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Cell Line to Finish Line

Zylidac guides molecules from cell line development through commercial manufacturing and packaging at a single site, eliminating tech transfers and reducing program risk for our biologics clients.

  • Monoclonal Antibodies

  • Bispecific Antibodies

  • Fusion Proteins

  • Complex Biologics

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About Zylidac & Our Facility

Built for Complex Biologics, Engineered for Scale

Zylidac has coalesced decades of biologics experience at one site by assembling a team that has conducted 40+ cell bank programs, advanced 30+ molecules into the clinic, and demonstrated expertise in tech transfer, regulatory, and commercial manufacturing across antibodies, bispecific, fusion proteins, and other complex biologics.

Our 83,000 ft² commercial-scale GMP biologics manufacturing facility in Emeryville, California, was designed from the ground up to meet FDA guidelines, not retrofitted to comply with them later.

Facility Highlights

  • Robust upstream cGMP manufacturing capacity
    • 1 ×100L SUB, 1 ×500L SUB, 4 ×2,000L SUBs
  • Automated bulk drug product filling systems
  • More than $100 million invested in facility and capital upgrades
  • Drug substance manufacturing, fill-finish, labeling, and packaging all sit under one roof
  • GMP warehouse with 2-8°C and -20°C

  • 30+

    clinical molecules

  • 40+

    cell bank programs

  • >90

    FTE employees

  • 83,000 ft²

    commercial-scale GMP facility

Development Solutions

Where Molecules Take Shape

From cell line to the market, our integrated teams efficiently advance your molecule. Nearly every Zylidac scientist spent years on the sponsor side and now leverages that experience to offer world-class CDMO solutions, efficiently moving programs through each stage of development, creating robust processes and reducing risks.

  • Zylidac's cell line development team supports a molecule from manufacturability assessment through cell bank generation, working across multiple platforms. The team offers flexibility in expression systems, letting clients weigh cost against performance. Screening, cloning, and stability testing comply with FDA expectations, with clone traceability documented in electronic records.

  • Our upstream development team carries out a process spanning media and feed optimization, clone selection, process characterization, and validation support from IND submission through BLA filing. The team sits on the same floor as the downstream and analytical groups, and the use of equipment from leading manufacturers across process development and manufacturing simplifies technology transfer for incoming clients.

  • Our downstream development team has extensive expertise working with monoclonal antibodies, bispecifics, fusion proteins, and other biologics. The team adapts platform process unit operations to accommodate molecule-specific physicochemical characteristics, generates purified material for formulation development and animal PK studies, designs process validation protocols, evaluates validation results, and much more. The same team works with a molecule throughout its lifecycle, building product knowledge and understanding.

  • Zylidac's formulation development team evaluates critical parameters such as pH, buffer composition, and solubility using streamlined amino acid- and sugar-based platform approaches, with broader screening as needed. As programs progress, the team demonstrates formulation robustness, evaluates container closure compatibility, and generates the data required for regulatory filings.

  • Our analytical development team supports large molecule programs, regardless of expression system, from post-toxicology through commercial manufacturing. The lab executes biochemical, biological, and physicochemical methods, with mass spectrometry capability for impurity identification and structural characterization. The team has developed methods for dozens of products, and in recent months, more than $2 million has been invested in new state-of-the-art instrumentation.

Manufacturing Solutions

Where Molecules Become Medicines

Operating under our robust Quality Management System (QMS), Zylidac supports molecules from drug substance through drug product, packaging, and testing, all within one facility. Established processes, close cross-team collaboration, and rigorous quality controls keep programs moving forward without the delays and gaps that can come with multiple sites or vendors.

  1. Drug Substance Manufacturing

    With expertise in upstream and downstream monoclonal antibody processing, bispecifics, biosimilars, fusion proteins, and other biologic modalities, the team utilizes established, well-characterized processes and can readily adapt to programs with unique demands. We write specifications and standard operating procedures in close collaboration with our cross-functional development teams, aligning equipment, such as single-use bioreactors, and documentation throughout all phases of the product lifecycle.

  2. Drug Product Manufacturing

    Zylidac's fill-finish operation uses a state-of-the-art, non-interventional robotic filler, eliminating human contact with sterile product across vial sizes from 2 mL to 25 mL. We conduct a 100% visual inspection, plus Acceptance Quality Limit (AQL) sampling after filling and labeling. In-house labeling, serialization, and secondary packaging support are also fundamental to the value we provide our biopharmaceutical clients.

  3. Analytical Testing

    Our dedicated in-house analytical laboratories combine state-of-the-art technology with deep scientific expertise to ensure products meet safety, efficacy, and regulatory expectations. Advanced analytical instruments support impurity profiling and characterization, particle analysis, container-closure integrity testing, and visual inspection. cGMP microbiology testing assesses bioburden, endotoxin, sterility, mycoplasma, and viral contaminants.

  4. Secondary Packaging & Labeling

    Zylidac's fill line applies labels with expiration date and lot number printed inline, plus full serialization capability, for vials ranging from 2 mL to 25 mL. Standard packaging supports efficient, shippable presentations for clinical and commercial clients. Additionally, our automated cartoning and secondary packaging system can fulfill custom inserts and other commercial branding needs.

  5. Tech Transfer

    Tech transfer begins with a detailed gap assessment, interrogating incoming process documentation parameter by parameter, then defining mitigation actions for any gaps identified. Rather than a one-time handoff, the team stays actively involved through validation and into commercial manufacturing, drawing on years of experience managing transfers both into and out of CDMO partners.

Contact Us

Ready to Get Started?

Whether you're exploring a partnership or ready to move your program forward, our team is here to help. Let’s discuss your molecule, your timeline, and how Zylidac's integrated capabilities, from cell line to finish line, can support your path to the clinic and beyond.

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