We support your journey of your potent drug-delivery device
through product, process and analytical development.
Where is your product on
its journey to market?
Journey / Development
Product Development
At DEC we consider all aspects of the product development process – from end-user requirements to the scalability of manufacture. We will support the development of product requirement specifications using Design for Manufacture principles. We focus on quality, and scalable process design for long-acting implant and device development.
Journey / Development
Process Development
Scalable, cost-driven process design is intricately linked to the future viability of the product. DEC follows a Quality by Design (QbD) approach to ensure that process development is not at the expense of CQAs.
Journey / Development
Measurement / Analytics
In-process, and final product measurement is at the heart of your product Quality Control. DEC have decades of experience in method development for quantification assays, and measurement. DEC will develop and implement these controls for your product to ensure quality can be tracked and quantified. This includes testing of raw materials, in-process controls and finished product testing ensuring high-quality product that meets specification.
Journey / GMP Ready
Equipment and Tooling
Our in-house product development and engineering team will work with you to design, specify, procure, install and qualify any new equipment, including production tools required to manufacture/assemble your product.
Journey / GMP Ready
Quality Plan
Based on your user and product specifications, DEC will work with you to develop a Quality Plan, including measurement, stability, documentation and risk assessments.
Journey / GMP Ready
Testing and Validation
Pre-production testing and validation includes manufacturing tool tests, equipment qualification and process and analytical validation in our dedicated pilot-scale GMP suites. DEC will plan these activities for you as part of our product Qualification and Validation programme.
Journey / Commercial Supply
Technical Transfer into GMP
DEC will transfer process and quality testing into dedicated GMP suites. This will include Quality and process documentation, further Qualification and Validation at-scale, and Technical File development.
Journey / Commercial Supply
GMP Quality Control
DEC has a dedicated GMP analytical laboratory to support raw material testing, in-process controls, finished product testing, and stability. Whether this be dissolution or content assay, or mechanical testing of the product, we can ensure that Quality can be scaled with manufacture.
Journey / Commercial Supply
Scale Up
What makes GMP production at DEC different is our experience from prototype, to scaled manufacture. We work with biotech businesses to ensure that scaling is handled efficiently through a range of process studies, and where appropriate, automation of manufacture and assembly processes. Our current implant batches are up to 600kg, manufacturing up to 10 million implants per year.
Make. Make Perfect. Repeat.™
Let’s discuss how we can help bring your product to market.
