Outsourcing

As the development pipeline becomes more saturated with complex molecules and patient experience becomes more important, developers are looking to outsourcing partners to provide more specialized expertise and solutions.

Establishing OEL data and ensuring appropriate engineering controls are crucial aspects of safe handling.

An understanding-during early development-of the solid form landscape of an API can enhance product quality and manufacturing processes.

New therapies, new technologies, global supply chain challenges, and political pressures draw pharma professionals to major industry event.

Bora Pharmaceuticals has announced it has achieved success in the latest FDA general inspection of its Zhunan facility with zero 483 observations.

FDA issued a statement about the importance of reporting adverse events resulting from the use of compounded drugs.

The new antibody, Citryll’s CIT-013, could offer new treatment options for various human diseases including lupus, vasculitis, pulmonary fibrosis, and organ damage due to sepsis.

The editors welcome technical article contributions from the bio/pharma industry.

CDMOs are adding facilities and services to their portfolios in anticipation of the biologics industry’s continued growth.

Alvotech and Prestige Biopharma, have announced the formation of a new contract manufacturing partnership for the commercial production of a biosimilar.

The latest research from GlobalData has revealed that more than two-thirds (69%) of CMOs high-containment facilities are based in the top five European Union countries and Switzerland.

Nephron Pharmaceuticals is partnering with Clemson University to create a robotic solution for syringe-filling automation to enhance sterile manufacturing.

Using Alternating Tangential Flow in a 3000-L perfusion bioreactor, the company expects to reduce production time by up to 30%

A risk-based approach to CMC enables drug sponsors to focus on clinical and manufacturing development paths.

As vaccines gain prominence within pharma, there is an expectation that specialized CDMO services will provide opportunities.

Pharmaceutical Technology Europe celebrates 30 years in publishing the latest insights, analysis, and developments of the bio/pharma industry.

The evolution of CDMOs has led to increased investment in new technologies, capabilities, and expertise.

To help customers succeed, CDMOs have moved away from the ‘fee-for-service’ model to offer flexible, full-service partnerships.

Complex and potent molecules demand greater technical and regulatory expertise to ensure safe handling.

A one-size-fits-all strategy is not the best approach for the development of a chemistry, manufacturing, and controls program.

Now that the first genetically modified cell therapies are being manufactured, the industry must move beyond “whatever works” to meet growing demand.

Does the pharmaceutical industry have adequate access to contained equipment, facilities, and infrastructure for the manufacture of highly potent APIs?

Key considerations when searching for an analytical service provider include workflow, hardware, and regulatory support.

Cambrex has revealed that it is expanding its solid form screening and crystallization process development facility in Edinburgh, Scotland.

Catalent Biologics has entered into a long-term strategic agreement to develop and manufacture an AveXis gene therapy treatment for spinal muscular atrophy (SMA), Zolgensma.