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Analytical Services for Proteins
53Biologics provides the protein analytical services you need at every stage of your journey.
Analytical services run across the entire workflow. From raw materials and cell banks through drug substance, drug product and stability studies. Switch systems to see where they sit in each pathway.
Overview
Analytical Expertise Built Around Your Protein
n order to successfully develop, produce and market biologics, 53Biologics provides a full range of analytical services. Our cutting-edge labs and highly skilled staff are prepared to support your product from early development through commercial launch since the intricacy of biologic medications necessitates accurate and sophisticated testing.
We guarantee the highest levels of quality, safety and regulatory compliance at every stage of the product lifecycle with our analytical services.
53Biologics Provides the Analytical Services You Need for Your Protein
Raw Material Analysis
Ensure the safety and quality of your raw materials through comprehensive analyses specific to your product and your requirements.
Cell Bank Testing
Ensuring the safety, consistency, viability and reliability of cell banks (MCB, WCB, EOP) used to produce your biological drug.
In-Process Control Analysis
Analytical tests that ensure consistent product quality and faster development, enabling us to supply biological products with complete confidence.
Method Development and Validation
Develop and validate reliable analytical methods to ensure the quality and reliability of your cell bank, drug substance or drug product.
Release Testing
A wide range of analytical methods covering active pharmaceutical ingredients (APIs), investigational medicinal products (IMPs) and finished commercial products.
Stability Testing and Storage
Conduct stability studies to assess the long-term behaviour of your drug product under various conditions, including in specific cases accelerated degradation studies.
Analytical Testing Throughout the Entire Protein Manufacturing Workflow
| Recommended assay | Primary use |
|---|---|
| Quantity | |
| Protein concentration by UV280 / BCA | IPC / DS |
| Purity & Identity | |
| SDS-PAGE, reduced and non-reduced | IPC / DS / SS |
| Western Blot or specific immunodetection | DS |
| SE-HPLC or SEC-HPLC | DS / SS |
| RP-HPLC or CE-SDS | DS / SS |
| Peptide mapping / intact mass, if required | DS |
| Product-related impurities | |
| Aggregates / fragments by SE-HPLC | DS / SS |
| Charge variants by IEX-HPLC / cIEF, if relevant | DS / SS |
| Host/process impurities | |
| Host Cell Proteins by ELISA | DS |
| Residual host cell DNA by qPCR | DS |
| Residual Protein A | DS, only if Protein A is used |
| Residual IPTG, antibiotics, methanol, antifoam or process-specific reagents | DS, host/process-dependent |
| Potency / Activity | |
| Enzymatic activity, binding ELISA or cell-based assay | IPC / DS / SS |
| Safety / Microbiology | |
| Endotoxins by LAL or equivalent | DS / DP |
| Bioburden | DS / DP |
| Sterility | DP |
| Mycoplasma | Mainly mammalian DS / DP |
| Safety / Viral | |
| Viral safety / adventitious agents, if required | Mainly mammalian DS |
| General physicochemical | |
| pH | IPC / DS / DP / SS |
| Appearance, clarity and color | DS / DP / SS |
| Conductivity / osmolality | DS / DP |
| DP-specific | |
| Fill volume / extractable volume | DP |
| Visible particles | DP |
| Subvisible particles | DP |
| Container Closure Integrity Testing, CCIT | DP |
| Stability | |
| Stability-indicating subset: appearance, concentration, purity, potency, pH, endotoxin/bioburden as applicable | SS |
IPC: In-Process Control; DS: Drug Substance; DP: Drug Product; SS: Stability Studies. The final analytical panel will be defined according to the product characteristics, expression system, manufacturing process, intended use, development phase and applicable regulatory requirements.
Why Choose 53Biologics for Protein Analytical Services
Fit-for-Purpose Testing
Every analytical package is tailored to your molecule, development stage and regulatory needs, ensuring you generate the right data without unnecessary testing or cost.
From In-Process Control to Product Release
We support analytical activities across the entire manufacturing workflow, including IPC, DS and DP characterization and stability studies, providing continuity from very beginning.
90+ Validated Analytical Methods
With more than 90 validated and qualified analytical methods already available, we can leverage existing assays whenever possible, reducing method development time and accelerating your project timeline.
Support
Frequently Asked Questions
Common questions about our protein analytical services. Can’t find what you need? Talk to our team.
Which types of recombinant proteins do you support?
Our analytical services support recombinant proteins produced in both microbial (E. coli, Pichia pastoris, Bacillus and other hosts) and mammalian (CHO-derived and HEK293) expression systems. Analytical strategies are tailored to the molecule, expression platform and intended application.
Can analytical methods be transferred to 53Biologics?
Yes. We can transfer, optimize and qualify existing analytical methods or develop new fit-for-purpose assays when required, ensuring continuity throughout your development and manufacturing program.
Do you provide analytical services as a standalone offering?
Our analytical services are primarily integrated with our process development, Drug Substance and Drug Product manufacturing activities. This approach ensures analytical methods are aligned with your process and quality objectives while reducing technology transfer risks.
Do you develop new analytical methods?
Yes. When existing methods are not suitable, we develop and qualify fit-for-purpose analytical methods tailored to your protein, manufacturing process and regulatory stage.
Are all analytical tests performed in-house?
Most analytical testing is performed in-house by our experienced analytical team. When specialized assays are required outside our capabilities, we coordinate testing through qualified external laboratories, managing the entire process so you continue working with a single point of contact.
Talk With an Expert About Your Protein Analytical Project
Tell us about your molecule, expression system and development stage — our team will get back to you as soon as possible.
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