Drug Substance​
News
Why BioPhorum’s trace element approach will save you time, money and wasted batches
Drug products can be heavily impacted when raw materials cause variability – anecdotal evidence suggests that batches ...
How to understand and mitigate the problem of trace element variation
A reliable supply of life-saving drugs requires understanding and mitigating any variability to support consistent suppl...
Boosting training in single-use technologies through vendor and end-user collaboration
Collaboration in BioPhorum can bring many benefits to member companies. There are the usual cost and schedule...
Taming the documentation beast using the power of human performance
Documentation is one of the most pervasive and inescapable facets of our highly regulated industry. Documents drive ever...
The four steps for registering innovative and complex raw materials
The Covid-19 pandemic has put extra strain on an already stretched biopharmaceutical supply chain. As industry has grown...
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...
How to replenish working cell banks with a risk-based scientific approach
Cell banks represent the fundamental starting substrates for biological drug substance/drug substance intermediate manuf...
BioPhorum’s Deliverables Report 2021 – all of our content at your fingertips
Where can you read about industry trends, progress against shared challenges, and best practice solutions...
Harmonizing the industry and improving confidence through risk-based microbial testing
LONG READHarmonizing the industry and improving confidence through risk-based microbial testingThe integrity of...
With net zero the ultimate target, how can the industry work together to usher in a sustainable future?
As the 26th UN Climate Change conference takes place in Glasgow, what part is BioPhorum playing to help the industry ach...
The Spontaneous Infection: Did you leave the back door to your cultivation suite open?
In Shared clean-in-place systems: To share or not to share? and How much harm can a single droplet do? Consideratio...
Steps to eradicate undetected contaminations in anaerobic testing
All biopharmaceutical manufacturers have a legal obligation to monitor the microorganisms that are found ...
Why BioPhorum’s trace element approach will save you time, money and wasted batches
Drug products can be heavily impacted when raw materials cause variability – anecdotal evidence suggests that batches worth millions of dollars are sometimes discarded due to trace elements coming through the supply chain. Not only does this increase costs and significantly impact production sched...
How to understand and mitigate the problem of trace element variation
A reliable supply of life-saving drugs requires understanding and mitigating any variability to support consistent suppl...
Boosting training in single-use technologies through vendor and end-user collaboration
Collaboration in BioPhorum can bring many benefits to member companies. There are the usual cost and schedule...
Taming the documentation beast using the power of human performance
Documentation is one of the most pervasive and inescapable facets of our highly regulated industry. Documents drive ever...
The four steps for registering innovative and complex raw materials
The Covid-19 pandemic has put extra strain on an already stretched biopharmaceutical supply chain. As industry has grown...
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...
How to replenish working cell banks with a risk-based scientific approach
Cell banks represent the fundamental starting substrates for biological drug substance/drug substance intermediate manuf...
BioPhorum’s Deliverables Report 2021 – all of our content at your fingertips
Where can you read about industry trends, progress against shared challenges, and best practice solutions...
Harmonizing the industry and improving confidence through risk-based microbial testing
LONG READHarmonizing the industry and improving confidence through risk-based microbial testingThe integrity of...
With net zero the ultimate target, how can the industry work together to usher in a sustainable future?
As the 26th UN Climate Change conference takes place in Glasgow, what part is BioPhorum playing to help the industry ach...
The Spontaneous Infection: Did you leave the back door to your cultivation suite open?
In Shared clean-in-place systems: To share or not to share? and How much harm can a single droplet do? Consideratio...
Steps to eradicate undetected contaminations in anaerobic testing
All biopharmaceutical manufacturers have a legal obligation to monitor the microorganisms that are found ...
How to appropriately classify your cleanroom at early-stage design
BioPhorum Drug Substance Closed Systems in Controlled Non-Classified Workstream has recently published its room...