Parenteral, Aseptic & Fill-Finish

Upperton is home to one of the first Annex 1 compliant sterile manufacturing facilities in the UK, offering crucial capacity for early phase projects, and meeting the very highest standards in sterile manufacturing.

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Sterile Manufacturing

Among the first UK CDMO facilities aligned to new Annex 1 Requirements

Located in Nottingham, UK, our sterile facility is one of the only fully Annex-1 facilities in the UK. Designed specifically for sterile liquids, our 7,000 sq. ft sterile manufacturing facility includes two grade C cleanroom manufacturing suites, alongside an Envair technology Solid Wall VHP Three-Chamber Isolator, LAST Technology Dry Heat Sterilizer Depyrogenation Oven and LTE Scientific Autoclave (terminal sterilisation). With aseptic filling technology equipment from Flexicon, advanced HVAC systems to independently monitor and control air supply, and PUPSIT (Pre-Use Post Sterilisation Integrity Testing).    

Our Parenternal, Aseptic and Fill Finish Capabilities

Our sterile manufacturing capabilities span early formulation and feasibility, with our Annex 1 facility capable of taking biotechs from early stage through to clinic.

Flexible aseptic processing and fill/finish processes

Rapid transfer solid-wall VHP three-chamber isolator

Aseptic liquid filling capability (2R-20R vials)

Independent HVAC supply and return systems

PUPSIT

Terminal moist-heat sterilisation

Container closure integrity testing

Isolator technology

Submission ready in 12 Weeks

Regulatory Submission Ready in 16 Weeks

Upperton’s time to clinic is significantly quicker than other CDMOs due to our Annex-1 aligned facility, and unique operating setup. Whilst other CDMOs work to 18-month to 2-year timelines, we can get clients regulatory submission ready in just 16 weeks.  

Speak to us about how we can get you regulatory ready in just 16 weeks. 

Request our 16 week to IND brochure

Key features of our sterile facility:

Designed to support early phase projects with fill-finish, aseptic processing and terminal sterilisation.

01

Annex-1 Compliant

Upperton is one of the only fully Annex-1 aligned facilities in the UK, offering significantly enhanced expectations for contamination control and the highest standards of quality.

02

Regulatory Ready in 16 weeks

Due to our unique one-site setup, and optimized operating model we can get clients regulatory submission ready in just 16 weeks. This is particularly advantageous for emerging biotechs that currently experience waiting times between 12-18 months.

03

Isolator Technology

Isolator technology offers the highest level of contamination control, offering sterile formulation and manufacturing for niche, early-phase clinical projects.

03

Two Grade C Cleanrooms

Our facility is built to support emerging small sized biotechs. In the second phase of our sterile build, we are developing a second isolator for future aseptic spray drying, as a further development of our spray-dried particle engineering expertise.

partnership

Why Partner with Upperton

We provide fully integrated services across every stage of drug product development:

One Site

Integrated, end-to-end capabilities delivered under one roof.

One Team

The same team from your early-stage development through to preparation for commercial launch.

Scanning electron microscope (SEM) photograph showing a powder made up of solid amorphous spray dried dispersions (SDDs) of the optimum size for inhaled formulations (1 to 5 micrometres)

Complex Molecule Expertise:

Proven track record in solving formulation and delivery challenges.

Executive Leadership on Every Project:

Direct access to experienced senior leadership for strategic oversight and decision-making.

Download our sterile brochure to learn more about our fill-finish services.

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Parenteral, Aseptic & Fill-Finish FAQs

Upperton’s Annex-1 aligned status, and unique operational structure means that we can get clients into the clinic in just 16 weeks, which is significantly quicker than the typical 12-18 months offered by competitors. 

Our aseptic offering features advanced VHP isolator technology, enabling aseptic filling of small-batch biopharma and small molecule products. We will also be bringing in aseptic spray drying capabilities in the near future. 

Annex-1 has significantly increased the standards for contamination control and quality. Our Annex-1 alignments ensures that the highest standards of quality and contamination control are upheld throughout every project we work with. 

Our sterile manufacturing services are specifically tailored to small to medium sized biotech companies. A large part of our offering involves providing small and mid-sized biotechs faster access to the high-quality sterile formulation development and manufacturing capacity they need to progress into clinical trials without unnecessary delays. This facility is a major part of that commitment. 

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We provide fully integrated services across every stage of drug product development.

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