- About Us
- Services & Solutions
- Nucleic Acid Vaccines
- Viral Vector Vaccines
Offering End-to-End Solutions
WuXi Vaccines provides industry-leading and state-of-the-art final vaccine product development services. We specialize in the development of clinical and commercial vaccine formulations and processes. Our capabilities include the development of liquid, frozen, and lyophilized dosage forms and we have extensive experience with multiple container closure systems (CCS) that include vials and combination products such as pre-filled syringes (PFS), PFS with needle safety devices (NSD) and autoinjectors (AI).
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:
Specialized services include but are not limited to:
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:
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:
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:
Prefilled Syringe & Prefilled Syringe with Needle Safety Device Options
• 1 mL long, 1 mL standard, 2.25 mL, 3mL Syringes
• Staked Needle & Leur Lock
|Plunger Stoppers Available
• 1 mL long & 1-3 mL plungers
• Nest, RTP Bag
• 0.15 mL – 3 mL
• Cut (CF), Round (RF), Small Round (SRF)
• Extended Finger Flange
• Plunger Rod
• Color, Material • Plunger Rod & optional extended finger flanges
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:
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.
WuXi Vaccines End-to-End DP Development Program