Biologics

Powering excellence for your development & manufacturing

Biologics are an important drug class used in oncology, anti-immunity, and chronic inflammatory diseases. They are drug therapy products where the active substance is extracted or produced from a biological source. 

Biologics include monoclonal antibodies (mAbs) and further therapeutic recombinant proteins. They are proteins produced mainly by mammalian cells or bacteria. 

With decades of experience in providing high quality raw materials, instruments and solutions for biotherapeutics manufacturers, we offer proven solutions for your unique process.

 

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Discover products for your biologics workflow

Drug development

FcRn affinity column

Functional Characterization: FcRn Affinity column for mAb testing
 

The FcRn Affinity Column enables the analytical differentiation of even marginal variations in the structures of monoclonal IgG antibodies, accelerating and standardizing the antibody half-life analysis, so you can develop a meaningful lead candidate more quickly.

FcRn chromatography provides a powerful solution to the common challenge to control the chemical and structural integrity of the antibody during manufacturing, filling and storage. 
 

Discover more about FcRn Affinity Gen2 Column

Upstream process development

Cedex Analyzers

Process Control: Cedex Analyzers for metabolite & cell analysis testing 


Bioprocess control is essential to identify expected and unwanted changes in cell cultivation and fermentation. This can be achieved by the Cedex Analyzer Family which combines the functionalities of multiple instruments to deliver powerful testing capabilities with reduced workflow complexity.

Rely on one instrument family and assays to capture useful and timely insights into your bioprocess and make the right decisions for optimal manufacturing outcomes.
 

Discover more about Cedex Analyzers

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Biologics are defined and ready for future processing

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Downstream

Proteases

Protein Processing: Proteases for processing of proteins and antibody fragments

For optimal, sensitive and highly regulated manufacturing workflows in biopharmaceutical applications. We offer a wide range of highly pure proteases.

These proteases are specifically designed to be utilized  as critical raw materials materials in the production of Active Pharmaceutical Ingredients (API), such as in insulin or vaccine production to tissue dissociating enzymes, up to proteases for total protein degradation (e.g. mRNA manufacturing).

Select from a wide range of  animal-component-free and GMP grade enzymes. All our enzymes have a high lot to lot consistency increasing the safety of your production processes.

 

Discover more about CustomBiotech proteases

ivge

Modification: Glycosylation


Glycosylation is a CQA of glycoproteins. Consequently, separating glycosylation management from protein yield grants greater control.

In vitro glycoengineering enables the creation of high levels of galactosylation or sialylation to unambiguously select and implement the structure with the best therapeutic and pharmacokinetic profile.

This will lead to a speed optimization development of the glycoprotein as well as improved control of the manufacturing process.

 

Discover more about in vitro Glycoengineering

Drug Substances

FcRn affinity column
quality control mycoplasma testing
mycotool

Functional Characterization: FcRn Affinity column for mAb testing
 

The FcRn Affinity Column enables the analytical differentiation of even marginal variations in the structures of monoclonal IgG antibodies, accelerating and standardizing the antibody half-life analysis, so you can develop a meaningful lead candidate more quickly.

FcRn chromatography provides a powerful solution to the common challenge to control the chemical and structural integrity of the antibody during manufacturing, filling and storage. 
 

Discover more about FcRn Affinity Gen2 Column



Quality Control: Kits for host cell DNA contamination and mycoplasma testing


Robust, specific and sensitive quality testing for every step in your process with the MycoTOOL kits to increase efficiency for medium and high-throughput workflows. 

These solutions are key components for an optimal quality control strategy to safeguard the manufacture of your products.
 

Discover more about quality control kits like MycoTOOL

All regulatory disclaimers are listed on the respective product pages.

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