Contract Analytical Services

Contract organizations offer assistance for testing raw materials obtained from outside suppliers.

Contract organizations offer sponsors specialized equipment, capacity, and expertise for testing, manufacturing, and packaging bio/pharmaceutical products.

With the acquisition, Olink will join Thermo Fisher’s Life Sciences Solutions business.

The need for preclinical testing expertise is growing as molecular complexity increases.

The company is investing more than $2 million in its analytical testing services and adding suppository manufacturing capabilities.

The company’s Itasca, Ill., facility will offer chemistry, manufacturing, and controls analytical testing support.

Under a new collaboration, Lonza and Oxford Nanopore aim to commercialize a CGMP-validated test for advanced analysis of mRNA products.

Strategizing a PK/PD study approach in early phase development facilitates a successful clinical progression.

Sufficient stability studies show a drug product meets regulatory requirements, therefore ensuring the drug reaches the patients who rely on it.

MilliporeSigma has expanded its biosafety testing laboratories in Shanghai, China, with the completion of new lab space at its new €29 million (US$43 million) Biologics Testing Center.

The new centralized hub will provide advanced testing of nucleic acids, which is expected to simplify mRNA substance testing.

CN Bio and LifeNet Health LifeSciences have teamed up to provide direct access to a portfolio of highly characterized hepatic cells for the creation of advanced liver-on-a-chip assays.

Illumina’s new solutions center in Bengaluru, India, will expand access to genomics in the country.

Preclinical studies specifically benefit from the “smart” drug development trend through deeper data access and analysis.

Ginkgo Bioworks has acquired StrideBio's AAV capsid discovery and engineering platform and has formed a partnership with WARF for development of next-gen cell therapies.

Under two new agreements, Societal CDMO will offer analytical, technical transfer, formulation, manufacturing, and packaging services for novel therapeutics.

A thorough understanding of both regulatory requirements and study challenges can help develop and validate the appropriate methods for a bioanalytical study program.

It is important to understand regulatory requirements and study challenges to develop and validate the appropriate methods for a bioanalytical study program at the clinical stage.

Through the Thermo Fisher Scientific and LabShares Newton partnership, life science startups can accelerate early-stage discovery and development with shared lab spaces.

PerkinElmer has expanded its genomics testing services with the launch of its ultrarapid whole genome sequencing.

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.

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

Defining expectations, such as GMPs, is paramount for sourcing the right biopharmaceutical raw materials.

SGS is investing in a new E&L lab in Navi Mumbai, India, that will provide testing services.

Manufacturers should consider the benefits and risks of contract packaging for stability studies.

LGM Pharma will offer contract analytical testing and stability services to pharmaceutical developers and manufacturers.

The increased number of regulatory filings for cell and gene therapies requires reevaluation of bioassay methods because of their complexity.