In 2018, we saw a record-setting year for new-molecular entity (NME) approvals (59) at the FDA1 versus 46 in 2017. 58% were for orphan drugs (patient population less than 200,000 in the US) with 17 biologic-based NME’s. Biosimilars are gaining traction in Europe, in particular. Major factors that are driving the market growth are next-generation business, high growth in chronic diseases, less expensive biosimilar drugs and favorable government regulations.
Biologic manufacturing subjects the formulation to different stresses and conditions that may compromise quality and stability. Recently, the requirement for the development of subcutaneous formulations for high dose drugs, such as monoclonal antibodies, at high protein concentrations has created additional challenges, including degradation. Read about the options provided by wearable technology offers new alternatives that were not previously possible due to historically binding parameters for formulators.
Developers need to look beyond the formulation of a stable drug all the way to patient compliance. Numerous pitfalls exist along the journey to bring a biologic combination product to market. This integrated solutions program can help you simplify the journey.
As innovations in medicine enable the introduction of new therapies for the treatment of chronic conditions impacting patients around the globe, safely containing and delivering these therapies is top of mind for both pharmaceutical companies and their manufacturing partners. By partnering with a device or delivery system manufacturer early and often in the drug development journey, pharmaceutical manufacturers can not only move to market with an approved, commercially viable drug delivery system, but also gain valuable insight into the drug product along the way.
Viral clearance studies are a critical part of the production of biologics. However, performing studies that are accurate and cost-effective can be challenging. Here are seven things to consider while performing your next chromatography viral clearance study.
To meet the oxygen demand of cells a stable pO2 control is an essential part of every cultivation. The objective of this application note is to demonstrate the performance of a new generation of mass flow controllers in the BIOSTAT® B-DCU bioreactor system. Several comparative cell cultivations were performed.
Ensuring that the cells do not have too much or too little, enables them to grow fast and maximize the product secretion. Within this application is an example method on how to establish glucose feed control is documented and as well as highlighting the key benefits of applying this method to other processes.
Challenges of T cell immunotherapies include the costly manufacturing process relying on lengthy and complex open workflows with high manual labor requirements that influence product variability. This application note describes the details of a robust CAR T cell manufacturing workflow that can be adapted for cGMP compliance in commercial production of CAR T cells.
This study presents how strategic enhancements to the sparge and agitation systems of Thermo Scientific HyPerforma S.U.B.s have revealed the potential for a three- to four-fold improvement in mixing and mass transfer performance compared to legacy S.U.B. designs.
Learn how a structured 3-step approach can help overcome the challenge of molecular characterization and a limited budget.