Digitizing to Modernize Manufacturing

Pharmaceutical Technology

May 29, 2019

By Michael Jovanis


Moving from paper-based to digitalized processes is the first step to enabling quality management and manufacturing to work in sync.


There is a significant opportunity for digital technology to improve quality and efficiency in pharmaceutical manufacturing. Life-science organizations that replace paper-based processes and siloed systems with modern digital applications are better positioned to meet current and future drug manufacturing demands, especially as the industry embraces precision medicine and treatments become more individualized.


The pharmaceutical manufacturing plant floor is ripe for digital transformation, where it can enable operators to quickly find current information and gather data in real time for smarter decision-making. Organizations are moving to modern cloud solutions to connect people, processes, and technology for greater agility and efficiencies. With a digitally connected facility, operators can use mobile devices to enter quality data or access the right information at the right manufacturing station at the point of need.


Precision medicine is transforming supply chains


In 2018, FDA approved 62 new therapeutic drugs, of which 25 were personalized medicines (1). This emerging approach to disease treatment targets a patients unique molecular and genetic profile and requires changes in the way that products are manufactured. Precision medicines are typically made for small groups of people with hard-to-treat illnesses and can be complicated to produce and difficult to scale.


Additionally, with many precision therapies, the patient becomes an integral part of a highly specific end-to-end manufacturing process. For example, with chimeric antigen receptor (CAR) T-cell therapy, approved for relapsed and refractory leukemia and lymphoma, the patients cells are collected at the hospital, shipped to a manufacturing center for engineering to target the persons specific cancer, and then sent back to the hospital for infusion into that patient.


Traditional, large-scale drug manufacturing processes are not aligned with this highly individualized approach. The success and scalability of personalized medicine requires new strategies for automation and improved workflows to produce them reliably, safely, and economically.


Opportunity for change on the manufacturing plant floor


Today, much of the information on the pharmaceutical manufacturing floor is buried in paper binders or siloed applications. Without centralized systems for tracking and distributing content and intuitive applications that offer easy access, operators cannot quickly access the right information they need to perform their jobs and increases compliance and quality risks. Significant overhead is required to ensure that work instructions, standard operating procedures, and other information workers need to perform their jobs remain up-to-date and accurate.


If there are systems in place, they are disconnected. As a result, business process gaps between quality management systems (QMS) and content management applications develop, making it challenging to deliver quality products effectively.


Additionally, companies may try to get as much value as they can from their quality management and manufacturing systems by operating them way past their shelf life. This practice can actually increase costs because aging systems tend to be over-engineered and customized, and require frequent maintenance. Older systems are often too rigid to adapt to new processes, manufacturing or training methods, or production requirements, and they cannot efficiently scale down for small batch production.


The life-sciences industry has continued to lag other industries in adoption of new technologies. In a recent survey by Deloitte with MIT Sloan Management Review, only 20% of biopharma companies are maturing digitally (2). Leveraging modern solutions to enable timely delivery of information to the plant floor and tying real-time data with quality management systems can improve agility and help manufacturers meet requirements for innovative therapies such as personalized medicines.


Companies like Samsung BioLogics, a large contract development and manufacturing organization for biologics, are taking a fresh approach to ensure that they remain efficient and agile as they scale. Leveraging modern technology and its parent companys manufacturing expertise and experience, Samsung BioLogics is progressively building larger and more advanced facilities that can run continuously 24 hours a day, seven days a week. Its challenging to manage and maintain information on the manufacturing floor and ensure operators are working from the latest procedures, said James Choi, chief information officer at Samsung BioLogics. Delivering content directly to manufacturing stations through a mobile application will make it faster for teams to stay up-to-date.


Going mobile for greater plant agility


Mobile devices such as tablets are ideal for collecting and distributing real-time information to the plant floor. Using tablets, operators and technicians can deliver updated content and collect data that can be analyzed for improved visibility and efficiency. Cloud applications that were designed specifically for the manufacturing plant floor can be run on mobile devices and support manufacturing processes with up-to-date content and seamless integration with quality management systems.


Synchronizing content on mobile tablets at each work station has many benefits. First, the content is completely accessible to operators, and also available for offline viewing. This prevents them from having to page through stacks of paper to find the right instructions.


