Manufacturing, Biologic Drugs

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.

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 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.

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

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.

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

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 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 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.

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.

Internal release limits help ensure that a batch of drug product remains within specifications throughout its shelf life. This article explores what internal release limits are and why they are important.

The companies partnered to build a 500-L single-use pilot-scale plant for biologics production.

A collaboration using Pall’s bioprocessing technology in G-CON’s PODs enables flexible continuous bioprocessing and viral vector facility solutions.

GE Healthcare, Cobra Biologics, and the Centre for Process Innovation (CPI) have entered into a collaboration to advance manufacturing of adeno-associated virus vectors for gene therapy.

The sterile-manufacturing contract development manufacturing organization is approved by FDA for viral vector manufacturing fill/finish processing at its biologics facility in Scotland, UK.

Cell-line quality has a significant impact on biologic drug quality; learn more about this and other upstream challenges at the new bioLIVE launching this year adjacent to CPhI Worldwide 2018.

FDA awarded nearly $3 million in grants for continuous manufacturing and other advanced manufacturing technologies as part of the agency’s efforts to ensure a robust and reliable supply of biological products.