OSD
Outsourcing in the biopharma industry is on the rise, driven by factors such as increasing competition, the emergence of start-ups, and the demand for affordable medicines. While outsourcing offers numerous advantages, including access to specialised facilities and expertise, technology transfer (tech transfer) remains a critical challenge.
Tech transfer ensures the seamless and accurate replication of manufacturing processes, safeguarding product quality, maintaining regulatory compliance, and minimising costly delays. However, this complex process involves the intricate transfer of knowledge and expertise, presenting various hurdles that must be overcome.
Common tech transfer challenges include:
- Misaligned expectations: Discrepancies between initial assumptions and actual product behaviour or regulatory requirements can lead to delays and rework.
- Product knowledge gaps: A lack of comprehensive understanding of the product and its manufacturing process, particularly for legacy products or those in early development, can hinder the transfer process.
- Lack of standardisation: Inconsistent processes and documentation at the receiving site can create challenges and inefficiencies.
- Absence of dedicated teams: Assembling experienced teams at both the sending and receiving sites is crucial for effective tech transfer management.
Strategies for efficient and effective tech transfer
Experienced CDMOs employ proactive strategies to ensure seamless tech transfers while mitigating risks and streamlining timelines.
- Statistical modelling: Employing data-driven insights to accelerate development, optimise API consumption, and de-risk tech transfer, leading to consistent, high-quality results.
- Digital tools: Utilising advanced knowledge management systems and communication platforms to enhance connectivity, streamline data flow, and foster collaboration.
- Transparency and collaboration: Sharing comprehensive documentation, enabling site visits, and conducting engineering runs under observation to facilitate knowledge transfer and ensure accurate process replication.
- Established methodology: Defining clear processes with predefined phases, milestones, and a robust gate system for efficient tech transfer and production system establishment.
By embracing these strategies and collaborating with experienced partners, companies can navigate the complexities of tech transfer and bring innovative therapies to market faster.
To dive deeper into this topic, read the full article here.
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