Manufacturing of pharmaceutical products is a burgeoning industry, driven by the demand for increasingly powerful active ingredients to develop ever more sophisticated drugs. Security of supply, pressure to cut costs and the need to ensure the safety and authenticity of ingredients are just some of the issues pharmaceutical companies are facing in the production of medicines.
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In this issue we investigate the trends in contract manufacturing and speak to custom synthesis providers about developing active pharmaceutical ingredients to strict deadlines. We also look at issues of GMP compliance, especially in emerging markets, and find out why a global approach to the regulation of API manufacturers is needed to ensure the safety of products throughout the supply chain.
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Quality by Design
The fragmentation of pharmaceutical regulation is detrimental to the industry and the patients it serves. Chris Lo looks at the organisations trying to bring about a more unified process for both regulators and manufacturers.
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Mighty Materials
Demand is rising for increasingly powerful active pharmaceutical ingredients to create ever more sophisticated drugs. Sarah Blackman talks to Stuart Needleman of Aptuit about the manufacturing methods used to produce quality materials in a safe and controlled environment.
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The Right Ingredients
It is essential for the delivery of safe and effective medicines that manufacturers comply with good manufacturing practices, in particular if APIs are bought from suppliers in emerging markets that may not be certified to the same standards. Dr Pauline McGregor explains why the issue of GMP compliance requires a global approach, and how companies can control quality throughout the supply chain.
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Custom Chemistry
When pharmaceutical companies need compounds for drug development, custom synthesis providers satisfy demand. Chris Lo talks to Onyx Scientific CEO Tony Flinn about the challenges of synthesising molecules to a strict deadline.
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Awash with Ideas
The use of water in manufacturing processes is vital to the industry. Ensuring water quality is essential to the quality of the final product and to making sure manufacturing processes are in line with regulations, as Dr John Hutcheson explains.
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Pipeline Partners
Outsourcing the manufacturing aspects of the pharmaceutical pipeline has become a popular option for companies big and small. Frances Cook talks to Dr Robert Hardy, CEO of Aesica, about industry trends, emerging markets, and how the economic downturn has affected the industry’s development.
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Next Issue: Packaging and Labelling
Faced with increasingly strict regulations for the packaging and labelling of medicines, as well as the threat from counterfeits, the packaging industry relies on sophisticated procedures to ensure the safety of pharmaceutical products.
Next month we take a look at innovative drug packaging that protects against misuse. We also explore the implications of new drug labelling standards on packaging producers.
Regulators and industry are working hand in hand in the fight against counterfeit medicines. We investigate a new tracking model aiming to increase traceability and safety of medicinal products, and also find out how the European directive on falsified medicines will impact on pharmaceutical packaging companies
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