This group supports the Environmental Protection Agency’s (EPA) efforts to protect public health and the environment through the Residual Risk and Technology Review (RTR) process and recognizes the
need to develop stringent emissions standards to mitigate any potential hazards posed by Ethylene Oxide (EtO) emissions. However, they are also cautious of the impact these changes may have on the availability and timely delivery of biotherapeutics to patients who rely on them. Biotherapeutics, including vaccines, therapeutics, and other life-saving medications, play a crucial role in improving patient health outcomes and saving lives. For the biopharmaceutical industry, EtO sterilization is a critical process used to ensure product safety and efficacy. The EtO Response team raised several concerns regarding the potential impact of the proposed rule changes on the biotherapeutics market. This document discusses the concerns.
Supply Chain to Patient
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BioPhorum GS1 position paper
Jul 2023 | Deliverable, Deliverables Report, POI - Supply Chain to Patient, Publication, Supply Chain to Patient
This BioPhorum member only paper provides an overview of the GS1 system of standards and its importance. It emphasizes that through wider industry adoption the GS1 system of standards has the potential to greatly improve communication, data sharing, and safety in the healthcare and pharmaceutical industry.
Supply chain constraints benchmarking survey
Apr 2023 | Benchmarking, Deliverable, Deliverables Report, POI - Supply Chain to Patient, Supply Chain to Patient
This BioPhorum member only survey explores the challenges of the internal supply chain and the impact they are having on the business. One key theme that appeared to be emerging is that internal resource is a constraint within the supply chain for many companies.
BioPhorum environmental sustainability roadmap 2022
Dec 2022 | Cell & Gene Therapy, Deliverable, Deliverables Report, Development Group, Drug Substance, Fill Finish, Information Technology, MediPhorum, POI - Sustainability, Publication, Regulatory, Supply Chain to Patient, Supply Partner, Sustainability, Technology Strategy
Climate change and global warming resulting from greenhouse gas emissions are widely recognized as the biggest threats to global health. The healthcare sector is responsible for 4–5% of global emissions, more than 70% of which are driven by supply chains.
CGT Viral clearance validation aspects
Oct 2022 | Benchmarking, Cell & Gene Therapy, Deliverable, Deliverables Report, Supply Chain to Patient, Validation
A BioPhorum member only survey to understand viral purification and clearance practices member companies are undertaking in CGT.
Secondary Packaging: Electronic product information
Mar 2021 | Deliverable, Fill Finish, POI - Supply Chain to Patient, Publication, Regulatory, Supply Chain to Patient
BioPhorum has created a structure and approach to respond to the challenge of developing ePI solutions that add value to patients and healthcare providers alike highlighting the benefits and challenges of the broad range of factors surrounding the design and implementation of ePI, supporting the objective of finding a solution that can be implemented globally . The packaging perspective on ePI is simple: agree on an ePI format, and packaging functions can agree on how to apply it to product packaging. This paper looks at the opportunities and challenges and recommends the adoption and use of GS1 standards and recommendations both to meet supply chain and point of care needs and as a way to harmonize implementation of regulatory requirements.
Logistic service provider (LSP) integration
Sep 2019 | Deliverable, Information Technology, POI - Supply Chain to Patient, Publication, Supply Chain to Patient
Many biomanufacturers use a network of logistics service providers (LSPs) to deliver warehousing, transport and distribution services. Typically linked using customized, electronic, point-to-point connections. These connections can be expensive and slow to set-up and expensive to update in response to changing market demands. There is no dominant technical solution that monitors the condition and location of shipments, and that enables companies to adopt different solutions for different regions and partners. There is a need to raise the awareness of software vendors of this unmet need and the real interest of many industry stakeholders if a suitable LSP integration solution was available.
This paper provides an overview of the current needs of manufacturers and their technical integration with their network of LSPs. It contains a high-level requirements specification for a common, cloud-based, integration platform, that would reduce customization and multiple point-to-point solutions. The specification is designed to help technology companies develop this services. Informal benchmarking across member companies indicates that ‘collaboration hub’ use would deliver a 50–70% saving in time and cost when linking to a new partner. These benefits would be realized by both partners making the new connection.
Transport: Best practice on transport qualification: good distribution practice
Jul 2019 | Drug Substance, POI - Supply Chain to Patient, Publication, Supply Chain to Patient
Shipping lane validation or qualification of thermal protection systems is not a simple task. Each pharmaceutical company and regulatory body use different standards leading to inconsistency. Vendors also do not have a standard for the specific tests that customers require. This absorbs huge amounts of resources for qualification testing, where work is unnecessarily repeated and existing data is not leveraged. To address this, the guidance details a best practice for standardized shipping lane validation that can deliver an annual saving of between $0.5m and $1m per shipping solution, a 50% reduction in resource requirements, and a reduction in product submission timelines by as much as 6-12 months.