Second, mobile applications provide real-time visibility into quality events, allowing manufacturing and quality teams to address and resolve issues quickly when they first come to light, before they have a bigger impact. For example, with a tablet, workers can detect deviations right on the plant floor and enter them immediately at the point of observation, permitting rapid triaging, impact assessment, and remedial action as quickly as possible.


Centralized and more complete data


A connected shop floor has the potential to improve productivity and enable better decision-making. Managers track how content is consumed at each facility, station, and device, and update the content on an as-needed basis. This functionality offers a new lens into the effectiveness of the content. For instance, managers can measure whether document-based instructions are performing better than a short instructional video by measuring the impact on compliance and quality.


Video is gaining popularity as an effective training tool. Delivering video though mobile devices directly on the shop floor can dramatically improve manufacturing efficiency and compliance. Managers see how employees are engaging with the content that is delivered digitally to each station, and, using that data, design instructions and training modules that fit best with that particular task or even with a particular employees learning style.


Centralizing quality event information provides a more complete view and enables greater insights for better decision-making. Data and metrics help identify trends for proactive, and eventually predictive, quality decisions. Teams gain a deeper understanding on how quality events are related, furthering the ability for improving quality and manufacturing operations.


By applying modern tools used in everyday lifemobile devices and intuitive cloud applicationsthe plant floor becomes more flexible and more aligned to business requirements. Content that is delivered to the manufacturing floor via mobile applications remains current, and information is gathered in real time to support quality and compliance.


Training for optimal quality management


A connected shop floor supports training methods that provide the flexibility and versatility needed in modern manufacturing. Information, such as relevant digital procedures and work instructions, can be presented to workers at specific points in the manufacturing process, reducing complexity and, with it, variation.


This targeted learning approach is replacing passive read and understand instructions, ensuring that employees master the procedures most important to their jobs. Companies can expect better results from training programs that are shifting from individual, content-driven events to learning that is deeply contextual, social, and embedded into the flow of everyday work (3). This approach ensures that individuals are not just qualified but also prepared to do their jobs.


Training platforms that apply these techniques are catching on in the life-sciences industry. By connecting learners with training content at the time of need and according to specific learning styles, companies can change behaviors to decrease quality events. Mapping training content to learner roles based on job functions, then delivering it through a role-based, content-centric experience simplifies training, while making it more cohesive and integrated with quality goals.


Quality 4.0 and the rapid detection of quality events


Quality 4.0 comes from Industry 4.0, and is typically defined as the adoption of new technology to improve operational efficiency and product quality. It can simplify processes and speed up manufacturing while enhancing compliance and quality. Connecting the plant floor with mobile devices and cloud-based applications is a prime example of Quality 4.0 in action. Almost 60% of biopharma managers say that digital is a top priority, and they expect to realize the value of their investments within the next five years (2).


A modern QMS provides transparency for greater collaboration among employees and suppliers. Information shared with partners builds alignment and progress toward common goals. Further, connecting operational data allows proactive risk management by addressing quality issues before they arise, as well as by providing real-time quality data for analysis to increase productivity and allocate resources based on risk and need.


Seamless integration with MES, ERP, or PLM across the value chain


Quality 4.0 enables a quality system to integrate seamlessly with a manufacturing execution system (MES), enterprise resource planning (ERP), or product lifecycle management (PLM) system across the value chain for a more holistic view. For instance, connecting a QMS with a MES enables rapid detection, triaging, and remediation of non-conformances. When a MES detects a potential non-conformance, it promptly sends the information to a QMS. The quality team can then quickly evaluate, remediate, or resolve the non-conformance.


With a more connected environment, including on the plant floor, pharmaceutical manufacturers can build stronger relationships internally and externally with systems that track, engage, and facilitate communication and problem-solving in real-time.


Quality 4.0 doesnt mean adding layers of technology or customized systems to manufacturing processes that are already overloaded. Instead, the approach simplifies systems and reduces complexity. A simplified environment supports both standardization and harmonization through streamlined processes that eliminate siloes and other roadblocks to managing quality in manufacturing. Standardization is one process to deliver quality products efficiently on a global scale, while harmonization allows for regional variability and flexibility.


