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The Right CDMO for Your Enzymes & Ancillary Reagents
Reliable Supply. Flexible Quality. Competitive Value. Whether you are scaling production, optimizing costs or securing your supply chain, we provide enzymes and other ancillary reagents that keep your operations moving.
Overview
Secure Your Supply Chain With a Partner That Delivers More Than Products
Reliable supply is no longer just a purchasing requirement; it’s a competitive advantage. At 53Biologics, we manufacture and supply high-quality enzymes and other ancillary reagents designed to support the most demanding life science, diagnostics and biopharmaceutical applications. Whether you require standard products or customized protein production, we combine scientific expertise, flexible manufacturing, and dependable supply to support every stage of your project.
Why Companies Choose Us
Partnership Shaped Around You
We work closely from day one, building partnerships rather than transactional supplier relationships. By becoming an extension of your team, we foster open communication, scientific collaboration, and shared decision-making throughout every stage of your project.
Scientific Depth You Can Rely On
Scientific expertise is at the heart of everything we do. Our experience in ancillary reagents production covers cytokines, growth factors, IVD and IVT enzymes and other proteins used in cell and gene therapy, bioprocessing, diagnostics and life science research.
Adaptability That Keeps Things Moving
Project requirements evolve. Production volumes change. Regulatory expectations increase. Our flexible manufacturing capabilities allow us to provide enzymes and other proteins with quality specifications aligned to your actual needs.
A Partner That Grows With You
One of the greatest risks in today’s biotech environment is supply disruption. Our manufacturing strategy is designed to provide long-term continuity through scalable production, robust planning, and proactive inventory management.
Process
From Process Transfer to Reliable Supply
Whether you are working with milligram quantities during early development or preparing for commercial production, our manufacturing capabilities fit every necessity. We support customers throughout the entire product lifecycle.
01
Process Transfer
We receive and implement your manufacturing process, ensuring an efficient and reliable technology transfer.
02
Manufacturing Set-up
Our team prepares production, quality controls and manufacturing documentation to ensure consistent execution.
03
Production
We manufacture your ancillary reagent or enzyme using robust microbial production processes with consistent quality.
04
Ongoing Supply
We deliver reliable production volumes to support your needs, from research and assay development to diagnostics and commercial applications.
Why Long-Term Partnerships Matter
Choosing an ancillary reagent supplier is about more than selecting a product. It’s about finding a partner that can support your business as it grows. Our approach is built on the principles that create lasting, successful collaborations.
Scientific Collaboration
Working alongside your team to solve technical challenges.
Manufacturing Reliability
Consistent production and dependable supply.
Transparent Communication
Clear, responsive support throughout every project.
Operational Flexibility
Solutions tailored to your application and production needs.
Continuous Improvement
Optimizing processes as your requirements evolve.
Long-Term Commitment
Supporting your growth from development to commercial scale.
Capabilities
Let’s Build a More Reliable Supply Chain Together
Microbial production of enzymes and ancillary reagents like in vitro diagnostic enzymes, in vitro transcription enzymes and growth factors, backed by integrated manufacturing, analytical support and Fill & Finish.
Expression System
E. coli · P. pastoris · other microbial hosts
Quality Standard
Non-GMP · ISO 13485 · GMP (by intended use)
Fill Formats
Vials · bottles · single-use bags
Non-GMP Line
Up to 500 L
Flexible capacity for development and research-grade batches.
GMP Line 1
Up to 200 L
Consistent manufacturing for small-scale productions.
GMP Line 2
Up to 2,000 L
Scalable manufacturing capacity suitable for high-volume needs.
Our Core Advantages
Work Side by Side
Our technical team works directly with yours to understand the intended application, critical quality attributes and performance requirements. Close collaboration keeps specifications, testing and manufacturing aligned from the outset.
Scientific Depth You Can Rely On
We apply strong analytical and manufacturing expertise to support consistent enzyme activity and reagent performance. Technical decisions are guided by data, product knowledge and the requirements of the intended process.
Built Around Your Requirements
Quality level, batch size, testing scope and documentation can be adapted to the needs of your program. This flexible approach supports research, diagnostic, ancillary-material and regulated manufacturing applications without imposing a standard package.
A Reliable Supply Partner
Move from initial batches to recurring supply with one manufacturing partner. Maintaining process knowledge, quality controls and documentation within the same team helps protect consistency and reduce supply-chain risk.
Talk to an Expert About Your Enzyme Program
Tell us about your enzyme or ancillary reagent and our team will get back to you as soon as possible.
Latest News
Latest From Our Blog
Insights, protocols and perspectives from our scientific team.
Support
Frequently Asked Questions
Common questions about our enzyme and ancillary reagent manufacturing. Can’t find what you need? Talk to our team.
What types of enzymes and ancillary reagents can 53Biologics manufacture?
Our experience includes enzymes such as T7 RNA polymerase, DNase I, Proteinase K, lysozyme and reverse transcriptases, as well as growth factors (FGF, EGF), cytokines (IL-2, IL-15), protein ligands such as Protein A, and other recombinant proteins used for in vitro transcription and in vitro diagnostics as ancillary reagents.
Which host systems are available for this service?
The service can support E. coli, Pichia pastoris and other microbial hosts like Bacillus or filamentous fungi. Clients can transfer an existing strain or work with 53Biologics on strain development and banking where additional support is needed.
Can production be performed under GMP?
Yes. Depending on the intended use, production can be structured as non-GMP, ISO 13485 or full GMP. The required quality standard, documentation level and release package are defined at the beginning of the project.
What manufacturing scales can you support?
53Biologics supports microbial production at multiple scales. For example, its 200 L and 2,000 L fermenters can be operated under ISO 13485 or under GMP, and there is also a non-GMP line up to 500 L. The final batch size and expected output depend on the product, yield, process conditions and downstream requirements.
Can 53Biologics support analytics and Fill & Finish?
Yes. The service can be connected with in-house analytical support for in-process control, QC, release testing and stability studies. Where required, Fill & Finish can also be integrated for vials, bottles or single-use formats, helping reduce external interfaces and keep the project moving with one team.