What Does It Cost To Perform A Technology Transfer?
Posted by Wellspring Pharma Services
May 30, 2014 10:50:00 AM
Whether it be to augment your manufacturing capacity or provide resources for commercial manufacture and launch, you have been looking for a Contract Manufacturing Organization for some time, and ask: what is the cost of a technology transfer?
Before we answer that, ask yourself what performance indicators would you use to measure the effectiveness of the process for a product manufacturing site transfer?
Technology Transfer Success Depends On Full Engagement Of Both Parties
Effective technology transfer, the process of ensuring all critical information pertinent to the manufacture of a product is available when and where required; is critical to successful site transfer for manufacture of a pharmaceutical product. One definition of success:
“Technology transfer can be considered successful if the receiving unit can routinely reproduce the transferred product, process or method against a predefined set of specifications as agreed with a Sending Unit and/or a Development Unit.”
It is critical 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 co-ordinator 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 which must be understood and managed by all stakeholders. This should include product histories, past vendor non-conformances; and any regulatory issues. Technology Transfer plans, timing, and responsibilities should be understood by everyone involved and will ensure:
- Health, safety and environmental concerns are addressed and appropriate engineered controls are utilized
- Analytical methods are transferred, qualified and validated
- Material suppliers are audited, and held to agreed standards of quality, and on time delivery commitments, while making an effort to contain costs
- Documentation, Methods, Specifications, Master documents
- Understand & support the Regulatory Strategy as it pertains to the technical transfer
- Manufacturing equipment, processes, process parameters and control mechanisms are reviewed, gaps identified and strategies developed to ensure each process is qualified, repeatable, and scalable.
- Validation requirements / strategy is understood
- Successful manufacture of demonstration batches aids in site training and demonstrates that the receiving site has the ability to perform the process adequately and forms the basis for Process Validation.
- Product process being transferred runs as expected (yield, purity, cycle time, etc.), On time (product launch) and on budget without non-conformances and crisis situations.
The success of an effective technical transfer will be demonstrated by on-time and on-budget project data performance expectations and product conformance to specifications, as outlined in the technology transfer plan.
Factors That Can Attribute To A Technology Transfer Going Wrong
Listed below are some definite technology transfer show-stoppers:
- absence of clearly defined roles and responsibilities
- lack of communication and poor visibility of progress vs. timelines, and results
- problematic analytical methods that cannot support production
- incomplete, inaccurate or outdated documentation
- failure to perform a thorough and detailed assessment of the sending and receiving sites' equipment, facilities, procedures and supply chains leading to lack of understanding of the product process and all the required process parameters
- standards and procedures to be followed while conducting the site transfer are not clearly defined or agreed upon by the participating organizations,
- required documentation is not completed in an accurate, timely, and compliant manner
- improper planning and accounting for the impact that the technology transfer will have on functional units, such as quality, regulatory, laboratory, and supply chain.
Under any of these circumstances, the site transfer project becomes inefficient, and may lead to more time spent in development, an increased risk of product non-conformance, unsuccessful process validation, product stability failures, costly schedule revisions, excessive labour requirements, higher manufacturing costs or result in a delayed regulatory submission, product approval, and product launch.
So, What ARE the Associated Costs of Technology Transfer?
Costs will vary dependent on the complexity and specifics of each project, product, and processes, but organizations planning to transfer their manufacturing site to a CMO (contract manufacturing organization) should, at minimum, budget for:
- Regulatory Fees: Site Audit: 1-2 days, plus travel and hotels
- Legal Fees: Non-Disclosure Agreement, MSA (Manufacturing Services Agreement) and QA (Quality Agreement)
- API (Active Pharmaceutical Ingredient) is typically supplied to the CMO so it’s critical to account for that material being used in development batches, confirmation batches etc. Validation of the production processes also consumes API, but favorable timing and with Regulatory approval, it is possible the Validation batches may be saleable.
- CAPEX – Costs of Project specific equipment, or change parts and tooling, which are often born by the sponsoring company. Typical costs for production tooling may be $7,000 to $10,000 with packaging change parts $4,000 -$8,000.
- Time: Frequent cross functional Team Meetings are required to share information, develop project requirements and timelines, approve documentation, as well as track and review progress
- During the site transfer, it is important for the CMO to perform numerous studies to support manufacturing – for example:
- 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 of the studies are documented via protocols and reports, therefore time required to create, review, and approve these documents must be considered. Some companies prefer to submit validation batch results. If the submission is a P.A.S. (prior approval supplement) its important to keep in mind that these batches are losing shelf life and due to product dating requirements, may end up not being saleable. So it is important to understand the regulatory expectations going into the project.
- Stability testing of the Confirmation/Demonstration batch and Validation batches.
- Analytical methods transfer costs – assuming that analytical methods are current and already validated
As you can see, there are many contributing factors to what a successful Technical Transfer Project may cost depending on your production needs.
Topics: Manufacturing Scale-Up
WellSpring Pharma Services is a full-service provider of pharmaceutical contract manufacturing and packaging outsourcing solutions for solids, semi-solids, and non-sterile liquids. WellSpring offers full-service contract cGMP manufacturing, packaging and analytical testing services from a single FDA inspected and Health Canada licensed facility.
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