The future of quality in pharmaceutical manufacturing


Quality 4.0 is becoming a reality in pharmaceutical manufacturing as companies adopt new technologies to improve operational efficiency and product quality, and adapt to the manufacturing of precision medicines. Adopting Quality 4.0 for a connected shop floor enables manufacturers to gain real-time visibility across content and quality management processes for better tracking and more meaningful and actionable insights.


Transforming quality management is key to successfully scaling production of new therapies and is ripe with opportunities. Next-generation solutions that emphasize flexibility and efficiency position manufacturers to reap enormous benefits in simplifying and improving quality management. Samsung BioLogics is already seeing a positive impact with its modern approach, which is reducing product switching time and enabling greater agility as it scales.


As companies shift to multi-product lines, they need to be more nimble. To meet current and future needs of patients, life-science companies can enable processes that are flexible and always compliant. Eliminating siloed systems in favor of streamlined solutions allows for greater agility and stronger collaboration while enhancing compliance and end-to-end control. This will help enable life-science organizations to meet the new demands of quality management in manufacturing and help support innovation in precision medicine.


Success and scalability of personalized medicine require new strategies for automation and improved workflows to produce them reliably, safely, and economically.


References

  • 1. Personalized Medicine Coalition, Personalized Medicine at the FDA, Progress and Outlook, www.personal-izedmedicinecoalition.org/Userfiles/PMC-Corporate/file/PM_at_FDA_A_Progress_and_Outlook_Report.pdf.
  • 2. M. Standing, Survey Finds Biopharma companies lag in digital transformation, deloitte.com, Oct. 4, 2018, www2.deloitte.com/insights/us/en/industry/life-sciences/digital-transformation-biopharma.html.
  • 3. T. Warner, Corporate Learning Programs Need to Consider Context, Not Just Skills, hbr.org, Nov. 10, 2017, www.hbr.org/2017/11/corporate-learning-programs-need-to-consider-context-not-just-skills.


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Fiat Chrysler Puts Merger Offer to Renault That Would Create World’s Third Largest Car Manufacturer

Mail Online UK

May 29, 2019

By William Cole


Italian-U.S. auto giant Fiat Chrysler presented a merger proposal to Frances Renault on Monday that would create the worlds third largest automaker.


Fiat Chrysler delivered a non-binding letter to Renault proposing a combination of their respective businesses as a 50/50 merger, with a group that would be listed in Paris, New York and Milan, it said in a statement.


Renault said its board would meet on Monday to discuss the offer. According to a source within the French company, the meeting began at 8am at Renaults Boulogne-Billancourt headquarters near Paris.


The source said, however, that a decision was not expected by the close of the day: it will take days, or even weeks.


Mondays board session would merely examine whether or not to explore the offer on the table, the source said.


After the news broke, shares in Fiat Chrysler Automobiles (FCA) soared 18% when the Milan stock exchange opened on Monday, before falling back slightly.


Fiat Chrysler said the merger would create a pre-eminent global automotive group, with annual sales of 8.7 million vehicles.


It could also generate around (EURO)5 billion ($5.6 billion) in annual savings.


The brand portfolio of the two groups would be broad and complementary… and would provide full market coverage, from luxury to mainstream, it said.


The combination would be carried out as a merger transaction under a Dutch parent company.


The French government, which owns a 15% stake in Renault, supports the merger in principle would want to see more details, its main spokeswoman said on Monday.


It is believed officials would want to see certainties around employment and production due to the thousands of French employees currently working for Renault.


Renaults current major partnership is with Japans Nissan, in which it holds 43%.


Nissan in turn owns 15% of its French partner Renault but the imbalance in the relationship has led to serious friction, highlighted by the arrest of former Renault and Nissan chief Carlos Ghosn in Tokyo.


The Renault-Nissan-Mitsubishi alliance currently makes around 10.8 million automobiles, compared with Germanys Volkswagen and Japans Toyota, both on around 10.6 million.


However, the tie-up with FCA could make Renault much more powerful, potentially further upsetting the balance in the Renault-Nissan-Mitsubishi alliance where Ghosn was pushing for much more say before his downfall.


In recent weeks, Renault has been pushing for changes to its tie-up with Nissan, suggesting the formation of a 50-50 holding company to run both firms.


