This poster recently presented at CASSS Bioassay and BEPA describes selected results of an industry collaboration to encourage discussion on common approaches to ready to use (RtU) for bioassays cell manufacturing, testing and implementation across the industry.
POI - Development Group
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Speed to clinic benchmarking survey final report
Apr 2022 | Accelerate CMC Development to Marketing Application, Benchmarking, COVID 19, Deliverable, Deliverables Report, Development Group, POI - Development Group, Publication
A comprehensive benchmarking survey aimed at collating data on the technical practices involved in therapeutic protein production and evaluation of if/how this has changed in response to the COVID-19 pandemic.
Slide Deck – Forced degradation studies (FDS): An industry perspective on common practice in forced degradation studies of biopharmaceuticals
Jun 2021 | Deliverable, Forced Degradation Studies, POI - Development Group, Webinars and podcasts
The slides that support the webinar presentation ‘An industry perspective on common practise in forced degradation studies of biopharmaceuticals’, presented on 15 June 2021.
Justification of small-scale models: an industry perspective
May 2021 | Deliverable, Development Group, POI - Development Group, Publication, Qualification of Small-Scale Models
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.
Trends in outsourcing of CMC development services for biologics
Jan 2021 | CMC Regulatory, Deliverable, Development Group, POI - Development Group, Publication
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
Monoclonality: Implementation of plate imaging for demonstration of monoclonality in biologics manufacturing development
Jul 2018 | COVID 19, Development Group, POI - Development Group
In the manufacture of biologics produced in mammalian cells, one recommendation by regulatory agencies to help ensure product consistency, safety, and efficacy is to produce the material from a monoclonal cell line derived from a single, progenitor cell. The process by which monoclonality is assured can be supplemented with single-well plate images of the progenitor cell. In this paper the BioPhorum Monoclonality team highlight the utility of that imaging technology, describe approaches to verify the validity of those images, and discuss how to analyze that information to support a biologic filing application. This approach serves as an industry perspective to increased regulatory interest within the scope of monoclonality for mammalian cell culture–derived biologics
Host cell protein (HCP): Risk assessment tool and papers
Jun 2018 | Development Group, Host Cell Protein, POI - Development Group
Host cell protein (HCP) constitutes a significant class of process-related impurities in biological drugs. The complexity and diversity of residual HCP composition in biologics and the incomplete understanding of their potential impact also pose unknown risks besides some of the well-known risks from certain problematic HCPs. This can make the HCP risk assessment and management an industry-wide challenge.
Although attempts have been made to address these challenges in the biopharmaceutical industry, gaps still remain in terms of how to manage the risks associated with HCP during bioprocess development. To this end, a BioPhorum Development Group (BPDG) HCP working team consisting of several companies initiated a collaboration among its members to align industry best practices and generated a generic risk assessment tool to manage HCP-related risks identified during biologics development from both an assay development and process development perspective.
Distinct from individual HCP identity-based safety risk assessment, this tool focuses on the manufacturing process through process development. The tool will help companies to tackle the risks associated with HCP within the development lifecycle. The intent the tool is to provide a template in order to guide process development teams using a scientific knowledge-based risk control strategy, where process or assay changes may be deemed necessary to reduce the risks caused by inadequate removal of HCP upon experimental studies to assess impact of HCPs on product safety, efficacy, and stability.
Companies implementing this risk management model can apply their own unique set of circumstances, products and experience to perform a more comprehensive and robust assessment of risk, identify the priority in which risk reduction steps should be applied.
Expedited development: An overview and discussion of how accelerated scenarios impact CMC workflows and strategies
Mar 2018 | Development Group, POI - Development Group
This poster summarizes thoughts of the CMC Considerations for Expedited Development Point Share team on opportunities and challenges of CMC development under accelerated registration pathways and includes some proposes for unconventional approaches for accelerated development. With a focus on breakthrough therapy and based on a benchmarking survey, discussions around the tiered requirements for CMC sections by eCTD subchapters, as well as risks associated with the acceleration options. The results of this industry collaboration reveal several key common approaches such as risk-based approach and leveraging platform knowledge.
Formulation: An intercompany perspective on biopharmaceutical drug product robustness studies
Feb 2018 | Development Group, Fill Finish, POI - Development Group
To gain a better understanding of current industry approaches for establishing biopharmaceutical drug product (DP) robustness, the BPDG-Formulation Workstream conducted an intercompany collaboration exercise, which included a benchmarking survey and extensive group discussions around the scope, design, and execution of robustness studies. The results of this industry collaboration revealed several key common themes: (1) overall DP robustness is defined by both the formulation and the manufacturing process robustness; (2) robustness integrates the principles of quality by design (QbD); (3) DP robustness is an important factor in setting critical quality attribute control strategies and commercial specifications; (4) most companies employ robustness studies, along with prior knowledge, risk assessments, and statistics, to develop the DP design space; (5) studies are tailored to commercial development needs and the practices of each company. Three case studies further illustrate how a robustness study design for a biopharmaceutical DP balances experimental complexity, statistical power, scientific understanding, and risk assessment to provide the desired product and process knowledge. The team discusses identified industry challenges with regard to biopharmaceutical DP robustness and presents some recommendations for best practices.