The COVID-19 pandemic has created unprecedented stress on supply chains in nearly every global manufacturing segment. Bioprocessing and healthcare have been hit especially hard as suppliers struggle to find materials to meet the demand for COVID vaccines and therapeutics. On top of ongoing non-COVID biologics projects being manufactured, this has created serious supply chain stress. The bioprocessing industry has been instrumental in addressing...
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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 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.
Jan 2021 | Cell & Gene Therapy, COVID 19, Covid-19, Deliverables Report, Development Group, Drug Substance, Fill Finish, Information Technology, Long Read, MediPhorum, Publication, Regulatory, Supply Partner, Technology Strategy
LONG READHow industry is reacting to the Covid-19 pandemicKeeping in touch with peers and colleagues has never been more important. Following the postponement of meetings such as the annual Executive BioPhorum meeting, coupled with the heightened need for communication between industry leaders, BioPhorum established the Senior BioPhorum Connect – a group for senior leaders to share ideas, discuss problems and find solutions to counter the...
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.
This article looks at the role of technology in the workplace and specifically how the Senior BioPhorum Connect group is addressing issues such as the use of remote working technologies, cyber security and digitizing the cGMP space.
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.
Lab of the Future: Manifesto: digital technology-based capabilities for the quality control (QC) lab of the future
Most quality control labs in biomanufacturing have not yet achieved digital transformation. Lab processes are often manual which is slow and leads to errors and variability as well as long lead times.
Now those traditional ways of working are further challenged by the drive towards inline monitoring and real time release testing, and by new cell and gene therapies with tiny batch sizes and short shelf-lives.
The lab of the future is digital and requires much stronger IT for demand management and process automation, increasingly informed by data analytics and connected to manufacturing operations. This will be enabled by stronger IT security and operations, systems interoperability and governance, and data aggregation using common models, analytics and visualization.
Huge changes in lab personnel skills and culture are needed to work with the systems and the data in these new ways.
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.