UniD Manufacturing are the first global Contract Development and Manufacturing Organization (CDMO) fully dedicated to micro-implants based on sustained release and polymeric formulations.
2024 is an important year for UniD Manufacturing, their first as a CDMO open to external customers, with new projects expected to be launched by the year’s end.
Ahead of CDMO Live 2024, Chief Operational Officer Pascal Bertholet shares the company’s innovative strides in micro-implant technology and their vision for a sustainable future.
Unique Approach to Micro-Implants
“2024 marks a significant year for us as we undergo a substantial shift in our business approach.” says Pascal. The company was originally established to develop ocular implants for sister company, EyeD Pharma, but has recently expanded to offer small implants in other therapeutic areas.
“What sets us apart is our expertise in developing both the formulation and the manufacturing process for micro-implants that release active ingredients according to a specific dissolution profile. This can range from a few hours to several years. Our formulations include biodegradable, non-biodegradable, and resorbable polymers,” explains Pascal.
Patents for biodegradable implants will soon expire in Europe and the US, presenting new generic opportunities in profitable markets, says Pascal.
“The FDA and EMA offer scientific advice procedures to facilitate the development and registration of these complex products. They also publish product-specific guidance that clarifies regulatory expectations, simplifying the registration pathway for these generics, thereby reducing risk and cost for customers.”
Investing in Quality Control and AI
Pascal explains that the main challenge in their development is controlling the long-term dissolution characterization of our products. To address this, they have invested heavily in Quality Control (QC) capabilities.
“We employ robots and an internal distribution method to control the dissolution profile of thousands of samples simultaneously.”
Another strategic investment is in data analysis using Artificial Intelligence (AI) to handle large datasets and variables beyond human capacity with traditional statistical tools, says Pascal.
“Our AI system performs unlimited multivariate statistical analyses, detecting complex correlations that aid our development team in creating more robust processes and products.”
Expansion and Capacity
“In 2022, we moved to a new facility with different production areas totaling almost 5,000 square meters of GMP-approved Grade C and D space, with 4,000 square meters allocated to our current in-demand technology. We also have two clean rooms, totalling 100 square meters, ready for quick qualification for new applications.”
UniD Manufacturing’s new building in Belgium “meets and often exceeds” national and European regulations for energy efficiency and insulation, says Pascal.
“The HVAC system, controlled by a SCADA, operates in reduced mode during off-hours, significantly cutting our annual energy usage. We’re investing in solar panels to cover about 45% of the plant’s energy consumption and promoting electric cars and commuting bikes for employees to reduce our CO2 footprint.”
The Ideal Partner
“As a CDMO specializing in micro-implants, our ideal customer seeks solutions for local delivery of known APIs, preferably small molecules with an OEB of five or lower. The application should be for a small body part, justifying the implant’s size, with treatment durations ranging from days to years. We offer a range of services from formulation to GMP manufacturing for clinical batches, managing projects at any development stage.”
“Our QC techniques are currently focused on small molecules, as we’re not equipped to store or control biologics. Our EHS containment systems are designed to handle API having an OEB equal or lower than 5.”
Balancing speed with robust data
Pascal’s advice to customers is to balance speed and cost with the robustness of data.
“Quick and inexpensive data generation can be tempting, but it’s crucial to remember that such data may not always be reliable and should not be overinterpreted. It’s not uncommon to encounter unexpected results during subsequent development phases, which can differ from initial data.”
“To mitigate this, we’ve implemented a strategy that involves conducting a broad Design of Experiments (DOE) with over 30 configurations simultaneously. This approach allows for Quality Control with a larger sample size, significantly enhancing the statistical robustness of our preliminary results.” says Pascal.
“Maintaining speed in development while ensuring data quality is crucial. Our QC strategy enables us to test a vast number of samples in parallel, ensuring we gather more data without compromising on development pace. “
Meet with UniD Manufacturing at CDMO Live. Register for your ticket here
