supply-chain-tech-transfer

Perspectives

Digitizing tech transfers to advance biopharma innovation

Five pillars to help enhance supply chain success

Technology transfers play an important role in pharma commercialization, helping to bridge the gap from research and development to full-scale production. Digitizing tech transfers can help transform and accelerate the process. Discover five pillars that can help optimize tech transfer processes and realize cost savings, operational efficiency, and improved product quality.

The indispensable role of tech transfers

Technology transfers are at the heart of pharmaceutical manufacturing organizations. They’re a key component in bringing pharmaceutical products from research and development to initial pharma commercialization and, eventually, to full-scale production. Tech transfers can also be important when outsourcing production to contract manufacturing organizations (CMOs), utilizing alternate production sites to reduce supply risk, and during portfolio transitions such as mergers and acquisitions (M&A).

Suboptimal tech transfers can delay the development or transition of drugs and medical devices, resulting in costly inefficiencies that can slow down entire organizations. Moreover, slow or noncompliant tech transfers may delay product launches or scheduled batches, which may have severe impacts to global supply and product sales. Given their critical nature, executing effective tech transfers is imperative for life sciences companies looking to increase capacity, optimize manufacturing processes, and maintain compliance with global regulatory bodies.

This report explores how digitizing tech transfer capabilities can help transform and accelerate this complex set of activities and disciplines. We define five pillars essential for building a robust digital foundation to execute effectively.

Blueprint for innovation: Advancing biopharma through technology transfer

Prioritizing tech transfers for competitive advantage

Optimizing tech transfers involves fostering collaboration, innovation, and continuous improvement, which allows organizations to improve quality, compliance, development costs, overall cost, and time to commercialization. Because tech transfers rely on so many different functions working in unison, streamlining efforts can help speed up transfers. Furthermore, bolstering tech transfer capabilities can serve as the foundation for an end-to-end digital thread, which may drive benefits beyond just the tech transfer process.

By investing in digital tools to improve upstream enablers within the tech transfer scope, life sciences companies can get a jump-start on supply chain digitization, improve downstream visibility, and position themselves for long-term success and sustainable growth outcomes. In the face of an ever-shifting landscape of patient circumstances and regulatory requirements, prioritizing effective technology transfers will likely become a competitive advantage in the coming decade.

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Integrated digital product data and process models within a connected ecosystem can enable improved visibility to data and usage during earlier stages of product development.

Value levers

  • Enhanced decision-making
  • Improved regulatory compliance
  • Accelerated time to market

Organizational benefits

Life sciences companies that invest in product data awareness can see many organizational benefits including:

  1. Integrated product structure at all levels of the drug product (FP, DP, DS, API etc.) with formulation.
  2. Digitized analytical process models (process steps, process actions, process parameters, equipment, etc.).
  3. Closed-loop change control process connecting the product and analytical process model.
  4. Extensive capabilities where used.

This innovation can help effectively increase data availability throughout the end-to-end process allowing for downstream data to be used more productively during earlier stages of product and process development

Early mover examples

Goal: Enable closed-loop change processes through clear stage-gate processes during tech transfer for product structure, BOMs, jurisdictional control on production batches, etc.

Approach: An end-to-end digital thread was implemented across clinical and commercial for integrated tech transfers.

Outcome: Significant benefit to data availability and transfer efficiency/performance.

Optimization of the technical transfer process with next-gen capabilities such as generative project task management to dynamically manage transfers.

Value levers

  • Shorter end-to-end transfer time
  • Improved forecasting
  • Improved compliance
  • Reduced rework

Organizational benefits

Successful integration of digital project management tools and process streamlining may lead to many organizational benefits via:

  • Harmonized processes with standard templates across stage-gate milestone tasks and deliverables, enabled via closed-loop workflows for real-time process intelligence insights.
  • Digital execution use cases, prioritized paperless validation, process robustness analysis, batch record reviews, and regulatory filing preparation.
  • Fit-for-purpose governance models that scale with the size and duration of portfolio, and eliminate siloed processes across functional areas.
  • Persona-based life cycles: Right knowledge is readily available for the right people at the right time.
  • Strategies for managing and controlling changes

Early mover examples

Goal: Resolve failure to execute tech transfers on time and consistently deal with delays in project timelines.

Approach: Implemented a digital end-to-end planning solution that could generate project plans, templates, stage gates, and task breakdowns customized based on individual product/process archetypes and required deliverables.

Outcome: Faster and more efficient tech transfers.

Utilizing real-time data to generate persona-based contextual information.

