The growing trend of partnerships between small biotech companies and CDMOs makes the need for conducting CMC due diligence increasingly important.
It is critical to evaluate specific considerations, from design to application, for the benefit of downstream bioprocessing and manufacturing.
Increasingly complex monoclonal antibody molecules will require the right “tool box” for scaling up manufacturing.
The growing trend of partnerships between small biotech companies and CDMOs makes the need for conducting CMC due diligence increasingly important.
Today, there is a global adoption of buying and selling used equipment. This article reviews what organizations should look for when considering the purchase of used equipment.
The growing trend of partnerships between small biotech companies and CDMOs makes the need for conducting CMC due diligence increasingly important.
Downstream process development and manufacturing play a crucial role to ensure safety, quality, identity, purity, and efficacy.
The growing trend of partnerships between small biotech companies and CDMOs makes the need for conducting CMC due diligence increasingly important.
This article presents some key differences between the US and European regulation of biosimilars, including naming conventions and pharmacovigilance of biosimilars, and the impact of biosimilars on commercialization and affordability of biotherapeutics.
This article presents some key differences between the US and European regulation of biosimilars, including naming conventions and pharmacovigilance of biosimilars, and the impact of biosimilars on commercialization and affordability of biotherapeutics.
This article presents some key differences between the US and European regulation of biosimilars, including naming conventions and pharmacovigilance of biosimilars, and the impact of biosimilars on commercialization and affordability of biotherapeutics.
A plant-based expression system could provide greater speed and capacity at a comparatively low cost.
The authors discuss an alternative to traditional Protein A resins.
Rapid microbial screening provided by contract laboratories can save companies time and money.
Dual-sourcing and redundant manufacturing capabilities are crucial in a single-use supply chain strategy, but must be applied correctly.
Dual-sourcing and redundant manufacturing capabilities are crucial in a single-use supply chain strategy, but must be applied correctly.
Project: transfer a manual concentration/diafiltration process for siRNA production.
As SUS become prevalent in the biologics industry, the question of safety becomes increasingly important.
In this study, a novel aldo-keto reductase was cloned and purified, and its important conserved sites were analyzed.
In this study, a novel aldo-keto reductase was cloned and purified, and its important conserved sites were analyzed.
In this study, a novel aldo-keto reductase was cloned and purified, and its important conserved sites were analyzed.
In this study, a novel aldo-keto reductase was cloned and purified, and its important conserved sites were analyzed.
In this study, a novel aldo-keto reductase was cloned and purified, and its important conserved sites were analyzed.
In this study, a novel aldo-keto reductase was cloned and purified, and its important conserved sites were analyzed.
A plant-based expression system could provide greater speed and capacity at a comparatively low cost.
Ever since Twitter launched in 2006 and Facebook became mainstream, most industries have sought ways to connect with their consumers through social media.