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.
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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.
Covid-19: Reference for COVID-19 viral control strategy in the biological manufacturing industry – industry position on the FDA guidance
This paper provides an in-depth exploration of the characteristics of SARS-CoV-2 (the virus) and COVID-19 (the disease). It also discusses how likely these may impact current control strategies that maintain product quality, safety and efficacy in the biopharmaceutical industry. It covers the areas that need to be assessed by biomanufacturers regarding SARS-CoV-2 risks for their patients, employees and products. Mitigation actions for the risks and associated benefits are also proposed. Just as importantly, it also discusses the areas that do not need to be evaluated – as current control strategies for endogenous and exogenous viruses, standards of work and the GMP framework are appropriate to prevent SARS-CoV-2 impacting on product. This is the case when the characteristics of SARS-CoV-2 do not make it unique when compared to the existing controls in place.
BioPhorum has developed a risk-based deviation management system (DMS). 13 member companies have implemented this approach, and summary data from these companies shows improved quality performance plus an average time saving of 22,200 work hours per site per year, which is equivalent to a $888k cost saving.
This guide outlines the work of the BioPhorum DMS Workstream in defining and creating a simplified and effective risk-based deviation management system with advanced RCA methodologies, and a track-and-trending process of low-risk events. It includes everything required to build a risk-based approach to DMS, including the business case for change, the new process, risk-based tools, and a detailed sharing of post-implementation benefit.
Jul 2020 | COVID 19
BioPhorum’s covid-19 Workforce Protection Survey was completed by the Senior BioPhorum Connect group, consisting of leaders and sponsors from the BioPhorum communities. It assessed how industry was reacting to covid-19 to identify and share best practices that would help guide its reaction to the crisis. This article looks at the detail of return to work (RTW) and asks specific questions on how the Senior BioPhorum Connect group is addressing issues such as the RTW criteria, phased approaches and a possible ‘return to lockdown’.
This paper characterizes this framework, and the associated mixed environments, to illustrate the drivers and success metrics for the key functions of business management of information systems, and that of plant-floor instrumentation and controls engineering. For people working in this arena, this paper will help develop an understanding of this landscape and foster a cooperative approach to implementing network resilience and cybersecurity solutions that allow more robust and secure delivery of essential drug products to the market.
As the maturity of digital manufacturing plants increases, so does the risk of a cybersecurity or other digital incident. A successful phishing attack, for example, could adversely impact manufacturing operations and potentially take a facility offline for hours, days or even longer. A company’s ability to minimize the risk of a digital disaster in its manufacturing plants, and quickly restore operations if one occurs, is a vital area for investment to ensure delivery of drug products to patients. To do this, biopharmaceutical manufacturers must understand the cyber resilience at their differing plants and how each site fits into the context of their overall business.