By Progress Project…
Progress-PME Technology Transfer (TT) services
Progress Project Management & Engineering (Progress-PME) provide project management expertise and specialized knowledge of strategic issues facing life science and healthcare organizations. These issues include Technology Transfer, the outsourcing of proprietary processes involving intellectual property to third parties or to other facilities or departments within the same company.
Progress-PME can help manage and implement the entire Technology Transfer (TT) process from agreement of scope to auditing outcomes.
Constant considerations facing pharma and life science companies is how best to leverage innovation into actual product, accelerating the R&D pipeline and also how to ramp up capacity in manufacturing, distribution or marketing. Technology transfer can play a vital role in all three areas and more.
Technology transfer has been defined as a “logical procedure that controls the transfer of any process together with its documentation and professional expertise between developers and/or manufacturing sites.” More simply, it involves transferring proprietary knowledge and information to a trusted partner. Reasons to do this might include transferring a newly-developed production process from the originating research company to a contract manufacturing organization (CMO), outsourcing of analyses to a contract research organization (CRO) or laboratory, transfer of full scale production to another production site, for example when moving into new geographical markets. .
Technology transfer can be very necessary but is always fraught with potential pitfalls. Protection of intellectual property (IP) is the obvious imperative but is not the most difficult issue to handle. More complex issues include assigning ultimate ownership of process and product quality, maintaining control over costs, documentation, regulatory compliance issues and risk management.
To manage such a raft of issues demands in-depth expertise but this can be a tall order for an organisation who may be undertaking a technology transfer for only the first time or whose core expertise is in research, rather than production management.
Progress-PME technology transfer services
Over more than 20 years, Progress-PME has performed technology transfer projects of various sizes and has amassed a huge body of specialized expertise in every aspect of the process.
It can help organisations at every step of the way to a successful TT, from initial definition and scoping of the knowledge and information that need to be transferred through to helping manage actual implementation of the transfer.
Progress-PME can prepare the technology transfer at both ends, being present at both donor and receiving locations. It can help assemble the right project team for the transfer, including representatives from both originating and implementing sites, right from the start.
The Progress-PME project consultants can also help the parties reach clear and explicit agreements about the scope of the transfer, the required documentation, the milestones and the final results. They can also help define what requirements the receiving location must fulfil and identify the key problems that need to be resolved.
Complete documentation transfer
For a successful technology transfer, good and complete documentation transfer is essential. Progress-PME ensures the availability of approved master production specifications and records, and packaging, cleaning and logistic records. Together with the client, we determine the validation requirements at the receiving location. These are based on risk analyses and depend on the scope of the technology transfer. Validation can prove the consistency and robustness of the transferred activities, for example. It is important to constantly consider what influence a location change can have on a validated process or analysis method and to bring the validations in line with this.
The following aspects are important for a successful transfer:
✔ Stability survey
✔ Transport and storage conditions
✔ Changes in suppliers
✔ Influence of technology transfer on stock management
✔ Changes in registration
✔ Knowhow transfer instead of documented information transfer
✔ In depth personnel training by sending party at location of receiving party
✔ Relocation of equipment
Progress-PME has direct experience of all these aspects and more and has frequently proved itself to be a reliable, conscientious and expert partner in technology transfer.
Progress-PME is an independent Project Management and Consultancy Company with customers in life science, (bio) pharmaceutical, medical device and healthcare industries. The company was founded in 1999, operates mainly in the Dutch market and provides support throughout the entire range of process development to commercial production.
Progress-PME provide services in the field of project and interim management and consultancy. Fields of expertise: CMC, Quality (cGxP), Validation, Engineering and LEAN Six Sigma.