Manufacturing, Biologics

The authors present a shift toward more integrated purification processes.

Perfusion processes can attractive for biologics drug manufacturing; however, obstacles remain.

Continuous processing of 100 g of monoclonal antibody in 24 hours has been demonstrated using lab-scale equipment.

Sartorius Stedim Biotech combined the company’s ambr 15 bioreactor system with the Nova BioProfile FLEX2 cell culture analyzer for laboratory experiments.

This article summarizes the approaches, challenges, and future perspectives for the characterization of N-glycans in biopharmaceutical products.

An increase in biologics raises awareness of particle generation and its role in negative patient outcomes.

Operated by BioOutsource, Sartorius’ subsidiary, the Glasgow, UK-based service center will offer physicochemical properties and structural attributes testing and allow clients to perform structural and functional analyses in parallel.

Can bioprocessing runs be consistently replicated in an inherently variable production environment?

The unique structures of fusion proteins lead to expression, heterogeneity, and stability issues.

Improving the bioreactor growth environment increases the rigor of bioprocessing runs.

Chromatography modeling can enhance bioprocessing efficiencies.

OrlaSURF technology can be used for the development of target-binding assays to monitor the binding of an ADC to its antigen.

The mAb is the first approved treatment that targets the progressive form of the disease.

Tony Pidgeon, process technology director at Patheon discusses challenges associated with and recent innovations in the fill/finish process for biopharmaceuticals.

The Basel office will house the clinical development team and other functions to progress the company’s lead compound emapalumab.

Richard D. Braatz, PhD, will discuss using mathematical models to design a continuous drug manufacturing plant and the differences between batch and continuous operations for biologics.

The process control and automation requirements of single-use systems differ from those of stainless-steel equipment.

The decision to use disposable bioreactors is now driven by commercial rather than technological considerations.

Manufacturing for originator molecules is restricted by regulations, but drug makers can exploit newer technologies for the manufacture of biosimilars.

Communication and taking the time to develop the process are key to successful transfer and scale up of biologics

FDA granted inotuzumab ozogamicin priority review and accepted its BLA for filing.

CellGenix will add R&D, production, and warehouse space in Freiburg, Germany for GMP-grade raw materials for cell therapy, gene-therapy, and tissue-engineered products.

Under the agreement, Abzena will manufacture magacizumab, an antibody created using the ‘Abzena inside’ Composite Human Antibody technology.

EvaluatePharma and BioPharm International highlight the antibody-based therapeutics that may gain United States Regulatory approval in 2017.

This three-year partnership will explore and identify new tools and methods to modify and optimize the Chinese hamster ovary (CHO) cell line performance.