05.17.24 -- Let's Clean Up That Bioburden — The Aseptic Suite's Persistent Plague

Examine the steps of cleaning validation for both low-volume and high-volume manufacturers and the important role these studies play.

Early product characterization can serve to uncover crucial information about an advanced therapeutic candidate, affording new insight into its CQAs and helping to shape better analytical assays.

Determining ideal media composition for a bacteria is critical because it fosters a satisfactory grow rate, allowing the bacteria to reach the required growth yield.

Explore current and emerging technologies to optimize mRNA manufacturing, especially when considering commercial production and the validation of processes in a cGMP environment.

Discover how microphysiological systems are revolutionizing the life sciences, offering a more accurate and reliable approach to studying human physiology and developing promising new drugs.

This article addresses key advancements at each step in the production of viral vectors from maximizing titer output at scale upstream to optimized formulation compositions at fill/finish.

Explore key process operations, some of the challenges in manufacturing high-concentration biologics, and factors to consider for process optimization.

Discover how an effective approach to risk management can further ensure the delivery of a high-quality drug or medicine to the patient.

Learn the principles of commercialization readiness and guidance to address them in process development as well as the best time to implement automation and minimize commercialization risks.

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

This analytical instrument, designed to analyze AAV samples, can precisely determine the empty/full capsid ratio in samples of any serotype in a cost-effective, simple to operate way.

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

Review how to develop and use QC assays that can facilitate both product and process understanding and control.

Reduced the risk of contamination caused by repeated handling of the culture during transient protein production in suspension CHO cells

This five-step platform approach to process characterization ensures the entire process is right first time and results in a highly consistent product to facilitate efficient BLA filing.

Microfluidic mixing is one of the most effective means to formulate LNPs for its scalability and reproducibility. Explore LNP formulation, polishing, sterile filtration of mRNA-LNPs, and more.

As highly potent active pharmaceutical ingredients become increasingly common across the industry, it is critical to work with partners who use a risk-based approach to ensure safety and quality.

What solutions did the client featured in this case study find when they sought help in transferring their formulation process to a turbulent Impinged Jet Mixing (IJM)?

Could an “engineering biology” approach be the solution for biopharmaceutical leaders struggling to scale-up and meet the growing demand for advanced therapeutics?