02.21.24 -- Strategies For Minimizing The Impact Of Bioburden And Sterility Testing On Gene Therapy Batch Yield

Standardization and flexibility in aseptic filling were thought to be mutually exclusive. But what if there was a standardized system with flexibility built into the aseptic process, so you didn’t have to choose?

Here, we demonstrate a rapid method for the separation of empty and full AAV8 particles by linear gradient elution on CIMmultus® QA monoliths with 80% recovery.

There are several technology solutions that, when applied to a cell and gene therapy workflow, can streamline development and improve workflow integration.

This poster reviews studies for three monoclonal antibody drug candidates utilizing a panel of small scale, fast, and predictive tests used to evaluate therapeutic antibodies’ developability.

The rising demand for vaccines and complex biotherapeutics has led to an increased role for CDMOs in the development process when it comes to characterizing impurities to ensure product quality.

A scalable manufacture promises increased process understanding and manufacturing flexibility to deliver a robust, reliable commercial product, and it helps with timely delivery to market.

How can drug sponsors and developers leverage these increasingly strategic commercial fill/finish partnerships? These tips can help put your programs on a firmer footing.

Synthetic oligonucleotides are primarily used in therapeutics, as well as in diagnostic kits and PCR primers. This animation explains the repetitive four-step cycle of the oligonucleotide synthesis process.

Gain confidence in your container closure system selection by utilizing a stepwise and data-driven approach to predicting and verifying container closure integrity.

Learn the best practices in HCP immunoassay development, common mistakes and misconceptions, and advanced orthogonal methods of immunoaffinity chromatography and mass spectrometry.

Recently developed process intensification has allowed for increased product output. This output requires increased production efficiency and input, pushing many bioreactor systems past their limits.

Drug developers must successfully navigate the path to market, under the growing pressure of regulation and competition, and while carefully managing technical and financial risk.

What is microcalorimetry and how is it used? Learn about measuring enthalpy and heat capacity changes during reactions using differential scanning calorimetry and isothermal titration calorimetry.

Examine the drivers behind the recent successes in the clinic, current challenges with development and manufacturing, and what the future might hold for the ADC industry.