Drug Substance

Viewing related articles

Industry feedback on ICH Q12: implementation considerations for FDA-regulated products

Industry feedback on ICH Q12: implementation considerations for FDA-regulated products

The aim of ICH Q12 is clearly stated as a framework to facilitate the management of post-approval CMC changes. This document in the industry response to an agency consultation on draft guidance on ICH Q12. The biopharmaceutical industry through these comments commends the agency on leading the way to the implementation of ICH Q12. The BioPhorum comments are heavily influenced by the principle of simplification, which is why our views sometimes differ from the draft guideline.

read more
An industry reflection on the application of the Russian Pharmacopeia to the registration of biologics

An industry reflection on the application of the Russian Pharmacopeia to the registration of biologics

In this paper, a BioPhorum member team of experts in biologics and vaccines have summarized the current challenges linked to the registration of global products in Russian Federation. This paper describes some of the challenges faced by the industry in relation to current pharmacopoeial requirements for biologics and vaccines and presents a framework of options and activities that would lead to greater alignment with the ICH and the expectations of other regulatory agencies.

read more
Single-use system audit guide

Single-use system audit guide

The single-use audit guide has been designed to help the auditor and auditee understand the areas of focus in SUS audits, referencing relevant requirements and SUS manufacturing ‘elements’. It is also designed to assist the auditor in reporting their assessment of SUS manufacturers to the end-user. It includes sections on general quality management system areas and products and production processes to consider. It is designed to be applicable to audits of single-use system manufacturers.

read more
Microbial Control: Detection of Cutibacterium acnes, a high-risk aerotolerant anaerobe recovered in the biopharmaceutical industry

Microbial Control: Detection of Cutibacterium acnes, a high-risk aerotolerant anaerobe recovered in the biopharmaceutical industry

This peer-reviewed paper outlines the risk of aerotolerant anaerobic bacterial contamination during the manufacture of biologic drug substance and the challenges of detection. It examines the issues that manufacturers may consider regarding anaerobic bioburden testing during mammalian cell culture biologics processing, focusing on the detection of aerotolerant anaerobes. It also contains case studies from multiple biopharmaceutical companies, which detected Cutibacterium acnes (C. acnes), the primary anaerobe of concern.

A survey of the BioPhorum Microbial Control Workstream found that more than half of the participants reported contamination events with C. acnes. This survey reported variability in the ability of the compendial microbial enumeration tests to detect C. acnes, thus presenting a challenge for bulk biologics manufacturers. This paper recommends testing conditions designed to increase the likelihood of detecting aerotolerant anaerobe contaminations.

read more
BioPhorum deliverables mid-year report 2021

BioPhorum deliverables mid-year report 2021

BioPhorum is here to help you make better decisions, faster in your operations. Membership puts you and your team at the center of current debates and helps you to stand shoulder to shoulder with those moving the performance dial on challenges that need a collective voice and a global perspective to resolve. The BioPhorum Deliverables Report is a consolidation of the benchmarks, position papers, guidance documents, assessment tools, industry...

read more
Raw Materials: Supplier change notifications: change areas and requirements

Raw Materials: Supplier change notifications: change areas and requirements

This guidance document identifies the relevant change areas, and for each area, exemplifies the type of changes which the biopharmaceutical industry needs to be informed about. It also lists the required information, in terms of supporting data and documentation, to support notification of changes. This guidance is relevant to all raw materials used to produce biopharmaceutical products, including but not limited to cell culture media, fermentation broth components, column resin, buffers, solvents, and excipients. By highlighting the changes biopharmaceutical industry end-users need to know about and specifying the information required, the intention of this industry-aligned guidance is to reduce the quantity of rework required and the time taken to process change requests. In turn, this will reduce variability in demand patterns as end-users refrain from building extensive inventories to mitigate against the perceived risks which arise from proposed changes. While complete alignment and standardization on the information which should be provided for changes is not possible, a more robust alignment on the typical information required, as set on in this guidance, will significantly improve the current state.

read more
Raw materials: Best practice guide for preparation of cell culture media solution

Raw materials: Best practice guide for preparation of cell culture media solution

The purpose of this best practice guide is to provide key information and best practices for media supplier partners and companies in the biopharmaceutical industry on the design, development and controls for manufacturing of media and medium solutions to minimize potential variation that may impact product quality, process performance and operational efficiency and costs. It is intended that it can be used to support a proactive approach to evaluation and self-audit of internal processes.

read more
Peer to peer practical guidance on remote inspections and audits

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.

read more
Closed systems: How much harm can a single droplet do? Considerations for a viral inactivation step

Closed systems: How much harm can a single droplet do? Considerations for a viral inactivation step

This paper discusses a systematic approach to assessing virus segregation measures, which can help biopharmaceutical developers achieve sufficient segregation for the low-pH inactivation steps in their downstream processes. It covers a process description, mathematical modeling, failure modes and the effects on viral clearance, and the importance of proper design.

read more