Manufacturing, Biologics

This milestone achievement will allow the companies to move forward with developing a GMP-compliant manufacturing process for clinical testing.

A variety of assays should be used to detect bacterial, fungal, and viral contaminants in the human source cells used for cell therapies.

The new patented process results in uniform, scalable production and the ability to deliver cell cargo similar to natural exosomes/extracellular vesicles.

Emergent BioSolutions will help develop and manufacture an oral vaccine candidate and will develop plasma-based antibody therapeutics.

The new BIOSTAT STR Generation 3 with BIOBRAIN bioproduction platform offers process intensification with automated feed and bleed and integrated cell retention functionality.

FDA issued a notice to drug compounders regarding the transition of licensure of biologics to the Public Health Service Act.

The technology enables the rapid production of large numbers of recombinant antibodies at 80-mL scale.

Better understanding and control of cell behavior is yielding benefits, upstream and beyond.

The future of raw material sourcing for mAb production may lay in the sustainability of the source and the added benefits of newer technologies.

Ensuring the quality of data in process monitoring and control systems starts in process development phases.

Single-use and modular systems will meet demand for rapid implementation at different scales.

The expansion gives the company diversified capacity running cell production lines featuring Sartorius-brand 2000-L disposable bioreactors and now GE-brand 2000-L single-use bioreactors.

The company presented data on its G2 glycosylation studies at the 15th European Conference on Fungal Genetics in Rome on Feb. 19, 2020.

The need for lyophilization services is growing as a burgeoning pipeline of new biologics matures.

The company has said that all three of its operating sites in China started back up on Feb. 12 and that it is closely monitoring the outbreak.

The new facility includes six classified environment rooms with space to expand.

The trend toward personalized medicines includes more complex manufacturing cycles that can benefit from advanced process modeling early on in the therapeutics’ development.

The production of viral vectors for use in gene therapy benefits from being able to use similar cell-culture processes as mAbs, but it faces limitations under current cell-culture technologies.

Developers need to transcend the limits of existing separation technologies, to maximize vector recovery while preserving therapeutic potency.

The new facility, to be operated under the newly formed CDMO, The Center for Breakthrough Medicines, will be located in King of Prussia, PA, and will increase manufacturing capacity for cell and gene therapies.

The formation of the new gene therapy company stems from the progress and success of Nationwide Children’s Hospital’s clinical manufacturing and gene therapy work.

The next-generation gene editing system can be applied to the development of novel cell and gene therapies.

Achieving effective manufacturing processes and sufficient capacity remains a top priority across a diversified biologic drug pipeline.

Temperature-sensitive biologics are lyophilized to preserve therapeutic viability, but the process presents complexities and challenges that are as yet not fully understood.

Industry experts debate the pros and cons of “going bigger” than the 2000-L industry norm in a single vessel.