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A risk-based blueprint for process control of continuous bioprocessing

This paper gives an overview of an accompanying risk assessment template and acts as a blueprint for industry. It will be useful for any organization new to continuous bioprocessing, while experienced companies can use it to benchmark their existing operations.The blueprint will accelerate the realization of commercial continuous biomanufacturing processes and signals to regulators that this is the direction of industry travel, with a consensus view of how it should be done.The control plan will help lower the implementation barrier for starting continuous bioprocessing and provide a better understanding of its needs for end-users and potential vendors as it aligns and standardizes the industry’s validation approach.

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Peer to peer practical guidance on remote inspections and audits

Drawing on their real-world experiences, a group of experts drawn from 28 BioPhorum member companies has provided guidance on the detailed working methods that support a successful remote inspection or audit; for example, how to manage information flows between the inspectors and the site subject matter experts’ team. With the impact of Covid-19 likely to be seen for the foreseeable future, virtual inspections may be required for some time. This guidance will help all stakeholders prepare and to avoid the potential problems of remote inspections and audits.

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Risk and Business Continuity: Risk management in the biologic industry supply chain

This best practice guide to risk management in the biologics industry supply chain is based on the premise that adoption and implementation of the principles and framework reflected in ISO 31000 (Risk Management: 2018) provide an effective and efficient way to support biologics industry growth while maintaining, and potentially increasing, benefit to patients and companies, in addition to satisfying the demands of regulatory agencies and meeting legislative requirements. It is designed to encourage the industry to review their approach to risk management to validate, or refine and improve, current company practice, in terms of principles and risk management processes in this vitally important business function.

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NIIMBL Roadmaps: 1. Vaccines: 2. Antibody-Drug Conjugates (ADC) and Bi-specific Antibodies: 3. Gene Therapies

The National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL) collaborated with BioPhorum to create and publish three technology roadmaps covering Vaccines, Gene Therapy and Antibody-Drug Conjugates/ Bispecific antibodies. Developed using the highly successful roadmapping process that led to the first edition of the BioPhorum Biomanufacturing Technology Roadmap. These documents compliment the original Technology Roadmap and detail the manufacturing challenges, technology needs and areas of opportunity in each of the three product categories with additional focus on US regulatory and workforce challenges.

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Supply chain mapping: A best practice for the biopharma industry

The complexity of the support networks needed to deliver biopharma products, makes good supply chain mapping (SCM) essential to ensure reliable drug product supply.  This is especially the case given the impact that natural disasters, adverse weather and politics can have on supply chain security.

This guide from the Supply Chain Mapping workstream can be tailored to the needs of both suppliers and manufacturers and helps them map and master supply chain risk.  The guide details reasons why companies should adopt the approach, an implementation model, a standardized questionnaire to collate and manage basic supplier data and a maturity model against which a company can assess its own level of supply chain mapping and understanding.

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