Technology Transfer in Pharma: Practical Challenges and the Role of Quality by Design

Introduction

Pharmaceutical manufacturing demands technology transfer, which serves as an intermediary between research and development and commercial production. It guarantees that a process that has been developed at a research site can be consistently and compliantly replicated at a manufacturing facility. However, this phase is one of the most vulnerable and prone to failure. Costly delays, product shortages, or even regulatory setbacks may result from a poorly executed pharmaceutical technology transfer.

This is where the principles of Quality by Design (QbD) distinguish themselves. The scientific rigor and structured methodology required to surpass technology transfer obstacles are provided by a QbD-driven approach, which results in dependable outcomes and robust processes.

Common Challenges in Pharma Technology Transfer

Knowledge Gaps & Poor Documentation

Robust documentation is frequently substituted by tacit knowledge in transferred processes. For instance, release profile mismatches and costly delays were the result of a failed transfer in tablet manufacturing, which was caused by incomplete process details. Structured knowledge capture is essential for the successful validation of processes, as evidenced by these instances.

Organizational and Strategic Missteps

Poor planning is the primary cause of many project failures, rather than technical issues. A multinational pharmaceutical company attempted to close five plants, but was unable to transfer a single product within six months. This was primarily due to a lack of regulatory strategy, unclear leadership, and unfulfilled budgets.

Cultural and Educational Barriers

The successful transmission of pharmaceutical technology necessitates a transition from reactive testing to proactive, science-based comprehension. However, a significant number of teams lack of formal training in QbD tools, including the Design of Experiments (DoE) and risk assessments. In the absence of this foundation, process knowledge remains isolated, and variability persists.

Fragmented Data & Systems

Knowledge transmission is slowed by paper-based systems and siloed documentation. In one instance, the fragmented records and unstructured data of a generic manufacturer significantly slowed transfer timelines and elevated compliance risks.

Method Transfer Pitfalls

Upon transfer, even validated analytical methodologies may not be successful. Frequently, vulnerabilities that were not addressed during development are revealed by variations in laboratory conditions, instrumentation, and operator technique.

How Quality by Design Strengthens Technology Transfer

Scientific and Risk-Based Foundations

QbD prioritizes a profound comprehension of Critical Process Parameters (CPPs), Critical Quality Attributes (CQAs), and Critical Material Attributes (CMAs). This knowledge enables teams to establish a design space, which is a tested set of operating conditions that ensure quality while allowing for manufacturing flexibility.

Standardized Knowledge Transfer

Consistency across sites is guaranteed through the utilization of standardized templates and structured frameworks. This "common language" is one of the most effective methods for overcoming technology transfer challenges, as it reduces miscommunication and expedites the transfer process.

Improved Efficiency & Lower Risk

QbD mitigates conformance issues, rework, and batch failures by facilitating "right-first-time" manufacturing. Additionally, a well-defined design space provides a greater degree of regulatory flexibility by demonstrating a strong understanding of and control over the process.

Digitalization and Visualization Tools

ValGenesis iRisk and other digital QbD platforms are revolutionizing tech transfer by centralizing risk assessments, facilitating real-time collaboration, and providing visualization tools such as heat maps. These digital systems enhance the overall process validation and eradicate inefficiencies associated with paper processes.

Real-World Applications of QbD in Tech Transfer

Fixing a Tablet Coating Transfer

A tablet manufacturer encountered difficulties in replicating a release profile at a new location as a result of a lack of process knowledge. The team constructed a robust design space, tested ranges in pilot setups, and identified critical parameters by applying QbD principles. This facilitated a consistent production and a seamless scale-up.

Digital Transformation at GSK

A famous pharmaceutical manufacturer replaced paper-based risk assessments with a digital QbD platform to modernize its pharma tech transfer approach. As a result of this transition, knowledge was centralized, workflows were streamlined, and cross-team collaboration was enhanced, resulting in more predictable and expedited results.

DoE for Sustained-Release Tablets

A sustained-release paracetamol tablet was developed by researchers who employed Process Analytical Technology (PAT) and Design of Experiments (DoE) to investigate the impact of drug concentration and screw speed on dissolution. The outcome was a well-defined design space that enhanced the reliability and readiness of future transfers for validation.

Insights for Better Implementation

A few critical principles are underscored by the industry's experience:

• Standardization is Critical: Technology transfer is more consistent and reliable when frameworks and templates are utilized.
• Effective communication is essential: Delays and misunderstandings are prevented by dismantling silos between R&D, manufacturing, and quality teams.
• Regulatory Alignment: In addition to ensuring compliance, well-documented QbD principles also offer increased operational flexibility.
• Investment Pays Off: The long-term costs are reduced by training staff, upgrading digital systems, and incorporating QbD thinking.
• Adaptation for Global Markets: The adoption of fundamental QbD elements risk assessment, process mapping, and knowledge capture significantly enhances outcomes, even in regions with limited resources.

Final Thoughts

In the pharmaceutical industry, technology transfer is a critical procedure that has a direct impact on the quality of products, the safety of patients, and the time it takes to reach the market. The obstacles, siloed data, knowledge deficits, and organizational missteps are genuine. however, they can be surmounted.

Companies acquire scientific insight, enhance communication, and establish resilient processes that consistently perform and validate by incorporating QbD principles into each stage of the transfer process. QbD has demonstrated its practical value by rescuing a failing transfer, incorporating digital platforms, or utilizing DoE to enhance product design.

The cornerstone of successful, efficient, and future-ready pharma tech transfer is QbD, which is more than a regulatory expectation in the complex pharmaceutical landscape of today.

Check our upcoming masterclass on Pharma Technology Transfer to gain cutting-edge insights and practical skills from an industry expert!

By Sasly Ahmeth, Social Media Executive, GLC Europe, Colombo Office, Sri Lanka.