Development Group


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How to make in-use stability and compatibility studies a success

In-use stability and compatibility studies are often used in biotherapeutic development to assess biologic drugs with diluents and/or administration components. The studies are done in conditions that are relevant for the target route of administration (usually intravenous, subcutaneous, or intramuscular) to ensure that patient safety and product efficacy are maintained during clinical use. To understand the current industry position on these...

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Formulation team sweeps away barriers to sharing

Biopharmaceutical formulations often present as complex mixtures that can be sensitive to heat, light, and many other factors, all of which must be monitored and assessed. However, until recently, developers worked mostly independently, with only their own resources and expertize to develop those assessments and set acceptable parameters. Within BioPhorum, competing companies can work together and benefit from sharing information that...

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How to create a toolbox to assess your high-risk HCPs

Host cell proteins (HCPs) are process-related impurities derived from host cells that may co-purify with a biopharmaceutical drug product.   The detection, quantitation, and removal of HCPs from the final biotherapeutic process can be complex and some HCPs can be considered high-risk. They include those that are immunogenic, biologically active, or enzymatically active with the potential to degrade either product molecules or...

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BioPhorum launch new sustainability phorum

BioPhorum members have given us a clear message; to be an industry that supports sustainability is extremely important to them. With no other single organization providing ‘one voice’ for the industry, discussions have been gathering pace to launch a dedicated sustainability phorum. This will become the prime vehicle to translate high-level corporate statements and commitments into practical, on-the-ground, scalable and transferable solutions....

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How to overcome the hurdles of using small-scale models

Small-scale models (SSMs) are critical to biopharmaceutical process development, technology transfer, process characterization, and process validation. Demonstrating that an SSM represents the large-scale manufacturing system is also required by regulatory authorities.   However, while many biopharmaceutical companies are trying to implement qualified SSMs, there are many hurdles to overcome when designing, executing, and analyzing...

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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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Expedited development: Leveraging prior knowledge (PK) for marketing approval filings in accelerated settings

This presentation details the benchmark survey conducted by the member companies of the CMC Considerations for Expedited Development Point Share .  The purpose of the survey was to help members understand how companies are defining and using Prior Knowledge (PK) to support marketing approval (eg BLA) filings in accelerated settings. The survey was completed by 16 companies and covers 11 key questions including, types of data considered as PK, how PK is obtained and used, the form of PK, and perceived and real benefits

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Microchip electrophoresis and novel excipients: learnings and opportunities

Development Group’s (DG) mission focuses on better and faster process development of biopharmaceutical medicines. Formed in 2011, DG now has more than 700+ subject matter experts collaborating in teleconferences every month across 13 collaboration workstream topics. There are also three face-to-face meetings (currently virtual) throughout the year with subject matter experts and key opinion leaders collaborating on the key hot topics and...

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Start your procurement journey with the right approach to knowledge management

Many IT systems allow information capture, storage and retrieval. And with the advent of advanced analytics and ‘big data’, more and more data can now be connected. However, the way data is transformed into information and then knowledge requires careful consideration. This is why the BioPhorum Knowledge Management Workstream has published a User Requirements Specification for a Knowledge Management System for Use in a Biopharmaceutical Setting...

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