Feliza Mirasol

The expected growth of the global bio/pharmaceutical market is pushing for the continued evolution of the CDMO arena.

Demand for recombinant microorganism-based cell culture supplements is rising on the back of lower contamination risk.

The innovation of single-use technologies is applicable early on in the manufacturing process.

The adoption of single-use technologies in fluid-handling systems helps streamline downstream bioprocessing operations.

Dynamic light scattering presents a good analytical technique for testing protein stability.

FDA’s newly proposed draft guidance will support IND filings of antisense oligonucleotides, a new class of drugs.

A growing pipeline of gene therapy candidates aimed at treating neurodegenerative diseases has prompted new guidance.

Overcoming time and cost constraints can help enable seed train intensification efforts to maximize product yield.

While manufacturing increases have been implemented for vials and syringes, meeting future market needs remains unpredictable.

CDMOs address the unique challenges of liquid and lyophilized forms as well as preparing for the large capacity needed for COVID-19 vaccines.

Cell-culture optimization may see benefits from a synthetic biology-based approach that improves product titer, quality, and time.

Establishing an automated inline dilution system can potentially ease bottlenecking delays resulting from higher upstream yields.

Viral clearance processes and guidance must evolve along with newer biotherapeutic modalities.

Scaling needs for potential COVID-19 vaccines depend not only on capacity, but also on supply chain challenges and technological hurdles.

The shift to single-use technologies is driving the need for innovation in PAT-friendly sensor technologies.

Complex manufacturing processes pose challenges for final product inspection needed to ensure product integrity at commercial launch.

Early detection and more sensitive methods of detecting adventitious agents are becoming increasingly critical in bioprocessing.

Bio/Pharma companies are galvanized to develop COVID-19 therapies under FDA’s acceleration program.

Recent industry guidance aims to anchor rapid COVID-19 vaccine development in good manufacturing practice protocols.

Automation, digitalization, and supply-chain strategies help mitigate vulnerabilities in both autologous and allogeneic cell therapy manufacturing.

An innovation such as synthetic biology can develop a consistently stable starting cell line for cell therapy source material.

Fill/finish inspection for vaccine vials and syringes must remain GMP-compliant while aiming for fast, efficient methods.

Glycoengineering is growing in importance as a technique to improve antibody therapeutic efficacy, safety, and product quality.

As technology matures, inefficiencies and process limitations in downstream process chromatography are improved.

Current and newer biologic modalities pose increasingly complex challenges to the detection and characterization of protein aggregates.

Process modeling offers an opportunity to troubleshoot for and anticipate difficult aspects of a bioprocess.

Glycoengineering is growing in importance as a technique to improve antibody therapeutic efficacy, safety, and product quality.

This article reviews FDA’s recent efforts to streamline the biosimilar approval process and address quality concerns with the publication of new guidelines that suggest resources to aid in the biosimilar development and characterization process.

In an effort to secure a continuous, sustainable supply of an important vaccine ingredient, Agenus is turning to a plant cell-based cell culture method for production.

The commercialization of cell and gene therapies has become a reality, prompting deeper considerations of logistics, technology, and design for manufacturing facilities.