Drug Administration (FDA) require detailed evidence of monoclonality of production cell lines. Failing to provide sufficient evidence of monoclonality will require additional manufacturing controls, which can lead More

Improved Clone Evaluation and Selection of CHO Cell Lines using ambr15®

8th August 2017

Category: Cell Line Development

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By: Anton Stefan - Scientist, Dirk Mueller - Team Leader, Dr Christoph Zehe - Lead Scientist, Michael Grauf - Scientist,

The global market for biopharmaceutical products continues to expand, making it a highly attractive market for biopharmaceutical companies. Due to the rising number of projects with variant protein drug candidate molecules, increasing productivity of cell culture process development to support material production for early phase clinical trials has been an important task in recent years. More

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