Using a closure analysis method to reduce CGT contamination risks
Many cell therapy manufacturing processes use open unit manipulations. As a result, they are at risk of potential contam...
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Supporting particle investigations with risk-based decision-making
Jan 2022 | Fill Finish, News
BioPhorum’s Visual Inspection workstream has invested considerable time and effort to add clarity to the uncertainty around how to assess the risk of atypical particles during investigations. The team’s Standardized methodology to support particle investigations and classification in biopharmaceutical parenteral products was recently published by BioPhorum and provides practical, risk-based guidance to support the decision-making process....
Meeting the challenges in serialization to win in the battle against counterfeiting
Sep 2021 | Fill Finish, News
The World Health Organization (WHO) estimates that medicine counterfeiting causes one million deaths a year and that 10% of all drugs sold globally are fake. Events such as Covid-19 increase these risks by disrupting the supply chain and increasing internet purchases. A key weapon in the battle against counterfeiting is track and trace (T&T), which is the ability to track and trace products through a supply chain – with ‘track’...
Connecting vision systems with how the patient reads a label
Sep 2021 | Fill Finish, News
The packaging of pharmaceutical products is regulated in most countries. Authorities expect that any printed information – such as product, use and storage data on the packaging material artwork or batch-specific data (e.g., expiration date) – is readable by the patient. Batch-specific data is commonly checked by vision systems using optical character verification. Pharmaceutical companies must be able to document traceability...
BioPhorum launch new sustainability phorum
Jul 2021 | Cell & Gene Therapy, Development Group, Drug Substance, Fill Finish, Information Technology, MedTech, News, Regulatory, Supply Partner, Technology Roadmapping
BioPhorum members have given us a clear message; to be an industry that supports sustainability is extremely important to them. With no other single organization providing ‘one voice’ for the industry, discussions have been gathering pace to launch a dedicated sustainability phorum. This will become the prime vehicle to translate high-level corporate statements and commitments into practical, on-the-ground, scalable and transferable solutions....
How to perform aseptic process simulation for lyophilized products
May 2021 | Fill Finish, News
Proposed 2020 revisions to EU Annex 1 around aseptic process simulation (APS) for lyophilized products have prompted extensive discussions on the need for clear best practices for the process simulation of the lyophilization unit operation. To address these expectations, BioPhorum has written an article called A better approach to aseptic process simulation for lyophilized products, which presents a risk-based, holistic best...
PUPSIT: identifying risks and preventive controls
Jul 2020 | Fill Finish, News, Sterile Filtration QRM & PUPSIT
Pre-use post-sterilization integrity testing (PUPSIT) continues to generate considerable debate in the industry. Committing to a PUPSIT strategy is no mean feat because, while it is recommended by regulatory bodies, it may compromise downstream sterility and it is expensive to mitigate these risks. To help clarify industry thinking, the Sterile Filtration Quality Risk Management (SFQRM) Consortium is sharing its knowledge and expertise on...
Alternative and rapid micro methods (ARMM): A framework for the evaluation, validation and implementation of alternative and rapid microbiological testing methods
Jul 2020 | Fill Finish
There are now available to the biopharmaceutical industry several alternative and rapid microbiological methods (ARMMs) for the detection and enumeration of microorganisms during testing. Regulatory authorities are encouraging the biopharmaceutical industry to adopt innovative technologies. Together these methods will lead to improved monitoring and assurance of control of biopharmaceutical processes and manufacturing environments, as well as shortened cycle times in the supply chain. This paper addresses the need for a systematic and best practice approach to the evaluation, validation and deployment of these methods. The absence of such best practice has hindered the adoption of ARMMs, resulting in slow adoption. A nine-step framework and common language is described which can be applied by biopharmaceutical companies wanting to take advantage of the numerous benefits of ARMMs.
PUPSIT and the annex one revision
Jul 2020 | Fill Finish, Sterile Filtration QRM & PUPSIT
This article presents an update on the efforts of the joint PDA and BioPhorum collaboration workstreams—masking studies, historical data mining, filter manufacturing and use risk assessments and PUPSIT risk assessment and the development of a best practice guide.
SFQRM: Test process and results of potential masking of sterilizing grade filters
Jul 2020 | Fill Finish, Sterile Filtration QRM & PUPSIT
This paper is one in a series of publications that are the result of the collaboration, and these should be considered together and viewed holistically in order to determine the best course of action with regard to PUPSIT. This paper examines the test process and looks at the results of potential masking of sterilizing grade filters.
SFQRM: The use of scientific data to assess and control risks associated with sterilizing filtration
Jul 2020 | Fill Finish, Sterile Filtration QRM & PUPSIT
This article draws conclusions from the scientific studies, workstreams, and publications delivered by the Sterile Filtration Quality Risk Management (SFQRM) consortium formed between BioPhorum and PDA. It uses those conclusions to provide guidance to industry (sterile drug manufacturers, filter suppliers, and regulators) on the use of quality risk management principles and scientific data to prevent undetected non-integral sterilizing filters.