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With the current pandemic surpassing all countries globally, the life sciences industry is under pressure to find a vaccine through clinical trials and deliver high quality medicines. Contributed by Körber. 

Teerapong Cheepchol, President Software for Asia, Körber Business Area Pharma

However, due to rigorous production processes and strict legal requirements, it is challenging for pharma and biotech manufactures to increase efficiency and productivity and speed up the production. 

Moreover, the lack of effective interaction between IT systems and data transparency affects the overall competitiveness in terms of product quality and costs. Thus, to bridge this gap, the software experts from Körber’s Business Area Pharma formerly Werum IT Solutions, provides their Manufacturing Execution System(MES) Werum PAS-X MES.

This software product helps pharmaceutical and biotech companies to increase their manufacturing efficiency and productivity and maintain a sustainable competitive advantage in the market. 

 

Challenges In Pharma 4.0

One of the biggest challenges in the pharma industry is the resistance to innovation and change, and adoption of the latest technologies in manufacturing. 

However, due to the increasing commercialisation of products, organisational digital transformation is inevitable and companies need to react fast in order to stay competitive and relevant in these uncertain times.

Körber works closely on applying and deriving the benefits of Industry 4.0 to Pharma 4.0 with international organisations such as ISPE to shape the pharma manufacturing concepts of the future through innovative Industry 4.0 technologies for pharma, biotech and cell & gene therapy manufacturing. 

This is achieved by combining the firm’s software expertise with its partners’ machine and plant operations know-how.

 

Transformation Projects

Implementation of Voice-Directed Technology in injectable manufacturing, Cloud-based solutions, Augmented Reality (AR) technology for training and maintenance, and biometric authentication used in the production environment are the benefits derived from Pharma 4.0.

  • Augmented Reality: The latest potential game-changer is Augmented Reality (AR), a new human-to-computer interface that revolves around use of a virtual reality type headset to overlay information on top of our physical surroundings. By simply putting on a pair of goggles and using hand gestures to respond to commands, users gain a simpler and much more efficient way to interact with control systems at their production facilities. 

With AR, a systems engineer can walk freely around a facility and receive notifications in real-time. For instance, the engineer will be informed of a glitch in process equipment, or of a location that will soon require replenishment, or of an instrument showing signs of requiring preventive maintenance. This brings a completely new meaning to the concept of manufacturing control as more potential errors will be addressed in advance, leading to lower costs and enormous gains in efficiency.

  • PAS-X In The Cloud: Werum’s PAS-X MES went live as a cloud-based solution at the Californian facility of a leading US T-cell immunotherapy manufacturer. A top priority for the state-of-the-art plant was the ‘cloud first’ approach to all IT systems. 

PAS-X was hosted out-of-the-box and 100 percent offsite. Customer requirements were met by configurations only and no additional IT infrastructure was required to be installed locally, reducing overhead in IT support, and validated EBRs (Electronic Batch Recording). 

The biopharmaceutical company can thus focus on its core business – manufacturing vital, life-saving T-cell immunotherapies. The clinical production was launched completely paperless, never requiring adoption of paper batch records onsite.

  • Hands-Free Line Clearance With Voice-Directed Technology And PAS-X Electronic Batch Record Integration: AstraZeneca Australia together with Werum revolutionised the operation of PAS-X MES at their production site in North Ryde: operators can now perform the packaging line clearance hands-free through their headset. 

AstraZeneca integrated the technology familiar from warehouse picking into Werum’s PAS-X MES. Operators receive their instructions audibly through the headset, execute the step and confirm it verbally step by step.

  • K.Me-In: The Next Level of Authentication For Your Pharma Plant: Together with customers and partners Werum developed solutions for the smart authentication of employees on the pharma shop floor. 

Werum’s K.ME-IN product innovation allows users on the pharmaceutical or biopharmaceutical shop floor to securely and seamlessly authenticate to systems, devices, machines, and premises via biometric means. 

A wristband can be worn under all types of protective clothing and is uniquely assigned to every user, based on their irreplicable biometric identity. 

K.ME-IN replaces the traditional method of entering username and password, PIN codes, or badges, and is the most secure solution available on the market today ensuring that only the logged-in user is making the entries.

 

The Future Of Pharma 4.0

The industry is expected to see further technological developments in the coming years. Innovations such as wearable control devices, nanotechnology, and precision medicine are already changing the landscape of the life sciences industry. 

Going forward, Körber strives to generate sustainable competitive advantages for its customers in the pharma, biotech and cell & gene therapy industries through innovative Industry 4.0 technologies. 

Considering its growing client base in Asia Pacific, the company aims to support all local PAS-X users in the region with the same global quality and competence of services.

“Our strong project team is capable of providing world-class services to global pharma manufacturers with projects of diverse complexity levels in a variety of manufacturing processes,” stated Teerapong Cheepchol, President Software Asia at Körber Business Area Pharma.

 

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