A key driver for success is excellent product design. This is the step that will determine if your candidate drug achieves adequate exposure, reaches the site of action, is manufacturable and robust. Seda has world-leading expertise in the design and application of conventional and novel formulation and drug delivery technologies to give your asset the best chance of success. The design must be tailored to the specific challenges of your molecule and starts with a deep understanding of the inherent properties and likely impact on quality, safety and efficacy.
Aligned to Product Design it is critical to develop an understanding of likely Product Performance. Seda have expertise with in silico and in vitro techniques to predict performance, e.g. likely pharmacokinetic profile, to guide the selection of the most appropriate formulation technology and to de-risk your clinical programme. Seda have a proprietary software suite that allows Clients to understand whether a certain formulation is likely to provide the required exposure and if not, what formulation approaches are most likely to deliver optimum performance. This software suite also allows the impact of product release rate on pharmacokinetics to be determined so that formulations with the optimal ‘modified’ release can be developed.
Seda are recognised leaders in the field of clinically relevant dissolution and this knowledge along with biorelevant dissolution data (which can be generated in Seda’s laboratory) allows screening and development of formulations that are most likely to produce the required exposure and optimal pharmacokinetic profiles in patients. In later phases of development and the post launch setting clinically relevant dissolution ensures consistent clinical performance between different batches of drug product and is a critical regulatory expectation.
To be effective, any new product development must meet the regulatory requirements for approval. Our Project Leaders have extensive regulatory experience from First Time in Human through to full Marketing Authorisation and will ensure that any data package is suitable and appropriate for the stage of development. We are able to author submissions and support you through regulatory defence.
An important element for success at this stage is to be able to use the data generated during development to demonstrate that the Sponsor has sufficient understanding of the product, process and associated analytical tests that ensure high quality product is always produced. Seda have extensive experience of taking development datasets and curating these into a compelling description of a regulatory Control Strategy.
Excellence in Product Supply with a focus on Quality is a specific skill set and is rarely well aligned with excellence in Product Design. At Seda we do not manufacture clinical supplies, rather we work with a range of CDMOs and select the most suitable to meet our Clients’ needs. We provide project management and technical oversight to ensure the timely supply of product to clinical studies.