Cynthia A. Challener

Affinity chromatography resins must perform well under mild elution conditions yet withstand robust cleaning and sanitization protocols.

Digitalization of bioprocessing is slowly bringing benefits to the biopharma industry.

Increasing molecular diversity is creating a need for the reinvention of process development and control strategies.

Both demand for and investment in fill/finish capacity continue to rise.

A holistic view of the product, manufacturing, and ultimate use of the viral vector is required.

Manufacturers are taking the first steps toward process intensification.

Enriching process understanding enables robust process controls.

Linking structure with function is paramount.

Some progress has been made, but improvements are needed when harvesting cells for cell therapies.

Battles against antibiotic-resistant bacteria can be won with bacteriophages.

With high-concentration biologics, careful selection of excipients in formulation is crucial for reducing viscosity without destabilizing the protein.

The need to increase efficiency and productivity is driving adoption.

Careful selection is essential for achieving viscosity reduction without protein destabilization.

Analytical approaches must keep pace to ensure the identity, safety, and efficacy of evolving mRNA candidates.

Multispecific analysis is complex but can be achieved using appropriate strategies.

Timing is everything, and it might be ideal for acceleration of real-time monitoring solutions.

Surrogate analytics are no longer sufficient, as simple inexpensive real-time analytics are urgently needed for high value products.

Speed-to-market, capacity, technology development, and increased investment top the list.

Alternative materials, as well as supply-chain planning, are essential to ensure a reliable supply for parenteral drug packaging.

The benefits of single-use technologies for upstream viral-vector processes clearly outweigh their disadvantages.

Advances in technology are accelerating the development and manufacture of subunit vaccines, an established class of vaccines.

Understanding the process and product goals is just the first step to a holistic approach to process development.

Contract manufacturers play a key role in the production of lipid nanoparticles for RNA vaccines.

Mass spectrometry and automation are growing in importance for protein characterization, but further improvements are still needed.

Biopharmaceutical companies and contract manufacturers respond to changing demand dynamics for upstream bioprocessing capacity.

In a pandemic, genetic vaccines offer several advantages over traditional approaches.

Plasma-based proteins and cell-based therapies have significant potential to address unmet medical needs.

Connected, integrated bioprocessing enterprises with greater data analytics capabilities are coming.

Clear understanding of what exactly the biomolecule entails is essential.

A holistic approach to validation and quality assurance is essential.