Driving the harmonization of regulatory requirements – one country at a time Regulations play a significant role in assessing marketing authorizations for drug products that are submitted for approval. Yet, regulatory agencies often differ in their degrees of harmonization. This has created an environment of divergence, in which countries each have unique standards, requirements, submissions […]
How do you justify your sample sizes for container closure integrity testing? Most leading biopharmaceutical companies do not routinely perform container closure integrity testing (CCIT) for each batch of a commercial product, but rely on a holistic approach to ensure the consistent integrity of the finished product. However, when sampling is required, scientifically valid approaches […]
Why we all stand to gain from harmonized electronic product information Electronic product information (ePI) is gaining increasing interest from many national and regional regulators, and there is a genuine desire to develop ePI solutions that add value to patients and healthcare providers. For example, EU legislators and regulators have published their views of the […]
Environmental monitoring (EM) programs are an effective tool in assessing the state of control in classified manufacturing areas. They are a vital part of the quality system in all modern drug production facilities and are scrutinized by regulatory agencies. However, designing an EM program is a relatively complex task; facilities vary considerably, there is inadequate […]
An iterative design of experiments (DOE) approach has traditionally been used to perform lyophilization cycle development at small and manufacturing scales. Unfortunately, this is resource-intensive and needs large amounts of material that can make it prohibitively expensive, particularly on a commercial scale. This often prevents the use of screening experiments required to identify the optimal […]
In normal conditions, regulatory inspections and audits are conducted on-site, with inspectors viewing operations, talking to staff and reviewing documents to ensure they meet requirements. However, travel and social restrictions due to the Covid-19 pandemic have forced regulatory inspections and audits of affiliates to be conducted remotely. This is a very different way of working […]
In a year unlike any other, BioPhorum takes a look at its achievements over the last few months, celebrating the growth and continued collaboration that helps the global biopharmaceutical industry navigate the challenges it faces. Watch this snapshot of highlights from 2020.
Container closure integrity testing (CCIT) is critical for ensuring the safety and efficacy of parenteral drug product presentations. Unfortunately, current technology has many deficiencies in testing capability and cannot meet all user needs or test the increasing range of products most companies routinely support. To encourage the development of optimized technologies for CCIT, BioPhorum has […]
Environmental monitoring (EM) data provides assurance that medicines made in an aseptic facility are safe for patients and that supply is not interrupted due to contamination issues. An EM program is a vital part of the quality system in modern drug production facilities and is scrutinized by regulatory agencies. Designing an EM program is a […]
Faced with the travel uncertainties caused by the pandemic and a backlog of inspections, remotely conducted health authority inspections and affiliate audits have become a necessity. With appropriate use of technology and after ironing out any initial problems, they could become part of the toolkit of the future. In response to this growing trend, a […]
Founded in 2008 with one Phorum, Drug Substance, the BioPhorum collaboration has focused on bringing leaders and SMEs together, mobilizing communities, creating partnerships and replacing isolation with collaboration. Now, BioPhorum is proud to announce Takeda as the 200th membership across its seven Phorums that represent the thriving communities of over 3,400 active participants. In joining BioPhorum […]
The use of technology in its many forms was a recurring theme in BioPhorum’s recent COVID-19 Workforce Protection Survey that was completed by the Senior BioPhorum Connect group, which consists of the leaders and sponsors from the BioPhorum communities. The survey assessed how industry was reacting to COVID-19 to identify and share best practices that […]
Pre-use post-sterilization integrity testing (PUPSIT) continues to generate considerable debate in the industry. Committing to a PUPSIT strategy is no mean feat because, while it is recommended by regulatory bodies, it may compromise downstream sterility and it is expensive to mitigate these risks. To help clarify industry thinking, the Sterile Filtration Quality Risk Management (SFQRM) […]
Several alternative and rapid microbiological methods (ARMM) are now available to detect and enumerate microbiological contamination. Regulatory authorities are encouraging the biopharmaceutical industry to adopt these innovative technologies – but the path is sometimes clouded. Although there are some guidance documents available, a holistic description of the entire end-to-end implementation process is still missing. This […]
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 […]
During the covid-19 pandemic, it is even more important that we connect, share information and help each other meet the unique challenges faced by our industry. The Senior BioPhorum Connect group – consisting of the leaders and sponsors from the BioPhorum communities – has been meeting online since April to discuss and adapt their responses […]
Excellence has always been at the heart of everything we do – from holding face-to-face meetings to publishing technical papers. Yet we are always looking to improve, which is why BioPhorum has launched a peer review process that will help make its papers even more robust and trustworthy. “The peer review process is designed to […]
How to learn about PUPSIT in terminal sterilizing filtration – the science, implications and implementation Pre-use post-sterilization integrity testing (PUPSIT) continues to generate considerable debate in the industry. Committing to a PUPSIT strategy is no mean feat because, while some regulatory bodies are asserting its need, it may compromise downstream sterility and it is expensive […]
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? […]
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 […]
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 […]
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 […]
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 […]
We are delighted that BioPhorum has been ranked in the fourth annual list of FT 1000 Europe’s Fastest Growing Companies. The project, run jointly by the Financial Times and Statista, ranks Europe’s private companies with the fastest-growing sales.
