ARTICLES BY BIOPHORUM
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Digital Certificates Of Analysis: A Vision For The Transfer Of Quality Data1/23/2025
The pharma/biotech industry must ramp up adoption of digital certificates of analysis, which are transforming the way quality data is transferred between organizations in the supply chain.
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A Justification For Using In-Process Controls In Place Of Cleaning Validation1/9/2025
This article provides a procedure for using and cleaning shared columns and column packing equipment and using in-process controls that eliminate the need for cleaning validation.
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A Risk-Based Approach To Filter Integrity Testing Annex 1 Requirements For Biologics DS11/8/2024
How do the principles of filter integrity testing described in EudraLex Annex 1 apply to low bioburden drug substance manufacturing? And how can using a risk-based approach help?
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A Holistic Approach To Container Closure Integrity5/20/2024
Regulations are pushing for an approach to container closure integrity that builds quality into the design and processes rather than testing/inspecting the manufactured item.
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How To Unlock Efficiency In MES Integrations5/16/2024
This article outlines the significant benefits and framework for manufacturing execution system (MES) integration with systems such as enterprise resource planning.
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Developing & Implementing A Continuous Bioprocess Control Strategy2/20/2024
A key challenge to better uptake of continuous processes in biologics manufacturing is the necessity to link unit operations. This article defines a standard template approach for developing and implementing a continuous bioprocessing control strategy, providing a visual and technical aid, and sharing considerations when selecting control schemes.
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Improving Digital Integration Between Biomanufacturers & Partners5/1/2023
Sponsors are working with more contract organizations, and contract organizations are working with more sponsors. There is often a mismatch in digital maturity (IT capabilities) between the two sides of a partnership. We must work toward a bidirectional sharing of data and process knowledge. This road map from BioPhorum will help.
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Risk-Based Strategies For Revalidating Bio/Pharma Equipment & Systems4/20/2023
While equipment and systems validation is a regulatory requirement, it would take thousands of annual tests to retest all equipment and systems. BioPhorum shares risk-based approaches to new product introduction, controlled temperature chambers, sterilization processes, and more.
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Best Practices For Cell Culture Media Fingerprinting3/13/2023
This three-tier approach to cell culture media fingerprinting helps you to define an alternative method that will allow verification of the quality of the medium as well as fingerprinting. It helps you to choose suitable methods for incoming ID testing based on raw material properties, goals of media characterization, and the resources available.
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Using QbD Principles To Register Innovative Raw Materials2/13/2023
Control of biopharmaceutical raw materials is defined by the license holder. We propose a best practice approach to registering innovative and complex raw materials based on quality by design (QbD) principles. It can be applied to different families of non-compendial raw materials used when manufacturing biologics.
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A Methodology To Support Particle Investigations In Biopharma Products11/22/2022
Particles in parenteral products are a major cause of product recalls, and appropriate management of risk from visible particles is vital. This standardized methodology provides users with a decision-making tool to clarify the risks presented by a particle to a batch.
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A Phased Approach To Adopt In-Line Monitoring & Real-Time Release10/26/2022
The biotech plant of the future will use in-line monitoring (ILM) and real-time release (RTR), which includes process technology, operational systems, facility design, and construction innovations that will increase capacity and enable efficient processes. This article is a guide to adopting that vision.
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Biopharma Facility Modular Design & Construction: Key Considerations9/12/2022
In facility design, the term “modular design block” is used for “pre-engineered” or “predesigned” solutions. This approach suggests that a new facility design need not be unique but can use and leverage a pre-engineered set of component pieces. The further down the supply chain standardized modules and components reach, the wider the benefits.
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The Process Map To Ensure Biopharma Raw Materials Supply8/16/2022
In new product introduction, there is often a lack of a basic data package for a product being scaled up for clinical or launch supplies. This can lead to several issues, e.g., capacity and lead time restrictions, oversupply, and more. A stepwise process can be used as a guideline for introducing a material to support new drug substance manufacture.
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How To Integrate Continued Process Verification & Annual Product Review For Biologics1/3/2022
In biologics manufacturing, continued process verification (CPV) requirements are similar to those for evaluating quality standards that determine changes to manufacturing or control procedures in an annual product review (APR). Many companies have mirrored CPV and APR reporting processes. Few have realized the efficiencies of integrating them.