Manufacturing

The company showcased its compact robotic nest filling machine at CPhI Worldwide 2019 on Nov.–7 in Frankfurt, Germany.

Rentshler Biopharma has begun its expansion project in the United States by putting a single-use bioreactor into operation at the Milford facility in Massachusetts.

Sangamo Therapeutics has revealed that the United Kingdom’s Medicines Healthcare Products Regulatory Agency (MHRA) has authorized the first in-human clinical trial evaluating a chimeric antigen receptor regulatory T cell (CAR-Treg) therapy.

The goal of Design for Reliability (DfR) is to eliminate defects at the design stage; PharmTech interviews Jacobs about DfR for pharma equipment.

Trends affecting primary pharmaceutical packaging include the shift to more complex drug-device combination products.

The company introduced its new advanced elastomer, the 4040/40 formulation, and a new line extension of its AccelTRA component program, AccelTRA Select, at CPhI Worldwide from Nov. 5–7 in Frankfurt, Germany.

Through a partnership with the Sobti family, the CDMO will expand is injectable dosage form capabilities.

The new service will assist pharmaceutical companies with quality control and analytical requirements.

Hovione Technology worked with Harro Höfliger on powder filling of blisters for the reusable Papillon DPI.

The new center will handle the delivery of novel and high-quality therapeutics by providing expertise in critical analytical processes and specialized workflows.

The plant in Singen, Germany will be used for formulation, filling, and packaging of Takeda’s vaccine candidate.

The new addition will also launch a single-use bioreactor for the 93,000-ft2 facility.

The companies plan to promote and manufacture Maverick, an emergency-use, cartridge-based auto-injector.

GE Healthcare Life Sciences will supply Akeso Pharmaceuticals with the FlexFactory platform to accelerate production of antibody drugs in the Guangzhou region.

Through the agreement, Samsung will provide flexible business terms while offering full regulatory support and improved batch release from small to large scale.

The technology is set to heighten the company’s GPEx expression platform through the utilization of a glutamine synthase knock-out Chinese hamster ovary cell line.

The company will invest $24 million into its Inchinnan, Scotland, site to expand global bioproduction capabilities with additional large-volume liquid manufacturing capacity for cell-culture media.

Schott will combine its adaptiQ platform with West’s Ready Pack system.

PATH’s Microarray Patch Center of Excellence aims to accelerate transdermal patch technology for public health needs.

The pressure to improve operational technology performance combined with the rapid pace of technology change is driving adoption of new automation models in pharmaceutical manufacturing.

The author provides an overview of common residual moisture methods for lyophilized drug products and key points to consider during method selection and method development.

The project will seek to deliver treatments for the underlying cause of cystic fibrosis through submitted proposals from potential collaborators.

The new Javené, France-based facility is expected to increase the company’s production capacity of injectable grade sodium hyaluronate obtained by fermentation by 2.5 times.

The company is expanding its bioanalytical capacity and capabilities to support biologic drug development, cell and gene therapy development, and biomarker analysis.

A recent report released by an FDA task force highlights the financial, manufacturing, and policy issues underlying the drug shortages of important prescription medicines in the United States.

The successful inspection comes after the facility passed a pre-approval inspection in June 2019 from Japan’s Pharmaceutical and Medical Device Agency for an innovative drug.

GE Healthcare Life Sciences’ KUBio box is an integrated, flexible biomanufacturing environment for viral vector-based gene therapies.

US-based SP Industries acquired the sterile filling line assets of Spain-based i-Dositecno.

Gerresheimer enlarged a cleanroom, installed a high-performance furnace, and automated testing and packaging systems for pharmaceutical glass packaging in Essen, Germany.

A second lawsuit has been filed by Centrient Pharmaceuticals India in the High Court of Delhi in New Delhi against Dalas Biotech for patent infringement.