The life sciences industry is experiencing a significant transformation caused by market pressures. In response, leaders of
pharmaceutical and biotech organizations of all sizes are looking to streamline the R&D process, provide greater manufacturing
flexibility, reduce regulatory burden and development costs, and accelerate time to market.
Quality by Design (QbD) will be key to the success of such initiatives. When executed properly, its benefits include improved
compliance, more efficient product development, and enhanced business performance. The US Food and Drug Administration also
has begun to back this approach with a pilot program for regulatory submissions based on QbD methodologies.
Yet QbD initiatives typically are affected by organizational challenges, as can be expected when trying to integrate business
processes and systems across different divisions toward an enterprise goal. These challenges are more prevalent in large organizations,
giving smaller biotech organizations an advantage for rapidly launching effective QbD programs.
Many small biotechs ask, "Where do we begin?" The three core elements of QbD described below point the way forward:
A scientific, risk-based, "holistic and proactive" approach to product development
It is not enough to think of QbD as a manufacturing initiative. Although most companies initiate QbD projects based on information
in manufacturing systems, they should be initiated further upstream in product development. Adopting a risk-based and proactive
approach to development can ensure that knowledge associated with the development process is encapsulated and reused further
downstream. A common approach is to provide an integrated cross-functional platform for supporting design of experiments,
decision-making and reporting, and electronic batch records associated with development manufacturing.
Deliberate design effort from product concept through commercialization
A deliberate design effort implies that commercial manufacturing constraints are integrated into the development and technology
transfer processes. This ensures that final (scaled-up) processes and product qualification requirements are fully taken into
account when making design parameter decisions. Many biotechs can benefit from implementing a program and portfolio solution
for secure third-party collaboration integrated with iterative quality feedback. This will help achieve a deliberate design
effort during the technology transfer process, particularly when working with a contract manufacturing organization.
Full understanding of how product attributes and process relate to product performance
QbD is based on knowledge management throughout the product lifecycle. But collecting information across research, development,
manufacturing, quality, and distribution organizations is nearly impossible when these functions are spread over countries,
manufacturing facilities, operating units, and cultures. Creating a knowledge repository that provides a history of all development
iterations and related quality events in a structured database facilitates a full understanding of the parameters that affect
product performance. If this repository is searchable and reusable, it can be the cornerstone for a process knowledge management
Small biotechs today have the opportunity to create a competitive advantage by deploying QbD initiatives. Because they are
inherently agile, they can make significant progress toward QbD and improved performance in the short-term by introducing
a few basic processes and tools.
Todd Hein is the senior director of life sciences at Oracle Corporation, Redwood Shores, CA, 800.ORACLE1.