Mammalian

Starting with early-stage developability assessment and providing support throughout the entire formulation development life cycle, our services are suited for both large pharma corporations and early-stage companies alike. We have significant expertise in the development of the full range of vaccine modalities that include:

• Recombinant protein subunit vaccines
• Antibody-based prophylactic vaccines
• Viral vectors
• Live attenuated virus
• Virus-like particles (VLP)
• Nucleic acids (e.g., DNA, mRNA/RNA, plasmid DNA as raw material for mRNA or viral vaccines)

Specialized services include but are not limited to:

• Early-stage developability assessment for candidate evaluation
• Design of experiment (DOE) or one-factor-at-a-time (OFAT) experiments to identify the optimal formulation
• In-use compatibility studies to simulate and support clinical dose preparation, storage and administration in clinical setting
• Shipping simulation and validation
• Extractables and Leachables (E&L) studies
• Forced degradation and stability studies
• High-throughput screening (HTS) utilizing biophysical methods such as dynamic light scattering (DLS), differential scanning calorimetry (DSC), and differential scanning fluorimetry (DSF) amongst other advanced analytical equipment and methods

Regardless of your development phase, our scientists design the ideal formulation that can be adapted for the container closure system (CCS) of your choosing. Ready-to-sterilize (RTS) and ready-to-use (RTU) vials in multiple sizes are available for liquid, frozen, and lyophilized dosage forms. For clients looking for specialized drug delivery systems, prefilled syringes (with or without NSD) and autoinjectors are also available.

Container Closure Systems Features:

• Vials in 2R, 6R, 8R, 10R, 14R, 20R, and 50R sizes with RTS and RTU configurations
• Prefilled syringes (PFS) in 1 mL long, 1 mL standard, 2.25 mL, 3 mL syringe with staked needle or luer lock design
• PFS with passive needle safety device (NSD) options
• Autoinjector products optimized for improved user experience
• Pilot, clinical phase and large-scale commercial GMP production for all CCS types

To expedite your path to clinical or commercial vaccine manufacturing, our team of development experts support fill process development, scale-up and characterization using well established lab-scale models and full state-of-the-art analytical support.

Leveraging our advanced and automated fill line technologies, we offer a variety of process development and technology transfer services for process development for RABS (Restricted Access Barrier Systems), isolator-based filling lines, and fully-automated Vanrx systems including:

• Pilot scale (non-GMP) fill finish and lyophilization services for preclinical toxicology studies, non-GMP stability studies and scale-down process development
• End-to-end fill process development from bulk thaw through mixing, filtration, filling, stoppering and capping to final visual inspection
• Lyophilization cycle development and optimization
• Container and closure selection and integrity testing

Improved vaccine delivery solutions are becoming more vital to patient health and safety. Combination products such as prefilled syringes (PFS), PFS with needle safety devices (NSD) and autoinjectors offer greater convenience, operability and compliance to foster better patient outcomes.

WuXi Vaccines development teams offer the expertise and state-of-the-art equipment to design and develop the ideal delivery systems for your intended purpose and technical specifications. Our combination product development services assessment and evaluation includes:

• PFS functionality
• Silicone oil distribution
• Dimensional measurements
• Container closure integrity
• Automated PFS GMP filling lines
• Design Control
• Safety devices and autoinjectors assembly

Prefilled Syringe & Prefilled Syringe with Needle Safety Device Options

Autoinjectors (AI)

WuXi Vaccines works with well-established syringe and autoinjector vendors for combination product developers. For automated injectors (AI), our specialized team of our highly-trained scientists can evaluate:

• Standard design optimized for user experience
• Fully customizable based on client specific schematics
• Design optimized through AI selection, assembly, and human factor considerations

Using SOP-driven procedures, our development teams for technology transfer works closely with our GMP manufacturing teams to ensure smooth and efficient technology transfer from late-stage development into GMP production.

After technology transfer from our development team to our GMP operations, WuXi Vaccines leverages its single-source process technology platforms and expertise to provide clients with efficient and cost-effective GMP manufacturing solutions. Our global GMP manufacturing facilities provide automated and isolator-based production under current Good Manufacturing Practice (cGMP) conditions as defined by the worldwide regulatory agencies and our quality systems have been routinely audited by our clients and have passed inspections by multiple regulatory agencies.

Throughout all stages of the final vaccine product development lifecycle, starting from the development of First-in-Human (FIH) formulations through to late-stage container closure selection, final formulation lock and process validation, our analytical development teams support your program by utilizing state-of-the-art equipment and methodologies to provide all services in-house and to expedite your timelines.