Outsourcing

The contract research, development, and manufacturing organization has expanded API aseptic manufacturing capacity at its Valladolid, Spain, facility.

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majors are among the industry stakeholders who have commented and raised questions about FDA’s recently proposed draft guidance for analytical assessment of similarity in biosimilars.

In a productive year, 2017 was filled with acquisitions, facility expansions, and new biopharma technology.

In a productive year, 2017 was filled with acquisitions, facility expansions, and new biopharma technology.

Attracting and retaining qualified bio/pharma experts demands a mix of recognition, rewards, and opportunities.

Is pharma up to the task of developing knowledgeable, motivated employees?

For many processes involving hazardous chemistry, running in flow mode has safety and economic advantages.

Amid business and regulatory uncertainty, bio/pharma experts reveal opinions on salary, recognition, and training.

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

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

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

The facilities in Brescia, Italy and Karlskoga and Uppsala, Sweden, are the latest of Recipharm’s sites to be equipped to supply serialized products to the United States.

Pharma trends translate into increased need for not only external partners, but those will capabilities that can help advance today’s drug development and manufacturing challenges.

Avista Pharma Solutions facility and equipment upgrades at its Longmont, Colorado facility support processing of potent compounds.

Spectrum Chemical will provide BASF precious-metal-containing powder catalysts in research quantities for early product development.

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

The companies have established a joint laboratory to develop full continuous processing to manufacture high yields of monoclonal antibodies at reduced costs.

Alcami will manufacture clinical supply of the API for a drug candidate targeting various hematologics and solid cancers.

QuintilesIMS has changed its name to IQVIA to reflect its October 2016 merger with IMS Health.

As part of Recipharm’s ongoing initiative to improve profitability and competitiveness, a decision has been made to end operations in Stockholm and Höganäs.

The company has officially opened a local brand office in South Korean to support its existing business in the region.

The Human Vaccines Project has created the Universal Influenza Vaccine Initiative, a research program that will aim to understand the human immune system’s role in the development of universal influenza vaccines.

Data governance is necessary for compliance with current regulatory expectations for data integrity in pharmaceutical R&D and manufacturing organizations.

Almac Group will acquire BioClin Laboratories to expand Almac’s analytical service offerings.

Capsugel announced on Oct. 31, 2017 that it expanded clinical trial capabilities, as well as increased development and manufacturing capabilities for specialized drug products using liquid-filled hard capsule technology, at its Edinburgh facility in Scotland.

Recent acquisitions are creating CDMOs with scale that rivals global bio/pharma.

Industry experts were honored for business, scientific, and social contributions.

Catalent’s new Biologics & Specialty Drug Delivery unit will be led by Barry Littlejohn; Jonathan Arnold to lead Oral Drug Delivery.

The M&A advisory firm has developed an interactive map of manufacturing sites to give insight into the market size of global manufacturing.

The CDMO is investing £6 million into a new facility at its United Kingdom site to expand its milling, micronization, and solid form capabilities.