The road to commercial manufacturing for Cell & Gene therapies

Werum’s PAS-X MES targets the key challenges for cell therapy manufacturers, managing complex processes and controlling the chain of identity.

Imagine you are an up and coming cell therapy company. You have gone through the exploration phase, and are in the process of finalizing a breakthrough treatment.

When scaling-up to commercial manufacturing, electronic systems are emerging as the only option for managing complex processes and controlling the chain of identity.

Werum’s PAS-X MES is ideally suited to target the key challenges for cell therapy manufacturers through its capabilities to automate calculations and workflows.

SOLUTIONS

Our Plug & Produce solution allows a fast and easy integration of machines and automation systems into a pharmaceutical production environment – a prerequisite for the implementation of many Industrie 4.0 solutions.

PAS-X is the market-leading MES (manufacturing execution system) for the pharma and biotech industries. It is run by more than 50 percent of the world’s top 30 pharmaceutical and biotech companies and in more than 1000 installations around the globe.

PAS-X Manufacturing Intelligence helps you to enhance the shop floor performance within your manufacturing processes. For instance, our PAS-X KPI Solution supports operators and supervisors on the shop floor as well as production site managers to constantly monitor operational performance data from the shop floor. The live monitoring of the production and packaging lines allows optimizing processes or equipment very quickly, thus boosting your operational performance. PAS-X KPI is also available as a lean standalone software solution for fast and easy implementation.

PAS-X Process Quality Control captures events and deviations enabling companies to drastically reduce batch review and release time and to implement Review by Exception. It ensures a continuous monitoring of the production quality. In order to achieve the highest possible quality and to take preventative and flexible measures, PAS-X Process Quality Control supports process-analytical on-line, in-line, and at-line quality controls. The function supports the implementations of Process Analytical Technology (PAT) and state-of-the-art Quality by Design (QbD) concepts.

PAS-X Warehouse Management supports production-related warehouse logistics. The system components can be configured as required, and form the basis for implementing warehouse management systems, control systems and picking systems.

PAS-X Equipment Management administers and monitors cleaning procedures and statuses for all types of production-related objects. This includes MBRs and particular rules for cleaning scales, work rooms, containers, production equipment, setup parts and toolkits. Electronic paperless equipment logbooks keep status lists, cleaning rules and histories for individual container types.

Efficient electronic batch documentation is one of the most important objectives in introducing an MES to pharmaceutical production. With PAS-X Electronic Batch Recording all MBRs are electronically executed and the processes and results are documented in compliance with the applicable statutory provisions. PAS-X EBR ensures an error-free and guided execution of the entire production process and right-first-time manufacturing.

PAS-X Master Batch Records allows the customer to easily set up and maintain libraries with standardized, reusable building blocks which can then be used to create an MBR.

CONTACT INFORMATION

Werum IT Solutions America, Inc.

8000 Regency Pkwy #403

Cary, NC 27518

UNITED STATES

Phone: 973-646-3408

Contact: Shawn Opatka

WEBINARS AND VIDEOS

  • Why MES For Cell And Gene Manufacturers?

    To enable you to assert yourself in the highly competitive pharmaceutical market and to focus on your core business, we provide a complete MES solution (manufacturing execution system) comprising the PAS-X software, content and services. See how a state-of-the-art manufacturing Execution System saves time, saves effort, and avoids risk in your pharma factory.

  • Cell Therapy And Gene Therapy: A Case Study On Scaling Up For Commercial Manufacturing

    There are two new players on the biologics industry block – cell therapy and gene therapy. Join our featured speaker for a discussion of how cell and gene therapies differ from pharmaceuticals and learn about the challenges to achieving commercial manufacturing.

  • Data Integrity And The Manufacturing Control Strategy For Life Sciences Manufacturers

    As the Manufacturing Control Strategy initiative is relatively new, this webinar reveals the new opportunities that arise from the implementation of a manufacturing control strategy and its best practice-based methodologies. The speaker discusses best practice case studies, as well as, the enablers, elements and challenges of the production control strategy implementation.

FEATURED ARTICLES

  • Werum IT Solutions Receives The Prestigious ‘Asia-Pacific Bioprocessing Excellence Award 2020; For Its PAS-X MES

    Werum IT Solutions, the leading supplier of manufacturing execution systems (MES) and manufacturing IT solutions for the pharmaceutical and biopharmaceutical industries, was honored with the "Best Bioprocessing Supplier Award: Automation – Software" for the second consecutive year at the 7th Annual Biologics Manufacturing Asia 2020 conference, which was held virtually on 7-8 July 2020.

