Outsourcing

The contract development and manufacturing organization has invested £30-million (US$42 million) at its Dundalk, Ireland site to offer expanded clinical trial services.

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

Flexibility, innovation, and creativity are critical for success in navigating the challenges facing the bio/pharmaceutical industry.

KBI Biopharma's acquisition of Elion Labs expands KBI's biophysical and analytical characterization capabilities.

Paragon Bioservices will build a new cGMP facility in Maryland and expand its existing cGMP facility at the University of Maryland's BioPark.

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

A ceremony was held at Cambrex’s Karlskoga facility to mark the commencement of a long-term manufacturing agreement with AstraZeneca for a key intermediate.

The contract manufacturing company has completed construction on a new aseptic fill/finish facility in Wuxi, China.

Bio/pharma professionals manage expectations amid industry uncertainty.

The industry will see an impact from financing, M&As, advanced therapies, generic drugs, and the retail market in 2018.

MilliporeSigma will collaborate with IPS and G-CON to offer end-to-end, turnkey, modular MAb manufacturing.

The company has completed development of a first-generation production process for its chimeric antigen receptor regulatory T cell product portfolio and is selecting a CMO for clinical supply.

Abzena has entered into a Master Services Agreement with a US biotech company to provide process development and manufacturing services to progress a novel antibody-drug conjugate (ADC) to clinical trials.

The new 30,000-L, $150-million biologics manufacturing facility in Wuxi, China, quintuples the company’s existing manufacturing capability.

The company is expanding its 380,000-square-feet Molex Little Rock facility to include a FDA-registered manufacturing center of excellence for connected health and drug-delivery devices.

An increasing number of warning letters shows that FDA is observing more problems with pharmaceutical contract manufacturing.

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majors are among the industry stakeholders who have commented and raised questions about FDA’s recently proposed draft guidance for analytical assessment of similarity in biosimilars.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