3M brings UK manufacturing license up to date
assemble and import investigational medicinal products (IMP) for
clinical trials involving human use in the UK, writes Wai Lang
Chu.
Their successful application spells good news for 3M, which aims to use this license to further develop aspects of their Drug Discovery divisions and capitalise on the drug delivery market in which 3M already has a significant presence.
The Medicines and Healthcare Products Regulatory Agency (MHRA) granted a license to 3M's UK Pharmaceutical division enabling them to conduct human clinical trials throughout all European Union states.
3M's intention to manufacture IMP fit for consumption by patients and volunteers, manufacturing and quality systems has conformed to the specified Good Manufacturing Practice (GMP) guidelines, in accordance with EC Directive 2001/20/EC which was fully implemented in Europe on 1 May 2004.
A spokeswoman for 3M Health Care told In-Pharmatechnologist.com: "3M currently manufactures IMP for partner pharmaceutical companies. This license will allow us to continue to develop our Drug Delivery Systems business under the recently introduced European regulatory standards."
"The license also allows 3M to manufacture IMP for both its internal drug discovery business and also for third party partner pharmaceutical companies."
"Not all companies involved in the manufacture of IMP will have obtained this license yet. It will enable 3M to continue to provide drug delivery solutions, meeting all European and global regulatory standards, she added."
While 3M is well known in the development of inhalation and transdermal technologies, its new technologies are focused on offering drug delivery systems that are set to offer improved efficacy, better targeting and ease of administration.
3M core pop-up dispensing technology is being used to develop compact transdermal patch dispensers. The patented dispenser is designed to dispense patches making them more convenient to apply. The dispenser is also designed to provide protection from environmental factors such as humidity and reduces the use of packaging materials.
3M are currently working on excipients for chlorofluorocarbon (CFC)-free inhalers, which can be used, for suspension and solution formulations to increase the MDI delivery efficiency, increase the dosing range, and impart sustained release properties.
Their novel MDI actuators are particularly worthy of mention, having emerged as a technology that has shown great promise. Actuators are a critical part of the MDI system affecting the drug delivery efficiency of MDIs. 3M's breath-actuated MDI inhalers can eliminate patient coordination issues.
In addition, 3M Drug Delivery Systems has proprietary MDI actuators that increase the respirable fraction of the drug delivered. This can lead to MDIs with enhanced efficacy and reduced side effects.
Actuators also significantly affect the forcefulness of the MDI plumes for either pulmonary or nasal administration. 3M's SlowSpray actuator reduces the forcefulness of both pulmonary and nasal MDIs. This is particularly advantageous for nasal MDI products, which have historically delivered very forceful sprays using conventional actuator technologies.
