ARTICLES BY BIOPHORUM

• Digital Certificates Of Analysis: A Vision For The Transfer Of Quality Data

  1/23/2025

  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.

• A Justification For Using In-Process Controls In Place Of Cleaning Validation

  1/9/2025

  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.

• A Phase-Appropriate Approach For Assay Validation In Cell & Gene Therapies

  10/2/2024

  This article promotes alignment on a common phase-appropriate approach to analytical assay validation with respect to the critical quality attributes of the most common cell/gene therapy modalities. 

• How To Leverage Platform And Process Characterization Data To Accelerate Cell & Gene Therapies

  9/10/2024

  This article discusses how cell and gene therapy companies can use prior knowledge and platforms to leverage process characterization to reduce the testing and/or studies required during process validation for drug substance and drug product manufacturing processes.

• How To Minimize The Impact Of Stability Testing On Gene Therapy Batch Yield

  8/27/2024

  This article outlines strategies for reducing the volumes required for gene therapy stability studies, with the goal of conserving product for patients, while remaining compliant and delivering data on CQAs. 

• End-To-End mRNA DS And DP Manufacturing Processes

  7/10/2024

  This article demystifies the manufacture of mRNA encapsulated in lipid nanoparticles across unit operations for plasmid linearization, drug substance (DS) manufacture, and drug product (DP) manufacture.

• A Holistic Approach To Container Closure Integrity

  5/20/2024

  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.

• How To Unlock Efficiency In MES Integrations

  5/16/2024

  This article outlines the significant benefits and framework for manufacturing execution system (MES) integration with systems such as enterprise resource planning.

• Evaluating, Validating, And Implementing NAT-Based Mycoplasma Detection Methods

  5/3/2024

  Regulatory authorities advocate using alternative adventitious agent tests, but adoption has been slow. Here’s how to validate an alternative mycoplasma detection assay.

• Developing A Process Performance Qualification Master Plan For Gene Therapies

  4/19/2024

  This article provides considerations and a framework for a Process Performance Qualification Master Plan in the gene therapy industry. It is useful for sponsors with any level of experience.

• Strategies For Minimizing The Impact Of Bioburden And Sterility Testing On Gene Therapy Batch Yield

  1/2/2024

  It is widely recognized that gene therapy manufacturing processes result in low yields. This article outlines strategies for reducing the volumes required for bioburden and sterility testing and, therefore, conserving product for patients while remaining compliant and delivering process information on the microbiological status. 

• Understanding CQAs For mRNA/Lipid Nanoparticle Product Development And Manufacture

  12/13/2023

  BioPhorum recently created a resource of potential critical quality attributes (CQAs) for mRNA products from the early stages of drug development to commercial manufacturing. We asked two of the paper’s authors some questions to explore the key areas in more detail.

• Proposed Best Practices For Cell & Gene Therapy Aseptic Process Simulation

  10/25/2023

  Aseptic process simulation (APS) plays a critical role in demonstrating that the processes, equipment, and materials involved in sterile manufacturing work in synergy to maintain sterility. Applying existing APS guidelines to cell and gene therapies/ATMPs can be challenging, so BioPhorum proposes a best practice approach in alignment with regulatory guidance.

• Considerations For Viral Clearance In Cell And Gene Therapy

  7/27/2023

  Assuring viral safety in cell and gene therapy (CGT) products poses a unique challenge. This article focuses on adeno-associated viral (AAV) vectors but also applies to other viral vectors where possible.

• A Practical Proposal For Standardizing Traceability Of Cell And Gene Therapies

  7/21/2023

  For personalized therapies, it is imperative that patients are treated with the product meant specifically for them. Mistakes in products or on labels that lead to the wrong therapy being administered to the patient are likely to have fatal consequences. BioPhorum presents a practical vision for standardizing the traceability of cell and gene therapies across the value chain.