05.03.24 -- Meeting The Demand For Bioanalytical Services

Scorpius BioManufacturing offers a comprehensive range of biologics analytical testing services. Beginning with the end in mind, we design pre-clinical analytical test methods and IND-enabling programs that easily transfer to cGMP production.

While platform approaches offer time and efficiency savings, they are not always feasible for novel antibody formats. Explore how experts adjusted a mAb production and purification platform to be applicable for the rapid development and scale up of a BsAb.

This brochure introduces the potential for problems at BLA submission where a recent analysis of FDA complete response letters showed that 47% of the products that received them had CMC analytical issues.

Trust our analytical development and testing experts to rapidly advance your molecule for the greatest chance of success. Cambrex is a global CDMO that provides drug substance, drug product, and analytical services across the entire drug lifecycle.

Review the advantages and limitations of transcriptional assays versus reporter gene assays and how the transcriptional assay compares to ddPCR and flow cytometry for analysis of CGTs.

Analytics provide information for product quality and the impurity levels. By providing sensitive and accurate analytical data, analytics can help upstream development by performing spent media analysis or downstream purification by analyzing protein products.

Your programs deserve the most comprehensive suite of CDMO services available, and Ajinomoto Bio-Pharma Services has the Power To Make your therapeutic vision a reality — from pre-clinical through commercial production.

Meet your mRNA product's specific needs with assay packages that provide the product and process knowledge needed to develop a quality target product profile and identify critical quality attributes.

IDT Biologika offers comprehensive analytical services to support our clients’ development programs covering viral testing, microbiological testing, molecular-biological testing, biological testing, and chemical-physical testing.

Kymanox supports pharma, biotech, medical device, and in vitro diagnostic device manufacturers in the validation of methods according to regulatory guidelines. We ensure phase-appropriate validation characteristics are clear for the intended application.

At Resilience, our custom-fit biomanufacturing solutions put our collective talent and resources to work in the ways that free you from the obstacles impeding the success of your novel therapy.

Our team of analytical experts provides experience, efficiency, and technical proficiency in the development/validation of analytical methodology and GMP testing support for your project.

Combining disruptive technology platforms with unparalleled genomic medicine development expertise, Precision NanoSystems’ Biopharmaceutical Services accelerates the development of lipid nanoparticle (LNP) formulations and drug products.