Autolus: Nucleus QC Labs

12 Dec 2022
2022-23

Stevenage, United Kingdom

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Autolus is a clinical-stage biopharmaceutical company developing nextgeneration, programmed T cell therapies for the treatment of cancer. Using a broad suite of proprietary and modular T cell programming technologies, Autolus is engineering precisely targeted, controlled and highly active T cell therapies that are designed to better recognize cancer cells, break down their defence mechanisms and eliminate these cells.

Autolus has a pipeline of product candidates in development for the treatment of haematological malignancies and solid tumours.

The project

EEDN are engaged to deliver an operational QC lab on the second floor of the Nucleus manufacturing facility in Stevenage for the Client.

It also involves the phased move of the existing QC labs provision from the GSK site in Stevenage to
the new facility, maintaining the accreditation:
  • Stage I will see the project to a successful MHRA submission of the facility
  • Stage II will include the successful move of the QC operations from the current location.

Our role

Our Director, Tes Adamou is leading the day to day Project Management of the facility, including:
  • Purchasing, installation and qualification activities of all existing and new equipment
  • Method transfers to new QC laboratory
  • Preparation of necessary documentation (e.g. SOPs)

"We are delighted to be returning back to deliver a project at Autolus' new facility, helping the company manufacture the treatments and save lives"
Tes Adamou, Managing Director

Challenges

The project timelines are definitely a challenge, which can only be surmounted with proactive and creative project management and a thorough understanding of the science involved.

With a collaborative approach and clear prioritisation methods based on knowledge of the industry, we have reduced the project risk and put it on a good trajectory for timely completion.
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