Tag: <span>ind</span>

From the Editor-in-Chief: Many of the Toughest Biologicals are Becoming Easier to Produce

There are so many exciting things happening in the biotech industry. As we have all seen, antibody products are being approved for more and more cancer applications, in addition to those for auto-immune diseases, which used to dominate how they were being used. And of course, these applications are in addition to the many which use antibodies conjugated to chemotherapeutic drugs and imaging agents—where the antibody acts as a targeting mechanism. Then there are the hundreds of monoclonal and polyclonal antibody applications that have dominated diagnostic testing for decades…

Read MoreFrom the Editor-in-Chief: Many of the Toughest Biologicals are Becoming Easier to Produce

Biologics Production

aav adeno-associated virus air handling antibody conjugates biologics bioproduction cryopreservation diagnostic testing ind investigational new drug lentiviral vector systems monoclonal antibodies polyclonal antibodies regenerative tissues subunit vaccines transient transfection viral gene vectors

Antibody-Dependent Cellular Phagocytosis: The Mechanism of Action That Gets No Respect A Discussion About Improving Bioassay Reproducibility

Antibody-dependent cellular phagocytosis (ADCP), which relies on macrophages to attack and devour tumor cells following antibody binding, is a potentially useful mechanism of action (MOA) for antibody drug developers and vaccine makers to consider in determining product efficacy. Unfortunately, it is often ignored in favor of more accessible MOAs driving biological function such as antibody-dependent cellular cytotoxicity (ADCC) because the assays are tedious to prepare, perform, and reproduce.

Read MoreAntibody-Dependent Cellular Phagocytosis: The Mechanism of Action That Gets No Respect A Discussion About Improving Bioassay Reproducibility

Biologics Biologics Production Regulatory

adcc antibody-dependent cellular cytotoxicity bioassays ind investigational new drug mab mechanism of action moa monoclonal antibody ph eur USP

Regulatory and Monetary Drivers for Real-Time Analytics

Implementation of “real-time” analytics (RTA) in processes for biologics is challenging from a technological and timeline perspective. Therefore, there need to be significant drivers from both a regulatory (quality) and a monetary standpoint to justify investment. Understanding how regulatory agencies define real-time analytics and the expectations for implementations (how and when) is a key component to rational decision-making, and dovetailing process improvement and facility design is important in the planning and development process…

Read MoreRegulatory and Monetary Drivers for Real-Time Analytics

Biologics Production Cell & Gene Therapy Cell Lines Mammalian Cell Culture Manufacturing Regulatory Viral Reference Materials Viral Vectors

at-line analytics biolgics design space biologics cpp critical process parameters design-of-experiments doe fda guidance fmea in-line analytics ind investigational new drug mabs monoclonal antibodies on-line analytics pat process analytical technology real-time analytics regulatory considerations rta