ABSTRACT
Process development and manufacturing for biopharmaceuticals are often disjointed activities. Disconnects among groups are
aggravated by a lack of common terminology and poor data management practices. A UK biotech consortium has initiated a collaborative
development effort to address data management issues. The proposed outcome is a data model, based on the ISA-88 Standard for
Batch Control, to capture process and facility data throughout the product lifecycle. A data framework that follows the ISA-88
model can simplify process scale up and enable early views of project costs and facility fit.
Sartorius North America Inc.
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The biopharmaceutical industry shows signs of maturity, and increasing competitive pressure is driving the need for faster,
cheaper development and production processes. Companies are actively looking for solutions that speed progress from lab to
pilot-scale manufacture and that promote cost-effective production processes. Progress toward these goals is hindered by the
complexity and variability of biological product manufacturing, however, and current initiatives, such as quality by design,
are a reflection of how much the industry has yet to learn about bioprocesses.
Product development lifecycles typically range from five to eight years for biopharmaceuticals;1 the long lag times between development and manufacture make it difficult for companies to learn from past experience. Furthermore,
investigational process-development activities usually take second place to the main objective of producing product as quickly
as possible. The organizational divides that frequently separate development and manufacturing activities only aggravate the
situation, particularly when companies lack effective data management.
A survey of pharmaceutical companies conducted by Ken Morris, PhD, of Purdue University, and Sam Venugopal and Michael Eckstut
of Conformia Software, Inc., revealed that few companies can track data and decision-making processes during the development
lifecycle, and that most are dissatisfied with the ability of their existing IT systems to capture and manage drug development
information.2 Survey results indicate that drug development specialists spend five hours a week, on average, looking for data, and about
two-thirds of respondents reported they couldn't find 10–20% of the data they needed. It is virtually impossible to achieve
continuous improvement in such an environment, and the cost of lost time and rework during development can be significant.
The average cost to develop a new pharmaceutical is more than $800 million,3 and development costs continue to rise.
To manufacturers from other industries, the solution seems obvious: implement a new, comprehensive IT solution, or make better
use of existing systems. Even though there are many sophisticated IT solutions available, ranging from enterprise resource
planning (ERP) systems to electronic lab notebooks (ELNs), adoption has been slow and problematic in the biopharmaceutical
industry. There are several reasons for this. First, the widespread presence of paper lab notebooks and uncertainties about
electronic records and signatures have caused many organizations to be reluctant to abandon paper-based systems. Companies
that do make the switch often go through an awkward transition period where both paper and electronic systems are in use.
This doubles the workload of end users and can increase resistance to change. Second, software vendors tend to adopt a "one
size fits all" approach, often a flawed practice because it ignores the fact that different users can have different ways
of working, and there is a wide range of business models in the biopharmaceutical industry. Small companies may focus on discovery
and outsource their manufacturing requirements, large companies may buy in new processes, and so on. Third, in some cases
the issues go beyond data management and reflect more fundamental disconnects in communication. Adding a level of automation
to ineffective business processes often makes the problems worse.
DTI INNOVATION PROJECT
To address some of these issues, a research consortium was formed in 2006 to collaboratively develop a knowledge-management
model and supporting applications. End users are from research, process development, technology transfer, and manufacturing.
The consortium received a grant from the UK Department of Trade and Industry (DTI) for a three-year project. The consortium
is led by BioPharm Services Ltd., a technical consultancy with experience in bioprocess simulation and design, in collaboration
with Avecia and Cambridge Antibody Technology (CAT). BioPharm Services has created process simulation models for Avecia and
CAT in the past, and each company offers a unique perspective on the biopharmaceutical industry. In addition, the collaborative
agreement enables the model to be tested with sample process data and scenarios early in development. The following sections
outline the approach taken and the progress to date.
