Outsourcing

Optimizing the use of partners for clinical trials depends on selecting the right contractor.

Capacity concerns and regulatory compliance considerations will drive the decision about outsourcing the manufacture of clinical trial materials.

Moderna and Thermo Fisher Scientific have formed a collaboration to leverage dedicated commercial fill/finish manufacturing capacity in the US for mRNA vaccines and therapies.

The Center for Breakthrough Medicines and BioAnalysis LLC have formed a strategic alliance to offer novel analytical testing services for CGT clients.

Recipharm has strengthened its biologics manufacturing capabilities with the acquisition of both Vibalogics and Arranta Bio.

Thermo Fisher Scientific is expanding its Millersburg, Penn., site with a $40 million investment to support increased production of single-use technology for critical vaccines and biologics.

Thermo Fisher Scientific's solution for cell and gene therapies involves a combination of cold chain logistics, serialization compliance, and distribution

While companies today outsource numerous processes, from early development through to manufacturing, there are still many opportunities to realize the full potential of outsourcing services.

Piramal Pharma Solutions plans to construct a multipurpose ADC manufacturing and aseptic fill/finish facility in Grangemouth, Scotland, and to upgrades its existing API manufacturing facility in Morpeth, England.

China-based CDMO Asymchem acquires US-based chemical technology company Snapdragon.

The acquisition will include Rewrite’s DNA writing platform, expanding Intellia’s genome editing tools.

In this episode of Drug Digest, Chris Spivey, editorial director, and Meg Rivers, senior editor, dive into APIs, excipients, and formulation advances, specifically pairing the right APIs and excipients for optimizing formulations.

For some manufacturers, the goal was to be fully compliant with the DSCSA, including both serialization and aggregation, from day one.

Arranta Bio will use Cytiva’s FlexFactory single-use manufacturing platform to produce mRNA vaccines.

Recipharm will build up its biologics service offering with the acquisition of GenIbet.

Experience is an invaluable asset for outsourcing partners, particularly as more challenging method development services are in demand.

Demand for outsourced services of technical R&D activities is increasing.

Recent news surrounding CDMOs provides insight into ongoing trends in the sector.

A key benefit for companies when outsourcing formulation development is the broad experience they can gain from a dedicated service provider, particularly for niche markets.

Industry experts share their top outsourcing tips from both the perspective of companies offering outsourcing services as well as for companies looking to outsource.

Shifting demands from industry innovators is leading to an increased need for flexible and agile outsourcing partners offering broad and integrated models.

CDMOs need to consistently demonstrate agility as demand increases for newly developed therapeutic modalities.

CDMOs offer expertise and capacity for spray drying.

CDMOs offer expertise and customization options for sponsors of orphan drugs.

Pharmaceutical Technology Europe's BioPharma Outsourcing Innovation supplement examines outsourcing development services, spray draying, capacity challenges, and more.

Texcell North America’s new lab facility in Frederick, Md., will expand the CRO’s capabilities in R&D cell culture, viral clearance studies, and viral safety testing.

Samsung Biologics has signed an agreement with Biogen to acquire Biogen’s 50% stake in Samsung Bioepis, a joint venture formed by the two companies, for up to $2.3 billion.

Air France KLM Martinair Cargo and Envirotainer are collaborating on more sustainable air transport of pharmaceuticals

Cyxone has appointed a European CDMO to scale-up and produce the active ingredient of its T20K drug candidate.

After a previously announced merger, Protagen Protein Services, BioAnalytix, and GeneWerk have formed a new CRO under the name ProtaGene.