An outline of the cell development and process scale-up for an antibody program in which the antibody requires additional processing by a site-specific enzyme for correct functionality.
Once protein purification work surpasses a certain scale in terms of volume, a measured and step-wise development of the bioseparation process is vital.
The failure of drug compounds in mid- to late-stage development is far more common than anyone would like it to be. Only about 30% of compounds successfully transition from Phase II to Phase III.
The plug-and-play nature of single-use enables you to incorporate new technologies and innovations into the process workflow as they become available. But you need to consider your long-term needs.
The opportunities in developing global markets appear limitless, but the obstacles surrounding them can be daunting. With issues ranging from language barriers to protecting intellectual property rights, each solution must be as unique as the country the work is developed in. Download this eBook to learn key strategies to unlock foreign pharma markets.
The large buffer volumes required for biomanufacturing can be a bottleneck, especially when scaling up. Just-in-time buffer preparation can be the solution.
There are numerous solutions available to ensure effective process validation at sites within a global network. No matter the solution, a comprehensive process validation strategy is necessary.
While single-use processing has limitations with scale of operations when compared to stainless steel setups, several trends are mitigating the impact of these limitations significantly.
Protein purification at the lab scale bridges the gap between small-scale exploratory protein purification and high-throughput operations, such as industrial- scale manufacturing.
Managing the integrity of manufacturing data is becoming ever more challenging, particularly as more and more critical manufacturing functions are outsourced, thus limiting the amount of oversight a pharmaceutical company can provide. Life science companies need to demonstrate control over their data—whether internally or externally generated. FDA officials indicate that “data that are not valid and trustworthy is a sign that an entire operation or facility is out of control and cannot assure the quality of its medicines”. Without accurate data, companies are less equipped to ensure the safety, effectiveness and quality of their products.
|
|
|
|
|
|
|
|
|