Technology transfer is critical in any drug development program, occurring for various reasons and at different development stages.
A sponsor based in South Africa, Latin America, Algeria, Iraq, etc. may be looking for contract development and manufacturing organization (CDMO) like JoinHub Pharma for clinical trial manufacturing; to transfer a manufacturing process to a larger, commercial-scale CDMO; or to replace a CDMO that has quality issues.
The handling of a technology transfer can significantly impact the success of a product’s development and, ultimately, its commercial manufacturing.
In this blog, we will cover everything you need to know about the technology transfer process in the pharmaceutical industry.
What is Technology Transfer???
Technology Transfer is simply a “logical approach that regulates the transfer of any process along with its documentation and professional expertise between developments or pharma manufacture facilities.”
In the pharmaceutical industry, “Technology transfer ” is known as the process of successful improvement from drug discovery to product development, clinical trials, and eventually full-scale commercialization.
Technology transfer is beneficial to develop dosage forms in various ways. It delivers efficiency in the process, maintains the product quality, and helps achieve a standardized approach, facilitating cost-effective production. It is how an original innovator of technology makes its technology available to commercial partners that exploit it.
Technology transfer is vital for such researchers to materialize on a larger scale for commercialization, particularly in the case of developing a pharma product. Technology transfer includes patentable aspects of production and consists of the business processes such as knowledge and skills.
Reasons for the Adoption of Technology Transfer
- Some strict laws and regulations block the market in developing countries, mainly for foreign corporations. These laws protect local production in their own countries, especially drug manufacturing, making technology transfer for all foreign corporations a more feasible option.
- Transferring technology to local pharma manufacturers in developing countries such as Algeria, Iraq, Honduras, Guatemala, etc., leads to more affordable production and labor costs, thereby lowering the cost of pharma medicine manufacturing and increasing margins.
Increase in Manufacturing Capacity
- Pharma companies’ manufacturing capacity can potentially increase by 2x to 3x, eventually leading to actual savings of 30-40% in production cost over one to four years. JoinHub Pharma – A leading Indian Pharmaceutical Company, has been offering technology transfer to pharma companies worldwide and helping them gain savings using a WHO-GMP certified manufacturing facility in Gujarat, India.
How JoinHub Pharma Helps you with Technology Transfer
As a leading pharmaceutical company in India, we help our partners across the world to grow their pharma business with several documents to ensure a successful technology transfer:
Successful Process Transfer begins with an Assessment of the Product’s Technical Package
A detailed assessment of the technical package is completed to understand the scale and equipment differences in the planning stage. JoinHub Pharma’s Technical Team includes technical services, manufacturing, and engineering teams, perform process verification activities from small feasibility studies, small-scale, and scale-up verification runs to optimize the pharma manufacturing process and establish a successful product transfer.
Protocols are designed to determine the study plans, and data is collected to support technical reports, submission batch production, and regulatory submissions and licenses.
Detailed Analytical Methods
Analytical processes are one of the very first elements of a manufacturing process to be transferred. They are additionally the foundation of technology transfer success since the results of the analyses are utilized for comparability assessments.
Standardized Tech Transfer Procedures
Being a leading pharma contract manufacturer, we are very flexible to accommodate various client needs. A standardized tech transfer method and common language are specified to improve the tech transfer process.
Knowledge Transfer Package and Transfer Planning
We provide a detailed and complete knowledge transfer package as possible with product information such as:
- raw materials
- analytical methods
- validation reports
- manufacturing procedures
- process parameters
- equipment requirements
- regulatory requirements, etc.
These are the technology transfer packages, and we perform a thorough assessment and preparation to support the knowledge transfer process.
The Project Manager creates a transfer plan with the help of Subject Matter Experts (SMEs). The plan is agreed upon and executed by all the functional teams, and a kick-off meeting is arranged to ensure the team is aligned with the scope, strategy, and overall deadline.
Product Launch Preparation
As a top contract manufacturer, we have a defined process for product launch so that the team can be ready for commercial supply to support the product launch.
The defined process also has a flexible and adaptable mechanism to accommodate the early or delayed approval to support the product supply for various markets following different agency policies.
Technical Gap Analysis
This is a formal documentation of the assessment of known and potential gaps between the donor and receiving sites’ capabilities and their readiness for the transfer.
For instance, the analysis will decide if the receiving site has the right equipment in place to perform the transferred manufacturing process or analytical techniques. The document will also include a risk assessment.
Adequate Change Control Management System
Any changes or adjustments made to the process or equipment should be documented, assessed, and justified regarding their potential impact on the CQAs and the Quality Target Product Profile (QTPP).
Major Benefits for Pharma Companies
Based on our collaboration so far, this digitalization of technology transfer will help save pharma and biotech companies approximately $10-15 million for each product, eliminate the verification and qualification processes and batches by almost 50%, reduce the average technology transfer process to 6 months (rather than 20 months), and eliminate many pilot and engineering batches – as well as destroy several cycles of laboratory work related to those batches.
By integrating the solution with pharma manufacturers’ other systems, every organization and every function involved can directly steer quality in real-time throughout the production process. Careful change management is required to ensure the adoption of this new way of working along the journey from R&D to commercialization.
Several small pharma companies have rapidly adopted technology transfer in the last few years since it allows them to break into untapped markets while providing an opportunity for aggressive pricing.
Proper communication between the licenser and the licensee plays a significant role in a successful technology transfer process. A detailed and transparent contract between the two pharma companies is necessary for a successful collaboration where both the companies can grow.
JoinHub Pharma’s experts understand your varying compound needs, dosage form, or project and ensure optimal performance within your timeline and budget.
Our in-house CMC (chemistry, manufacturing, and controls) professionals can advise on formulation and design, manage site inspection and monitoring, design and review protocols, identify the most suitable validation strategy for FDA and other compliance, and provide invaluable strategic insights for manufacturing scale-up.
Looking for a reputed pharmaceutical company for Technology transfer in South Africa, Algeria, Iraq, Nigeria, Latin America, and CIS countries? Look no further than the best pharma technology transfer partner – JoinHub Pharma.
Contact us to learn how we can help your small pharmaceutical company grow across the world.