GHP June 2017

8 GHP / June 2017 , The chemical contract research and manufacturing sector is changing rapidly to meet customer demands in relation to quality, security of supply, timelines and cost, with opportunities arising for companies that can successfully deliver on these. Quality, customer care and delivery are now baseline expectations and demonstration of additional added value at the right price is taking centre stage. Chemical producers like Arran Chemical Company (a member of the Almac Group) are taking advantage of this mind-set. In this article Prof. Tom Moody (VP Technology Development and Commercialisation, Arran Chemical Company), Dr. Peter Cairns (Technical Manager, Arran Chemical Company) and Dr. Stefan Mix (Biocatalysis Group Leader, Almac Sciences) highlight how having Arran Chemical Company (Arran) as part of the Almac Group, and having access to state-of-the-art technology and development facilities, is reaping major rewards for winning complex intermediate supply projects. They also discuss major changes Freebie Irish Based Chemical Production Takes Centre Stage The pharmaceutical &healthcare industries are outsourcingmore andmore, and recent trends indicate this is not slowing downwhen it comes to procurement of advanced intermediates and building blocks for their Active Pharmaceutical Ingredients (APIs) and specialty products. in the mind-set of customers looking to re-direct projects once deemed for Asia back into Europe. With this in mind, Arran is certainly targeting the bullseye for success. Arran considers the following five benefits which a top outsourcing service provider & manufacturer can bring to the drug development and specialty chemical supply chain: (i) Protection of IP and robust quality systems; (ii) Technical knowledge and experience; (iii) Integrated technologies and service areas; (iv) Security of supply and; (v) Experienced project teams In each of these areas, there are opportunities for competitive advantage between the top companies and the potential for real value to be added to the supply chain process. Protection of IP and robust quality systems Protection of IP and/or maintaining trade secrets is at the forefront of many customers’ wish lists. As a standard, customers want to work with companies with rigorous systems to protect client IP and to protect their specific technology when accessing their product. At Arran, systems are in place to ensure that all customer project IP and know-how is protected and that no issues arise when manufacture is underway. As regulatory standards rise ever higher, having certainty that an outsourced manufacture will be run to the correct standards, encompassing operational excellence, use of ethical suppliers, environmental considerations and uncompromised Health and Safety systems is essential. If the quality system in the selected CRO isn’t sufficiently robust, there is a risk that either too much or too little attention is given to the quality of the manufacture. If too little attention is given, the process may lack critical detail; too much and the cost of the manufacture will be unnecessarily high. Within top CROs the quality systems are under regular scrutiny by several parties, including the customer. The quality unit within Arran ensures that its procedures and policies are fully fit-for-purpose for each customer project. Customer audits at Arran are typically completed as a weekly occurrence. This brings further confidence in the quality system as the combined expertise of all the auditors is brought to bear. Technical knowledge and experience First time scale up of a chemical intermediate or the delivery of a large-scale manufacturing process can be a complex challenge relying on a multi- disciplinary team to drive success. This is prevalent more so now than ever due to the complexity of chemical moieties that are being used in API synthesis and within specialty chemicals. Powerful technologies such as microwave chemistry, electrochemistry, mass-directed preparative HPLC and resin bound reagents have streamlined the working processes within medicinal chemistry and small scale supply laboratories, leading to ever more efficient strategies for the synthesis of families of drug candidates and intermediates. However, when this chemistry reaches early development phase and beyond, these