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Balancing Compliance with Economics: The New Role of Manufacturing
By Robert Di Scipio President and Chief Executive Officer Aegis Analytical Corporation
Continuing pressures on life sciences manufacturing, from increased competition
to expiring patents, are forcing organizations to achieve tighter operating efficiencies,
while improving their ability to satisfy quality compliance standards.
Pharmaceutical and biotechnology company executives are being forced to focus
on operating efficiencies to meet shareholder and customer expectations, while
doing what is necessary to meet the FDA’s requirements and expectations resulting
from new initiatives like implementation of Process Analytical Technologies (PAT)
aimed at improved process understanding. Increasingly, companies are realizing
that investments which lead to better process outcomes can positively affect quality
compliance and profit margins.
For decades, the role of manufacturing in the life sciences industry was to connect
the drug development pipeline to the commercial side of the business. Investments
were primarily made in R&D and in marketing – with manufacturing considered merely
a means to achieving the end product. Less money was spent on significantly improving
this “middle link” because profit margins were high enough to compensate for wasted
batches and inefficiencies that were considered a cost of doing business.
Commodity manufacturers, such as makers of consumer electronics, have demonstrated
that process improvement tools, such as Six Sigma and Lean Manufacturing programs,
can save millions of dollars and improve outcomes thereby enhancing manufacturing’s
value in the enterprise. As research pipelines and the outcomes of clinical studies
become less predictable, patents expire and generics and imports commoditize the
biopharmaceutical industry, manufacturing is becoming an important component of
margin optimization for life sciences companies.
Manufacturing is now seen as central to competitive advantage – whether it is
captive or outsourced - and senior executives have tuned to key performance metrics
that offer a view into process performance that will impact bottom line results.
With the FDA’s encouragement, the use of tools such as Process Analytical Technologies
(PAT) is on the rise, not only to meet regulatory requirements, but also to enable
a better understanding of process variability in order to make the process more
predictable and controllable.
Understanding the Process Across the Organization
While those directly involved in biopharmaceutical processes have always had a
more intimate relationship with process data, executive interest in such information
is a more recent trend that follows manufacturing’s new competitive importance.
Personalized access to production data, combined with a collaborative analytics
environment for continual operational improvement can help an organization best
use its process data.
Customized to individual levels of interest, (e.g., batch or campaign), data from
analytical software offers direct visibility into the manufacturing process that
goes beyond simply describing “what” happened during production to providing an
understanding of “why” it happened and an enhanced ability to predict and improve
production outcomes. From raw materials to finished product, manufacturers can
now identify exactly what is driving the success or failure of their processes.
With a deeper understanding of their processes, manufacturers can satisfy quality
compliance requirements and improve operational efficiency, thereby improving
the bottom line.
How IT Solutions Offer Insight
Most manufacturing processes generate large volumes of data, but without timely
access and analysis capabilities, turning data into actionable information is
difficult and often painfully slow. Tools for powerful statistical analysis, visualization,
animation and reporting functionality can help monitor and optimize the entire
manufacturing process for global operating efficiency.
As CIOs at biopharmaceutical companies make increased investments in software
systems to improve manufacturing performance, large quantities of raw data accumulate.
These disparate sources create “islands” of data scattered across several systems
that are loaded with information about process development and manufacturing that
can be leveraged to improve performance. Companies need a way to access the data,
extract the information content easily and make collaborative data-intensive decisions
faster, even in real-time. Maintaining the batch relationships between data from
existing systems without regard to their disparate physical locations – including
Enterprise Resource Planning (ERP), Laboratory Information Management Systems
(LIMS), Supervisory Control And Data Acquisition (SCADA), Electronic Batch Record
(EBR), Manufacturing Execution Systems (MES) and data from paper records at either
captive or contract manufacturing sites – delivers a complete collaborative environment
for data-intensive decision making.
Statistical and other process and data modeling capabilities can be used to derive
new parameters that provide telling insights into actual cause and effect relationships.
Calculations and computations are fully validated and the resulting data and reports
are validated outputs. Visual reporting capabilities help communicate results
more effectively to the right people at the right time so that everyone in the
organization (regardless of process experience or geographical location) understands
exactly what needs to be done to cut costs and boost revenue.
To monitor the pharmaceutical manufacturing process properly, readings such as temperature, carbon dioxide levels, humidity, cell density, and elapsed time must be recorded every few seconds – sometimes tracking hundreds of process parameters on a minute-by-minute basis over several weeks. One manufacturing process that illustrates this complexity is chromatography, used to purify a pharmaceutically active substance from the impure process stream. In this process, production specialists must transfer active ingredients at exactly the right moment to ensure that purification occurs correctly. Knowing when to make the move to the next purification step is crucial to success.
Before using an integrated data access and analytical software system, one large
pharmaceutical company used time as the indicator for determining when to move
the process stream to the next purification step. Production operators moved each
batch at exactly the same time in the process, but some batches would turn out
with impurities while in others the impurities were properly removed. The operators
could not understand why this variation was happening since they were apparently
following the same procedure every time. The pharmaceutical company needed deeper
process understanding to determine the source of the inconsistency in results,
and they implemented an integrated data access and analytical software system
to help them gain this understanding.
After using advanced statistical analysis capabilities on their process, production
specialists learned that time was not the right indicator at all. What mattered
most was the cell density achieved in the stage just before the start of the chromatography
process. The cell growth varied depending on environmental parameters of the growth
process that preceded the chromatography operations, and this was not adequately
taken into account by using time as the critical parameter. Once the operators
began using cell density as the critical parameter, the success rate was much
higher.
Using the right IT solutions can help bring process understanding to the larger
organization which can ultimately improve manufacturing outcomes much more quickly.
Conclusion
As process manufacturers search for ways to trim costs and boost revenue – whether
that be by increasing yield or speeding time to value – they can view the FDA’s
inspections and PAT recommendations as opportunities to better understand manufacturing
processes across the organization. Today’s IT tools enable data intensive decision-making
that places manufacturing at the center of new initiatives that drive a synergistic
balance between compliance and the bottom line.
About the Author: Robert Di Scipio is president and chief executive officer for
Aegis Analytical Corporation. Di Scipio’s 23 years of experience includes executive
positions with biotechnology, software and technology companies as well as corporate
law practice and public accounting. He can be reached at rdiscipio@aegiscorp.com.
Pharmaceutical Processing
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