Contract Development Services

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.

Data from BioPlan Associates’ 10th Annual Report and Survey of Biopharmaceutical Manufacturing Capacity and Production suggest that the interest in disposable devices has begun to extend to biopharma operations beyond basic single-use bags and connectors.

Through its educational and networking opportunities, the American Association of Pharmaceutical Scientists plays an important role in partnering throughout the drug- development and commercialization process.

New partnership aims to eliminate months from the typical transition time required to move chemistry from the laboratory into commercial applications.

Advances in techniques and single-use systems are revolutionizing vaccine manufacturing.

Are strategic partnerships in clinical research a model for CMC services?

Industry experts share their views on the outsourcing model and the current and future direction of contract chemical API manufacturing.

Advances in techniques and single-use systems are revolutionizing vaccine manufacturing.

Successful product development and technology transfer between a CMO and the sponsor company requires a multifaceted collaborative approach. The author, Marga Vines from Grifols International, analyzes a project for an injectable drug for which a new drug application was submitted to FDA.

External manufacturing plays a crucial role in pharmaceutical companies’ supply strategy. The author examines market trends for the captive and merchant global market for active pharmaceutical ingredients and intermediates.

Claudia Roth, President of Vetter Development Service USA, discusses trends in single-use technology for clinical manufacturing.

The US and EU move forward with measures to fortify the pharmaceutical supply chain.

As the strategic value of emerging markets increase, pharmaceutical companies increase their R&D and manufacturing investments.

When speaking of partnerships, the discussion typically focuses on the relationship between a pharmaceutical/biopharmaceutical company as the sponsor company and a contract-service provider.

Patheon will acquire softgel-specialist company Banner Pharmacaps, based in North Carolina in the US, for $255 million

The author provides results and commentary on a survey analyzing outsourcing strategies, practices, challenges, and outcomes in the selection of a CRO.

The author discusses how a CDMO helps in gaining process understanding and in developing robust, high-quality products and processes.

Jim Miller, president of PharmSource, examines the future direction of CROs/CMOs and the factors influencing the pharmaceutical contract services sectors.

Sponsor companies' increasing focus on strategic outsourcing has changed the rules of the game.

A technical forum featuring Catalent Pharma Solutions, SAFC, and Neuland Laboratories.