A world of outsourcing awaits - part III drug manufacturing

By Kirsty Barnes

- Last updated on GMT

Related tags Drug delivery systems Pharmacology

Although manufacturing is the most established of the pharma
outsourcing segments, many service areas are still rapidly
evolving. OutsourcingPharma.com gives a brief run down of the
current state of play.

Pharma companies now outsource a wide-range of manufacturing-related activities, including the production of active pharmaceutical ingredients (APIs) and chemical intermediaries, formulation, stability testing, packaging and labelling as well as whole drug products and drug delivery systems and more recently, biomanufacturing.

An API is the substance in a drug that that causes the pharmacological activity of the drug. An intermediate is a substance that is used as part of the manufacturing process in chemical reactions to create the drug.

In the API and intermediates market, pharma companies are spoilt for choice with an overcapacity of contract suppliers, mainly due to increasing competition from manufacturers in Asia, particularly India and China, and underperforming drug pipelines.

On the flipside, The drug formulation industry has seen a 38 per cent growth in the past five years and is expected to continue to boom, since there is now a real trend in drug companies turning to specialist formulation companies to find different ways of marketing both new and old compounds by coming up with new formulations and new ways of delivering drugs.

And as drug delivery systems are becoming more sophisticated, contract lab testing services, that can perform sophisticated analyses using tools such as near-infrared (NIR) chemical imaging, are growing in popularity.

This is because the complex components involved in advanced drug delivery systems, such as the size and distribution of the ingredient particles, need to be checked more carefully during formulation development and quality control than traditional delivery systems.

At the same time, new drug delivery devices are causing a stir in the contract drug delivery device sector, however, with only a handful of manufacturers in the world capable of designing and/or making such complex devices, drug companies are limited in their choice of providers.

Meanwhile, the contract packaging business has been moving from an ad-hoc to a more long-term approach, as more and more pharma firms are now catching on to the idea that taking the step to permanently outsource pharma packaging allows the contract manufacturer more time to optimise manufacturing efficiencies, leading to cost savings and more manufacturing stability.

Packaging and labelling complexities, particularly in relation to country-specific labelling for drugs used in multinational markets, as well as clinical trials, are also fuelling the use of these contract services.

Demand for smart packaging, such as radio frequency identification (RFID) tagging, is also set to see use of these services soaring once these technologies are more commercially viable.

Biotechnology-based drugs have now also become a particular focus for contract manufacturing because by its very nature, biomanufacturing is a very complex, costly and labour-intensive process and these factors, coupled with ongoing labour shortages and staggering costs of building biomanufacturing facilities, are forcing many biopharma firms to turn to outsourcing for help as they struggle to make enough product to meet escalating demand.

As a result, the number of specialist contract biomanufacturing organisations (CBMOs) - the newest breed contract manufacturers - is rapidly expanding to plug the gap.

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