Una actualización de nuestros amigos en Puerto Rico

Here's a quick update from our friend Vivian Freytes in Puerto Rico on some of the activities around Syncade. She writes:

"Here in Puerto Rico, pharmaceutical and biotech industries are continually challenged to improve their manufacturing quality, productivity and annual growth for key stakeholders while assuring regulatory compliance. Consequently, this highly regulated industry needs to have easy operational procedures that provide fast and accurate responses, resulting in high quality and safe products. Based on this principle many pharmaceutical companies in Latin America are searching for ways to optimize their manufacturing operations and systems. This is the case of a local pharmaceutical customer site which was selected by their corporate headquarters as a pilot plant for the implementation of Syncade. Syncade Smart Operations management suite is a group off-the -shelf modules designed specifically for cGXP- regulated industries."

She adds:

"Our local customer was searching for ways to reduce documentation errors, manual operations, rework and downtime. They needed a uniform system that provided minimum human error during their manufacturing operations. The plant completed Phase 1 of the implementation with the Syncade - Electronic Batch Record (EBR) module. The emphasis was on automating their processes by creating recipes integrated to their existing control systems such as Delta V as well as PLCs at the parenteral production area. This module provides completely paperless manufacturing records for good manufacturing facilities. With the EBR module and use of electronic work instructions, typical paper document execution and management error are eliminated. The solution provided by Emerson also includes a Recipe Authoring application, Workflow and Order Management capabilities. Moreover, the solution provides seamless integration with the customer’s Enterprise Resource Planning (ERP) system (used for product orders and business strategies). Going forward the facility is implementing other Syncade modules as they look to build on an all encompassing right first time manufacturing capabilities. Lastly, the solution has provided management at the site with greater visibility of their operations and support better business strategies decisions."

We understand that since the first set of modules have been successfully deployed . . . the customer is implementing similar solutions at other local and global sites. Gracias for the update, Vivian!

Faster Projects - A More Efficient Approach

The Life Sciences Industry continues to drive automation projects toward reduced time to market and total installed cost goals while maintaining highly aggressive schedules.

The FDA Guidance on cGMPs for the 21st Century and the evolution of ASTM 2500-07, GAMP 5, and ICH guidelines have been instrumental in achievement of these goals by introducing the concepts and practices behind Risk-Based Approaches. These streamlined methodologies have enabled Emerson to deliver highly efficient solutions for the Automation System Life Cycle from initial FEED through support of Performance Qualification on major projects.

Traditionally, Life Science companies have had difficulty maintaining schedule and cost control on automation projects that had been impeded by multiple layers of redundant testing and associated high volumes of documentation, coupled with an unacceptable level of field deviation resolution activities. The picture above depicts the real world advantage of Risk-Based versus traditional approach.

Risk-Based approaches provide a framework for Life Science customers to streamline the System Life Cycle activities associated with automation projects. They enable the reduction of testing, documentation and time lines associated with the traditional FAT, Commissioning, Qualification and Validation (CQV) phases of the project.

Effectively, Risk-Based approaches enable project teams to focus on the most critical process aspects affecting patient safety and product quality. It is a paradigm shift from the ‘test-it-all’ validation mentality to the use of assessments to determine what is critical and high risk. The results of these assessments allow the focus to shift to a ‘test what matters’ strategy.
A number of our major life sciences customers have begun to adopt this paradigm shift and Team Emerson with its Alliance Partner VALSPEC are uniquely qualified to support our customer base with developing their Risk-Based projects.

The projects typically included:

• Utilization of standard Emerson test procedures as part of the overall Verification approach.
• Leveraging of testing during cFAT for items of moderate risk.
• Develop and execution of Qualification level testing used in the cFAT environment to more robustly test the system and minimize field deviations.
• Full utilization of S88 designs to optimize test strategy and reduce test volume.
• Development of Requirements Traceability Matrices that map the Emerson automation engineering deliverables against the project’s specific requirements and subsequent test protocols.
• Elimination of unnecessary system testing by identifying specific requirements as Commercial Off the Shelf functionality that is covered under Emerson’s existing Quality Management System.
• Utilization of tools to efficiently migrate data while maintaining compliance.

