Delivering Scientific and Service Excellence for 10 Years

28th September 2017

Category: General

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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 - Head of Technology Development,

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 - Head of Technology Development, 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

Cell Line Development (CLD) 2.0

6th July 2017

Category: Cell Line Development

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By: Caroline Hauser - Team Leader, Dr Christoph Zehe - Head of Technology Development, Juliana Schubert - Scientist, Kristin Thiele - Scientist,

The production of biologics in Chinese Hamster Ovary cells (CHO) is becoming more and more challenging due to an increasing number of complex and difficult-to-express (DTE) molecules. Nevertheless, general Cell Line Development (CLD) platform processes should provide reliable high-titer cell lines irrespective of the therapeutic protein formats to be expressed. In the last 20 years More

How to achieve high-yielding cell lines

30th May 2017

Category: Cell Line Development

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By: Caroline Hauser - Team Leader, Dr Christoph Zehe - Head of Technology Development, Juliana Schubert - Scientist, Nico Erb - Scientist,

The global market for biological products is expected to reach $287bn by the end of 2020. There are many drivers for the continued investment and development of therapeutic protein products, such as: an increase in incidences of cancer and autoimmune diseases, reduction in side effects, advances in technology and patent expiry of blockbuster drugs. Although More

What is the best way to approach biosimilar development?

27th March 2017

Category: Bioanalytical / Biosimilars

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By: Dr Terry Gray, Field Marketing Manager,

Part one Monoclonal antibodies have a highly specific targeted action which allows a reduction in side effects compared to small molecule drugs, which has seen them becoming a mainstay of modern medicine. The innate complexity of these molecules allows them to be potent drugs that activate molecular cascades within the immune system. So what does More

Piecing together the biosimilar puzzle: Physicochemical & Functional Analytics

Category: Bioanalytical / Biosimilars

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By: Dr Terry Gray, Field Marketing Manager,

Part two A fundamental feature of a mAb is its biological structure as this defines the functional output of the biologic, as illustrated by figure 2. Figure 2 – The interplay between the structure of a monoclonal antibody, the affinity for interaction and the resulting functional activity. Fundamentally, the sequence of a biosimilar must match More

Choosing the right assay at the right time for biosimilar development

Category: Bioanalytical / Biosimilars

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By: Dr Terry Gray, Field Marketing Manager,

Part Three As highlighted in our previous blog articles, cost & throughput are important contributing factors to consider when developing a biosimilar. Another factor to consider is the choice of assay that will be used at each stage of the biosimilar product life cycle. There are two competing areas which drive the decision making process More

Preparing for future bioprocessing challenges with the Cellca CHO Expression Platform

13th July 2016

Category: Cell Line Development

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By: Dr. Brian Wendelburg, Sr. Field Marketing Manager,

Therapeutic protein development and production is a very technically challenging, time consuming and expensive endeavor. What are some of the challenges? There are numerous critical decisions that must be made with regard to mammalian cell line choice (CHO, NS0, etc.), appropriate gene and marker expression systems, cell culture medium and feed optimization, clone selection and More

ELISA – Conception and Applications

19th August 2015

Category: Bioanalytical / Biosimilars

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By: Laura Munro, Technical Services Scientist,

Since its conception in the early 1970’s the Enzyme Linked Immunosorbent Assay has been a primary method of analyte detection. In its four decades it has become a fundamental tool in a wide range of scientific fields, its diverse nature demonstrated by its range of uses. The ELISA was the first screening test widely used More

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