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Reliable, Compliant
Commercial Manufacturing

BioCina delivers worry-free global supply through disciplined GMP execution, robust quality systems, and seamless scale-up, ensuring your therapies reach patients safely and on time.
Explore cGMP Manufacturing

Commercial-Grade Release at Scale

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Drug Substance Batch Release

GMP-released microbial, pDNA, mRNA, and LNP drug substance with full batch records and Certificate of Analysis.
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Drug Product Batch Release

GMP-released fill-finish across BFS, sterile vial filling, PFS, cartridge, oral liquid, cytotoxic as well as controlled substance programs. Annual capacity exceeding 225 million units, approved by FDA, TGA, EMA, Health Canada, and ANVISA.
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On-Time In-Full Delivery

Greater than 95% on-time, in-full delivery target across clinical and commercial programs, supported by demand-aligned production planning, committed capacity agreements, proactive quality oversight and dedicated program managers.
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Lifecycle Supply Management

Annual Product Reviews prepared to ICH Q10. Continued Process Verification provides ongoing statistical assurance that your commercial process remains in a validated state of control. Qualified vendor and material programs and business continuity protocols protect supply integrity across both sites.
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    Continuously Maintained to Licensure Standards

    Processes Designed for Scale

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    Upstream Process Development

    QbD-aligned fermentation optimization across fed-batch and batch modes, with scale-up bridging from development scale through to GMP production.
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    Downstream Process Development

    Full downstream scope covering product recovery, refolding, chromatography, TFF, and hollow-fiber filtration, all designed for commercial scale-up. Inclusion body refolding supported by a dedicated DOE-driven platform and a 3,000 L refold tank. Continuous cell lysis scalable to 500 L fermentation.
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    Nucleic Acid Process Development

    Dedicated pDNA purification laboratory with continuous flow cell lysis, CIM monolith chromatography for high supercoiled content and purity, and TFF for concentration and buffer exchange.
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    Process Characterization

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      Scale-Up Ready by Design

      Quality Target Product Profile First

      Every program begins with a Quality Target Product Profile, establishing a shared understanding of your molecule, critical quality attributes, and the control strategy required to reach scale reliably.

      Analytical Development in Parallel

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      Closed, Single-Use Systems

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      Scale-Up by Design

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      Ready to Start Your Manufacturing Program?

      Connect with our team to discuss reliable, compliant commercial supply for your therapy.
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