Our commitment to next generation manufacturers

Advancing concepts 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, and scalable raw materials and analytical quality control solutions to ensure state-of-the-art manufacturing efficiency that meets regulatory requirements.

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, to advance process development and manufacturing of cell and gene therapies, from cell isolation to quality control release testing.

CustomBiotech Workflow Cell and Gene Therapy

 

High-quality, high-purity digestive enzymes for isolation

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 many different tissue sources that yields maximum numbers of viable cells needed for further use in manufacturing.

 

High-quality, well-charaterized raw materials

Isolation

Isolation enzymes - 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 many different tissue sources that yields maximum numbers of viable cells needed for further use in manufacturing.

 

 

 

Modification

mRNA raw materials  - Implement 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.

 

 

 

Expansion

Cell detachment enzymes - Effective cell detachment without compromising product quality

Fast, effective, yet gentle detachment of cells is vital for scaling 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.

 

 

 

CustomBiotech Workflow Cell and Gene Therapy

Establishing predictable product quality and reproducibility of manufactured cell and gene therapies is a challenge by the diversity of starting materials and processes used. In absence of a standard approach, implementing validated commercial technologies to monitor cell viability, cell function and culture conditions potential culture contamination during process development and manufacturing saves resources and minimizes risks.

Rapid and reliable analytical quality control tools

Deliver constant product quality with proven ready-to-use control solutions

Cedex Analyzers – gain insights into your process to optimize cell expansion performance

Featuring proven data reliability as well as options for and automated workflow integration, our Cedex Bio Analyzer and Cedex HiRes Analyzer enable flexible quality control of bioprocesses. With a broad assay menu, the Cedex Bio Analyzer accurately measures substrate and metabolite levels in low-volume samples of cell culture supernatant. The Cedex HiRes Analyzer uses scanner-based high resolution imaging to detect changes in cell concentration, functionally relevant morphology, and aggregation. Furthermore, a long manufacturing history as well as system suitability tests, ensure optimal instrument performance to minimize downtime and ease audit compliance.

 

 

 

MycoTOOL kits – Mycoplasma-free results in just a few hours

Our MycoTOOL Mycoplasma test kits use nucleic acid amplification techniques (NAT) and highly specific probes to detect over 140 cultivable and non-cultivable mollicute species. Validated according to EP 2.6.7 NAT guidelines,* MycoTOOL kits are sensitive, specific, reliable and precise, delivering results that are comparable to compendial mycoplasma detection methods but in a fraction of the time. Qualify our convenient kits for ongoing in-house testing to save costs and time compared to third-party testing.**

 

 

 

Revolutionize advanced therapy manufacturing with our proven solutions

The advancement of cell and gene therapies requires building unprecedented manufacturing processes. Success of innovative concepts hinges on anticipating and mitigating risks and overcoming barriers to commercialization. At Roche CustomBiotech, we support your development and manufacturing activities by eliminating uncertainties from critical raw materials and providing quality control analytical tools that fit your specific manufacturing requirements. More than a supplier, we aim to be your partner in bringing the next generation of therapies to market.  With past expertise, a commitment to advancement, and a unique portfolio primed for the realization of advanced therapies, we help you stay ahead and reach your target at every step of the way.

 

*Deutschmann, S.M. et al (2010). Validation of NAT-based Mycoplasma assay according to European Pharmacopoiea. Biologicals 38; 181-248. Plaese note, matrix interference and compatibility must be evaluated by the user.

**Chisholm, J. et al. "Strategy for an abbreviated in-house qualification of a commercially available Rapid Microbiology Method (RMM) for canadian regulatory approval." Cytotherapy Journal 19.12 (2017): 1529–1536.  celltherapyjournal. Web. 25 Apr. 2018.

Regulatory disclaimer
For further processing only.

Regulatory disclaimer for MycoTOOL Mycoplasma Testing Kits
For use in quality control/manufacturing process only.

Blended Proteolytic Enzyme for Tissue Dissociation
For further processing only.