Process Insights

Most bulk drug substances are filled into 2D single-use bags for one reason: they are about to be frozen. Yet filling and freezing are often treated as separate unit operations. Filling systems are selected for accuracy and throughput. Freeze-thaw...

How is your frozen drug substance moving through the facility?  While freezing performance and storage temperature often receive the most attention, day-to-day efficiency depends on what happens between those steps. Every loading, transfer, and...

As batch sizes for bulk drug substances continue to grow, many biopharmaceutical facilities are reaching the limits of their existing freezing and storage infrastructure. At first glance, this appears to be a capacity issue, but in reality, it oft...

Biopharmaceutical manufacturing has undergone a shift toward higher production volumes, more diversified modalities, and more flexible production models. Despite these new demands for handling varying batch sizes and customer-specific requireme...

Why are so many biopharma manufacturers adopting single-use technology instead of traditional stainless-steel systems? The answer goes far beyond convenience. Single-use technology has become one of the most transformative developments in modern b...

Coming from manual and uncontrolled freezing methods, manufacturers risk non-compliance and poor consistency when cryopreserving drug substances. Non-compliant CDMOs also risk falling out of consideration for pharmaceutical companies seeking partn...

There will continue to be an ongoing need for cryopreservation and cold chain management of drug substances. However, these processes will no longer depend on F-Gases.  The utilization of F-gases, also known as fluorinated greenhouse gases, is ste...

To fulfil cGMP in quality assurance for biomanufacturing, qualification and validation are essential steps demanded by several authorities. Since technologies must align with rigorous guidelines before they can be deemed suitable for use in a GMP ...

Freezing drug substances to ultra-cold temperatures is a standard step in biopharmaceutical manufacturing. Yet, beyond simply cooling, it’s the critical quality attributes (CQA), like product safety, consistency, and process efficiency, that trul...

For some time now, scientists have been discussing the challenges associated with freezing biopharmaceuticals in sterile bottles – especially the risk of cryoconcentration and how it might affect product quality. So, we decided to take a closer l...

Blast freezers have emerged as a reliable solution in the biopharmaceutical industry. However, pharmaceutical bulk freezing is not just about turning liquids into solids; it is also about preserving the integrity and quality of life-saving drug s...

One could read a lot about single-use bags in biopharmaceutical industry as a primary packaging in bioprocessing in the previous last years. The rise of bags has become more relevant, since they largely replaced single-use bottles. Nevertheless, s...