Product Portfolio

Excellence for cell and gene therapy manufacturing

Propelling advanced therapy medicinal products from concept to commercialization

Cell and gene therapies have the potential to revolutionize healthcare, but their implementation is technically complex because they build on living systems. Now that industry has progressed technologies to the point of commercial approvals, it is essential that producers of advanced therapeutics leverage well-defined, ready-to-use, scalable raw materials and analytical quality control solutions to ensure manufacturing efficiency and regulatory compliance.

With decades of experience in tackling challenges relevant to the manufacturing of advanced therapeutics, we offer proven solutions and support documentation tailored to your unique process, quality and regulatory needs.  We help to advance process development and manufacturing of cell and gene therapies, from cell isolation to quality control release testing.

 

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Our commitment to next-generation manufacturers:
high-quality, well-characterized raw materials

 

Cell and gene therapy workflow

Cell isolation

Isolation

 

Isolation enzymes

 

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Maximize yields of viable cells with efficient cell isolation

 

Only high-purity digestive enzymes with well-characterized performance parameters enable safe and efficient cell isolation from different tissue sources to yield maximum numbers of viable cells for further use in manufacturing.

Dual activity

Modification

 

mRNA raw materials

 

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Fit-for-purpose materials to reduce uncertainties

 

Anticipating growth in mRNA therapy development, we have designed raw materials to support manufacturing scale-up and regulatory approval of these new drug modalities.

Our raw materials enable traceable quality control, as well as change and deviation management that contribute to a standardized and reliable manufacturing process.

Choosing fit-for-purpose raw materials early in development minimizes the risk of project delays that can jeopardize a fast time-to-market. Plus, we continually optimize our mRNA portfolio to meet fit-for-purpose standards, bearing in mind that specifications are determined by the intended use of the manufactured therapeutic mRNA.

Dual activity

Expansion

 

Cell detachment enzymes

 

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Effective cell detachment without compromising quality

 

Fast, effective, yet gentle detachment of cells is vital to scale up manufacturing of cell and gene therapies. At the same time, the final product must be safeguarded against variability or contamination that raw materials like enzymes can introduce into processes.

Manufactured in state-of-the-art Penzberg manufacturing facilities that are certified according to DIN EN ISO 13485, our GMP-grade recombinant trypsin enzymes can be delivered at any scale to catalyze detachment of various adherent cell types on artificial substrates, such as plastic ware.

Cedex family

Analytical Quality Control

Cedex Analyzers

 

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Cedex family

Mycoplasma testing

 

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Rapid and reliable analytical quality control 
 

Establishing predictable product quality and reproducibility of cell and gene therapy manufacturing is challenging because starting materials and processes are divers. In the absence of a standard approach, implementing validated commercial technologies to monitor cell viability, cell function culture conditions and potential culture contamination during process development and manufacturing saves resources and minimizes risks.

Use the Cedex Analyzer family for flexible quality control of your bioprocesses and test for mycoplasma with the MycoTOOL kits.

 

Regulatory disclaimers are listed on the respective product pages.

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