By Aidan Harrington PhD, Program Manager, Primecore
Across the pharmaceutical industry, there is still wide variation in how organizations manage Technology Transfer (TT) and New Product Introductions (NPI). While ICH Q10 provides a clear definition of TT, processes can differ significantly between companies, and also between sites within the same organization. Different templates, stage gates, decision-making and governance processes and ownership models can all lead to misaligned expectations. These process variations in practice increases the complexity of transfers both within and between organisations, acting as a barrier to operational readiness.
In the current industry environment with the expanded use of contract manufacturing and development organisations, new product modalities, novel complex processes and regulatory complexity, there is now an even greater need to drive towards greater harmonization and standardization across the industry. A clear, consistent framework with culture and behaviours underpinned by clear accountability gives teams the structure they need to identify gaps, manage risk, align stakeholder accountabilities to confidently deliver both operational readiness and successful Process Performance Qualification (PPQ).
Building from a consistent framework
A stage gate process is a strong foundation for effective technology transfer. Both the ISPE and PDA through their detailed technical guides describe systematic approaches to effectively deliver all cross functional requirements to achieve operational readiness and regulatory approval. The benefit of these stage gate models is that it creates clear expectations around what must be completed, reviewed and approved before a program moves forward. In practice, this is not about creating process for the sake of process. It is about enabling the right behaviours based on clear and well understood accountability throughout the sending and receiving unit project teams and the Site Leadership Team (SLT). It provides teams a structured and robust process to confirm that technical, quality, engineering, validation and operational requirements are understood before they become late-stage risks.
Identifying Gaps and Managing Risk
Gap analysis and risk management are key enablers of an effective technology transfer program. The transfer of a product or process from one site to another is not a like-for-like exercise. Even for ‘Platform’ processes, gaps will likely arise that if undetected, will adversely impact program timelines. A Make-a-Batch / Test-a-Batch exercise brings subject matter experts from both the sending and receiving units together post team formation. Guided by a Make-a-Batch / Test-a-Batch tool, the team should virtually perform all processing steps, including ancillary steps, comparing how operations including testing are conducted at the sending and receiving sites. With an emphasis on identifying the facility, manufacturing, operational and testing differences, the outcomes of optimised mitigation plans, timelines and accountabilities is realised.
Creating ownership and accountability across stakeholders
While multiple stakeholders drive the product lifecycle, the receiving site functional groups should own the site related processes required to deliver both RFT PPQ and Operational Readiness. Each functional group team needs to understand their deliverables, timelines and dependencies on others. Where accountability is unclear, delays can build quickly. Actions remain open. Decisions move from meeting to meeting. Teams assume others are progressing key items. That lack of accountability will have an adverse impact on schedule, readiness and qualification outcomes. The governance process should empower the site functional groups to make decisions, with escalation pathways to off site groups clearly defined. Ultimately, the Site Leadership Team are accountable for program success, with this reflected in how programs are governed.
Treating knowledge as a project asset
Knowledge should be treated as an asset. Too often, knowledge transfer is viewed mainly as a document transfer, to the detriment of a similarly methodical transfer of tacit knowledge. The quality of the knowledge transferred will shape the receiving site’s ability to make decisions, train teams, troubleshoot issues and operate with confidence. A competent knowledge transfer and management program that practically operationalises knowledge flow captures both explicit and tacit knowledge in a way that is structured, accessible and usable. The facilitation by digitization of knowledge capture, dissemination and access in a global centre of knowledge mitigates against knowledge ‘leakage’. It ensures that the receiving site understands not just what the process is, but why it behaves as it does and what factors are most critical to performance.
Connecting technology transfer to overall program delivery
This is where experienced program management adds real value. In complex capital programs, technology transfer must be integrated with engineering, quality, validation, operations and commercial timelines from the outset. For organizations planning new product introductions or major capital programs, technology transfer should not be treated as a late-stage handover. When it is planned early, governed through a clear stage gate process and supported by strong risk management, accountability and disciplined knowledge transfer, it becomes an enabler of project certainty, operational readiness and successful commercial delivery.
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