VALSPEC has a group of Subject Matter Experts (SME)s in this area and as part of Team Emerson is experienced in leading the consultative process in establishing the unique Risk-Based project plan tailored to each customer-specific environment. This holistic approach has been highly effective in managing customer expectations to create an environment where everyone wins! For more information you can contact VALSPEC by clicking on this link.

Justifying the Switch to Single-Use Technology

I ran into Juliette Schick, Ph.D., President, SciLog Inc. 2 weeks ago at the BioProcess International show and she offered a number of comments regarding the OEM relationship with Emerson and the application of single use technology in the life sciences industry.

Q. Juliette, can you talk about the problem space as it relates to single-use technology?

A. Many promises have been made concerning the cost and time savings of single-use components (e.g. bags, tubing, filters, fittings). Most calculations of cost and time savings have been based on comparing single-use components with comparable stainless steel components and how they impact facility usage/design. The majority of savings are associated with decreased fixed costs (investment in facilities) of implementing single-use platforms. It has been established that single-use platforms significantly decrease fixed costs (facility investments) while increasing variable costs. Increasing variable costs is desirable, because variable costs are directly linked to output and occur only when there is a production run. Thus, single-use platforms upfront costs are less and the cost of consumables tend to be considered a variable cost, occurs only when used in production.

Q. Can you give us your insights on the integration of single-use technology with automation systems such as Emerson's DeltaV platform?

A. An additional factor should be considered when implementing single-use platforms – the effect that automation has on costs. Combining single-use platforms with automation achieves additional cost savings by increasing yield, reproducibility, and product quality of biologicals. All three of these cost savings come with the utilization of automated single-use platforms.

Q. Can you talk about your capability to automate single use platforms?

A. While manually operated, single-use purification platforms have been enthusiastically embraced by the biopharm industry, fully automated single-use platforms have, until recently, not been commercially available. It was only with the availability of SciLog’s pre-calibrated single-use sensors (for monitoring/controlling pressure, conductivity, temperature) that the automation of single-use platforms has been made possible. Automated data acquisition, implementing feedback loops, documentation of parameters in real-time, and the control and monitoring of important parameters have been critically important in optimizing single-use purification (downstream) applications.

Q. What's the value proposition of this automation opportunity?

A. The true value proposition of single-use technology comes from increased process performance, which is obtained with automated control systems and the associated software. It is well-documented that automation of processes have the highest effect on decreasing COGs and results in:

• increased reproducibility & product quality
• increased product yield
• reduced human intervention
• reduced user error
• reduce paperwork/validation protocol

Q. What specific SciLog solutions are you referring to?

A. SciLog has paired automation of purification applications with single-use technology in its SciPure platform. The SciPure protein purification platform provides the ability to easily switch from manufacturing one product to another. Traditionally, the biopharm industry has avoided utilizing automation for this purpose, because of the threat of cross-contamination. However, cross-contamination risks have been greatly reduced and/or eliminated with the utilization of single-use components and manifolds.

SciLog’s purification platform goes beyond giving the users an island of automation. SciLog’s purification system provides an automated single-use platform which utilizes Emerson’s DeltaV control system. This is the first commercially available automated single-use platform for automating protein purification (both diafiltration and concentration) in the DeltaV format.

Q. Are there any other process knowledge and product quality improvements that can be realized?

A. Improved process knowledge is directly dependent upon the data quality generated by sensors used in an automated platform. Do not be misled because of the term “single-use.” SciLog’s single-use sensors are robust, are pre-calibrated and are NIST-traceable!

SciLog’s single-use sensors were designed to exhibit high response stability. SciLog’s sensors are able to generate a real-time data stream and provide improved data quality without need for in-field calibration! SciLog’s sensors: SciPres (Pressure), SciCon (Conductivity), and SciTemp (Temperature) are in-line sensors which are modestly priced, can be used once or multiple times – depending upon the application.

In summary, the blending of SciLog’s single-use sensors and automation provides a significant decrease in COGs with an increase in product quality/production. Considering the value addition which numerous other industries have found by embracing automation and the special values that single-use technology brings to the biopharm industry - this is a combination that will strengthen the biopharm industry.

Juliette Schick is founder and president of SciLog, Inc., located near Madison, Wisconsin. She may be contacted at: js@scilog.com.