In August, Tefen Ltd., founder of the BioPharma Operations Excellence Consortium, and BioPharm International announced in
this column that we would work together to provide periodic coverage of consortium activity.
The consortium held a quarterly meeting on October 2nd, hosted by IDEC Pharmaceuticals at its San Diego, CA headquarters.
About 20 leading biopharma companies sent over 30 representatives to the full-day session. The meeting focused on automation
and information technology (IT) solutions and how they are being put in place to support operational improvement within the
Tefen led off the day with a summary of automation-related findings from its recent industry-wide benchmarking study (published
as a BioPharm International supplement, September 2003). The general conclusion from the benchmark study is that business-process
automation and IT systems are not yet considered crucial to achieving operational efficiency, but their importance is expected
to increase significantly during the next 5 to 10 years. Tefen found that only 36% of polled industry executives feel that
automation and IT currently play a critical role in their operations. Slightly more, 37%, recognize IT is necessary but its
not the solution to everything.
In response to a question about the future of a paperless environment, 65% of the executives surveyed said the reality of
paperless production and laboratory records is still 8 to 15 years in the future. The remainder of executives feels that this
trend will affect industry sooner, with leading biopharmaceutical companies implementing such solutions within the next five
to eight years.
Based on Tefen's consulting experience, we've found that some of the first business processes moving towards full automation
are within the quality assurance function. In a few companies, we have seen deviation management and change control already
conducted as paperless processes (at least partially). Many more companies are in the selection phase for such a system. An
interesting finding, which could indicate confusion about 21 CFR Part 11 guidelines, is that nearly all companies are using
some type of electronic database to manage deviations; however, only 20% of them are relying on a Part 11 compliant system.
Figure 1. LIMS system integration
The adoption of laboratory information management systems (LIMS) was also discussed. Although LIMS is a common fixture in
most QC environments, there is wide variability in the extent of its implementation and integration with other systems. Where
LIMS is installed, it is still mostly used as a data repository for test results, not as an operations management tool or
source of metrics for continuous improvement. Figure 1 shows that LIMS integration with other systems, such as lab instrumentation,
electronic document management systems, and training databases, is still in its infancy - even though this functionality is
a major selling point of LIMS. Technical complexity, lack of previous experience, validation requirements, and competing IT
priorities are preventing companies from moving in this direction.
The study also found that production automation and data collection are tied directly to the age of the plant, which often
determines the extent of sophistication available. It seems most data collection occurring in manufacturing is focused on
process parameters and not on operational performance.
Tefen concluded that although industry is starting to move in the right direction for business process automation, there is
still a significant opportunity to enhance these isolated systems. Eventually, these tools will routinely provide key information
and metrics that can drive continuous performance improvements in all key parts of the organization.
New Plants and Paperless Systems
Marcus Webb and Gary Mitchell are responsible for systems engineering at IDEC Pharmaceuticals. They presented their company's
automation plan for its new manufacturing facility nearing completion in Oceanside, CA. The result will be an almost fully
automated plant, with electronic recipes and the ability to provide electronic batch records.
Webb and Mitchell outlined the selection process for their plant automation. Instead of using a typical RFP and bid process
or relying on a single source (based on an existing vendor relationship), IDEC developed a more robust methodology. This involved
developing a close relationship with a short list of vendors and sponsoring their development of detailed design specifications
of the final product (not just responses to an RFP). Through this collaborative process, the technical and personality fits
with vendors could be more effectively evaluated. IDEC's representatives said this technique - although costly and time consuming
- guarantees better implementation of complex, long-term software projects.
Also at the meeting, Peter Watler, director of manufacturing for VaxGen, discussed his company's two new facilities. One is
currently being built in Incheon, South Korea as part of a partnership with Celltrion. The second is a clinical facility in
South San Francisco, CA.
VaxGen's relationship with Celltrion is something new for biopharmaceuticals and speaks to the desire to remain flexible in
this risky industry. Through this partnership, Celltrion will manufacture product for VaxGen and also act as a contract manufacturer.
The biggest challenge for VaxGen is helping Celltrion develop expertise in biopharmaceuticals - something new to South Korea.
In his presentation, Christian Węling, director of marketing and sales for Werum Software & Systems, focused on his company's
electronic batch record (EBR) system, which is currently in use by a number of life sciences companies.
Most recently, Werum completed what is considered the first implementation of a truly paperless EBR system in the biopharmaceutical
industry. According to Węling, the key to EBR implementation is performing a detailed upfront re-engineering and rationalization
of the existing batch records before attempting automation.