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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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Viral clearance:  Retrospective evaluation of cycled resin viral clearance studies

Viral clearance: Retrospective evaluation of cycled resin viral clearance studies

This paper sets out a retrospective analysis of industry data, comparing virus clearance in new and repeatedly cycled resins for two of the most commonly used chromatography steps in biopharmaceutical manufacturing: protein A and anion exchange. The vast data, collected over several decades from 12 member companies, was analyzed by the authors with the support of a statistician. The result is a coherent data set in an accessible, collated format.
The compelling conclusion of the paper is that viral clearance capability is not negatively impacted by resin cycling. This supports the view that viral clearance studies for repeatedly cycled resins are not necessary if appropriate cleaning methods are applied. Companies will be able to compare their own product-specific data with the collated data in the paper to provide an evidence-based rationale for health authorities and regulators for their own manufacturing processes.

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Development outsourcing: Balanced scorecard tool

Development outsourcing: Balanced scorecard tool

The measurement of contract development and manufacturing organization (CDMO) performance and relationship management is complex and challenging. This ‘members only’ balanced scorecard (BSC) tool is based on the experience and inputs of Merck Inc, Pfizer, Roche and Sanofi and provides a spreadsheet-based tool that subject matter expert can customize as required for use within their own organization.

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