However Nissan has resisted, feeling it is the bigger company and should be treated as such.


Fiat Chrysler has been under pressure in Europe, stoking speculation it was looking for a partner as the industry is forced to consolidate in the face of declining demand and a costly switch into electric cars.


Fiat Chrysler is widely seen as a latecomer to the electric vehicle market but does well in the U.S. SUV and pick-up sectors.


Renault meanwhile has pushed ahead in electric cars but is relatively weak in North America so the two companies would be a good fit.


Fiat Chrysler said the merger would put the group in a strong position in transforming technologies, including electrification and autonomous driving.


Early this year, rumors circulated that Renault was interested in Fiat-Chrysler after its hopes for a full merger with Nissan or even French competitor PSA were dashed.


Fiat Chrysler said the merger would create in excess of five billion euros ($5.6 billion) estimated annual run rate synergies on top of existing Renault-Nissan-Mitsubishi Alliance ones.


All counted, including Nissan and Mitsubishi, it would mean the production of close to 16 million vehicles, besting Volkswagen and Toyota.


The merger would not result in the closure of any production sites, and the board of directors of the new group would be composed mainly of independent members, Fiat Chrysler said.


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Samsung Galaxy Fold Launch Likely to Be Delayed Again

Korea Herald

May 28, 2019

By Song Su-hyun


Samsung Electronics seems to be taking more time than expected to fix flaws in the main display of its first foldable smartphone Galaxy Fold, according to industry sources Tuesday. It has been more than one month since the South Korean tech giant officially announced the postponement of the foldable devices launch in the United States, but it keeps maintaining that a new schedule will be announced in coming weeks.


Some telecom officials say that the launch is likely to take place after June, Samsungs initial goal. Since the firm has been conducting network connection tests on devices with local mobile carriers, the process of addressing the display defect is known by industry sources. However, the company denied such speculation saying, The improvement process is taking place extremely confidentially, and comments from telecom industry sources cant be confirmed.


On May 9, Samsung CEO Koh Dong-jin said the company will soon announce a rescheduled plan for the Galaxy Folds launch in the U.S. and other markets, adding that it wont be too late. No official confirmation on the launch schedule has been made for the past three weeks, raising speculations that the display defect is more serious than previously thought. Due to the undecided schedule, Samsungs biggest U.S. retail partner Best Buy said Friday it has canceled all preorders.


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Domino’s Rolls Out Pizza Scanning Technology to Assess Pizza Quality

The New Zealand Herald

May 28, 2019

Dominos is bringing in some tech to challenge the age-old customer complaint that the ads always look better than the actual meal.


The Pizza chain has equipped its New Zealand and Australian stores with technology that scans and assess the quality of each pizza made.


The technology, which the trans-Tasman company has named Dom the pizza checker, is in response to its customers number one complaint: its pizzas not looking like the pizzas pictured in its advertising and marketing.


Dom the pizza checker uses artificial intelligence to analyze and grade the pizzas based on the size, how much topping it has and the even distribution of the toppings. If the pizza does not meet the data of the pizza type it is compared to, it is then rejected and operators are told to remake the order.


The pizza scanner has been implemented above the bench where pizza is cut.


Dominos Australia chief executive, Nick Knight, said the technology would regulate quality control and ensure that even in busier periods its quality would not be compromised.


At Dominos, we are always working on how we can be betterwhether that be delivering better ingredients, products or services to our customers. However, the reality of a busy store can sometimes mean pizzas go out which are below the high standards our customers expect, and quite frankly, deserve, Knight said.


The pizza scanner is the first stage of its innovation to regulate food quality, and more features would be added later this year, he said.


Dominos hopes to roll out a feature that allows customers to see their pizza in real time as it is put on the cut bench.


Weve been working hard with our technology partner Dragontail Solutions for more than two years to bring DOM Pizza Checker to life, and now its time for our customers to put us to the ultimate test.


ASX-listed Dominos Pizza Enterprises holds the master franchise rights to the Dominos brand in nine countries including Belgium, France, The Netherlands, Japan and Germany.


It has 830 stores spread throughout Australia and New Zealand. The company would not confirm its total number of New Zealand stores.


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