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.
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 2: Example of automated output for dashboard display.
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).
Figure 3: Example of automated dashboard.
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, firstname.lastname@example.org
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.
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).