Over 40 years’ Experience Manufacturing Solid, Oral Dosage Forms
Scaling up from our development services to full scale commercial drug product manufacture or transferring existing commercial products we can meet your commercial drug product manufacturing requirements.
Our range of commercial scale dry blending and wet granulation technology supports the commercial drug product manufacture of:
- Immediate and modified release
- Uncoated and coated (including enteric coating)
- Hard gelatin capsules (powders, pellets)
- Oral powders for reconstitution
With blend sizes from 10kgs up to 2.5 tons, our range of state-of-the-art processing equipment can flex to the batch size requirements of your particular product needs.
Ensuring That Your Products Meet Specifications
We are MHRA licensed and have been successfully inspected by the FDA, Pmda, ANVISA, Turkish Ministry of Health and South Korea FDA. With UK Home Office approval, we are also licensed for the storage and processing of controlled drugs (schedules II-V). A quality led environment is the foundation of our operations and we impose comprehensive standard operating procedures, rigorous training and a range of process controls.
To support operational activities, we have a dedicated in-house engineering team who provide equipment maintenance and calibration, tooling design and machine prototype manufacture. With dedicated specialists in place, we are able to facilitate the rapid turnaround of tailored solutions and provide equipment designed to meet the unique requirements of each and every project.
Ensuring a Successful Technology Transfer
We work side by side with our client partners to carefully plan and identify preliminary considerations in order to ease the process of technology transfer. To facilitate the transfer for all commercial projects, each of our client partners is allocated a dedicated Product Supply Manager. This single point of contact leads an experienced multi-disciplinary team, defining roles and responsibilities, generating and reporting against an agreed project plan of deliverables to ensure that the transfer process is as simple, clear and as defined as possible.
Our distinct method ensures delivery of the highest quality by incorporating a consistent process that is repeatable and robust.
Ensuring Quality from Development to Commercialisation
Our manufacturing operations have been built and designed around the concept of enabling scalability, ensuring we have superior integration of all technologies. From non-GMP to GMP development, to clinical supply, through to commercialisation, we can ensure ease of transfer and scientific continuity.
From the outset, our development scientists strive to develop robust formulations and processes that are suitable for scale-up and large-scale commercialisation. With both the development and commercial teams working closely together on a single site, the result is a smooth project management process and continuation of scientific knowledge.
Demonstrating our Commitment to Building Long Term, Strategic Relationships
In partnership with our clients, we have a leading reputation for delivering complex, time sensitive capital projects in support of growing, innovative products. Over the past two years, we have significantly co-invested in excess of $15M with our client partners. Such investments include:
- Supporting a US client with the installation of a dedicated commercial fluid bed dryer and high speed encapsulation suite for their first global product launch.
- Installation of a dedicated RH controlled blistering suite for two Japanese clients. Additionally installing an offline HAPA digital print unit to facilitate JIT (just in time) blister printing for smaller markets.
- Expansion of client dedicated commercial sachet facility (x3 dedicated lines) with sachet output of 400 million sachets per annum to meet current demand and entry into new markets.