Manufacturing

Belgium-based CDMO MaSTherCell will expand its European manufacturing capacity for cell and gene therapy products by setting up a new facility in Belgium.

Serialization-ready packing equipment and services to manage data assist companies with DSCSA compliance.

The Dual Cell-E Robotic Palletizer from ESS Technologies integrates a FANUC robot with custom-designed end-of-arm tooling for palletizing in a small footprint.

At INTERPHEX 2019, MG2/MG America stages a packaging/processing summit; exhibitors offer packaging equipment innovations for parenteral products.

Think ahead to production requirements when planning strategies in early development of gene and cell therapies.

The companies aim to assess automated CAR-T cell therapy manufacturing at the point-of-care and develop technologies to facilitate patient access to immunotherapies.

The Pharma Services business of Thermo Fisher Scientific will invest $150 Million at three facilities.

Catalent announces investment for its Zydis ODT technology, offering increased drug load and taste-masking capabilities.

The company received $4.8 million from the Bill & Melinda Gates Foundation to accelerate global health research in the development of vaccines and antibody-based treatments for infectious diseases.

The collaboration’s enhanced data exchange combined with advanced analytics are expected to reduce raw material variability and improve biomanufacturing performance reliability.

The companies will join forces to improve gene- and cell-therapy manufacturing using the cloud and machine learning.

The acquisition of the site in Copenhagen, Denmark, will significantly expand Fujifilm’s capacity and capabilities.

Process optimization improves process mass intensity, reduces environmental impact, and improves cycle time for bio/pharmaceutical processes.

The new facility, located at the company’s headquarters in Pittsburgh, PA, is expected to meet all clinical and commercial development needs of the company’s lead gene therapy program.

Iksuda Therapeutics and Femtogenix, have signed a license agreement aimed at progressing Iksuda’s lead ADC to clinic, with the aim of targeting difficult-to-treat solid tumors.

The companies will use GeoVax’s vaccine technology to develop malaria vaccine candidates.

Sartorius Stedim Biotech (SSB) and Novasep will partner to develop systems for membrane chromatography using Novasep’s BioSC platform and SSB’s single-use technology.

FDA guidance on quality considerations for continuous manufacturing should help advance implementation by providing clarity and giving companies more confidence to make investments in the new technology.

The Tandem 4.0 augmented reality-enhanced collaboration tool from Apprentice.io has a new user experience and user interface design.

AST will unveil its multi-format robotic filling system, the GENiSYS R, at INTERPHEX.

The Marchesini Group will introduce the CMP pharma inspection system to the US market at INTERPHEX 2019.

The company is voluntarily recalling four lots of Drospirenone and Ethinyl Estradiol Tablets, USP because of the possibility they may contain defective blister packs and incorrect tablet arrangements.

Identify the warning signs and follow best practices for refurbishment to improve tablet press yields.

New technologies in the digital factory enhance quality, efficiency, and flexibility for bio/pharmaceutical manufacturing.

HPLC coupled with charged aerosol detection is a suitable analytical technique to quantitate and characterize polysorbate-80 in therapeutic products; allowing quality assessment of raw material, content confirmation during manufacturing, and monitoring product stability.

A monoplant may offer greater supply security and flexibility for specialist medicines.

Containment valves and smart monitoring can keep employees safe and improve manufacturing efficiency when handling potent APIs, intermediates, and solid-dosage drugs.

Single-use systems can be a cost savings for CMOs, and these savings can be passed on to clients and, ultimately, to patients.

While allogeneic therapies can use existing regulatory and quality frameworks, autologous treatments will require pharma’s adoption of true just-in-time and right-first-time concepts, says consultant James Blackwell.

Optical coherence tomography can improve quality control and development of coated dosage forms by allowing film thickness to be measured in real time.