Drug Substance

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Deviation Management (DMS): Guide to implementing a risk based deviation management system

BioPhorum has developed a risk-based deviation management system (DMS). 13 member companies have implemented this approach, and summary data from these companies shows improved quality performance plus an average time saving of 22,200 work hours per site per year, which is equivalent to a $888k cost saving.

This guide outlines the work of the BioPhorum DMS Workstream in defining and creating a simplified and effective risk-based deviation management system with advanced RCA methodologies, and a track-and-trending process of low-risk events. It includes everything required to build a risk-based approach to DMS, including the business case for change, the new process, risk-based tools, and a detailed sharing of post-implementation benefit.

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BioPhorum strengthens supply chain resilience through digitization of the supply chain and alternatives to gamma sterilization

Since 2016, BioPhorum Supply Partner has made great progress in bringing together manufacturers and supply partners to build modern and effective inbound supply chains and develop a program of work that addresses some key areas: risk; planning; and education, qualification and control. Its industry expertise and ‘horizon scanning’ mean its transformative program reduces risk and adds value for members. This can be seen in the creation of two...

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Shared clean-in-place systems: to share or not to share

This paper discusses design challenges such as how biomanufacturers often use extreme measures to segregate a post-nanofiltration operation from a cell-culture operation – but use a common glass washer or clean-in-place (CIP) skid for cleaning and sanitizing components from the two operations. The article looks at this apparent contradiction by using a mathematical model to evaluate the potential carryover/crossover risk.It aims to simplify production facilities so that a manufacturer doesn’t have multiple systems performing the same task. This means lower costs and complexity and facilities that are quicker to build and operate.

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Single-use: Testing, validation and release (TVR) standards

When testing single-use items, at what point is it appropriate to leverage vendor data, and when does an end user need to carry out testing? Is current regulatory guidance clear and sufficient in the fast moving area of disposables? And wouldn’t it be great if we had a tool that gave the industry a harmonized risk based approach to testing requirements.  These are the questions that the BioPhorum Drug Substance TVR team have been...

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How to make single-use systems supply chain proof?

In the second half of 2020, BioPhorum Drug Substance  will publish a comprehensive set of tools and guidance to help the industry foolproof the transportation, deployment and use of single-use systems.  Inspired by the work of Bayer's Berkeley facility, who over many years reduced leak rates from totally unsustainable 40% to a phenomenal 0.04%, the industry package takes the position that single-use systems are complex delicate...

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Making and moving operational cell banks

Moving the site of manufacture for commercial cell banks, microbial or mammalian, the renewal of working cell banks for commercial products, or making minor changes to cell banking processes is becoming more onerous from a regulatory perspective and does not have a consistent harmonized approach even within a single regulatory body such as the FDA. In the past analytical comparability of cell banks was acceptable and this changed to requiring...

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Avoiding the rabbit holes: how to develop successful ILM-RTRT strategies

Reducing the time-to-release for drug product is a key goal of the industry as it can lower production costs and accelerate speed-to-market. This is why BioPhorum has completed a significant piece of work on the development of in-line monitoring technologies, which are fundamental enablers of real-time product release. The result is a new and extensive white paper, In-line Monitoring/Real-Time Release Testing in Biopharmaceutical Processes –...

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Key updates to Brazilian post-approval change requirements and use of Polysorbate 80 in China

The BioPhorum Post-Approval Strategy Team has been working hard in international regulatory environments over recent years and can now share intelligence on some significant breakthroughs in the key markets of Brazil and China. Brazil is planning to reduce its data requirements for post-approval change submissions, which will make it aligned with other ICH countries. While China has issued new monographs for Polysorbate 80, which means that the...

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New disinfectant efficacy approach saves member $1.5m through stronger compliance

Cleaning and disinfection are crucial during the drug manufacturing process. However, while these tasks support the control of microbial contamination through preventive and corrective actions, specific compendia methods do not exist – yet cleaning and disinfection is now a regulatory requirement. This is why BioPhorum’s Microbial Control Workstream has published Disinfectant Efficacy: Understanding the Expectations and How to Design Effective...

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Microbial control: Disinfectant Efficacy: Understanding the Expectations and How to Design Effective Studies That Include Leveraging Multi-Site Data to Drive an Efficient Program

This paper provides general guidance on how to perform disinfectant efficacy validation and implementation. It includes how to ensure the concepts of disinfectant efficacy are understood, how to interpret facility data and use it to demonstrate control awareness for your facilities, and how to leverage the data to reduce redundancies in validation or verification. It also details an efficient way to qualify disinfectants without impacting the quality of the study. The recommended program could be more robust than any individual approach developed in any one site.
As regulators now require thorough validation studies, the paper is not about why you need to do disinfectant efficacy, but how you do it so you can meet that regulatory challenge for study data and will help build a business case for change.

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