Improving Technology Transfer - Pharmaceutical Technology

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Improving Technology Transfer
This article focuses on the growing need for effective data management in the life sciences industry—especially among smaller pharmaceutical manufacturers.


Pharmaceutical Technology
pp. s47-s50

Change-management considerations

There are clear socio-political and change-management challenges that occur when applying a new approach to an organization. Introducing a shift from "the way it's always been done" requires that internal teams and CMOs understand how existing systems will be tapped to meet high-level goals, such as Six Sigma, technology transfer, APRs and other regulatory requirements. Demonstrating the value of a new approach can provide solutions to day-to-day challenges as well.

A process-intelligence platform approach can simplify CMO buy-in. It can provide contracted sites with web-based, on-screen forms where they can enter data, rather than sending spreadsheets over nonsecure Internet links to provide sponsors with data and reports. It also can address data-confidentiality obligations that CMOs have to make sure that only the data owned by a specific sponsor is available to that sponsor.

CMOs, like any type of organization, may be resistant to change or added requirements. Most CMOs have a contract with a sponsor and may be delivering on specific measurable-result promises within a particular cost structure that was agreed to in the contract. To incorporate a mutually beneficial system for collaboration and continuous improvement, sponsors need to demonstrate value to CMOs' businesses, including:
  • Automated trending and alerting
  • Faster Chemistry Manufacturing and Controls (CMC) preparation and approval
  • Shorter time to market
  • Higher yield and quality
  • Lower process variability
  • Acceptable process economics
  • Access to supporting data and institutionalized knowledge regardless of geographic location.


Figure 2: Example of automated output for dashboard display.
CMOs add value to sponsor relationships by allowing self-serve, on-demand access to designated process parameters with easy methods to capture paper-based data. This value cuts down on workloads, risks of errors, and time delays associated with sponsor requests for data. Reports like those shown in Figures 2 and 3 can be generated and automated.


Figure 3: Example of automated dashboard.
FDA has stated that it hopes continued process performance verification will become a lifestyle that is consistent across an entire manufacturing network, including CMOs. "As a result of the 'trend toward outsourcing,' FDA is paying closer attention to contract relationships," said FDA Office of Compliance Director Richard Friedman at the PDA/FDA Joint Regulatory Meeting in September 2011, in Washington, DC. "Sponsors should expect to hear questions during inspections about how their companies are making sure that their CMOs are actually being monitored" (5).

A new approach to process intelligence that relies on a process-intelligence platform for collaboration using scientific process understanding to reduce risks and improve compliance can ultimately lead to the desired state of tech transfer excellence and achieved QbD goals. Manufacturing, quality, and process development teams can work together across geographic boundaries to minimize capital costs for investors and risks to healthcare consumers, while at the same time delivering business benefits, including minimized variability, reliably predictable product quality attributes and positive supply chain impacts.

Justin Neway, PhD, is vice–president and chief science officer at Aegis Analytical Corporation, 1380 Forest Park Circle, Suite 200, Lafayette, CO, 80026, tel. 303.926.0317,
, http://www.aegiscorp.com/.

This article is based on "Reducing Technology Transfer Risks Using a Process Intelligence Platform That Spans Organizations and Geographies," presented at the CBI PharmTech Biomanufacturing Partnerships Conference in July 2012.

References

1. FDA, Guidance for Industry: Process Validation: General Principles and Practices (Rockville, MD, Jan. 2011).

2. FDA, Guidance for Industry: PAT — A Framework for Innovative Pharmaceutical Development, Manufacturing, and Quality Assurance (Rockville, MD, Sept. 2004).

3. CDER, Meeting of the Advisory Committee for Pharmaceutical Siences and Clinical Pharmacology (FDA Briefing, July 27, 2011), p. 31.

4. A. Webb et al., Pharm. Engineer. 30 (4) 2010.

5. International Pharmaceutical Quality 1 (4) (2010).


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