In the pharmaceutical industry, technology transfer (tech transfer) is arguably one of the most critical steps a contract development and manufacturing organization (CDMO) and drug sponsor will undertake. The scope of knowledge sharing related to a drug product ranges from process development through production.
Scaling From Promising Candidate to Successful Product
After a drug process is developed, it must be scaled, first to meet clinical demand and eventually to satisfy commercial demand. Navigating scale-up for clinical – and ultimately commercial – production is an often challenging, and rarely linear, aspect of tech transfer. Methods such as alternate route scouting can help alleviate scale-up challenges by developing processes which are more scalable, more efficient and often greener.
In the last decade, it has become much more common for both process- and product specification changes to occur after a product has received regulatory approval.
In some cases, these modifications to processes or specs may be unavoidable, such as when a threshold limit must be changed to better reflect process parameters. In other cases, alternate processes offer some tangible benefit (cost, effluent reduction, energy savings, time, equipment scale or type, etc.).
The key to avoiding such a change is to place strong emphasis on early collaboration between the process and analytical development teams. Ideally, all stages of product development should occur with a view towards ultimate commercialization.
What are some of the typical changes or modifications that occur during and after tech transfer?
- Scale/batch size changes
- Manufacturing process/route changes
- Raw material adjustments
- Equipment changes
- Production site changes
Every change can have a significant impact on the Critical Quality Attributes (CQAs) of the final drug product. For obvious reasons, changes that result in a failure to consistently meet CQA specifications must be avoided.
To help ensure commercial success, pharmaceutical companies and their partners must take a calculated approach to production scale-up. As commercial production activities are re-scaled and relocated or shared among different facilities, regulatory agencies require complete and detailed documentation. The agencies expect a planned, methodical approach to these often-unavoidable changes.
Drug commercialization projects which go off-track often share a common trait: somewhere along the way, the right information was not shared with the right stakeholder. To avoid this, interactions must be frequent and thorough within and between companies while also monitoring and confirming communication exchanges to eliminate misunderstandings. An article at PharmTech several years ago explained that – at its core – successful tech transfer means “understanding who needs to know what.”
Importance of Tech Transfer
Since tech transfer guides the movement of knowledge and product through the supply chain, its activities are foundational to:
- Process validation
- Strategic planning
- Ongoing process control.
Keys to Tech Transfer Success
Challenges with tech transfer aren’t uncommon, and it is rarely a straight-line process. Successful tech transfer involves multiple disciplines within an organization, all working in concert:
The project team members from all of these diverse disciplines must possess robust:
- Communications know-how
- Hands-on experience
- Knowledge sharing abilities
- Intra and inter-organizational collaboration skills.
A core success factor in nearly all tech transfer projects has always been precise communication – whether with the project sponsor, relevant suppliers, or between and among different production sites or departments. This helps break down knowledge silos to maintain product quality and identify ways to maximize or improve manufacturing outcomes.
Communication skills paired with knowledge of specific processes and pharmaceutical products are invaluable to the success of a tech transfer. However, an acute understanding of the individual company and industry-wide expectations is also important, including a firm grasp of:
- Assigned responsibilities and roles
- Industry regulations and expectations
- Required equipment
- Workplace culture
- Necessary training
According to the Parenteral Drug Association, other issues which can impact a successful technology transfer include “process and product robustness, the readiness of organizations to engage in transfer activities, availability of experts, and the timely execution of all the work needed to complete a transfer.”
Experienced CDMOs such as LGM Pharma have identified several keys to a successful technology transfer. These include:
- Defined criteria for success. To meet tech transfer goals, the goals must be predefined in writing. Once CQAs are in place, all parties involved must agree on them.
- Adherence to regulatory guidelines. As governing regulations mandate, to avoid unexpected setbacks the tech transfer must be organized and specific.
- A disciplined, detailed approach. The inclusion of all pertinent details can help minimize assumptions and avoid misunderstandings. Intentional, well-devised planning must precede and guide the transfer.
- Language adjustments. Differences in culture and vernacular at separate facilities can hinder communication and cooperation.
- Equipment adjustments. Adjustments may be needed to account for differences in facilities and equipment.
Partnering With a CDMO
Mistakes during tech transfer can have far-reaching consequences. The broad experience and skillsets of a quality CDMO can simplify tech transfer activities and may prove the difference between a successful collaboration and a catastrophic supply chain disruption. Partnering with a CDMO that has the expertise needed to guide the tech transfer can help ensure smooth collaboration.
When selecting qualified CDMOs for partnership, companies should seek organizations with a strong track record in cGMP manufacturing, and a history of regulatory audits and inspections.