Manufacturing

The companies will collaborate to improve the manufacturability for two of Sanofi’s biotherapeutics.

Orphan and cancer drugs continue to lead, but treatments for many common diseases were also approved in 2018.

Agenus will leverage Selexis’ SUREtechnology Platform to progress Agenus’ portfolio of next-generation antibody programs.

Fujifilm increases capacity of its Bio-CDMO business with an expansion of production in North Carolina.

The new reagents are designed to support clinical-phase and commercialization stages of cell and gene therapy production and to enhance DNA transfection.

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

Compensation and professional challenges are key pieces to solving the biopharma employee satisfaction puzzle.

Bio/pharma companies are successfully launching novel therapies; however, the industry still needs to work on manufacturing innovation.

Kinetic models can be used to study aggregation and fragmentation to help ensure stability.

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

Automation in cell-line development and cell culture is leading to more consistent quality while improving efficiency, and, ultimately, speed to market.

A key technology that can help achieve a continuous production flow is single-pass tangential flow filtration.

A new facility in California will expand Orchard Therapeutic’s capacity to develop and deliver lentiviral vector and gene-corrected hematopoetic stem cells.

The company will use GE Healthcare’s off-the-shelf KUBio biologics factory, which is expected to start operations in 2020, to provide development and manufacturing for early- to late-clinical and early-commercial manufacturing stages.

GSK and TESARO have entered into a definitive agreement concerning GSK's acquisition of TESARO for an aggregate cash consideration worth approximately $5.1 billion.

Microbial identity data can be critical for determining contamination sources.

This research proposes a method for separating and purifying tissue-type plasminogen activator from a fungal cell source.

Unprocessed bulk material harvested directly from the bioreactor should be tested for contamination prior to downstream processing.

Bioconjugation requires aseptic manufacturing and containment for cytotoxic payloads.

Advances in single-use technologies, sensors, and cell retention systems facilitate processes designed for the long run.

The investment builds on a collaboration the companies entered into in 2007 for various biomanufacturing projects.

FDA’s 21st Century goals can be realized by using a multi-purpose manufacturing facility with a flexible design that provides reliable production without extensive regulatory oversight.

A multi-purpose biopharmaceutical manufacturing facility using a matrix of multi-functional cleanrooms can be adapted to efficiently meet the capacity challenges of both supplying clinical trials and launching products.

A matrix of multi-functional cleanrooms can be adapted for launching products.

GE’s new facility, which will be operational in 2019, will produce a fiber-based chromatography platform for more efficient biopharmaceutical purification.