Werum PAS-X Biotech solution for biopharma excellence

Over 60 percent of the world’s top 20 biotech manufacturers use PAS-X software to ensure flawless process execution, digital data management and fast batch review. 

Biotech manufacturing creates specific challenges such as

• Complex processes with need for tight, real-time control
• Huge amounts of data that need to be analyzed
• Continuous manufacturing 
• Loss of highly valuable batches must be prevented

Körber’s software solutions PAS-X MES and PAS-X Savvy support process control, enable real time control of the process, collect all exceptions that can be managed real time, and allow for direct intervention. 

Software

PAS-X MES drives 100 percent paperless, digitized processes in batch execution, review and documentation. Biopharma companies using PAS-X MES safeguard regulatory compliance, achieve a high right first time of up to 98 percent and drastically speed up batch release by using review by exception. Zero downtime upgrades enable continuous production. PAS-X MES is available on-premises, in your cloud, or as Software as a service. When you are using PAS-X MES as a Service, internal IT efforts are further reduced by 75 percent and initial investment by 65 percent. Körber also offers a set of preconfigured adapters and state of the art interfaces to seamlessly integrate with the customer's existing automation landscape, e.g., fermenters, bioreactors, and analytic equipment.

PAS-X Savvy blends biotechnological process expertise with cutting-edge data analysis techniques. The cloud-based data science platform collects, contextualizes, visualizes, analyzes, and simulates biopharmaceutical process data in real-time. PAS-X Savvy helps to make decisions faster, increase productivity and reduce time-to-market by 50 percent. It enables holistic control strategies, process optimization and a reduction of failed batches, resulting in substantial cost savings by reducing experiments by more than 50 percent. It speeds up the process development by 40 percent and supports Continued Process Verification (CPV) during routine manufacturing with its unique CPV functionality and the seamless integration with PAS-X MES data.

Content

In addition to its biotech-specific functionalities, PAS-X MES includes the PAS-X Content Suite. For example, this suite includes best-practice and biopharma-specific MBR design elements that enable the team to speed up the development of lean and high-quality MBRs. 

Services

With Körber’s PAS-X MBR Services, biopharma manufacturers can reduce workload by outsourcing MBR design to Körber or receive expert advice and health checks for existing MBRs. With PAS-X CMC Innovation Consulting, our experts support you in the application of the right statistical tools for process development and validation, achieving regulatory filings, and improving product quality. On top of that, Körber's Academy assists companies in enhancing employees’ skills and knowledge - online or on-site. 

Trusted by the world’s top biopharma companies

PAS-X MES is trusted by 60 percent of the world’s top 20 biopharma companies and Körber is recognized as a Leader for PAS-X MES in the 2023 Gartner® Magic Quadrant™ for Manufacturing Execution Systems and is placed furthest on the ‘Completeness of Vision’ axis among all MES vendors.

Thought leader and advancing the industry

As an industry thought leader, Körber actively collaborates with global biopharmaceutical forums to shape technology roadmaps, exchange best practices, and deliver cutting-edge solutions tailored to the industry's evolving needs. Our active engagement with ISPE (CoP Biotech) reflects our commitment to contributing to the industry's future vision.

PAS-X for biosimilar and personalized biotech production

In addition to its established role in classical biotech production, Körber’s PAS-X solutions are also the optimal choice for biosimilar and personalized biotech manufacturing.

Biosimilars

Biosimilar manufacturing is complex and requires extensive analysis and comparative studies to meet the same quality, safety, and efficacy standards as biologics. Our solution can help optimize the development and production of biosimilars by developing complex models that consider factors influencing biosimilars, such as cell lines, production patterns, process parameters, quality attributes, etc. PAS-X Savvy simplifies and accelerates data analysis by extracting and reviewing critical process parameters (CPPs) and critical quality attributes (CQAs) to meet biosimilar specifications. Our PAS-X MES offers the classic benefits of a paperless system, including traceability, compliance, efficiency, etc., and can also improve data provisioning for biosimilar development and approval by storing and transferring data in a standardized and integrated format. We also provide a systematic approach to ensure analytical biosimilarity to maximize the chances of drug approval.