Manufacturing

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.

This paper describes how the concept of acceptance value can be redefined to remove bias and more closely reflect quality targets.

Survey results and record attendance show positive signs for various bio/pharma regions.

The latest Manufacturing Barometer report, published by SWMAS, indicates concern over Brexit by UK manufacturers and an anticipation of lower business growth over the next six months.

New data highlights ability of the SQZ cell therapy platform to preserve cellular functions.

… Brexit may be a bumpy ride. Here, the new European editor of the PharmTech Group, Felicity Thomas, discusses Brexit and its implications for the pharma industry.

A project funded by BioProNET will investigate optimization for bioprocessing of gene therapy vectors using hydrodynamic fluid flow fields.

A statement from FDA Commissioner Scott Gottlieb and Deputy Commissioner Anna Abram detailed FDA’s new plan to advance plant and animal biotechnology innovation.

The acquisition will allow Lonza to further develop technology for scalable autologous cell-therapy manufacturing.

This article explores major aspects for United States biotech companies to consider when creating a compliant post-Brexit strategy.

Ross, Charles & Son’s Laboratory Paddle Blender offers advanced features for automated powder blending and liquid spraying operation with recipe management.

Collaborative robots work beside laboratory employees to improve efficiency in pharmaceutical research and quality control labs.

Cambrex will create a new center of excellence for API process development and clinical supply at its High Point, NC facility and expand its API manufacturing facility in Italy.

Clovis Oncology and Lonza celebrated the grand opening of a dedicated production train at Lonza’s Visp, Switzerland site for manufacturing Rubraca (rucaparib).

The company’s planned investment in its alkoxylation facility in the United States Gulf Coast will also expand production capacity for its polyethylene glycols.

The company will collaborate with GlycoBac to offer an insect cell line for the development of viral vaccines and gene therapies.

The new facility will include comprehensive mammalian process development and manufacturing capabilities.

The companies will develop and commercialize ARO-HBV, a Phase I/II subcutaneous, ribonucleic acid interference therapy candidate being investigated for the treatment of chronic hepatitis B viral infection.

The companies signed a three-year clinical manufacturing agreement to manufacture GlaxoSmithKline’s specific peptide enhanced affinity receptor T-cell receptor therapy for United States, Canadian, and European clinical trials.

At CPhI Worldwide 2018, Tom Wilson, vice president of Contract Manufacturing Operations for Pfizer Global Supply and Pfizer CentreOne Contract Manufacturing, will discuss best practices for meeting manufacturing challenges of compliance as requirements shift.

The UCL-Pall Biotech Centre of Excellence will address industry challenges and provide workforce training.

Advances in biologic drug development require increased methodological and technological innovation from the biopharma industry. Learn more at the new bioLIVE launching this year adjacent to CPhI Worldwide 2018.

The new bioLIVE event, launching this year with CPhI Worldwide 2018, will explore innovation in bioprocessing and manufacturing with a focus on the roles of innovative methods and technology for biopharma continuous manufacturing.

Luxembourg-based pharmaceutical group, C2 Pharma (formerly known as Centroflora CMS) successfully validated the manufacturing process for two APIs-digoxin and digoxin micron.

The companies will work together to discover, develop, and commercialize immunotherapies for patients with solid-tumor cancers in a collaboration worth $695 million per program.

Innovative technologies, such as drug-loaded devices and 3D printing, enable advances in implantable devices and other novel dosage forms.

Barrier materials, scavengers, and good seal integrity maximize shelf-life of oral solid-dosage drug packaging.

A twin-screw extruder can be used as a continuous wet granulator.

Engineering controls and safe practices for containment protect both operator and product in tablet and capsule production.

Experts blame the recalls, not on cGMP failures, but on inadequate risk assessment of processes that can generate toxic impurities.