From Ad Hoc to Enterprise-Wide: Building a Parent Company’s Materials of Construction Risk Management Program.

About the Client

Company T is one of the world’s leading biotechnology companies. It operates a global network of biologics manufacturing plants and had recognized that managing materials of construction independently at each site — rather than as a coordinated, network-wide discipline — was introducing a risk that no single plant could fully see or control.

Industry Context

Materials-of-construction risk, often studied today under the closely related discipline of extractables and leachables (E&L), has moved from a best-practice concern to a binding regulatory requirement in the years since this engagement. The United States Pharmacopeia’s General Chapters <665> and <1665> — the first compendial standards dedicated specifically to evaluating extractable and leachable risk from components and systems used in pharmaceutical and biopharmaceutical manufacturing — become mandatory on May 1, 2026. Industry groups such as BioPhorum Operations Group, a consortium of roughly 90 manufacturers and suppliers, have spent the years since 2013 building the kind of harmonized, benchmarked testing standards that Iknow’s original recommendations anticipated. In effect, the risk-based, network-wide MOC framework Iknow built in 2013 addressed, more than a decade in advance, the same discipline the wider biopharmaceutical industry is only now being required to formalize.

Current Situation

Company T managed materials of construction standards independently across its network, with no coordination between manufacturing process design and the individual manufacturing sites responsible for executing them. That lack of consistency, structure, and supplier management discipline posed an unacceptable risk to product quality, prompting the company to seek an external partner capable of building a coordinated, company-wide program.

• Fragmented, site-by-site management. Each manufacturing plant handled materials of construction independently, with no shared standards, data, or coordination with process design.
• Direct contamination risk to product and patients. Any material in contact with drug substance or drug product — through dissolution, leaching, chipping, or flaking — could compromise product quality, with potentially serious consequences for patients and its parent company’s reputation.
• No risk-based method for prioritization. Company T had no structured method for identifying which spare parts and materials posed the greatest risk and therefore warranted the most scrutiny.
• Weak supplier management discipline. Material profiles, data sheets, and supplier qualification practices varied across sites, with no consistent standard for what constituted a compliant material or vendor.

• Determine the quality oversight requirements needed for an effective, company-wide MOC program.
• Implement a risk-based approach for identifying critical spare parts and materials across its parent company’s manufacturing network.
• Build the business processes required to mitigate the risks inherent in replacement parts used in drug manufacturing.
• Deliver both a near-term action plan and a multi-year roadmap for building lasting MOC management capability.

How Iknow Structured the Work

Iknow structured the engagement around a current-state assessment of its parent company’s existing manufacturing network, a formal risk-assessment methodology applied consistently across sites, and a set of governance and process recommendations designed to convert fragmented, site-level practices into one coordinated, company-wide program.

Key Activities & Decisions

• Network-Wide Current-State Assessment. Iknow identified and documented the materials of construction in use across the company’s six biotechnology manufacturing plants.
• Risk-Based Assessment Methodology. The team evaluated materials against a structured set of risk factors, including proximity to the active pharmaceutical ingredient and drug product, extraction capability of process conditions, exposure time, exposed surface area and temperature, material characteristics (reactive, additive, or absorptive), pre-exposure treatment, potential for downstream impurity removal, resistance to mechanical stress, and the potential effect of leachables.
• Risk Management Planning. Iknow developed a network-wide MOC risk management plan alongside detailed, plant-specific plans and remediation projects tailored to each site’s actual conditions.
• Standards & Governance Development. The team developed a company-wide standard for managing materials of construction issues and prepared recommendations on the governance policies and procedures needed to support it.
• Supplier & Procurement Alignment. Iknow worked directly with its parent company’s procurement function to develop detailed material profiles and data sheets and to identify new suppliers capable of meeting the new standards.

Stakeholders & Collaboration

Iknow engaged manufacturing, quality, engineering, and procurement stakeholders across the company’s six-plant biotechnology network, coordinating a risk assessment and standards-development effort that required input and buy-in from every site rather than a single central team.

Standardizing a Historically Decentralized Network

Six manufacturing plants, each with its own history, suppliers, and local practices, could not simply be handed a single uniform standard and expected to comply. Iknow addressed this by pairing a network-wide risk management plan with detailed, plant-specific remediation plans, and by explicitly designing those plant-level plans to emphasize knowledge sharing and collaboration across sites so that plants were not duplicating the same risk-assessment work independently.

Building Supplier Discipline Where None Existed

Without consistent material profiles or supplier data, its parent company had no reliable way to know whether a given vendor or material met an acceptable risk standard. Iknow addressed this by working directly alongside its parent company’s procurement organization to build detailed material profiles and data sheets and to identify new suppliers capable of meeting the newly defined MOC standards — embedding the new discipline into the sourcing process itself rather than leaving it as a separate quality function.

Operational Outcomes

• Delivered a summary report describing the current-state MOC assessment across its parent company’s six biotechnology manufacturing plants.
• Delivered a risk-mitigation plan for biologics manufacturing sites, including a prioritized project portfolio built from site-level Local Impact Assessments.
• Delivered plant-level risk mitigation plans designed to promote knowledge sharing and collaboration across plants and minimize redundant work.
• Delivered recommendations benchmarked against peer biotechnology manufacturing companies to improve its parent company’s MOC practices, procedures, and document management discipline.

Strategic and Organizational Outcomes

Iknow’s recommendations gave its parent company a comprehensive path to closing a systemic contamination-risk gap before it could affect product quality or trigger regulatory action. The recommendations spanned targeted investment in product quality, regulatory, and patient-supply risk, and a more centralized governance structure with an executive sponsor and hands-on program tracking. They also called for a structured business-process redesign incorporating the new MOC standards and new IT systems to share MOC analyses and vendor information, manage vendor change notifications, and track critical spare parts across the entire manufacturing network.

Timeline to Impact

Iknow completed the current-state assessment, risk management plans, and standards recommendations within the three-month engagement, delivering both a near-term MOC action plan its parent company could act on immediately and a three-to-five-year roadmap for building sustained MOC management capability across its global network.

Core Skills

• Quality & risk management consulting
• Manufacturing process advisory
• Supplier & materials risk management
• Governance & standards development

Methods & Frameworks

• Risk-based materials assessment methodology
• Local Impact Assessments and portfolio prioritization
• Cross-site benchmarking against peer manufacturers
• Business process redesign and governance model design