Manufacturing

Single-use components for biopharmaceutical manufacturing have a lower environmental impact than reusable components, but disposal is still a consideration.

Kimberly-Clark Professional’s Kimtech A5 Sterile Boot Covers with Clean-Don Ties and Vinyl Edge provide reliable sterile protection for ISO Class 5 or higher cleanrooms.

To ensure the sterility of parenteral biopharmaceutical products, it is necessary to employ certain tools, technologies, and standard operating procedures.

Most extractable and leachable (E&L) studies are based on liquid formulations. This article examines options for E&L studies to evaluate leaching from primary packaging into lyophilized drugs.

Parker Bioscience Filtration added a cleanroom at its site in Birtley, UK for manufacturing single-use assemblies and sensors used in biopharmaceutical processing.

TC BioPharm (TCB), developer of CAR-T immuno-oncology products, has completed its first allogenic Gamma Delta T (GDT) cell banks.

Full commercial launch of the drug is underway in the United States, with Europe to follow.

G-CON will provide a complete cleanroom infrastructure for GE Healthcare’s cell therapy and viral vector production platforms that will simplify early-stage manufacturing efforts.

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

Univercells, a business-to-business provider focused on biologics, has commercially launched its proprietary bioproduction system, NevoLine.

The agreement gives Sanofi access to Biomunex’s proprietary bi- and multi-specific-antibody-generating platform.

The company is set to expand biologics and fill/finish capacity at its biologics manufacturing sites in Madison, WI, and Bloomington, IN.

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.