Manufacturing

The draft revisions of Annex 1 are driven by a quality risk management approach and will provide more clarity and detail for manufacturers.

HHS is tasked with establishing a public-private consortium for advanced domestic pharmaceutical production.

Die table segment cleaning equipment features a fixture that holds the segment within the tank and leaves the bores unobstructed.

The 3M Harvest RC clarifier condenses three process steps into a single-stage purification of recombinant protein therapeutics.

ROSS’ Sanitary Ribbon Blenders allow operators to safely empty bags of powder through a bar grating while a contiguous vibrating tray assembly catches debris and off-spec ingredients.

The acquisition of Intermountain Life Sciences will double Cytiva’s capacity for buffers and liquid cell culture media at its manufacturing site in Logan, Utah.

The extended manufacturing agreement between Pinteon and Lonza enables future clinical production of PNT001, a novel Tau antibody therapeutic that targets Alzheimer's disease and traumatic brain injury.

Selexis and KBI Biopharma will use integrated services to advance Immatics’ TCR bispecifics drug development program to the IND stage.

Catalent expands capabilities for stem cell-based therapies with acquisition of RheinCell’s GMP-grade human iPSCs.

Vectura will provide preclinical development services for Incannex’s inhaled drug product for the treatment of traumatic brain injury.

Developing bioassay methods requires a new approach for cell and gene therapy drug development.

With COVID-19 vaccine facilities receiving recent citations, it is evident that failure to meet cleaning and sanitization requirements puts patients, facilities, and operators at risk.

Amgen’s greenfield facility near Columbus, Ohio to assemble and package vials and syringes is expected to be operational by 2024.

CDMO Yposkesi will increase its current gene therapy vector capacity through French government’s “Plan de Relance” scheme.

Thermo Fisher Scientific has introduced its new Quick to Clinic solution, which is designed to accelerate biologic drug development from discovery to the IND phase in a shortened period.

The Cell and Gene Therapy Catapult will establish offices and laboratories in Edinburgh, Scotland.

Evonik has released an innovative green technology that can enable the large-scale synthesis of APIs in water.

Pharmapack Europe event organizers have revealed increased levels of innovation in drug delivery across the industry, substantiated by the level of regulatory approvals.

Genezen Laboratories has broken ground on a new current good manufacturing practice (CGMP)-compliant lentiviral vector production facility.

Pharmaceutical Technology discussed the potential increased risk of counterfeit medicines in the UK post-Brexit and how blockchain could be a useful tool to tackle the issue.

SP Scientific Products’ SP Hull LyoStar 4.0 R&D freeze dryer supports rapid freeze-dry cycle development, optimization, and process scale-up.

The University of Birmingham has been confirmed as the third National Training Centre in the Advanced Therapies Skills Training Network (ATSTN) initiative

Centrient started production at its new statins API manufacturing unit in Toansa, India.

Ilya Pharma has been granted approval by the Swedish Medical Product Agency and Swedish Ethical Review Authority for initiation of a Phase II clinical trial of its ILP100 gene therapy.

The US government will invest $3 billion from the American Rescue Plan into a COVID-19 antiviral development strategy.