Manufacturing

Biopharma majors are among the industry stakeholders who have commented and raised questions about FDA’s recently proposed draft guidance for analytical assessment of similarity in biosimilars.

Lonza has entered into strategic license agreements for exclusive rights to a gene-therapy platform for developing treatments for hearing and balance disorders.

The company has opened a new California facility that, combined with its existing site in Foster City, CA, will quadruple its laboratory footprint for gene therapy products.

In a recently released statement, FDA Commissioner Scott Gottlieb warned of an amino acids supply shortage and gave an update on a saline supply shortage, both due to the impact of hurricanes on Puerto Rican manufacturing facilities.

Biopharma employees reveal employment objectives, opportunities, and frustrations.

Single-use systems provide replaceable fluid paths.

A technology roadmap aims to drive and consolidate improvements in a process that has remained unchanged for more than 70 years.

A quality-by-design approach that implements PAT offers advantages in upstream cell-culture processing.

A roundtable Q&A with biopharma executives elucidates the challenges posed by single-use bioreactor bags in contributing to extractables and leachables in the biomanufacturing process.

The Biomanufacturing Technology Roadmap is accelerating innovative manufacturing strategies for biopharmaceuticals.

Cross-functional reliability rooms identify risk and planning metrics, provide insights for production forecasts, and predict trends and areas for improvement.

Small-molecule therapeutics can also benefit from the implementation of PAT in the manufacturing process.

Biocad and Sothema Labs have partnered to release cancer-treating biosimilars into the North African market.

Binding Site has introduced a number of new monoclonal antibodies targeting infectious diseases, including cytomegalovirus, hepatitis (A, B, C, and D), herpes, human immunodeficiency virus (HIV), rubella, and toxoplasma.

The acquisition gives GE Healthcare access to a nanofiber-based platform purification technology that can offer improvements in biopharmaceutical productivity.

Manufacturers and trading partners struggle to meet drug tracking requirements

The agency has approved a biologic-based new molecular entity for treating hemophilia A and has expanded the indication for a leukemia drug to now treat a common form of non-Hodgkin lymphoma.

SciLog Select Go Single-Use Assemblies from Parker Hannifin uses an assortment of validated parts and assemblies to build needed devices for biopharmaceutical manufacturing.

Germany tops quality ranking in the inaugural CPhI Global Pharma Index.

Bayer will make a $400-million upfront payment to develop and commercialize two anti-cancer compounds in Loxo Oncology’s portfolio.

As part of the deal, J&J’s Janssen will pay an upfront payment of $50 million to research, develop, and commercialize up to six bispecific antibodies.

The company’s new modules offer scalable single-pass diafiltration and were exclusively showcased during its Leadership Forum series in Westborough, MA.

A new facility type integrates next-generation mobile cleanroom systems.

The use of therapeutic vaccines presents a new way to manage diseases, such as cancer and sexually transmitted diseases.

This article explores some of the challenges, services, and technologies that go into ensuring that vaccines are properly temperature controlled and maintain product integrity for delivery to patients.

Challenge trials may increase in coming years as new and improved challenge agents better emulate “natural” disease states.

Alternatives to time-consuming, error-prone operations promise to reduce vaccine manufacturing costs and improve facility flexibility.

Despite the challenges and high cost of development, vaccine innovation is at an all-time high, as new approaches aim to improve global access.

The use of approved platform technologies can reduce the time and cost required to generate new vaccines.

ADC Bio experts warn of impending problems in the ADC pipeline with millions wasted in development costs.