Process digitization for tech transfer in pharma helps reduce risks in data availability and persistence

A sound digital strategy can avoid common pitfalls in BioPharma tech transfer

Accelerating technology transfer (tech transfer) in pharma and biopharma has become ever more important with the advent of precision medicine and regulatory scrutiny of product quality, data integrity and the management of external partners. The primary driver for successful technology transfer is the sharing of accurate and timely product and process knowledge both within pharma organizations and between drug sponsors and external partners, such as a contract manufacturing organization (CMO).

The global CMO sector was valued at $116 billion in 2021 and is expected to jump to $230 billion by 2027.¹ Key to driving this market is drug sponsors’ interest in outsourcing a variety of drug manufacturing activities. In support of this growing need, sophisticated digital knowledge management systems that consolidate data required for tech transfer have emerged. Their goal is to make tech transfer effortless, timely and secure. These digital solutions not only enhance the efficiency of the tech transfer process, saving valuable time and resources, they also decrease the risk of human error. Consequently, there is an anticipated rise in the investment of such systems in the coming years.²

What is technology transfer in pharma?

Tech transfers are a critical element in the pharmaceutical product development journey. Tech transfer in pharma is the transfer of any process, together with its documentation/knowledge and professional expertise. This tech transfer can be between the development and manufacturing stages within the same facility or from an originating site to a separate receiving facility.²

End-to-end management of the pharmaceutical product lifecycle includes drug candidate identification, drug development, clinical trials, manufacturing processes and supply chain activities. While each of these resides in separate areas of an organization, a successful tech transfer bridges them together by sharing information about development, manufacturing and quality assurance.

But, too often, sharing that data can get muddled. If a manufacturer supplies batch data in an Excel spreadsheet or on paper, this can hinder production, lead to batch release delays and affect data integrity. Similarly, a CMO needs to be clear and concise about its tech transfer requirements or risks compromising product quality.

Digital data sharing for collaborative and dynamic tech transfer

Fortunately, as Ken Forman, Senior Director of Product Strategy at IDBS, recently shared with LabioTech.eu, there are commercially available tools that facilitate digital sharing and promote a collaborative and dynamic tech transfer. Forward-looking companies are deploying cloud-based, 21 CFR Part 11-compliant, centralized data hubs as “libraries” for process, product and patient data. These collaborative data platforms even capture relevant documents and notes and provide a full audit trail of changes to specifications and target control limits. This approach eliminates the risks associated with the “transfer” of technology as the data remains persistent and available.

One such technology example is Skyland PIMS, a product and process data management platform purpose-built for life science manufacturing and sponsor/CMO collaboration. It provides the end-to-end product lifecycle data transparency and knowledge sharing critical to driving effective technology transfer. Skyland PIMS provides a complete change history with a full audit trail for specification and target control limits, seamlessly capturing authorship, timestamp and rationale at every stage of the product lifecycle. This delivers historical technology transfer analysis, enabling commercialization teams, for example, to quickly identify and understand obsolete product specifications.

But even the most well-established biotechnology companies are challenged when it comes to implementing tech transfer successfully. Forman pointed out that some modalities, such as monoclonal antibodies and small molecules, lend themselves to a platform approach. Others, such as cell and gene therapies, are relatively new to the industry and the complexity and variability of these newer therapeutics continue to add pressure to an already brittle process.

Assessing the digital maturity of tech transfer capabilities

Pharmaceutical companies need to assess their digital maturity in tech transfer capabilities, said Forman. This includes:

• Identifying critical bottlenecks that lead to delayed manufacturing readiness
• Ascertaining the tools they have to meet business goals
• Seeking partners who can help bridge the tech transfer gaps.

As manufacturing tech transfer solutions continue to evolve, there is an opportunity for drug sponsors and external partners to digitize their process for tech transfer even further, ensuring the data is available and persistent. This will ultimately benefit the patients who will be able to access therapies earlier.

References

1. Global Healthcare CMO Market Report 2022: Escalating Role of Artificial Intelligence Technology Presents Opportunities, ResearchAndMarkets.com, Nov. 8, 2022.
2. Addressing the key pitfalls hindering technology transfer success

3. LabioTech.eu: Meeting tech transfer challenges when manufacturing new biopharmaceuticals