Cell Line to Finish Line

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.

• Cell Line Development & Engineering

  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.

• Upstream Development

  Our upstream development team carries out a process spanning media and feed optimization, clone selection, process characterization, and validation support for 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.

• Downstream Development

  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.

• Formulation Development

  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.

• Analytical Development

  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.