Contract development

Stemmatters provides comprehensive product, process, and analytical development services, designed to address the unique challenges and goals of each project. Stemmatters is more than a service provider - we are your dedicated development partner, working hand-in-hand with academia and industry to drive innovation and deliver transformative solutions.

Each of our customers’ needs are unique

Our integrated offering enables us to provide tailored solutions to meet development goals and objectives along the journey towards commercial success.

Designing and establishing product specifications to ensure a well-defined, controlled product that can be consistently manufactured.

Transforming early-stage processes into validated, cGMP-compliant manufacturing operations meeting regulatory expectations.

Optimising cost of goods and ensuring efficiency and scalability for future commercial demand.

Developing and validating analytical methods to ensure product quality and regulatory compliance.

Our Approach

We bridge the innovation gap between R&D and cGMP manufacturing by designing and implementing a comprehensive strategy that meets each customer's unique needs and requirements. Our structured approach integrates:

Process gap analysis
Quality by Design (QbD) framework
Design of Experiments (DoE) methodology
Agile process development
Analytical method development

Our development services include

Planning and execution of tech transfer

Process scale-up and cost-of-goods optimisation

Development and validation of novel bioprocess designs

Specification development and formulation

cGMP process development and validation of biomanufacturing processes using closed systems (both 2D and 3D)

Analytical Quality Assurance (QA)/Quality Control (QC) method development and validation (product and process)

GMP-compliant analytical method(s) validation

Implementation of end-product stability studies (accelerated and long-term conditions)

Have questions or want to connect with us?

Get in touch to learn more about our work and how we can collaborate.