At Scitech, we provide consultancy, design, construction, qualification and validation for high value manufacturing, research, emerging technologies, and highly regulated industries including biotechnology, pharmaceutical, life sciences and radiopharmaceutical. Our engineers are at the heart of what we do, working with and supporting our clients to upgrade existing facilities, debottlenecking and improving manufacturing capacity, developing new processes or designing a new facility.
The companies and organisations that we support are involved in drug discovery, diagnostics, and pharmaceutical manufacturing, all of which help to treat illnesses and keep people healthy. We also support other industries, such as the animal health sector – working with companies that develop and manufacture veterinary medicines – consumer health companies who manufacture vitamins and other healthcare products – all of which contribute to improving lives.
Designing a new facility
Through our work, we have supported many companies to scale up production, moving a product from small scale to large scale production whilst maintaining efficiency and safeguarding the integrity of the medicine. The rapid scaling of existing production processes is something that proved absolutely critical during the COVID-19 pandemic and is an ongoing need across the pharmaceutical sector. Often when scaling for commercial production, a company will require the design of a new facility, requiring the input of the full suite of specialist engineers spanning design, process engineers, mechanical engineers and those with expertise in building services, qualification and validation, for example.
We are currently supporting a biotechnology company with a large expansion project at its existing facility. The project involves significant new build and refurbishment on an operational site, with regulatory compliance drivers, including controlled environments and processes. Our engineers are supporting all stages of the project from procurement, through to construction, commissioning, and validation. The result will lead to significant increase in the manufacturing capacity of recombinant human albumin – a constituent of biologic therapeutic products that is used to optimise drug dosing and enhance therapeutic performance of active pharmaceutical agents.
Our engineers support projects such as this across the UK and Europe. Through our European team, we supported the development of a research and development (R&D) facility allowing clinical phase 3 cGMP production within an existing building. Our specialist engineers designed and built the new laboratory facility, ensuring that it was compliant with BSL3 and cGMP guidelines.
Developing new processes
While process engineers were integral to the multi-disciplinary teams mentioned in the examples above, we feel they deserve a closer look for the impact and value they can provide. Our expert process engineers are integral to the success of our projects and are consulted throughout the project life-cycle.
For example, we were approached by a biotechnology company to provide a front-end engineering study, including a feasibility study and an extended study for design optioneering, for a standalone large scale manufacturing facility that incorporated its innovative reaction vessel. Our engineers developed different iterations for the facility design considering different scales of bioreactors and downstream manufacturing process, process scheduling and options to implement the services and utilities to assist with the client’s investment strategy. This was to ensure the client could make the right choices based on their business needs and desired outcome.
Our process engineers lead workshops to define the fundamentals of process, engineering, biologics, and chemistry in a combined approach and formulate the requirements for the required facility. It led to the development of an overall programme and cost plans to estimate the full turnkey delivery of the commercial manufacturing facility inclusive of the design, User Requirement Specifications development, procurement, installation, commissioning, construction services.
Improving manufacturing capacity
At Scitech, many of our clients are looking to improve manufacturing capacity. Technology is constantly evolving and improving, and over time companies need to replace and upgrade existing equipment or will look to make improvements to existing production lines to maximise the output they can achieve. Often the need for capacity improvements is driven by commercial need and is essential to ensure that the medicines, devices and healthcare products are available for members of the public when they need them. We are proud to play a part in supporting companies to meet this demand.
For example, our engineers at our European office were approached to support an increase in manufacturing capacity at a secondary packaging plant that packaged ophthalmic prescription drugs. They supported the client with the development of user requirement specifications for 33 machines and provided final equipment evaluation and selection. The team developed the line layouts taking into account building restrictions before undertaking and documenting all qualification and validation according to required regulations. The result was the successful installation of five secondary packaging lines providing a total production capacity of 57 million packs per annum.
Many of our engineers hold specific expertise in niche areas, becoming subject matter experts in, for example, specific equipment installations and within certain fields. This is particularly the case with our radiopharmaceuticals subject matter experts who are widely recognised and respected in the industry. Their expertise has seen us provide consultancy on radiopharmaceutical facilities around the world and led to a large scale project with Guy’s and St Thomas’ NHS Foundation Trust and King’s College London which spanned 10 years.
During this project, our specialist team supported the trust to relocate its diagnostic scanning cameras from the basement scanning facility in St Thomas’ Hospital in London to a new scanning suite on the first floor. The team also converted the old scanning facility into a new radioisotope manufacturing facility for Research and Development (R&D) and for clinical manufacturing of isotopes for use by the new first floor diagnostic scanning facility.
The diagnostic scanning facility improves lives by providing early indications of cancer sites within the body. The radio-labelled isotope mimics glucose which the cancer needs to grow within the body. On introduction to the body the cancer site absorbs the radioactive glucose which is detected by the scanning camera, the image of which can see the radioisotope as a bright spot where cancer sites are present. This technique allows clinicians to establish the size and location of cancers. It is then possible to determine if a particular course of treatment has stabilised (same number of spots) or is reducing (fewer spots) a cancer, or indeed if a cancer has grown/worsened (more spots) which may necessitate a change in treatment or an increase in dose or intensity. The early detection and effective treatment of cancer clearly benefits society by reducing the amount, and duration, of unpleasant cancer treatment (for example chemotherapy).
The scanning facility uses radioisotopes made within the ground floor radioisotope manufacturing facility. For this project, we provided all design stages from feasibility design to detailed design of facility and utilities. We performed all specialist equipment integration, commissioning planning and support and performed all quality testing and associated document closure for the medicinal and nuclear regulations. The design stages included the development of the layout for the particle accelerator, its concrete bunker, the specialist radioisotope handling equipment and the associated support quality control laboratories to meet the hospital user requirements.
Qualification and validation
Our CQV business unit, with our team of validation engineers, has a vital role to play in assuring quality and validating processes, systems and equipment within laboratories and manufacturing facilities.
When taking a product from R&D to commercialisation time to market is critical. Our team can support companies from project inception and ensure assurity of audit compliance, all of which brings drugs to patients quicker.
In addition, we are uniquely positioned to be able to deploy an engineer or team very rapidly – something that is critical if a problem has developed on a production line meaning that manufacturing has had to stop. Our engineers are able to quickly respond and support the qualification and validation following the installation of new equipment or repairs meaning that any downtime is kept to a minimum. This means that any pause in the production of the vaccines, medicines and other therapeutics are kept to a minimum – something that is increasingly important during times when there are shortages of drugs.
We are proud of the contribution that our engineers, and all of our team members, provide to deliver quality results for our customers, helping to ensure that the laboratories and facilities operate as they should within the stringent regulations required.