Early discovery and small-scale production are only part of the lifecycle of an antibody therapeutic. When a lead antibody shows promise (e.g., strong efficacy in animal models, desirable specificity), the focus shifts to manufacturability: can you produce enough of the antibody for IND-enabling studies and clinical trials? What are the yields and costs at large scale? Biointron addresses this through our Large-Scale Antibody Production service, which leverages Chinese Hamster Ovary (CHO) cells as its mammalian cell system.
Core Components of Biointron’s Large-Scale Production:
Transient and Stable Production Modes: Biointron offers flexibility in how the antibody is produced at scale. We can perform large-scale transient expression (useful for getting grams of material quickly without making a stable line) or generate a stable cell pool or clonal stable cell line for the project. Transient expression in large bioreactors (up to 200 L scale as indicated in their workflow) can yield significant quantities in a few weeks, ideal for supplying protein for preclinical toxicology studies or initial clinical material. On the other hand, a stable pool/line is essential for longer-term production and consistency, especially if the project is moving towards clinical manufacturing. Biointron’s ability to do both means they can do a rapid scale-up for immediate needs and in parallel start developing a stable CHO line for the eventual technology transfer to a GMP facility.
CHO-K1BN Cell Line & Licensing: A unique advantage Biointron has is our CHO-K1BN cell line, licensed from ECACC, for which we hold exclusive sublicensing rights. Using a cell line for commercial production often involves licensing IP – many industrial CHO cell lines (like CHO-K1, CHO-S, etc.) have restrictions. Biointron’s clients can leverage the CHO-K1BN line to develop production cell lines without worrying about infringing or negotiating separate licenses; Biointron can grant sublicenses for commercial use. The CHO-K1BN is a suspension-adapted CHO cell line known for high productivity. Years of experience with this line have given us confidence in guaranteeing high-yield stable clones.
High Yields and Fast Turnaround: Biointron has more than a decade of protein production expertise, and we can go from gene to grams of purified antibody in as short as a few weeks (approximately 4–6 weeks for large scale). We have built a validated cell culture process that can be quickly scaled. For instance, in a case study, we produced 1.97 grams of a mouse IgG2a antibody (yield ~288 mg/L) in just a few weeks, achieving extremely high purity (SEC-HPLC >99%). A yield of ~288 mg/L in a large volume suggests a strong transient expression titer or a high-producing stable pool. Such yields are on par with industry-standard titers for monoclonal antibodies in fed-batch culture.
Quality and Consistency: All production for a project can be from a single batch or clone to ensure batch-to-batch consistency. We perform stringent QC on the large-scale output, identical to small scale (SDS-PAGE, endotoxin, SEC-HPLC, etc.), to meet regulatory standards. Our attention to regulatory compliance and quality assurance measures for mass production provides R&D grade material.
Value to Biopharma:
Large-scale production services allow biopharma companies to de-risk and accelerate the transition from discovery to development. For example, a biotech that has a lead antibody from discovery can engage Biointron to produce a bulk lot (say 1–5 grams) for IND-enabling toxicology studies in animals. Trying to produce that in-house might take many months if they lack the bioreactor facilities or expertise. Biointron can do it in a month or so, and in parallel, already start the stable line process so that if the program moves forward, a production cell line is ready or in progress. This means when the biotech files an IND, they already have a plan for manufacturing the clinical trial material (often a question from regulators) backed by a clonally derived CHO line.
The consistency and quality of material from Biointron’s large-scale process also ensure that the data from preclinical studies are reliable (no surprises due to impurities or variability). One client testimonial from a large pharma, Merck KGaA, noted that “everything went well and was super-fast” with their large-scale expression at Biointron, indicating satisfaction with both speed and outcome. Another from a smaller company mentioned Biointron achieved expression of all sequences with higher yield than other providers, which is crucial when scaling up – yields become a cost factor.
Economically, outsourcing large-scale R&D production can be cost-effective compared to investing in expensive bioreactors and hiring teams to run them, especially for small to mid-size biotechs. Biointron’s validated 200 L platform and experience in producing hundreds of grams mean that clients essentially rent a world-class production facility for the duration of their project without long-term overhead. By maintaining “market-competitive rates” with efficient turnaround, Biointron makes a compelling case for outsourcing.
Success Stories and Use Cases
Biointron’s impact on the antibody development field is perhaps best illustrated through the successes of our clients.
Major Pharma Collaboration
Speed Differentiation
Consistency and Activity
High Success Rate in Expression
818 Antibodies Case Study
Bispecific Antibody Delivery
Academic Partnerships
The cumulative effect of these success stories is a demonstration that Biointron is not just a collection of services in theory, but a proven partner in practice. Projects big and small have benefited: from Big Pharma validating molecules with Biointron’s proteins to nimble biotechs accelerating their pipeline by outsourcing critical steps. It’s telling that our client list includes household names in pharma like AstraZeneca, AbbVie, Sanofi, Merck KGaA, Moderna – these companies have vast resources and could choose any partner (or do it internally), yet they chose Biointron, often returning for more. That speaks volumes about Biointron’s quality, reliability, and value proposition.
At Biointron, we are dedicated to accelerating antibody discovery, optimization, and production. Our team of experts can provide customized solutions that meet your specific research needs, including HTP Recombinant Antibody Production, Bispecific Antibody Production, Large Scale Antibody Production, and Afucosylated Antibody Expression. Contact us to learn more about our services and how we can help accelerate your research and drug development projects.
