Search results for " therapeutic"
Article
Quality by design for biotechnology products—part 1
Understanding the structure and functional attributes of therapeutic proteins, including monoclonal antibodies (MAbs), is key to developing the design space, because that understanding facilitates the…
Article
Top Process Development Trends for 2021 and a Look into 2022
However, the focus in 2021 shifted beyond the pandemic to optimization and scaling up adeno-associated virus (AAV) production, process workflows and considerations for messenger RNA (mRNA) therapeutic…
Article
Leveraging Computational Models of Glycosylation for Biopharma QA
Glycosylation is also widely acknowledged as a major source of therapeutic protein heterogeneity (3), which is highlighted by work that found considerable glycosylation variation among different comme…
Article
Cell-free Expression Systems Pose Cell Culture Alternative
The professors explain that protein therapeutics (biologics) produced by cell culture face limitations, such as high product variability created by glycoform (micro- and macro-) heterogeneity; difficu…
Article
The Evolving Role of Starting Materials in Cell and Gene Therapy
Unlike other biological drug products such as therapeutic proteins, monoclonal antibodies, or vaccines, drugs based on living cells are by nature uniquely vulnerable to supply chain complications and …
Article
Science Focus Fuels Successful Process Development for Startups
BriaCell Therapeutics (BriaCell) is an immuno-oncology company that develops novel targeted immunotherapies for multiple cancer indications. These immunotherapies include Bria-IMT and Bria-OTS, which …
Article
Platform Technologies Improve Protein Expression
In addition, new technologies for genomic engineering of cells for the production of therapeutic proteins are “opening up a new world of possibilities to tailor-make protein-based drugs with appropria…
Article
Continuous Manufacturing: A Changing Processing Paradigm
The platform flows a liquid culture medium from a perfusion bioreactor into a preliminary multi-column chromatography system (MCCS1), then the eluate of the MCCS1 containing the recombinant therapeuti…
Article
Regulatory Challenges in the QbD Paradigm
This model is especially evident in FDA's Center for Drug Evaluation and Research (CDER) as used for therapeutic biological products, such as proteins and monoclonal antibodies. These products were tr…
Article
Addressing the Challenges in Downstream Processing Today and Tomorrow
In the future, mAbs may represent a smaller percentage of the pipeline as portfolios concentrate more on development of antibody fragments, nanobodies, biosimilar protein therapeutics, conjugated prot…