Analytical instrument vendors have been integral to developing and publishing our technology roadmaps and developing product monitoring requirements and proof-of-concept activities. As the biomanufacturing community moves to adopt recommendations in BioPhorum’s Technology Roadmapping roadmap vision, senior leaders recognize that including vendor partners in extended programs will greatly improve the integrity,...
As technologies become available that allow us to better monitor and understand manufacturing processes, quality professionals will be able to make decisions more quickly, so lead times will shorten. As analytical testing moves from the traditional quality control (QC) laboratory to the production floor, one of the challenges is how to ensure the required independence of QC from production. However, current good manufacturing practice (GMP)...
Industry research indicates that using smart maintenance could mean manufacturers and suppliers in the chemical and pharmaceutical industries gain 5–15% in plant up-time and reduce maintenance costs by 18–25%. Reports also suggest a 5–20% downtime reduction and a 10–40% maintenance cost reduction. Yet, while predictive maintenance technology is already advancing in the chemical industry, especially with retrofit solutions in aging continuous...
There is a common misunderstanding that 100% visual inspection (VI) of biopharmaceutical products should mean 100% detection of defects. This idea is repeated across geographies and arises within companies and externally (e.g., during internal audits and regulatory reviews). Yet if you routinely work in VI, you know the process is inherently probabilistic and so, despite all units of a product undergoing full VI, identifying all defects is not...
Have your outbound supply chain costs increased? Do you want to leverage data and digital technologies more effectively to reduce complexity and risk in your outbound supply chain? Want to be instrumental in developing the biopharmaceutical supply chain of the future? Well, now you can, by being part of our new Supply Chain to Patient Phorum. The complex nature and multiple challenges of the outbound supply chain make meaningful changes across...
A user requirement specification (URS) for equipment, facilities, utilities and systems should define all the requirements needed to create a feasible design to meet a system’s purpose. It should ensure that essential quality elements are built-in and any risks to good manufacturing practice, product quality, and patient safety are mitigated. Success relies on a clear, shared, industry-wide understanding of definitions and requirements.
Viral clearance studies are mandated as part of the viral safety evaluation of products derived from human or other mammalian cell lines. When acceptable ranges of process parameters are known, the ICH and EMA recommend that scale-down models are evaluated under worst-case conditions for viral clearance. To identify operating parameters that are commonly considered to present worst-case conditions for viral clearance, our Development Group...
Accelerating industry progress with the new BioPhorum Council
BioPhorum is built on a foundation of providing value to members that benefits industry and, ultimately, the patient. Value comes in many forms, from simply sharing experience and knowledge to co-developing industry-changing recommendations and best practices and providing regulators with ‘one voice’ for change.
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. There is therefore an increasing need to focus on reducing emissions across our sector. Many organizations have set or aligned with science-based targets, requiring them to work with their...
Developing high-dose biologic drugs for subcutaneous injection often requires high-concentration formulations. It also needs to optimize viscosity, solubility, and stability while overcoming analytical, manufacturing, and administration challenges. To understand industry approaches for developing high-concentration formulations, we conducted several surveys that provide an industry perspective and a summary of experience and insight into the...