This paper has been written to address the compliance challenges of RTRT and the continued compliance with GMP standards.  To evaluate these challenges, we have reviewed the current quality guidelines that apply to RTRT and considered the areas and activities that will be impacted by an RTRT process.
This paper describes use cases and their technical solutions for implementation of predictive maintenance solutions in the biopharmaceutical manufacturing environment. Predictive maintenance is a significant component of smart maintenance which comprises extra elements such as smart use of computerized maintenance management software (CMMS), digital twin technology etc.
The intent of this paper is to illustrate that the probabilistic nature of detection is well understood and it aims to dispel the misunderstandings associated with VI through illustrated examples and by highlighting that the probabilistic nature of inspection is recognized in multiple
regulatory guidance documents.
A BioPhorum member only survey to help gain further insight around how the industry is approaching scaling the production of AAV in suspension HEK- 293 cells from lab to commercial scale.
The purpose of this paper is to stimulate debate in the biopharmaceutical industry and to work toward industry-wide alignment on the creation and use of optimized and lean user requirement specifications (URSs) for equipment, facilities, utilities and systems qualification.
Biopharmaceutical supply chains have evolved beyond single-source manufacturing to a complex network of collaborations and partnerships between sponsors and contract organizations. However, the expectations for deeper integration and visibility, automation and flexibility have increased and the lack of a standard framework has led to bespoke solutions which are unsustainable. This paper explains the current approaches to connecting biomanufacturing organizations, and the key benefits of improved digital integration. It articulates principles and patterns in the form of a simple maturity model that can be used to assess current state and plan for a more digitally aligned future.
This paper gives a best practice recommendation for fingerprinting cell culture media. It includes a standardized analytical test method suite, a three-tier testing approach and flowcharts that guide the reader to choose a suitable media fingerprinting method based on their goals and the raw material properties.Â
This paper summarizes the industry position and aims to start a strategic discussion on this situation. It will help ensure we have a common language and understanding across industry. Looking ahead, we will emphasize shared learning, best practices, and retrospective investigations to improve long-range planning processes
A BioPhorum member survey to gather preliminary information from across the biopharmaceutical industry on the characterization and risk assessment of HCP using mass spectrometry.
A BioPhorum member only survey to share knowledge into how, why and when enzymatic activity assays are performed.