Formulation

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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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“High-risk” host cell proteins (HCPs): A multi-company collaborative view

This database and paper provide a comprehensive review and list of potential problematic HCPs that could impact the safety, efficacy, and quality aspects of CHO-produced biologics during their development and manufacturing. They provide a reference on the best practice and control strategy for “high-risk” HCPs” in the biopharmaceutical industry.

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Formulation: An industry perspective on compatibility assessment of closed system drug-transfer devices for biologics

BioPhorum Formulation Workstream has identified the increased use of closed system drug-transfer devices (CSTDs) with biologics, without an associated compatibility assessment, to be of significant concern. The use of CSTDs has increased significantly in recent years due to the recommendations by NIOSH and USP that they be used during preparation and administration of hazardous drugs. While CSTDs are valuable in the healthcare setting to reduce occupational exposure to hazardous compounds, these devices may present particular risks that must be adequately assessed prior to use to ensure their compatibility with specific types of drug products, such as biologic drugs, which may be sensitive. The responsibility of ensuring quality of biologic products through preparation and administration to the patient lies with the drug product sponsor. Due to the significant number of marketed CSTD systems, and the large variety of components offered for each system, a strategic, risk-based approach to assessing compatibility is recommended herein. In addition to traditional material compatibility, assessment of CSTD compatibility with biologics should consider additional parameters to address specific CSTD-related risks. In this paper published in the Journal of Pharmaceutical Sciences the Workstream has proposed a systematic risk-based evaluation approach as well as a mitigation strategy for establishing suitability of CSTDs for use.

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How to assess the risks of using CSTDs for biologics

The use of closed system drug-transfer devices (CSTDs) has increased significantly in recent years due to the United States Pharmacopeia and the National Institute for Occupational Safety and Health recommending that they be used during the preparation and administration of hazardous drugs. However, while they help reduce occupational exposure to harmful compounds, CSTDs have risks that must be properly assessed before use to ensure they are...

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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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The BioPhorum and USP collaborative journey to new standards

BioPhorum and United States Pharmacopeia (USP) share a common direction – to accelerate biopharma innovation, quality and progress through collaboration. To this end, USP is engaging with industry to understand its pain points, its challenges and where there is the potential for new standards. “We have been looking at what additional standards we can develop that aren’t necessarily the traditional USP product-specific standards, but that would...

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Formulation: Surfactants in biologic formulations survey

This blinded survey was devised and completed by 11 companies, compares and explores the use of surfactants in biologic formulations.  In total the responsants covered 59 different questions in such areas as, general use of surfactants, polysorbate raw material, polysorbate handling for GMP manufacture, polysorbate degradation, specifications, poloxamer and health authorities interactions.

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