Like many other companies and institutions around the world, we are experiencing interference with some of our systems within the TNT network.
We are implementing remediation steps as quickly as possible. We have implemented operational contingencies to continue to complete collections from customers with scheduled stops. For customers who do not have a regular stop, collection should be arranged via our customer service centers.
Customers may experience delays in the transit of shipments, particularly inter-continental or non-EU European delivery, as we work to remediate our systems. Additionally, if customers do not have the facility for self-labeling, they may also experience delays.
We are not able to collect shipments of dangerous goods at this time.
We regret any inconvenience to our customers.
API Development and Manufacture - Late Phase
Supporting Late Phase API Development and Commercial Launch
We have an established reputation for developing processes for late clinical stage. Our extensive experience lies in taking processes from inception through to process validation, both in small molecule chemistry and peptides.
As an API moves from early clinical phase towards late clinical phase, the emphasis of the project changes. Whereas in early clinical supply, a lean fit-for-purpose approach is appropriate, other factors start to dominate when moving towards late phase, particularly process efficiency and knowledge. We strategically integrate the principles from regulatory guidelines (FDA, ICH, USP), such as risk management and quality by design, as a basis for development and manufacturing strategies.
To improve process efficiency, our chemists can perform process optimisation and intensification with the goal of increasing yields, reducing raw materials and waste, and simplifying process operability. Once the process starts to become established, the focus changes so that knowledge and understanding become the primary objectives, ensuring the process is robust.
Implementation of the following themes include:
- Purge and fate studies
- Hold point studies
- Identification of critical process parameters
- Design of experiments
- Development of control strategy
Part of the process understanding exercise is to gain an in-depth knowledge of the impurities generated, as well as, understanding their fate. Impurity identification is performed using our wide array of analytical techniques, particularly LCMS and NMR. Impurities can then be either synthesised using traditional chemical synthesis or isolated from process streams using preparative chromatography (column chromatography or preparative HPLC). The impurities are then characterised and can be used as reference markers / standards.
Analytical Development Optimisation
Analytical methods will continue to be enhanced during this phase of development and will undergo full ICH validation.