DESIGN SOLUTIONS FOR PERSONALISED MEDICINES

Get in touch

Are you planning to build an ATMP Manufacturing facility?

The rise of Advanced Therapy Medicinal Products (ATMP) heralds a new era in healthcare with potential to cure severe conditions. A key enabler to commercialising these life-saving therapies is to have the right facility which meets the required capacity, critical and challenging design and quality requirements, using fully compliant and cost-efficient solutions.

These facilities must be designed by experienced and knowledgeable companies which are competent to incorporate the latest solutions in spatial design, engineering and automation, aseptic processing/containment and preferably to have the capability to build and hand over the fully validated facility on time and on budget.

Scitech is proud of its reputation for successfully delivering Engineering, Procurement, Construction and Validation (EPCV) projects for life science clients for many years. Scitech is supporting the Cell & Gene Therapy (CGT) industry and aseptic processing projects with its in-house capabilities for full engineering design (process, building services and HVAC, electrical, automation), architecture and construction teams working closely with our regulatory, quality and validation experts. We are collaborating alongside many other industrial thought leaders to deliver tailored concepts for the ATMP industry, with solutions from small pharmacy/cleanrooms to prepare “Specials” and investigational products to full-scale multi-thousand dose per year GMP facilities.

Scitech solutions for 4 key design elements in an ATMP manufacturing facility

PRODUCT TYPE
MHRA “Specials”
Cell Therapy
Tissue Engineering
Gene Therapy

FACILITY SCALE
Aseptic Pharmacy/Cleanroom
Personalised Medicine Hub
Development Facility
Large Scale Commercial

The fast pace of technological innovation and new discoveries within medical biology, genetics and manufacturing platforms highlight the importance of a “Flexible Facility”.

How flexible is your facility to incorporate different manufacturing scenarios in future?

ATMP manufacturing companies need to consider options on how to future-proof their facilities for future disruptive technologies such as robotics and fully automated systems, different manufacturing volumes or product portfolios. We work closely with our clients to propose the best solutions for future flexibility (Expandable/Clonable) through a scale-out/scale-up route with minimum future re-investment.

The market is pushing companies to develop their manufacturing strategy as early as the development stages and early clinical trials.

Scitech offers a full integrated design (architectural, full engineering), construction and validation capability to streamline project delivery from concept to a qualified facility ready to manufacture. We can offer innovative solutions in bespoke modular and prefabricated cleanrooms to achieve an accelerated design, construction and validation programme.

Reducing cost of manufacturing will make the treatment more affordable for more people. An ATMP manufacturing business should have a clear understanding of the throughput of the manufacturing capacity and costs associated per dose.

Most ATMP products (especially autologous based therapies) cannot benefit from the economy-of-scale solutions (e.g. scale up to manufacture higher volumes/ doses) and must employ innovative approaches to reduce the cost of manufacturing.

Our Subject Matter Experts are working closely with suppliers and system providers to achieve integrated solutions, to develop options for better utilisation of cleanroom space and reduce manual handling with robotic systems. These solutions will benefit the manufacturing operation with better facility throughput in the provided space.

The core manufacturing process and the extent of aseptic and containment requirements define the key areas for the classified space in many projects.

Once the process and operation schedule, decision points, mass balances, the level of safety/containment and aseptic requirements are known, engineering and design solutions can be developed, and the concept for the facility can be realised early on.

With our team of experienced architects, engineers and regulatory and quality experts, we lead quality and safety risk assessments and offer final solutions that fully comply with all the applicable GMP and safety regulations.

Get in touch today

    YOUR NAME *

    EMAIL ADDRESS *

    PHONE NUMBER

    SUBJECT

    MESSAGE

    We take your privacy seriously and will only use your information as described in our Privacy Notice. By sending this form you consent to the uses of data as outlined in the Privacy Notice