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How to solve the CCI puzzle

Container–closure integrity (CCI) is a vital patient-safety and product-efficacy aspect of parenteral biopharmaceuticals. The challenge is how to identify, qualify and maintain the appropriate methods to ensure CCI’s role in providing patient and regulatory confidence in these medicines. To describe an overarching approach to CCI and BioPhorum’s work in this area, Scott Ewan has written an article called A Holistic Approach to Container–Closure...

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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 addressing and...

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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: Working abstract for an industry white paper.

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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Removing human intervention in aseptic filling: Realizing the full potential of seamless integration of robotics in filling operations

The greatest source of contamination in any clean room are the humans who work there. Historically this has been controlled by a mixture of guidelines, best practices and regulations. Applied together these guidelines and practices manage and prevent human contamination in the pharmaceutical clean room. But, what happens if a human is no longer present? How do we define, manage and monitor clean rooms when no humans are there? Do we need new...

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BioPhorum contributes to the US Congressional drug wastage debate

A BioPhorum Fill Finish team has given its rationale for vial-size choices in the pharmaceutical development process to a National Academies of Sciences, Engineering, and Medicine (NASEM) consensus study committee. The NASEM committee is commissioned by the US Congress to examine federal healthcare costs, safety and quality concerns associated with discarded drugs resulting from weight-based dosing of medicines contained in single-dose vials....

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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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MedTech considers drug device challenges

Following a positive response to BioPhorum’s proposal for a new collaboration in the combination products space, representatives from eight BioPhorum member companies gathered in early May to agree a plan for developing a MedTech Phorum program. Ten stakeholders joined the kick-off call and brought more than 125 years of combination product experience spanning functions across the full product lifecycle, including device design and engineering,...

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Isolator best practices: Benchmark and analysis.

This benchmark details the current industry operating practices on gloves testing, surface disinfection and interventions in isolators. It includes the practices from 26 biopharma drug product sites from 14 member organizations. The survey has been used to share practices and consider the opportunities for joint improvement in the industry.

in more detail the survey compares glove inspection both visual and automatic integrity testing, disinfection and cleaning methods as we as the use of H2O2.  Interventions, their categorization, tracking and approval, operator qualification and the handling of door seal failures.

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