Getting Medicines to Market Faster

Technology Transfer

Appropriate transfer of manufacturing technologies (Technology Transfer) is important for all sectors of the pharmaceutical industry; from start-up companies through to multinationals.

Transfer activities can involve the active substance and / or finished product and typically include:

  • Analytical processes and their validation (retest of products/ingredients from suppliers, release testing)
  • Manufacturing processes (site-site, scale-up, contract manufacturing, site relocation)

Technology Transfer impacts on all product types whether they are small molecules or more complex biotech products and at all phase of product development - from ‘bench to the marketplace’. Indeed, Technology Transfer is also important for established or ‘mature’ products as companies look for new ways of breathing life into older products. For example, simplification of tablet manufacture (e.g. moving from wet granulation to direct compression) which involves a site relocation.

As the pharmaceutical market becomes increasingly more cost conscious, transfer of technologies to the emerging markets has also become more prevalent (lower labour costs and where larger batches can be made more cheaply and facilities better utilised for less money).

In addition, the advent of newer technologies presents specific new challenges in this arena (e.g. transference of potency assays for biotech products where the use of correct media, cell lines etc are important considerations).

Our Technology Transfer Service

Technology Transfer services provided by CambReg include:

  • Identification of partners / partnering opportunities
  • Acting as an informed conduit in negotiations
  • Expert input on key transfer parameters for all product types (including biotechs)
  • Strategic advice on optimum transfer strategies and regulatory implications
  • Establishment and management of Transfer Team and Transfer Plan
  • Regulatory input (quality of both party data, compliance with regulations/guidelines)
  • Provision of reports (scoping, progress and final)
  • Verification tasks post transfer (e.g. audits) 

Our experience can help you

CambReg has assisted numerous companies in this area, examples of some of the projects we have worked on are described below :

  • Small companies/ research establishments partnering larger companies in order to advance product development and commercialisation
  • Companies entering the EU market – transfer of analytical technology to EU batch testing and release sites
  • Relocation of EU manufacturing sites to more modern, larger scale facilities ex EU for both large pharma and generic companies
  • Companies acquiring / divesting products involving multiple transfer operations

At CambReg, Technology Transfer is not viewed as a ‘one-time’ action during product development.

We recognise that it is an integral component of the life-cycle of any high quality product, vital to not only maintaining and upgrading product quality but also key in fully optimising its marketing potential.