Outsourcing

Articles

Novasep has entered into an agreement with Celladon to provide scale-up and pre-validation studies for the drug substance for MYDICAR.

Novasep to Manufacture Celladon's Mydicar API

Cynthia A. Challener is a contributing editor to Pharmaceutical Technology.

Protecting workers, patients, and the environment requires advanced technologies.

Minimizing Risk during HPAPI Manufacture

Agnes Shanley is senior editor of Pharmaceutical Technology.

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

Taking a "Development by Design" Approach to Cell Therapies

Eric Langer has over 25 years experience in biotechnology and life sciences strategic marketing management, market research, and publishing. He has held senior management and marketing positions at biopharmaceutical supply companies. He has published and authored many books and reports on topics in Biotechnology, Large-scale BioManufacturing, and bioscience commercialization and communication. He teaches at Johns Hopkins University marketing management, biotech marketing, services marketing, and marketing in a regulated environment. In 1989 he co-founded BioPlan Associates, Inc. to provide market analysis, and strategy to biotech and healthcare organizations.

Annual study shows CMO technical expertise is not enough.

Relationship-building at Top of Mind for Clients

Shrinking facility size, growth of biologics, and emerging market demand influence pharma investments.

Pharma Investments Reflect Key Industry Trends

Contract research, development, and manufacturing organizations invested in new facilities and technologies in 2014 for analytical testing, as well as small- and large-molecule drug development.

Contractors Invest in Capacity and Capabilities

Contract service providers describe how quality by design has influenced a drug sponsor's expectations of suppliers.

Quality by Design in Contract Service Relationships

Representatives of contract service organizations that develop biologic-based drugs discussed technology trends such as high-throughput screening and single-use systems.

Technologies Key for Biologics to Meet Expectations

Experts from contract testing laboratories and service organizations shared their perceptions of analytical testing advances, and challenges still ahead.

Analytical Labs Strive to Deliver More Information, Faster

Representatives of contract service organizations that specialize in parenteral drug development and manufacturing describe the evolving trends.

Contract Development Services