Outsourcing

Taking key considerations into account along the cell therapy supply chain can set cell therapy developers up for success.

The booming cell therapy market has created a need for capacity that outsourcing partners are ready to fill.

BioPharm International spoke with Colleen Floreck, vice president, Global Marketing and Strategy, Catalent Cell and Gene Therapy about the specific requirements and challenges for expanding production of viral vectors.

Under the two-year task order, ATCC will continue to support the DCEG MEAS program in receiving, processing, storing, analyzing, and distributing clinical specimens from different cancer types.

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.

Auditors must have access to the batch records of the activities they are reviewing, says Siegfried Schmitt, vice president, Technical at Parexel.

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

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.

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.

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

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.

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

Fujifilm Diosynth Biotechnologies' 89,000 square-foot expansion of its BioProcess Innovation Center in Research Triangle Park, N.C., will double its capacity to support process characterization.

The COVID-19 pandemic generated partnerships among organizations with the goal of changing the way in which assay development and tech transfer of these assays are conducted moving forward.

The urgency with which COVID-19 forced the biopharma industry to produce therapies has refocused the search for new tools to enable rapid therapeutic responses to a pandemic.

The agreeement will add to Merck KGaA’s LNP and mRNA capabilities.

The acquisition of Protein Metrics expands Insightful Science’s R&D solutions to include proteomics.

With this investment into Yapan Bio, Piramal Pharma adds new technologies and capabilities in large molecules, including vaccines and gene therapies, to its global offering.

Recent developments in the outsourcing industry include a focus on early development services, biosimilar production, and RNA technology.

FUJIFILM Irvine Scientific’s new manufacturing facility in Tilburg, the Netherlands, is now fully operational.

FUJIFILM Diosynth Biotechnologies plans to invest £400 million (US$528 million) to expand its Billingham, Teeside facility in the United Kingdom.

Lonza has signed a five-year services agreement to provide for the development and manufacturing of biologics and small molecules for portfolio companies owned by Bioqube Ventures.