Time to Invest in Bio-Pharma PLM

Selerant Briefing Note

By Daniel R. Matlis

The Executive Management team at Selerant recently briefed Axendia on its formula-based product lifecycle management (PLM) solution.

Founded in 1990, and headquartered in Milan, Italy, Selerant offers an AI enhanced PLM+ QMS solution that supports global formulation development, quality and risk management, regulatory compliance, and innovation management across the formulated product industries worldwide.

“Our Mission is to transform Life Sciences with advanced AI driven Product Lifecycle Management solutions, said Jacopo Colombo, President & CTO at Selerant.  “We are building a new generation solution of technology solutions that unlock the power of AI through product life-cycle management to deliver the highest value to our clients by driving revenue growth, operational excellence and reducing risks of our customers,” he added.

PLM for the Formulated Industries

Medical Device and other discrete product manufacturers have been using PLM systems for decades.   PLM has its roots in the in the Aerospace and Automotive industries.  As a result, PLM is well suited for managing 2 & 3D models, and the supporting parametric data, needed to engineer, design and manufacture discrete products. 

By contrast, PLM is not widely used in the Bio-Pharmaceutical industry.  This is due to the lack of regulatory focus on PLM and the challenges associated with managing formulas, recipes, and process variables across the lifecycle of molecules (large or small). 

In November 20, 2019 regulatory members of ICH adopted ICH Q12.  This globally harmonized guideline provides a framework on the technical and regulatory considerations for product lifecycle management across the Bio-Pharmaceutical industry.  Through Q12, the regulator’s intent is to promote innovation and continuous improvement in the bio-pharmaceutical sector, strengthening quality assurance and improving the supply of medical products.

Managing Innovation Across the Formulated Product Lifecycle

“Selerant brings 30 years of industry insight, innovation and business transformation experience, providing PLM to consumer packaged goods, food and beverages, beauty/personal care, specialty chemicals,” noted Colombo.

The company’s Devex PLM supports product development across R & D, quality management, regulatory compliance, and innovation in an integrated platform.  This approach can accelerate the time to market, improve quality, reduce risk, and increase operation excellence.

“We see big potential in Bio-Pharma and Life Sciences as some of the solutions and expertise that we have gained in other process industries can be applied to the Life Sciences segment, which can bring a lot of benefits,” stated Colombo.  

Image courtesy of Selerant

Making Sense of Formula Data

Formula development for new products or modifications and changes to existing products creates a massive amount of data. Currently, these data reside across a multitude of point solutions and systems owned by each functional area.

The ability to analyze model and simulate the process across the product lifecycle supports quality and design and process understanding. An integrated formula PLM can organize, control, manage and track all these data to create an efficient, effective process.

In addition, formula-based PLM can turn a generic recipe into a site one while maintaining compliance, can drive consistency across global operations, and automating the management of product-specific data.

Selerant’s Devex can address some of the challenges facing the Bio-Pharmaceutical industry including:

  • Quality & Compliance – streamline and automate processes
  • Development & Manufacturing – reevaluate processes and prioritize innovation
  • Value Chain – transforming the supply chain to integrate suppliers, partners & patients
  • Data & Knowledge Management – connect systems, people and data in an integrated virtual ecosystem to provide better visibility and promote better decision making

To address these needs, Selerant has developed several solutions that can be applicable to the Life Sciences, many with AI capabilities:

  • R & D Scientific Workbench – for modeling and collaboration
  • Laboratory Informatics – provides tools to support testing and analyze results
  • Labeling & Packaging – creating, developing and managing
  • Regulatory Compliance – regulatory management throughout the product life cycle
  • Supplier Management – manages the supply chain for onboarding, validating, auditing suppliers and collecting data on the raw materials supplied
  • Quality Management – includes track & trace, audits, risk assessments, doc control, etc.
  • Environment Health Safety – hazard/operating management of materials, safety handling and reporting
  • Sustainable Design – assess environmental impact of product

In Brief

With the adoption of ICH Q12, Axendia has seen increased interest from Bio-Pharma companies in formula-based PLM.

The use of PLM can drive innovation and continuous improvement in the Bio-Pharmaceutical industries while enhancing quality and the availability of medical products.

With 30 years of experience formula-based PLM for the CPG industries, Selerant is well positioned to help pharmaceutical and biopharmaceutical companies streamline and automate their product lifecycle management.

We will continue to monitor the Selerant’s formula-based PLM’s offerings in the Bio-Pharma industries.

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