A well-executed bioprocess technology transfer (tech transfer) is critical to ensure smooth knowledge transfer and optimal process reproducibility. If not executed properly, you risk reducing the quality and efficiency of your process. Waste time trouble shooting, and you may delay your time to market. In today’s global markets effective tech transfer is critical.
A significant concern in tablet manufacturing is speed to market. Moving too quickly, however, may cause delayed production, lost product, and missed deadlines. To reduce potential headaches, companies are embracing the principles of Quality by Design (QbD) and utilizing automated data gathering and tablet analysis during research and development. This allows organizations to reduce product development and delivery stress and loss.
Deriving in vitro dissolution test conditions represents a challenging area for many organizations progressing through early stage development. Unfortunately, the stakes here are high. Inappropriate dissolution test conditions during early phase formulation development may lead to a partial or complete failure of desired bioavailability in vivo.
With nearly 90 percent of the developmental pipeline drugs consisting of poorly soluble molecules, formulation experts must be prepared to address this obstacle by applying various approaches to improve an API’s pharmacokinetics.
Saurabh Kapure, Vice President, Business Development, USA for Jubilant Biosys, recently sat down with Michael Gallatin, Ph.D., president and co-founder of Mavupharma (Mavu), the drug discovery and development company, to discuss some of the latest developments in the industry and at Mavu. In this Q&A, Dr. Gallatin shares his thoughts about Mavupharma, his role at the company, the evolution of biopharma, drug discovery, development, and the road ahead for the industry with Saurabh.
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.
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.