Outsourcing

Industry experts discuss how extractables and leachables studies are designed using a risk-based approach.

Data integrity in the analytical laboratory is an area of increasing focus for regulators such as FDA.

The CMO industry's value proposition is limiting its market penetration.

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.

Outsourcing activity remains strong and unlikely to abate, especially in more traditional areas.

Changes in company ownership shake up the CMO industry.

Thirteen companies are accepted for participation in the supply chain program.

CMOs may find opportunities in alternative expression services.

Contract manufacturing organizations that are established in key markets can provide a competitive edge.

Traditional project decision-making is compared with a QbD approach.

Geographic location, customs and drug-development regulations knowledge, and transportation infrastructure were factors in Catalent Pharma Solutions' selection of Shanghai for its clinical-trials supply facility.

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.

Increased competition from CMOs in Asia means that Western CMOs need to understand fundamental changes in the market.

Pharmaceutical companies are adopting multiple choice partnership strategies to meet the challenges of today's R&D instead of being focused primarily on internal development.

A changing biopharmaceutical industry is going beyond typically outsourced activities and is using CMOs for more challenging processes. Review the top 10 outsourcing trends.

For a drug-development process that relies on outsourced services, special considerations are needed to ensure the proper transfer of technology and information from one phase to the next.

PharmaCell enters an agreement purchase TiGenix therapy production facility.

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

With numerous biologics set to come off patent soon and the percentage of new therapeutics based on biomolecules growing, demand for contract manufacturing in the biopharma space is heating up.

The R&D model is in transition and creating new demands on contract services providers.

Roger Hayes of MPI Research discusses highly potent drug development.

Siegfried Schmitt, principal consultant at PAREXEL, discusses the state of drug manufacturing in India.

Ongoing changes create new opportunities for CROs and CMOs.

Brian Galliher of Cook Pharmica discusses visual inspection systems.

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.

Recipharm has invested EUR 32 million ($43 million) in its Wasserburg, Germany site to expand lyophilization capacity.

Practicality of implementation should be a part of vision in the bio/pharmaceutical industry.

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.