Since 2013, Ask BPOG has become a great asset for the industry, with more than 3,000 questions being posted and 11,000 responses given. BioPhorum’s member-only Q&A facility has helped companies benchmark their practices and has even helped them avoid some unwise decisions around investments.
How does your organization perform glove management? Are you following best practices and using standard industry terminology? Can you benchmark your procedures within your company or with your peers? Are you able to demonstrate a harmonized approach that gives confidence to regulatory inspectors?
Do you need to commit to a pre-use post-sterilization integrity test (PUPSIT) strategy? Is it a control needed for your product? If so, what is the best way to implement it?
These are questions that have been challenging operations and their filtration experts since the inclusion of PUSPIT in Annex 1. Finding the correct answers has become increasingly significant with the ongoing debate about the wording and interpretation in the current Annex 1 redraft.
How do we transition from large-batch manufacture to small-batch, high-value packaging runs? This is the question driving the discussion and scoping activities of the Fill Finish Secondary Packaging program that was agreed at the FF20 meeting in March 2019. After initially focusing its activities on aseptic filling and lyophilization, Phorum leaders decided to explore collaborative […]
“We sense fear of the unknown… yes, the future may appear scary, but the future of our industry needs us to act now.” These are the words of Stefan Merkle, Senior Director Sterility Assurance at Janssen at last year’s Fill Finish Technologies to Reduce Drug Release Times event (FF18). While this comment was in relation […]
From glove management and cleaning/disinfection to regulator expectations and technology solutions, the operation of isolators has become an increasing concern among members. The question was: how to address these issues?
At October’s PDA/BioPhorum meeting in Berlin, it was agreed that the Pre-Use Post-Sterilization Integrity Testing (PUPSIT) consortium would be renamed Sterile Filtration Quality Risk Management (SFQRM).
The BioPhorum Particulate Control Workstream has developed a standardized methodology and risk classification tool for particle classification in biopharmaceutical parenteral products. “The methodology reduces the potential exposure that industry might experience from regulators and demonstrates that companies have a strong scientific approach to how they assess risk and classify visible particles,” says Scott Ewan, Facilitator […]
This paper outlines different applications of modeling to freeze-drying of biopharmaceutical products at commercial scale. It also signals the intent of the BioPhorum collaboration to champion a wider adoption, and realize the full potential of modeling across the industry to standardize lyophilization practices, accelerate technology transfers and optimize operational performance. An Industry Perspective on the […]
The Stopper Quality team has identified a new methodology by which biopharmaceutical companies can measure levels of particulate contamination on elastomeric stoppers in a way which is sufficiently sensitive to meet current and future industry standards. A survey conducted by the workstream found inconsistencies across member companies in how they measure particulate contamination. The methods […]
Despite substantial literature on the topic, lyo modelling is under-utilized on commercial scale facilities. To help to remedy this situation, the BPOG Lyo team has begun writing a detailed paper that will include best practices and comprehensive advice on how to exploit a lyo model to accelerate process development, transfers and increase capacity. This paper […]