Outsourcing

The agency releases five draft guidance documents related to drug compounding and repackaging.

Market forces may limit the success of CMOs.

Biomanufacturers are seeking more innovation and expertise from their CMO partners.

Whether outsourcing or developing cell therapies in-house, success demands a focus on quality, cost of goods, and sustainability from the start.

CMO executives share their opinions on where outsourcing is going and what is driving market change.

As CMOs shed their old toll processing role, sponsors can expect the right questions, proactive communication, and a firm grasp of risk management and tech transfer from contract service providers.

Data sharing and a common data model can improve CRO partnerships and trial results.

Better equipment and automated processes will be key. So, too, will the right way of approaching outsourcing relationships.

The company has installed and validated new instruments for structural analysis of proteins.

EMA Recommends Suspension of 700 Drugs Tested at GVK Site GVK Biosciences argues that EMA’s recommended suspension of 700 drugs is disproportional to reported infractions. The European Medicines Agency (EMA) has issued a recommendation that 700 medicines authorized for use in the European Union (EU) should be suspended, based on concerns about how GVK Biosciences, a contract research organization in Hyderabad, India, conducted clinical studies. GVK Biosciences, in response, argued “the action is unprecedented and highly disproportional.”

Nelson Patterson has been elected to Pharma & Biopharma Outsourcing Association board. The Pharma & Biopharma Outsourcing Association (PBOA) has announced that Nelson Patterson, vice-president, sales and marketing at Baxter BioPharma Solutions, has been elected to its Board of Trustees, effective immediately. Patterson was elected after Baxter BioPharma Solutions joined the PBOA as a Sustaining Member.

There are significant differences between small molecules and biologics fill/finish capacity.

Bayer has appointed Cardinal Health as US-based contract manufacturer for Xofigo (radium Ra 223 dichloride) injection, and Cardinal Health will build a dedicated facility.

New organization offers support to contract research organizations and contract manufacturing organizations in the New England area.

Biomanufacturing capacity expansion uses modular cleanroom design and single-use technologies.

Outsourcing is taking on a greater role in the biopharmaceutical manufacturing industry.

Advanced analytical methods are speeding up the targeted evaluation of potential viral contaminants.

The authors present a validation study of an analytical method for the simultaneous determination of nine human cytokines in human K2-EDTA plasma.

The authors describe a rapid, single-point calibration approach for ICP–MS analysis of raw materials used in drug product manufacturing.

European CDMOs want into the US market, but entry options are limited.

The trend of exits from the CMO industry looks to be gaining momentum.

Multidirectional collaboration is critical for the new pharma business model; cloud-based information services can offer a communications alternative.

John S. Ross, executive vice president at Metrics Contract Services, provided commentary on the evolving role of contract services in solid/semi-solid dosage development and manufacturing.

Experts at Catalent Pharma Solutions provided commentary on the evolving role of contract services in analytical services, biologics drug development and manufacturing, and solid/semi-solid dosage development and manufacturing.

Experts from PPD provided commentary on the evolving role of contract services in analytical services.