Need-to-Knows for a Successful Technology Transfer in the Pharmaceutical Industry
With the global pharmaceutical market set to grow with a CAGR of 3-6%, the US is predicted to spend somewhere between USD 605 to 635 billion on medicine by 2025.
The industry is constantly engaging in situations where there is a need to transfer technological processes between organizations. This transfer of processes and technology is critical to getting the product to the market.
That is what technology transfer is all about. In simple terms, technology transfer in the pharmaceutical industry is essentially the transfer of knowledge about a drug product, comprising information about manufacturing processes from development to production.
But how is a successful pharmaceutical technology transfer process executed? What are the key considerations in the triumphant execution of a technology transfer?
Read on to find out!
Project Management is a Must
A centralized project management team is vital for the success of a technology transfer process. In order to understand the product/services, the project management team has to work in close quarters with the Business Development Team (BD).
Once that is done, the PMO further collaborates with many internal departments assessing the technology package. The CMO makes it a point to comprehend all the product and process requirements in detail and thoroughly evaluate its internal competencies. That is how they can meet the client’s manufacturing requests.
Now that all this is done and dusted, the CMO will draft a proposal and a preliminary plan to transfer all the technology and initiate commercial manufacturing at their site.
Once this proposal is approved, the PMO will start with thorough project planning for technology transfer before execution.
Here are a few things you must keep in mind while preparing a project management strategy for successful technology transfer.
- The project manager must coordinate transfer activities on inter and intra-company levels, track milestones and action items, monitor budget, and so on. They must serve as the central hub for communication between the clients and the CMO such that there are no misunderstandings or improper exchange of information.
- A project steering committee must be put in place to ensure streamlined communication on project progress, issue discussion, critical decision-making, etc.
- A project transfer plan must be created and approved by the originating party, as well as the receiving party. That will give the companies a fair idea regarding resource requirements, timelines, level of effort, etc.
Detailed Assessment of the Product Technical Package
Understanding the scale and equipment differences in the planning stage is vital to a successful technology transfer between pharmaceutical companies. Therefore, you need to create a detailed assessment of the technical package to push the process in the right direction.
The technical team should ideally be composed of groups such as technical services, manufacturing, and engineering teams. These teams are vital in performing process verification activities such as small-scale feasibility studies, scale-up verification and optimization runs, etc.
Protocols must be put in place to define study plans, and data is constantly being gathered to support submission batch production, approvals, technical reports, etc.
Product Launch Preparation
The contractor manufacturer must have a defined process in place for product launch. It allows the team to have enough wiggle room to prepare for commercial supply to support product launch.
The process in question must also have an adaptable and flexible mechanism to comply with all early or delayed approval to support the product for various markets. All these markets might have different policies, hence, proving the need for a flexible mechanism in place.
Analytical Methods to Begin in Early Stages of Tech Transfer
Analytical methods must be implemented in the preliminary stages of the technology transfer. That is mainly because all studies require significant testing to provide data and demonstrate the study results.
Raw materials that match the required specifications are sourced, bought, and tested process qualifications and support study runs.
In order to perform their job successfully, the analytical team must:
- Perform raw material and finished product test verification
- Formulate methods and specifications in compliance with regulatory requirements
- Release materials and products for TS study and submission
Implementation of Robust Quality Systems
Here are some of the most robust quality systems for product quality and integrity assurance.
1. Pharmaceutical Quality System (PQS)
Robust quality systems have to be implemented to ensure a genuinely triumphant pharmaceutical technology transfer process.
These robust pharmaceutical quality systems are put in place to ensure that the drug products meet the desired quality and performance attributes.
These systems are vital in providing the FDA with confidence and accurate support information for making knowledgeable decisions.
For a successful tech transfer, the quality team must be familiar with the PQS Elements in ICH Q10 and 21 CFR 210 and 211 components of the quality system.
2. Investigation and CAPA
According to the 21 CFR 211.22, the quality assurance unit is said to have responsibility and authority over:
- Approval and rejection of all components. These components include drug containers, in-process materials, closures, packaging material, labeling, drug products, etc.
- Review records to ensure that no errors have occurred, and even if they have, the proper investigation has been conducted.
- The team must follow proper guidelines to perform detailed investigations when something goes off track. It is vital to have a clearly defined investigation procedure and a team of well-trained engineers to rule out all possible missteps completely.
Considering the rate at which the pharmaceutical industry is growing, technology transfer has become very common.
Although, there are still many problems standing in the way of a successful technology transfer, namely different product processes, scale, equipment design, and so on.
Therefore, every pharmaceutical company must have a standardized process to manage technology transfers to avoid hassles, miscommunication, and other blunders in the future.