Drug Development

The Awards honor innovations in drug delivery and packaging, for better patient safety and compliance.

Through its Janssen pharmaceutical companies, Johnson & Johnson, has partnered with Theravance to develop and commercialize a therapeutic for inflammatory bowel diseases.

Experts share insights on the various methods used for purity and impurity analysis of therapeutic proteins.

Greater clarity and harmonization in ATMP regulations are needed to promote the development and commercialization of these therapies.

Regulations and industry guidelines focus on ensuring excipient safety by specifying risk assessments and shared responsibility.

Mark Egerton, PhD, chief executive officer of Quotient Sciences, shares insights on a new approach to accelerate drug development, which integrates formulation development, real-time adaptive GMP manufacturing, and clinical research within a single platform.

Industry lessons from a fast-track technology transfer of a soft-gelatin capsule (softgel) are multifold. This case study reviews the success factors for effective execution of the technology transfer, which include: strong relationship between the customer, the contract development and manufacturing organization, and other partners based on deep knowledge in the technology; established and proven quality-by-design processes; risk mitigation management; project leadership; flawless execution; and mutual trust.

A collaboration between The Centre for Process Innovation and The Roslin Institute aims to develop commercially viable and scalable methods of producing biologics using transgenic animals.

Cambrex invests in development and laboratory facilities and adds staff.

Avista Pharma's strengthens early phase drug development offerings with acquisition of Solid Form Solutions.

Chemical engineers and chemists each bring unique skills to API process development and optimization. Success depends on their close collaboration, at both sponsor and CDMO facilities.

Successful outsourcing relationships in early phase drug-development analytics are driven by partnership.

This article describes how to improve the regulatory journey from classification to market clearance for sponsors of medical device combination products.

Particulate modelling has the potential to transform productivity within the pharmaceutical manufacturing industry, speeding up production cycles, reducing manufacturing costs, improving efficiency, and driving inward investment, with the potential to reinstate the UK as a global manufacturing powerhouse.

The new Acquity Arc Bio System by Waters is specifically engineered to enable efficient transfer and improvement of bioseparation analytical methods.

The acquisition will strengthen Sanofi's R&D strategy and expands its franchise for rare blood disorders.

Corning will feature its 3D bioprinting technology and tools to support 3D cell culture at booth #1029 during the SLAS 2018 conference on Feb. 3-7, 2018 in San Diego, CA.

Comecar will provide cell culture equipment for biopharmaceutical company CO.DON AG's new production site in Leipzig, Germany.

Hovione has installed a new MG2 Tekna Precision Capsule filler at its Portugal site.

Advances in analytical technology are making the screening of natural products and their substructures more viable.

The funding from the Walloon Region will enable Univercells to start developing a manufacturing platform aimed at driving down costs of biosimilars manufacturing.

GE Healthcare will equip Cellular Biomedicine Group's cell therapy manufacturing facility in Shanghai, China, with its FlexFactory single-use platform, designed to speed up cell therapy manufacturing timelines.

The company is developing a pipeline of combination therapies using its patented polymer-based matrix delivery system, known as TAOS (targeted orchestrated signalling matrix).

The acquisition strengthens Charles River Laboratories’ capabilities in the oncology and immunology therapeutic areas.

The two agencies have launched a program to develop safe and effective medical products to be used by American military personnel.