Manufacturing, Monoclonal Antibodies

MilliporeSigma’s use of modified amino acids can simplify the fed-batch process in biomanufacturing.

For rapid scale-up of biomanufacturing under expedited review status, facility design must better integrate product development and manufacturing lifecycle activities.

New ligands are being developed to meet the separation and purification needs of next-gen biologics.

The company has rolled out the first batch of TRACON Pharmaceutical’s lead product candidate from its Singapore-based single-use bioreactor.

This article will explore the requirements for media and supplements needed to maintain newer cell lines, such as those based on human cells and fungal cells.

The second half of this article describes the testing methods used by the authors to demonstrate the applicability of single-use mixing technology for virus inactivation.

This article explores the use of single-use mixing technology in a detergent-based virus inactivation step during a monoclonal antibody production process.

Hydrophobic interaction chromatography (HIC) in flow-through mode offers a more efficient and cost-effective polishing/purification process to remove monoclonal antibody aggregates while maintaining purity at ≥99% than a mixed-mode bind/elute procedure.

Testing demonstrates an automated semi-continuous process strategy for viral inactivation with steps that mimic batch processing.

BeiGene is set to build late-stage clinical and commercial production capacity for cancer monoclonal antibodies with GE Healthcare’s KUBio, the prefabricated biopharma facility based on single-use technologies.

Automation can improve many aspects of bioprocessing, but several hurdles must be overcome before the full range of benefits can be realized.

The quality of the cell lines used to manufacture biopharmaceuticals are crucial for the production of high-quality, stable biopharmaceuticals.

The media, by Tosoh Bioscience, is composed of calcium and phosphate buffers and offers mixed-mode properties for biomolecule purification.

Increasing demand for biologics is driving the need for innovation in bioprocessing.

Late-stage and commercial biomanufacturing pose a challenge to cell-culture processing.

The new resin used a combination of “jetting” technology and a high-performance Protein A ligand.

The contract development and manufacturing company has received an additional approval from Health Canada to manufacture monoclonal antibody drug substance at its first plant in Icheon, South Korea.

Biosimilars and biobetters have their own unique manufacturing strategies and challenges.

The company is launching a new pre-fabricated, ready-to-run manufacturing facility that is expected to significantly decrease the production timeline for viral vector-based therapeutics.

The biopharmaceutical firm has chosen Rhode Island as the site of its next-generation biomanufacturing plant, which will offer flexibility, speed, and efficiency.

The company plans to install 4000-L disposable bioreactors from ABEC at its new commercial manufacturing facility in Wuxi city, China.

Under this agreement, the companies will develop in parallel an antibody drug candidate and cell lines for other potential candidates.

Ferring Pharmaceuticals will expand its biologics capabilities at its headquarters and manufacturing site in Saint-Prex, Switzerland.

Single-use technologies are starting to gain ground as capacity needs change, but industrywide adoption remains low.

The new Acquity Arc Bio System by Waters is specifically engineered to enable efficient transfer and improvement of bioseparation analytical methods.

The funding from the Walloon Region will enable Univercells to start developing a manufacturing platform aimed at driving down costs of biosimilars manufacturing.

A new target for the treatment of multiple myeloma using CAR-T technology was discovered by researchers at Osaka University.

An antibody-based Zika virus therapeutic that protected monkeys from infection might be safe enough for administration to pregnant women.

Sartorius Stedim Biotech will equip Abzena’s contract development and manufacturing facilities in Bristol, PA, and San Diego, CA, with single-use equipment and scale-up technologies.

The contract manufacturing company has completed construction on a new aseptic fill/finish facility in Wuxi, China.