Chinese Hamster Ovary (CHO) cells are the backbone of modern biologics manufacturing, producing most therapeutic antibodies and recombinant proteins. During CHO-based production, host cell proteins (HCPs) – native CHO proteins – inevitably contaminate the drug substance. Even trace HCP levels can trigger immune responses or reduce drug efficacy, so regulatory agencies (FDA, EMA, etc.) demand rigorous HCP monitoring.
Today’s biomanufacturers use sensitive assays to verify parts-per-million purity: best-practice ELISA kits can measure HCPs below ppm levels, orders of magnitude more sensitive than older 2D PAGE or HPLC methods. In fact, the global HCP testing market is booming (projected from ~$310M in 2024 to ~$780M by 2033, reflecting surging demand for biologics, biosimilars and advanced cell/gene therapies.
In summary, comprehensive HCP analytics is essential at every stage – upstream and downstream – to ensure patient safety and meet regulatory quality targets.
Challenges with Off-the-Shelf HCP Assays
Many teams start with generic CHO-HCP ELISA kits, but these “off-the-shelf” assays have blind spots. A polyclonal ELISA kit only detects proteins against its preset antibody pool, which may miss low-abundance or process-specific CHO contaminants. For example, a 2022 study found that a typical ELISA failed to detect up to 30% of HCP species picked up by advanced proteomics. These gaps pose real risks: undetected HCPs can undermine drug stability or cause a batch to fail final validation. Furthermore, a single ELISA readout only gives a total HCP count and provides no clue which impurities remain.
- Limited coverage:
Generic kits use broad antibodies, but novel CHO strains or new culture conditions can produce unique HCPs that slip through. - Variable sensitivity:
While ELISA is inherently sensitive, its performance hinges on antibody quality. Even a “ppm-ready” ELISA can only detect proteins its antibodies recognise. - Regulatory risk:
A biologic that looks “clean” by a generic ELISA might later fail orthogonal testing or comparability studies, causing delays. In today’s climate, regulatory authorities expect more than a “check-the-box” assay – they want comprehensive impurity profiles to ensure safety and efficacy.
Because of these challenges, many companies outsource HCP analytics to specialized CROs. Industry experts now advise that biologics developers partner with proven HCP testing services (like Denovo Biolabs) to accelerate development and mitigate risk.
Our Custom HCP Analytics
Denovo Biolabs solves the limitations of generic kits by creating customised HCP assays tailored to each process. Our experts work with your team to understand the CHO cell line, culture conditions, and purification workflow. We then map the specific HCP profile using high-resolution mass spectrometry (MS) and develop polyclonal antibodies that cover even low-abundance CHO proteins. The result is a sensitive ELISA designed for your process.
- Tailored antibody development:
We immunize against your upstream CHO harvest to generate broad-spectrum anti-HCP antibodies. This maximises detection of strain-specific and rare CHO contaminants. - Orthogonal analytics:
We pair immunoassays with advanced proteomics. For example, a Denovo workflow may combine our ELISA with LC-MS (“dual-check”) to identify and quantify HCPs at the peptide level. This hybrid approach catches rare or unexpected impurities that an ELISA alone might miss, and provides confirmatory data for regulatory filings. - Dynamic process monitoring:
HCP profiles change during culture and purification. We use our custom ELISA kits (and complementary methods) to track HCP levels at each stage. This helps you fine-tune bioreactor conditions and chromatography steps early on, minimising impurities and streamlining scale-up.
By treating HCP analysis as a collaborative, iterative process, Denovo Biolabs ensures you have actionable data, not just a number. In practice, we’ve helped partners identify undetected media-related HCPs and adjust their processes, reducing impurities by ~40% before regulatory submission. As a CRO partner, our goal is to turn contamination risks into a controlled variable, so you can focus on development, not troubleshooting.
Enhanced Bioprocess Analytics and Support
Beyond HCP assays, Denovo offers end-to-end bioprocess support. We provide high-quality cell culture media (e.g. tailored CHO feed and basal formulations) to optimize cell growth and titer. Our custom media are rigorously tested for consistency, giving labs a reliable platform for robust productivity. We also supply assay reagents and biological materials to complement analytics: for example, purified normal CHO serum and IgG controls for ELISA validation, recombinant proteins for spiking studies, and GMP-grade ELISA reagents.
Our services extend to contamination control and QC: Denovo can help set up viral clearance studies, supply rapid mycoplasma and endotoxin testing kits, and provide documentation to support regulatory filings. In short, we supply the full toolkit – from custom antibodies and validated ELISA kits to media and QC reagents – so that CROs and biopharma companies have one trusted source for their analytics needs.
- Custom media and reagents:
Formulated CHO media, serums, and control reagents that improve cell culture performance and assay reliability. - Antibody services:
Bespoke generation of polyclonal or monoclonal antibodies against any antigen, with QC-ready validation. - Rapid kit development:
In addition to HCP kits, Denovo can create ELISA kits for PK, ADA, cytokines or other targets, shortening development timelines.
All Denovo products undergo strict quality control. We follow GLP/ISO standards in manufacturing and QC testing, providing certificates of analysis with your delivery. Every assay is supplied with a detailed data sheet (sensitivity, range, precision) so you have traceability from the start.
Why Choose us (Make-in-India Advantage)?
Denovo Biolabs, based in Bangalore, offers Made-in-India bioprocess analytics with global-grade performance. In fact, Denovo was the first Indian company to manufacture ELISA kits for pharmacokinetics and immunogenicity, supporting top biosimilar developers worldwide. We align with “Make in India” and “Atmanirbhar Bharat” initiatives, meaning our customers benefit from:
- National sourcing:
Local manufacturing eliminates long import waits and cutting-edge IP concerns. You get competitive pricing and support India’s bioeconomy. - High sensitivity:
Denovo’s CHO-HCP ELISA kits detect impurities down to single-digit ng/mL levels on par with international benchmarks. - Quality and compliance:
Our R&D lab and manufacturing facilities maintain rigorous QC, ensuring each kit is reproducible and ready for audit. We design assays with regulatory filing in mind (e.g. 21 CFR part 820, ICH Q6B guidelines). - Faster lead times:
Being local means rapid response. Custom kits or media that might take months from overseas vendors can often be delivered in weeks from Denovo’s Bangalore labs. - Outsourcing expertise:
As the industry recommends, partnering with specialized CROs like Denovo can shorten time-to-market and reduce risk. You get instant access to our technical team, with decades of assay development experience, without needing to build in-house capabilities.
In summary, Denovo combines “Made-in-India” convenience with global technical standards. We deliver the sensitivity and flexibility needed for today’s complex biologics programs, all backed by local service and support.
For CROs, biopharma developers, or academic teams looking to enhance their CHO HCP detection and bioprocess analytics, Denovo Biolabs is ready to help. Get in touch with us today to discuss your project requirements. Our team will work with you to design a tailored solution – whether it’s a custom CHO-HCP ELISA kit, specialized culture media, or an integrated analytical program – to accelerate your development and ensure regulatory confidence.