  • How A Manufacturing Execution System Supports Your Business Continuity During An Acute Crisis

    Remote services and digital manufacturing keep your pharma & biotech operations running, even in a situation of severe crisis. Learn how MES provide strategic resilience through flexibility and digitization.

  • Gaining Approval For Manufacturing IT Investments

    It’s no question that in the digital age, pharma and biotech production must be supported by manufacturing execution systems (MES). These systems digitize end-to-end pharma manufacturing processes – from receiving goods via warehousing through to production and packaging. Using MES results in process improvements and significant efficiency savings.

  • Werum IT Solutions Launches New Smart Biometric Authentication Solution K.ME-IN For Pharma And Biotech In Cooperation With Nymi

    Werum IT Solutions is excited to announce the launch of K.ME-IN, a biometric authentication solution with Nymi for Werum’s PAS-X Manufacturing Execution System (MES). The new solution will allow users on the pharmaceutical or biopharmaceutical shop floor to securely and seamlessly authenticate to systems, devices and machines via a smart wristband. In the future, K.ME-IN will be extended to allow user authentication via further biometric means such as iris scan, face recognition, fingerprint or a combination of those.

  • Making AI Usable For Pharma and Biopharma

    Artificial intelligence (AI) is already making a huge contribution to the global economy, even though this development is still in its early stages. AI is a kind of turbo drive for the new digital technologies, because it enables machines to imitate human decision-making processes. This white paper explores how to use artificial intelligence to uncover hidden business value in the regulated pharmaceutical and biotech industries.

  • Werum IT Solutions Honored With Frost & Sullivan Customer Value Leadership Award 2019

    Based on its recent analysis of the global manufacturing execution system (MES) market for pharmaceuticals, biotechnology, and cell & gene therapies, Frost & Sullivan recognizes Werum IT Solutions with the 2019 Global MES for Pharmaceuticals, Biotechnology, and Cell & Gene Therapies Customer Value Leadership Award. Its MES solution, PAS-X, supports complex operations, higher productivity, and adherence to regulatory requirements. Its end-to-end solution comprises the PAS-X software product, pre-configured content for pharma and biotech processes, as well as consulting, training, and support services.

  • MES – The Data Integrity Engine On The Shop Floor

    In the last years, the FDA has seen an increase in data integrity violations. Read how using an MES will boost your data integrity compliance and your process understanding, since your processes will be well structured, executed, maintained and documented across the pharmaceutical product life cycle.

  • What Is The Cost Of Not Doing MES?

    In this age of digitization, many pharma and biotech companies still struggle to gain senior level buy-in for investments in manufacturing IT. This whitepaper covers major saving areas with MES as well as typical steps to evaluate ROI.

  • Cloud-Based OEE Monitoring For Pharma And Biotech

    Competitive pressure and tight budgets are forcing pharmaceutical and biotech manufacturers to make optimum use of their existing facilities. Cloud-based OEE monitoring provides real-time insights into equipment performance – with quick and easy deployment and expansion, zero maintenance overhead and near-instant ROI.

  • The Importance Of Pharma 4.0 And Enabling The Factory Of The Future

    The terms ‘Internet of Things (IoT)’ and ‘Industry 4.0’ reference technology-driven initiatives that have begun to disrupt traditional manufacturing methods, equipment and processes. In this post, we’ll explore the relevance of these terms for the pharmaceutical and biotech industries. We’ll attempt to answer the question of how we can apply them to improve the world of pharmaceutical manufacturing – and bring about Pharma 4.0.

  • Digitization Of The Supply Chain: Challenges In Scaling Up Cell & Gene Therapy

    This white paper discusses the unique biopharmaceutical supply chain challenges of Cell & Gene therapy logistics and recommends forward-thinking solutions to address them. Successfully overcoming these logistics challenges is essential in order to scale up C&G therapies to treat large numbers of patients worldwide.

  • How To Speed Up Cell And Gene Therapy Treatments For Patients, Reduce The Number Of Manual Operations And Eliminate Operator Errors

    This white paper addresses the unique production problems of cell and gene therapy and explains how a manufacturing execution system (MES) can address them. It provides guidance on how to select an MES and a case study of two CAR-T therapy companies scaling up with and without an MES.