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Significant innovation in disease treatment, including the increased focus on complex biologic therapies1, has resulted in important industry trends that have had an impact on many aspects of aseptic processing.
While the requirements for serialization in the pharmaceutical supply chain are generally regarded as inevitable counterfeiting is simply too large of a problem to not be addressed there is some uncertainty around the specifics,particularly globally.
Digital technology has been driving change throughout the life science industry for years, however the sector is currently standing on the precipice of revolutionary development – some organizations have already taken the jump towards a more digital future.
The Falsified Medicines Directive 2011/62/EU, which is due for adoption in February 2019, will require pharmaceuticalcompanies to apply serialisation codes to every applicable pack (OTC and some minor exemptions).
When it comes to the manufacturing of drugs, particularly highly sensitive biologics, a high-level of expertise is required. Typically, small and medium-sized pharma and biotech companies lack the knowledge and know-how necessary to cover all the processes independently prior to completion of the entire final product.