Advancing the future of cell and gene therapy solutions
From advanced nanoencapsulation platforms that unlock personalized medicine, to integrating real-time, in-process analytics for enhanced bioprocess control, we help our clients develop cell and gene therapy technologies that change the face of healthcare.
Working collaboratively across applied science, engineering and user-centered design, our multidisciplinary experts excel at tackling the complex challenges inherent in cell and gene therapy technology development. From refining early-stage concepts to developing platforms ready for commercial launch, we help you navigate technical, regulatory and usability considerations to accelerate progress and deliver robust, scalable solutions.
Bridging the gap between laboratory processes and commercial products
Commercial success in cell and gene therapy remains a major challenge, primarily due to the complexity and high cost of manufacturing at scale. At Team Consulting, we help our clients translate the science behind lab processes into award-winning products.
Our applied science experts help you bridge the gap between research and real-world application by transforming complex laboratory workflows into scalable, automated solutions ready for clinical use. This means faster time to market, reduced risk and robust platforms that scale with your ambitions.
Faster development. Optimised results.
Risk-informed optimisation: We evaluate every step of your process to balance risk and benefit, safeguarding product integrity while accelerating development.
Modular scalability: Our flexible, modular automation strategies allow you to adapt quickly as demand grows, reducing future costs and complexity.
Cost-efficient implementation: Through pragmatic, phased implementation of analytics and automation, we maximise the return on your investment at each stage of your development.
User-centered design: By prioritising usability, we create systems that are both desirable in the market and that minimise use errors and batch failures.
Holistic integration: We consider analytics, consumables and all critical interfaces to deliver end-to-end solutions that meet regulatory compliance and deliver operational efficiency.
Explore our work in cell and gene therapy technology development
From an award-winning benchtop platform for nanoencapsulation, to bespoke in-process analaytics, find out how we’ve helped our clients transform cell and gene therapy manufacturing.
Our 5 As approach to cell and gene therapy success
Analytics
We embed tailored analytical technologies, focusing on therapy-specific, real-time, in-process measurements for adaptive process control and rapid quality control.
Aseptic consumables
We design single-use consumables to help you deliver closed-systems, high-volume reliability, cost-efficiency and a great user experience.
Actionable data
We apply high-performance algorithms, machine learning and digital twin systems to automate analysis and simplify workflows, creating integrated cloud systems and intuitive user interfaces to provide actionable data.
Automation
We translate your lab processes into automated, clinic-ready products, applying automation in phases to match your development stage and capital. The result is an end-to-end, modular approach that can scale.
Assurance built in
Our experience in cGMP-compliant equipment design and development enables us to identify and mitigate your quality risks early on. We help you validate your processes and implement closed-systems, traceable electronic records and compliance by design.
Built‑in analytics for trusted data and regulatory confidence
We integrate advanced analytical technologies into your process to deliver accurate, actionable data for robust cell and gene therapy manufacturing and regulatory compliance. Our solutions range from low-cost, in-process analytic technologies to tailored solutions, to enable adaptive control.
We follow a methodological approach based on quality by design principles, to help you develop a robust system.
Designing robust CGT systems through quality by design
Defining the design space: We clarify your requirements early to minimise risk and accelerate your development.
Precision analytics: Implementing the right process measurements and analytics ensures consistent product quality and dependable data for cell and gene manufacturing.
Pragmatic technology integration: We leverage existing, proven technologies where possible, reducing your development cost and time.
Data-driven optimisation: We map out relationships between your inputs and outputs, to help you create robust, repeatable systems built to scale.
User-centered design: From UX/UI digital interfaces to leading product design principles, our industrial design team help you design a product your users will love.
Automating complex analysis to streamline workflows
Combining our expertise in data science, applied sciences and AI, we develop algorithms that automate data analysis and provide meaningful results to operators, helping you streamline workflows and accelerate decision-making.
Scientifically grounded models: We apply scientific principles to build accurate, reliable data models.
Real-world validation: Our algorithms are iteratively tested and validated using real-world representative data and hands-on testing to ensure reliability.
Simplified user experience: We present results through clear metrics and contextual graphics, making complex data easy to interpret for technical reports.
Compliance by design: Every algorithm and software solution is developed with regulatory requirements in mind, supporting faster approvals and market entry.
Proven cGMP equipment design that de risks development
Core principles
We work closely with you to identify and proactively mitigate product quality risks early on, achieving validation through robust testing and qualification stages to demonstrate reproducible product quality. Our experts facilitate design qualification through a flexible, iterative design approach, collaborating directly with end-users to ensure that solutions are both practical and effective.
cGMP hardware design
For cGMP hardware design, we ensure full compliance with EU GMP Annex 11 and IEC 61010. This involves key considerations around product-contacting materials, closed equipment design and single-use consumable design to support aseptic processing and ease of use.
cGMP software design
In cGMP software design, our team adheres to GAMP 5 and FDA 21 CFR 11 standards as needed. We help you determine the best solution for your needs, whether that’s novel technology or off-the-shelf software solutions. Our experts help you generate comprehensive documentation, secure electronic records, audit trails, robust user access controls and advanced cybersecurity measures, to protect the data you generate and meet regulatory requirements.
Meet our Head of Cell and Gene Therapy
Kella leads the cell and gene therapy group at Team Consulting, with over 10 years’ experience delivering cell and gene therapy technology, medical device, diagnostic, and lab equipment projects from concept through to production.
She has a background in polymer chemistry and a PhD in biomaterials engineering from Imperial College London, where she developed tissue engineered cardiac patches for treating heart attacks.
