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Justification of small-scale models: an industry perspective

Justification of small-scale models: an industry perspective

Small-scale models (SSMs) are widely used in the biopharmaceutical industry. These models are used for process development and optimization, scale-up, technology transfer, process characterization, process validation, virus clearance studies, and resolution of deviations encountered during manufacturing throughout a product’s lifecycle. SSMs are also referred to as ‘scale-down models’ or ‘scaled-down models’. Demonstration that an SSM is representative of the large-scale manufacturing system is called ‘small-scale model qualification’ (SSMQ), which is sometimes also referred to as ‘assessment’, ‘evaluation’, or ‘verification’. The demonstration is an important task that supports process validation and is required by regulatory authorities. However, design, execution and analysis of SSMQ studies can be challenging due to the lack of clear guidance on current best practices. This white paper provides options and tools for design, execution, and data analysis of SSMQs together with illustrative case studies.

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

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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Trends in outsourcing of CMC development services for biologics

Trends in outsourcing of CMC development services for biologics

The interplay, engagement and interactions between Sponsor and C(D)MO are frequently considered, presented and discussed at the BioPhorum Development Group, a gathering of more than 20 global biopharmaceutical companies, representing both Sponsor and C(D)MO organizations, with a focus on chemistry, manufacturing and controls (CMC)-related clinical biopharmaceutical development, testing and manufacture. This self-survey was aimed at understanding outsourcing approaches and governance and focused on analytical development and testing, process development and manufacturing, project management and governance and quality system and regulatory support. From the aggregate survey responses in each area, key trends were identified, providing insights to potential best practices

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

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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Knowledge mapping for the biopharmaceutical industry: A test case in CMC business processes from late-stage development to commercial manufacturing (paper and tool)

Knowledge mapping for the biopharmaceutical industry: A test case in CMC business processes from late-stage development to commercial manufacturing (paper and tool)

The management of knowledge in biopharmaceutical organizations has been recognized as an important challenge over recent years. Defining the pain points and designing successful knowledge management (KM) solutions have proven difficult. To address this challenge, BioPhorum Technology Roadmapping applied a KM best practice methodology to capture a process-based knowledge map for a major business process; this was performed by companies who develop and commercialize new therapies. The resulting assessment of knowledge flows revealed that there are significant challenges to both explicit and tacit knowledge flow across the control strategy and method development / technology transfer processes. Some generalized solutions have been proposed. As part of this work, a detailed spreadsheet tool was developed so that organizations can repeat this work on their business processes to understand their knowledge–flow issues and develop fit-for-purpose solutions.

The knowledge mapping tool is available here. Detailed instructions are available within the tool itself. The data in the sheet reflects that used in the illustrative example documented in the companion paper. The data is intended to be removed and replaced with end users data in support of their own KM efforts.

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Forced degradation studies (FDS): An industry perspective on forced degradation studies of biopharmaceuticals: survey, outcome and recommendations

Forced degradation studies (FDS): An industry perspective on forced degradation studies of biopharmaceuticals: survey, outcome and recommendations

Forced degradation studies (FDSs) are often used in biotherapeutic development to assess criticality of quality attributes and in comparability studies to ensure product manufacturing process consistency. To gain an understanding of current industry approaches for FDS, the BioPhorum Development Group–Forced Degradation Point Share group conducted an intercompany collaboration exercise, which included a benchmarking survey and group discussions around FDS of monoclonal antibodies. The results of this industry collaboration provide insights into the practicalities of these characterization studies and how they are being used to support the product lifecycle from innovation to marketed products. The survey requested feedback on the intended purpose, materials, conditions, number and length of time points used, and analytical techniques carried out to give a complete picture of the range of common industry practices. This article discusses the results of this global benchmarking survey across 12 companies and presents these as a guide to a common approach to FDS across the industry which can be used to guide the design of FDS based on chemistry and manufacturing control product life-cycle and biomolecule needs.

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Registered content for S.4.2 analytical procedures

Registered content for S.4.2 analytical procedures

Delivered at BioProcess East, Boston, September 2019, this presentation details the conclusions from a survey and discussions about this topic. Designed, completed and discussed by 14 leading biopharmaceutical companies of the CMC Regulatory subteam, the purpose of the survey was to determine companies’ approaches to S.4.2 section content. More specifically what content different companies providing within each subsection of S.4.2 for non-compendial methods, understand to what extent the level of information provided in core dossiers can be aligned between countries, to minimize the need for global document lifecycle management and if specific feedback from any countries been provided to indicate what content is required?

This document is reserved for the use of BioPhorum Members only

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Bioassay development: Best practices in bioassay development to support registration of biopharmaceuticals:  Presentation

Bioassay development: Best practices in bioassay development to support registration of biopharmaceuticals: Presentation

This is a companion presentation to the paper Best practices in bioassay development to support registration of biopharmaceuticals has been written by members of BioPhorum Development Group Bioassay workstream and published online in BioTechniques in September 2019.

Available on to members of the phorum only was presented at USP’s 8th Bioassay workshop and at the PEGS Summit program at BioProcess International. Boston MA, Sept 2020.

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Bioassay development: Best practices in bioassay development to support registration of biopharmaceuticals

Bioassay development: Best practices in bioassay development to support registration of biopharmaceuticals

Biological activity is a critical quality attribute for biopharmaceuticals, which is accurately measured using an appropriate relative potency bioassay. Developing a bioassay is a complex, rigorous undertaking that needs to address several challenges including modelling all of the mechanisms of action associated with the biotherapeutic. Bioassay development is also an exciting and fast evolving field, not only from a scientific, medical and technological point of view, but also in terms of statistical approaches and regulatory expectations.
This paper discusses how bioassays are developed, challenges current thinking and discusses the benefits of different practices, and details a very practical industry-wide approach to the best practices for developing, implementing and maintaining cell-based assays.

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