Enabling Confidence and Security in the Supply Chain
Specialising in solid oral dosage forms, Almac has the technical experience and knowledge to develop robust formulations and manufacturing processes.
We have assisted many of our clients in the development of both immediate and modified release formulations, for their late stage clinical trials, registration batch manufacturing and commercial launches. Our expertise covers the development of the following dosage forms:
- Immediate and modified release capsules
- Immediate and modified release tablets
- Fixed dose combinations
- Powder / granule filled sachets
When developing modified release dosage forms, we often employ one of the following approaches to achieve the desired release profile:
Matrix Systems (Click to Read More)
- Insoluble / swellable
- Eroding matrix
Coating Systems (Click to Read More)
- Coated pellets
- Coated tablets
- pH Sensitive coatings
Our manufacturing technologies and processing scales range from hundreds of grams for small-scale process investigation studies to hundreds of kilograms for phase III/IV and registration batches.
We understand that the best way to ensure a smooth regulatory review process for an NDA or MAA is to clearly present the results from a well-defined series of experiments. By understanding the parameters that are critical to the quality of the product and the safety of the patient, we build quality into the product from the start, implementing effective control strategies.
Watch Almac’s webinar ‘Evaluating Capsule Manufacturing & Comparator Blinding Techniques for Clinical Trials’
Almac: Evaluating Capsule Manufacturing & Comparator Blinding Techniques for Clinical Trials from Almac Group on Vimeo.
Quality by Design
Quality by Design
Keeping Pace with the Changing Regulatory Landscape
Our team has in-depth experience with Quality by Design (QbD) applications and are experienced at interacting with regulatory authorities on this topic. We have incorporated the principles of ICHQ8, ICHQ9 and ICHQ10 into our quality system, and have developed internal guidelines on how to apply these to development projects.
When developing a commercial formulation, we use the Target Product Profile and Critical Quality Attributes (CQAs) identified by the client. This enables us to develop a range of prototypes and investigate a range of manufacturing processes. Once a lead formulation and manufacturing process is identified, our experts use formal risk assessment tools to identify all possible Critical Processing Parameters (CPPs). We use paper screening and lower resolution Design of Experiment (DoE) to ensure the number of parameters to be investigated is at a practical and sensible level. We then apply a more powerful DoE with higher resolution to generate more powerful data, which results in a clear understanding of the manufacturing process and which parameters have the most effect on CQAs.
Applying a Sensible, Logical and Scientific Approach
We make data driven decisions, capturing them (and the rationale behind them) in clear and professionally written development reports, which can be incorporated into your regulatory filing. We understand that companies have API, budgetary and time constraints and we can offer advice and guidance on what we believe to be the most suitable program of work for you.
Utilising our State-of-the-art Containment Technology
We have designed, manufactured and installed state-of-the-art containment technology to facilitate the processing of potent compounds in both our non-GMP and GMP pharmaceutical development facilities.
To contain airborne particulates, we have applied engineering solutions that employ rigid and flexible film isolator technology around the processing zones of equipment. Extensive dust monitoring exercises have determined the effectiveness of these containment solutions, demonstrating that we can process compounds with an OEL as low as 50ng per m3.
We have the capability to process potent compounds using a wide variety of processing techniques, which include:
- Dry granulation
- Wet granulation / fluid bed drying
- Tablet coating
Facilitating the Ease of Transfer and Scientific Continuity
From a single site, Almac is uniquely positioned to provide a full range of scalable services, from non-GMP to GMP development, to clinical supply (Ph I – III) and on into commercialisation.
From the outset, our development scientists work to advance robust formulations and processes that can be scaled-up and are suitable for large-scale commercialisation. With both the development and GMP teams working closely together, we can facilitate a smooth project management process and the continuation of scientific knowledge.