Manufacturing

Improving the manufacturing of gene therapy vectors will be crucial to making advanced treatments accessible to more patients who need them, agreed panelists at the 2018 Galien Forum.

Experts believe that the contract development and manufacturing organization market will reach $17.38 billion by 2022, with disruptive business models using Industrial Internet of Things (IIot) and single-use technologies proving more profitable and efficient in the long term.

GE Healthcare will collaborate with Wego Pharmaceutical in China for local production and supply of GE Healthcare’s Fortem single-use consumables.

The new program will provide cell and gene therapy companies a more efficient way to ensure quality compliance across collection center networks and to minimize quality system audit burden on these centers.

The expanded Frederick, MD, site will help meet global demand for diagnostic instruments and cell and gene therapies for clinical trials.

The International Society for Pharmaceutical Engineering (ISPE) named Shire as the ISPE 2018 Facility of the Year Awards Overall Winner for a facility integration project in Los Angeles, CA.

The expansion adds new capabilities and enhances existing service offerings for both oral and parenteral dosage forms.

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

An ERP solution provides for the management of multiple business activities and traceability requirements resulting from regulations, customer demands, sourcing, and international business needs.

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

Mechanistic process and product modeling turns data into knowledge that can be extrapolated with known confidence for design space characterization and risk assessment.

Irish manufacturer of generic medicines for both human and animal health, Chanelle Pharma, has been named as Pharma Industry Company of the Year 2018.

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.

New FDA guidance offers a time buffer but increases supply-chain-management complexity, as active DSCSA enforcement begins.

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.

The company has broken ground on the construction of a new laboratory space.

he acquisition expands the company’s formulation and analytical R&D services.

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.

The company added a new EUR 63-million (US$72-million) packaging center at its manufacturing site in Darmstadt, Germany.