Deliverable

Viewing related articles

Discussion on plasmids to establish release specifications using a risk-based approach to manage supply

Discussion on plasmids to establish release specifications using a risk-based approach to manage supply

This paper shares industry feedback after the publication of two BioPhorum papers that complement ongoing efforts in the wider CGT field. It supplements these publications by delving into identity testing and cross-contamination for plasmid master cell banks and plasmid DNA, and other plasmid DNA release tests (including DNA homogeneity, residual DNA and host RNA, and sterility or bioburden).

read more
Alternative adventitious agent detection methods in biopharmaceuticals: A proposal for a structured best practice approach for their evaluation, validation, and implementation

Alternative adventitious agent detection methods in biopharmaceuticals: A proposal for a structured best practice approach for their evaluation, validation, and implementation

This paper addresses the need for a systematic and best practice approach to the evaluation, validation and implementation of these methods related to adventitious agents testing to support the adoption of alternative adventitious agent testing (AAT) methods. A nine-step framework and common language are described which can be applied by biopharmaceutical companies wanting to take advantage of the numerous benefits of ARMMs and alternative AATs.

read more
Operational vision: Adoption of in-line monitoring and real-time release

Operational vision: Adoption of in-line monitoring and real-time release

Historically, the biopharmaceutical industry has relied on traditional pharmaceutical manufacturing practices to make and release products. This publication examines the future of biopharmaceutical manufacturing by presenting the vision of fully implemented in-line monitoring (ILM) and real-time release. This aspirational vision includes full ILM, predictive analytics and advanced process controls (APC) enabling release of product in real time, with concomitant predictive and preventative alerts and resolution of process, equipment and other production issues.

read more
Supply chain quality management optimal process and RACI

Supply chain quality management optimal process and RACI

These tools support sharing the optimal high-level steps to simplify a process and invite people into the discussion using a common language. The optimal process outlines the essential process steps and for each one lists the ‘who’ (i.e., which role) and the ‘how’ (i.e., what medium). The RACI supports people to understand where accountabilities and responsibilities lie.

read more
Accelerating multi-product biopharmaceutical manufacturing facility project lifecycle through modular design

Accelerating multi-product biopharmaceutical manufacturing facility project lifecycle through modular design

This paper uses a standardized, modular design and construction approach the benefits of a modular design approach to a multi-product viral vector (VV) facility at late-clinical/early-commercial scale, showing how significant speed benefits can be gained at each stage of facility design, procurement, construction, qualification and operation.

read more
Media and hydrolysates

Media and hydrolysates

This paper discusses the issues around trace elements and gives a suggested approach for developing a method for analyzing trace elements in cell culture media and hydrolysates. The approach is based on a ground breaking BioPhorum collaboration that shared blinded data and compared analytical methods between biopharmaceutical and media manufacturers.

read more