Insights

We’re pleased to share a video of ZAETHER’s “Optimized Tech Transfer” presentation from the QbD CMC Summit, featuring life sciences digital expert Tim Adkins and data solution architect Andy Zhang.

In the video, our ZAETHER experts:

• Highlight the complexity and pain around data and information management across process development, clinical and commercial manufacturing
• Share a case study showing how MES and QBDVision integration eliminates costly steps, lowers variance, and enhances future flexibility and scalability
• Review benefits: reduced cross-functional workload and documentation burden, and more efficient batch management for transfers and new product introductions

Tech Transfer is a common process across the entire Biopharmaceutical industry. The ICH Q10 guideline explains the goal of technology transfer activities is to transfer product and process knowledge between development and manufacturing, and within or between manufacturing sites to achieve product realization. There are many challenges and opportunities for improvement within the broader tech transfer perspective.

The biopharmaceutical industry has become ever more competitive in the post-pandemic era. Market expectations and pressure around applying digital enablement to innovation, speed to market, supply chain optimization and operational strategy are higher than ever. Regulatory agencies are moving rapidly in the direction of digital approaches to enhance the efficiency, accuracy, traceability, and transparency of the drug development and approval process.

New digital approaches are enabling a step-change in performance of the tech transfer discipline for process development and manufacturing science & technology, and operations teams. This is an exciting development and ZAETHER is at the forefront of helping customers understand what can be achieved with new platforms and integration approaches.

“Tech transfer fuels the transformation of ideas into action, propelling innovation from the lab space to the world of commercial manufacturing,” said Andy Zheng. With 5 years of experience in the automation space, Andy recognizes the growing importance of effective digital tech transfer, stating that it is “important in helping customers realize their full potential in the digital data sphere. It reduces the activation energy in performing efficient studies and streamlines data movement between sites and operations.”

Tech transfer comes with many complexities. Including:

• Product and related process information are transferred to multiple sites & plants during the entire process
• Each transfer includes critical info within many documents of various types
• Documented evidence of the entire process

When tech transfer information is digitized and made available, it provides many opportunities and use cases to companies that have deployed a knowledge management system. Below is just a short list of the possibilities:

• Research and Development Product and Process Data Repository – All critical data can now be managed throughout the lifecycle of a product. This can begin in the early product development stage providing a digital history of the product through commercial manufacturing and stability practices.
• Product Definition – Digital data provides an opportunity to create product definition documents from the knowledge management system to be ready for regulatory filings sooner.
• Digital Tech Transfer – Digital Tech Transfer can start to be realized through recipe and parameter management by organizing the product and process data (CPPs, CQAs, etc.) into tech transfer requirements. For companies that are using paper batch records, this digital format provides a method to provide approved parameters that can be manually entered into OEM control systems. For companies with a Manufacturing Execution System (MES) installed, organization of the data into industry standards like ISA-88 or ISA-95 to some extent may increase the company’s readiness for future integration to the MES

With 30 years of experience in the industry, Tim Adkins has seen the growth and evolution of industry practices. With an emphasis on digital solutions at an all-time high, Tim recognizes the necessity to embrace Digital Tech Transfer in order to keep up with the demands of today. “Optimized Tech Transfer is imperative for companies to significantly reduce time to market,” Tim added. “Digital Solutions are required to make that a reality.”

With the right strategy and planning, it is possible to not only address the tech transfer challenge, but to gain a competitive advantage in the industry. Digital Tech Transfer is currently a new concept within the Life Science industry, but it will become the new norm over the next few years. Biopharma companies and CDMOs that do not start moving in this direction will be at a disadvantage to the early adopters.

ZAETHER, with its life science industry experts and technical acumen, is uniquely prepared to help companies realize the vision of seamless Digital Tech Transfer.

Get ahead with getting products to market faster, managing process changes, standardizing development practices, and getting visibility into your Tech Transfer Process.

Contact us today to start your journey.

Learn more about Tim and Andy’s session at the Digital CMC Summit: “Beyond Digital CMC: Charting the Future of Digital Drug Development”

About the Team