Value levers

  • Improved resource forecasting
  • Reduced product life cycle costs
  • Reduced FTE costs

Organizational benefits

Advanced portfolio management tools enable life sciences companies to prioritize projects, allocate resources efficiently, manage risks, and streamline collaboration across departments and geographical locations. With the demand for accelerated development timelines and the need to optimize resource utilization, advanced portfolio management tools provide the framework to enhance productivity, mitigate risks, and maintain competitiveness in the industry.

Early mover examples

Goal: Improve visibility to their product data for use in strategic decision-making.

Approach: Organization analyzed and organized product data into visualization dashboards to show the value vs. effort ranking for each product.

Outcome: Insights to inform divestment strategies leading to more optimal portfolio decision-making.

Data-driven auto-generation of regulatory submissions artifacts using AI/GenAI-enabled digital tools.

Value levers

  • Improved authoring efficiency
  • Reduced cost of quality
  • Faster response to regulatory requirements
  • Accelerated time to market

Organizational benefits

Structured content authoring tools allow companies to capitalize off rapidly evolving GenAI capabilities to automate and streamline traditionally labor-intensive processes. As pharmaceutical processes continue to become more digital, this technology will likely have a dramatic impact on any process that relies on templated document generation such as regulatory and CMC submissions, batch record generation, SOP creation, product labeling, clinical trial documentation, etc.

Early mover examples

Goal: Shorten lead times for regulatory and CMC submissions.

Approach: Implemented a structured content authoring tool to automate regulatory document authoring.

Outcome: Streamlined submissions process and increased efficiency of the time spent on CMC document authoring more than 10%.

Use of advanced analytics to simulate engineering processes and gather real-time insights to process performance and compliance.

Value levers

  • Reduced cycle time per project
  • Reduced material, equipment, and FTE costs
  • Minimized risks related to tech transfers
  • Increased percentage of digital tool usage

Organizational benefits

Life sciences companies can utilize advanced process simulation and optimization tools to help build virtual representations of manufacturing processes and enable scenario testing and optimization without interrupting ongoing production. This can allow for much faster process validation, which has a significant impact on shortening tech transfer times, but it can also lead to more robust and efficient commercialized processes that use outputs from analytical process models to optimize critical process and quality parameters such as yield, potency, and uniformity.

Early mover examples

Goal: Optimize the tech transfer process and reduce end-to-end lead time for engineering process transfers.

Approach: Implemented pilots for digital tech transfer process models.

Outcome: Successfully enabled a 38% reduction in cycle time and reduced cost by more than $2M for one transfer.

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Define a global strategy for tech transfers
Ensuring global organizational alignment around a well-defined vision and objectives will help ensure investments are strategically focused on the most valuable capabilities. Having a strategic plan can also generate excitement among stakeholders and business partners to create a culture of innovation and collaboration.
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Build data foundations
To unlock the value in a fully digitized tech transfer process, life sciences companies likely need robust data management capabilities across their value chain to support new digital and analytical processes. Data structuring, accessibility, and accuracy are key to enabling the use of digital tools for process optimization, planning, and reporting.
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Welcome digital
Modern innovations in the tech transfer space rely heavily on digital tools and capabilities. Companies should not shy away from investing in digital tools and technologies for their tech transfer processes in the short term as a digital process will likely someday become the standard in pharmaceutical manufacturing.
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Embrace agility
Tech transfers are complex and constantly evolving processes that require agile and adaptable processes to quickly react to changing process plans or roadblocks. While standardization is a great goal for increasing organizational efficiency, the tech transfer process should still be fluid enough to accommodate accelerating timelines, new product modalities, and other considerations that could upset highly regimented processes.
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Explore the art of the possible
AI and GenAI have the potential to dramatically alter the way many companies conduct their business processes. To help ensure long-term competitiveness in the life sciences marketplace, companies should consider investing in innovative technologies and capabilities to stay ahead of trends in tech transfer process development.
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Charting the path forward

Prioritizing effective tech transfers will likely become a key competitive advantage for companies in the coming decade as the industry navigates a constantly evolving landscape of patient circumstances and regulatory requirements. While digitizing tech transfers may seem daunting, Deloitte’s Life Sciences professionals have in-depth experience around each of these elements. Our team can help you identify meaningful areas to begin developing industry-leading tech transfer processes.

Get in touch

Avik Neogy
Specialist Leader
Deloitte Consulting LLP

Laks Pernenkil
Principal
Deloitte Consulting LLP

Iknam Gill
Senior Manager
Deloitte Consulting LLP

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