Contract Development Services

Mergers and acquisitions have changed the shape of the contract services market as big players seek to build full-service capabilities.

For successful partnerships, it’s important to take a long-term view, focus on simple designs, and address potential payer concerns up front.

Novasep is building a new synthesis laboratory and adding capacity for kilogram-scale batches of synthetic molecules that are needed for biological testing and preclinical trials, at its Pennsylvania, US facility.

Patheon cites expanded API services with acquisition of IRIX Pharmaceuticals.

A facility expansion adds space for production of Repligen’s tangential flow system.

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

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

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

Annual study shows CMO technical expertise is not enough.

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

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.

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

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

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

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

Despite the growth of specialist companies with capabilities across various therapeutic areas in Europe, there is still a need for early development expertise with end-to-end pharmaceutical manufacturing capabilities.

Contract development and manufacturing organizations identify trends, challenges, and emerging technology and service needs for solid and semi-solid dosage forms.

For a bio/pharma industry in flux, contract services are playing a greater-and more diverse-role in drug development.

Hovione will use Merrion's GIPET absorption-enhancing technology for solid-dosage drugs.

PharmSource special report shows demand for cytotoxic injectable drugs could tap existing CMO capacity.

Biopharma companies should not overlook India's growing market.

The international pharmaceutical industry is changing its approach to R&D and is increasingly relying on outsourcing for drug discovery.

CMOs may find opportunities in alternative expression services.

The relatively low success rates for bio/pharmaceutical compounds in clinical development have prompted many organizations to explore ways of reducing risk in clinical development.

Regis Technologies passes a recent FDA audit with no Form 483 observations.