This paper proposes that shared and electronic data exchange (EDE) is a cornerstone of collaboration and innovation in the supply chain. The paper aims to demystify EDE, set out its importance for supply chain effectiveness, capture its benefits and help people understand the practical enablers.
Viewing related articles
This paper provides an overview of the current and near-future bioprocess supply situation and trends. This research provides insights into how the industry has adjusted as the Pandemic begins to abate.
This document communicates a strategic framework for solving technical problems relating to managing raw materials in the biopharmaceutical industry and encourages biopharmaceutical end-users and suppliers to work together to address specific raw material and end-user process needs. It highlights the importance of implementing industry solutions and sign-posts a range BioPhorum raw materials publications. These establish standard definitions, a common understanding of raw material requirements, and the importance of regulatory, quality, and supply chain links.
Jun 2022 | Cell & Gene Therapy, COVID 19, Deliverable, Deliverables Report, Development Group, Drug Substance, Fill Finish, Information Technology, Inline Monitoring and Realtime Release, POI - Drug Substance, Publication, Supply Partner, Technology Strategy
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.
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.
The biopharmaceutical manufacturing industry inbound supply chain strategic framework identifies the key five strategic objectives that will help drive operational excellence and improvements to solve some of the most important inbound supply chain issues for the industry over the next 2–5-years.
Serialization – challenges and good practices in packaging operations based on experience of track and trace systems
This paper provides an overview of points to consider and good practices relating to the most challenging areas identified following an industry benchmark on the serialization of sellable units. The purpose of this benchmark was to identify common industry challenges with serialization and to broaden the knowledge of good practice, industry capabilities and to identify the quickest route to implementation and compliance with global serialization requirements. The paper also seeks to encourage dialogue between industry, regulatory agencies, and track and trace system providers, by adding the unique perspective of secondary packaging customer, summarized after several years of using such serialization systems
This paper gives an overview of an accompanying risk assessment template and acts as a blueprint for industry. It will be useful for any organization new to continuous bioprocessing, while experienced companies can use it to benchmark their existing operations.The blueprint will accelerate the realization of commercial continuous biomanufacturing processes and signals to regulators that this is the direction of industry travel, with a consensus view of how it should be done.The control plan will help lower the implementation barrier for starting continuous bioprocessing and provide a better understanding of its needs for end-users and potential vendors as it aligns and standardizes the industry’s validation approach.
Drawing on their real-world experiences, a group of experts drawn from 28 BioPhorum member companies has provided guidance on the detailed working methods that support a successful remote inspection or audit; for example, how to manage information flows between the inspectors and the site subject matter experts’ team. With the impact of Covid-19 likely to be seen for the foreseeable future, virtual inspections may be required for some time. This guidance will help all stakeholders prepare and to avoid the potential problems of remote inspections and audits.
The checklist is a best practice checklist to define the recommended minimum required steps to generate a useful forecast. It is for companies moving towards mature demand forecasting practices, and biomanufacturers and suppliers with regular demand forecasting meetings. It should be used each time a new forecast is generated to ensure the key steps are carried out. The communications pack explains the recommended forecast and demand planning cycle of events, i.e. when you should sit down and talk, what you should talk about, what should be in the discussions, etc. This will help guide and structure the regular meetings between biomanufacturers and critical suppliers. Having a comprehensive framework for those meetings is essential, especially when discussing key materials. It includes everything from the minimum required agenda items and an action log template, to a forecast confidence ‘traffic light’ indicator and ‘hints and tips’ to get the most out of the pack.