Part 5 — The Cost of Getting a Technology Transfer Right

Posted by Norm Fong

Technology Transfer: Want To Get It Right?

[Editor’s note: Success in contract pharmaceutical manufacturing hinges on several critical factors, but chief among them is getting technology transfer right. This is part 5 of an in-depth, multi-part series on tech transfer.  Visit our blog page to view additional segments.]

The first step in estimating the cost of a technology transfer is ensuring all information pertinent to the manufacture of a particular product is available when and where required, and that both the donor and receiving companies are equally engaged in the process of developing technical transfer plans. Early and open communication between companies, the project managers and all technical team members is necessary to ensure that those involved in the manufacturing and testing of the product have access to the most relevant and up-to-date information, including past vendor non-conformances and any regulatory issues.

Assuring-Pharmaceutical-Technology-Transfer-Success-eBook

A common understanding of the overall plans, timing and responsibilities helps ensure:

  • Health, safety and environmental concerns are addressed and appropriate controls supported
  • Analytical methods are transferred, qualified and validated
  • Material suppliers are audited and held to agreed standards of quality
  • The regulatory strategy as it pertains to the technical transfer is understood by all parties
  • Manufacturing equipment, processes, process parameters and control mechanisms are reviewed, gaps identified and strategies developed to ensure each step in the manufacturing and packaging process is qualified, repeatable and scalable
  • The validation strategy is understood by all parties

By carefully addressing each aspect, everyone can be assured that product processes run as expected in terms of yield, purity, cycle time, etc., and that the product can be produced on time and on budget without non-conformance issues. Failure to address them may cause the site transfer project to become inefficient and may lead to more time spent in development, an increased risk of product non-conformance, unsuccessful process validation, product instability, costly schedule revisions, excessive labor requirements and higher manufacturing costs. Ultimately, it may result in delayed regulatory submission, product approval and product launch.

The Associated Costs of Technology Transfer

Costs will vary depending on the complexity and specifics of each project, product and the processes required as well as other factors, but listed below are costs that should be taken into account.

Regulatory Site Audit
  • One to two days of auditing plus travel and hotel fees
   
Legal Fees
  • Non-disclosure agreement (NDA)
  • Manufacturing services agreement (MSA)
  • Quality agreement (QA)
   
Active Pharmaceutical Ingredient (API)
  • Development, confirmations, etc. of batch supplies
   
Capital Expenditures
  • Project-specific equipment
  • Parts and tooling changes
  • Packaging part changes
   
Time
  • Frequent cross-functional team meetings
  • Sharing information
  • Development of project requirements and timelines
  • Documentation approval, as well as time to track and review progress
   
Feasibility Studies During a site transfer, it is important for the CMO to perform numerous studies to support manufacturing, including:
  • Process development batches to determine or confirm process parameter ranges
  • Applicable product hold studies
  • Confirmation batch and submission/registration batch production
  • Packaging engineering trials
  • Manufacture and packaging of validation batches
   

Many studies are documented via protocols and reports, and therefore time required to create, review and approve these documents must also be considered. Some companies prefer to submit validation batch results. If the submission is a prior approval supplement (PAS), it’s important to remember that these batches are losing shelf life and may end up not being saleable due to product dating requirements. Lastly, you’ll need to account for stability testing of the confirmation/demonstration batch and validation batches as well as analytical methods transfer costs.

When budgeting for a technology transfer, you will need to think through all the steps completely. Many factors contribute to the ultimate cost of a successful technical transfer, and it’s wise to also budget for unforeseen contingencies.

Next Time: Part 6 — In-Licensing Pharmaceutical Products: Due Diligence Can Help You Perform a Technology Transfer Successfully

Are you Facing Challenges of Scaling Up Production? Get a Free Consultation ►►

Topics: MSA, confirmation/demonstration batch, QA, Regulatory site audit, capital expenditure, legal fees

Norm is the technical transfer manager, business development, for WellSpring. He has over 21 years in the pharmaceutical manufacturing industry and has held development, transfer and commercial manufacturing positions over the course of his career with Patheon, Global Pharm (formally Pharmacia Upjohn) and Genpharm (owned by Merck). Norm is responsible for overseeing technology transfer and all validation activities in the organization.

About The Author