As the market for biologics continues to escalate—with six of the 10 top-selling drugs in 2021 being large molecules—the need for CDMO services for small-scale production of innovative bioengineered pharmaceuticals and biosimilars increases as well. Finding the right outsourcing partner that caters to small-volume mammalian manufacturing of biologics—antibodies, proteins, and cell therapies especially—for preclinical studies or early-stage clinical trials becomes essential for startups, small to midsize biotechs, and academic researchers.
The blockbuster biologics—from mRNA vaccines to oncology and autoimmune therapies—are taking capacity at pharmaceutical companies and their large CDMO partners. Yet many of the most innovative large-molecule drug substances nearing clinical trials are needed to treat smaller patient populations, such as those with one of the more than 5,000 rare diseases, each of which affects fewer than 200,000 Americans.
Biologics and biosimilars for these patient populations will never require the vast manufacturing capacity of blockbuster biotherapies for diseases like rheumatoid arthritis, diabetes, cancer, or global pandemics. That doesn’t make them any less important, especially to the patients in need. Unfortunately, the CDMO market shows a gap in services to small-volume biologics drug substance programs— especially the antibodies, proteins, and cell therapies that are made using mammalian cell culture.
Innovators needing small-scale mammalian production often feel lost at large CDMOs, where their volumes can’t compete. Enter the boutique CDMOs that have expertise and state-of-the-art facilities, plus offer advantages when it comes to service, collaboration, and priorities. Such CDMOs can handle the complexity of mammalian cell culture, in which cells are grown in vitro with a constant supply of synthetic nutrients under controlled lab conditions in a bioreactor.
Yet, for programs requiring smaller amounts of drug substance, a biologics CDMO with a smaller facility footprint and, therefore, less overhead, offers distinct benefits. The pricing structure and priorities for a boutique CDMO specializing in mammalian cell culture, with single-use bioreactors up to 1,000 L, are much different than for facilities designed to accommodate tens or even hundreds of thousands of liters of volumes for large-scale commercial biologics.
PRODUCTS MANUFACTURED WITH MAMMALIAN CELL CULTURE
Scorpius BioManufacturing mainly relies on two well-established cell lines, HEK293 and CHO, to provide mammalian cell culture process development and clinical-scale manufacturing. Scorpius can produce non-GMP small-scale batches for preclinical studies or cGMP batches up to 1,000-L for phase I or II programs. The mammalian cell culture team is highly experienced with expressing recombinant antibodies, proteins, and cell therapies from these cell lines, as well as other tissue.
Antibodies
Scorpius clients typically use CHO cell lines to make monoclonal antibodies, bispecific antibodies, and biosimilars.
Proteins
Additionally, our clients use CHO cells to make fusion proteins and HEK cells to make recombinant proteins.
Cell therapies
Scorpius BioManufacturing’s mammalian cGMP manufacturing suites are well-suited for certain cell therapy products. This includes allogeneic natural killer (NK) and CAR-T cell products. There has also been an increased interest in deriving exosomes from mesenchymal stromal cells (MSC). These intracellular delivery vehicles are gaining popularity after several exosome products have been approved by European and Japanese regulators.
Process Development
A complete manufacturing scheme requires mammalian cell culture process development. Ideally this includes optimizing upstream processes using design of experiments (DoE) and failure mode and effects analysis (FMEA). Miniaturized bioreactors (250 mL) can be used at this stage, followed by further development and optimization with larger bioreactors (i.e. 50-L). Scorpius’ process development lab utilizes the Ambr250 system, along with other single-use scale-up equipment that mirrors what is in their cGMP suites. Downstream processes, including cell harvest, aseptic processing, validation studies, and cryopreservation complete the development stages.
Finding a cdmo capable of small-scale development and preclinical-to-commercial production
Using living cells to produce structurally complex large molecule therapeutics requires more than state-of-the-art equipment and technologies. It requires partnering with a team dedicated to both science and quality who are motivated to bring therapeutic innovations to patients in need.
Scorpius BioManufacturing has 9 cGMP cleanrooms dedicated to the next generation of innovative mammalian clinical manufacturing. With single-use bioreactors ranging from 50-L, 200-L, and 500-L, the mammalian building on Scorpius’ San Antonio campus is ideal for the drug substance manufacturing needs of start-ups, emerging biotechs, and academic researchers.
Contact us to learn more
Contact Scorpius to find out how a boutique biologics CDMO that specializes in mammalian cell culture can support bringing your next large molecule to market, especially antibodies, proteins, and cell therapies.
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