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Recipharm Invests in its Single Dose Nasal Platform Capabilities

Recipharm Pharmaceutical Development AB




Recipharm, a global contract development and manufacturing organisation (CDMO), has announced that it is expanding its capabilities for its proprietary Unidose® Xtra (single dose) nasal delivery platform.

Offering advantages over standard systemic delivery systems, Recipharm has seen interest in intranasal drug delivery in pharmaceutical R&D increase significantly over the last 10 years. The potential benefits of nasal delivery include offering a more favourable patient experience, with targeted delivery resulting in a faster response to the medication.

Recipharm has already invested in several of its sites in the UK and US to expand its capabilities for the Unidose® Xtra delivery platform and the following services are now available:
  • Development of Unidose® Xtra prototypes
  • Filling and assembly capabilities to support pre-clinical evaluations
  • System performance testing with regards spray characteristics

The following services using performance-ready components will be offered:
  • Full method development
  • Formulation and Container Closure System (CCS) screening/characterisation
  • GLP material manufacturing and supply
  • Development stability testing

A feasibility study package will also be available. Furthermore, Recipharm’s new GMP suite is being built in North Carolina to support clinical manufacturing.

Joe Neale, Head of Innovation, Development and Programme Management at Recipharm said: “Our customers and therefore patients can benefit from Recipharm’s superior product, and we are proud to be creating a benchmark for ‘real world nasal drug delivery performance’. Our ability to offer drug formulation specific tailoring provides a competitive advantage.”
web www.recipharm.com
 
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News and Press Releases

Pistoia Alliance Publishes Free Guide to Accelerate the Implementation of FAIR Principles in Clinical Data

Boston, 25 January 2023, The Pistoia Alliance, a global, not-for-profit alliance that advocates for greater collaboration in life sciences R&D today launched its freely accessible FAIR4Clin guide. The guide will help clinical regulators, biopharmaceutical and healthcare organizations to implement the FAIR principles (Findable, Accessible, Interoperable, Reusable) in clinical datasets. The diversity of data types, standards, and regulatory and privacy requirements, combined with the huge volume of clinical datasets, has presented a particular problem in life sciences R&D. The guide emphasizes the value of FAIR to the clinical space, including making data machine-readable to support AI, innovating in clinical trial design, and enabling the transfer of data between sponsors, CROs, and regulatory agencies. FAIR4Clin was co-authored by the Pistoia Alliance and leading experts in the field, including from AstraZeneca, Bayer, Roche, Genentech, Galapagos, The Hyve, Elixir, The University of Manchester and Oxford University.
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