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Swindon

Steriles development and commercial manufacturing

Thermo Fisher’s Swindon facility specializes in integrated sterile liquid and lyophilized product development and commercial manufacturing, including high potency products and LVP. The Swindon facility offers extensive development and commercial capabilities for sterile dosage forms, including liquid vials, commercial fill finish lines, primary and secondary packaging vials.

The facility has:

  • 2 x liquid vial filling lines
  • 1 x liquid vial filling line with lyophilization capability

Additionally, the facility has extensive complex technology transfer expertise. Its Qualified Persons (QPs) ensure prompt release of bulk products within the European market. Swindon has received regulatory approval from various international regulatory inspection agencies, including MHRA, FDA and the Gulf Co-operation Council

Swindon is part of our European network of steriles sites, which includes Ferentino and Monza in Italy, and part of our Global network, including Greenville, North Carolina, USA and Singapore

 

Specialized capabilities

  • Sterile lyophilized products
  • Commercial fill finish lines
  • Primary and secondary packaging vials
  • Development and commercial supply of novel dosage
  • Facility design and build for unique manufacturing processes
  • LNP capabilities
  • Process development including mRNA
  • Engineering/process expertise
  • Extensive complex Technology Transfer experience
  • Qualified Person expertise
Location Image

Kingfisher Drive
Covingham, Swindon
Wiltshire SN3 5BZ
Phone: +44 1793 524411

Lifecycle by dosage form:

  Early Development Late dev Commercial supply
 
Formulation Development
Analytical Development
Phase l
Phase ll
Phase lll
Commercial scale up
Tech transfer
Regulatory
Liquid vials
 
 
 
 
 
Lyophilized vials
 
 
 
 
 

Helpful Resources

Infographic
Four special fill/finish considerations for vaccine production
Once your vaccine is ready for production, there are critical considerations needed in regard to the handling and process for fill/finish. The right choices can help ensure the stability and purity of your vaccine as well as limit unnecessary waste and cost. View the infographic for details on best practices for fill/finish.
Whitepaper
Challenges and Practical Solutions for Switching to Prefilled Syringes for Injectables
Learn the critical patient benefits and improved outcomes of prefilled syringes, as well as how to select the most appropriate type and how to bridge vials with them.
Whitepaper
Switching delivery formats: A lifecycle management strategy for sterile injectables
Switching delivery formats can be an effective strategy to enhance they lifecycle of your drug. This whitepaper provides insight into the benefits and challenges of transferring a therapeutic compound from one aseptic injectable format to another.
Webinar
Patient-centric sterile injectables: Improving patient experience through formulation and delivery
Join us for an expert panel of biologics experts as we discuss patient-related characteristics that should inform drug product design decisions, product-related characteristics that can be modified to address the needs of the target patient populations and innovative technologies that can be used to address patient needs