Feliza Mirasol

Capacity concerns and regulatory compliance considerations will drive the decision about outsourcing the manufacture of clinical trial materials.

A rich clinical pipeline of regenerative medicine product candidates bodes well for a robust future.

The growing use of automation and digitalization technologies push cell culture bioprocessing forward.

The need for sustainability and early considerations of a lyophilization strategy grow more pertinent on the back of growing biologics volume.

The urgency with which COVID-19 forced the biopharma industry to produce therapies has refocused the search for new tools to enable rapid therapeutic responses to a pandemic.

Upstream processing is better optimized with the help of automated workflows.

Enhancement of resin technology can improve the ability of chromatography to purify the growing landscape of increasingly complex biomolecules.

New and emerging biotherapeutic molecules drive the need for innovative solutions to meet cold-chain requirements.

Confounding signals pose challenges to analytical methods necessary for managing residual impurity removal in biotherapeutic manufacturing.

Glycosylation monitoring has been heavily dependent on manual processes, but the automation of sample preparation streamlines the overall workflow.

COVID-19 is refocusing calls for new tools and urgent therapeutic responses.

Part 2—Industry experts from MilliporeSigma, Lonza, Astrea Bioseparations, and Sartorius provide insight and examples about solving critical challenges in both analytics and process development for emerging therapies.

Part 1—Industry experts from MilliporeSigma, Lonza, Astrea Bioseparations, and Sartorius discuss key issues affecting the development of emerging biotherapies.

ADC development is on a positive trajectory from a deeper understanding of therapeutic mechanisms and technological advances.

The adoption of perfusion cell culture continues to advance with the help of PAT tools.

The biopharma industry is seeing more merit in strategizing clinical and commercial drug development as early as the preclinical phase.

Industry representatives sound off on FDA’s FARS report, released in January this year.

The complexity of newer biotherapeutic molecules calls for alternative drug delivery strategies.

Large-scale single-use bioreactors prove successful as limits are tested.

SUB bioreactor performance has had seen its limits and successes.

Establishing a data management strategy in-lab is a first step in generating successful analytical studies.

Establishing bioassay studies for biosimilar development is important for supporting regulatory filings.

Advancements in bioprocessing technologies test microbial fermentation adaptability.

Automation is one asset that benefits cell harvesting by cutting out laborious manual steps and minimizing contamination.

The ever-increasing complexity of biotherapeutic molecules presents unique analytical challenges for developers.

New biologic modalities, such as cell and gene therapies, pose increasing difficulties in viral clearance testing methods.

The emergence of new biotherapeutics is both the driver and result of innovative drug development technologies.

Cell-free expression is promising in preclinical applications, but still presents challenges to scale up for commercial production.

Recent innovations in chromatography resins offer promising advantage in downstream bioprocessing.

Digitalization of bioprocessing operations, equipment, and facilities can improve workflow and output, but maintaining data integrity is a concern.