Bioanalytic breakthroughs redefine drug development

Today’s drug development pipeline is filled with an arsenal of biomolecules of all shapes and sizes, from peptides and antibodies to antibody-drug conjugates, small molecules and oligonucleotides. The drug development process is pressured by the need for thorough bioanalysis to understand the physiological effects of candidate drugs including assessment of pharmacokinetics, pharmacodynamics, and immunogenicity. These analyses must adhere to guidelines set forth by regulatory agencies and the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH).

Mercodia supports drug development by providing bioanalytical services during preclinical and clinical studies. “We are experts in quantitative measurement of large molecules and biologics such us proteins and oligonucleotides in complex matrices.” says Annika Carlsson, Director of the Bioanalysis and Services team at Mercodia. “Our service offering includes the development of tailored and optimized assays for PK, PD, and ADA assessment, validated according to the most recent regulatory guidelines. In our long-established production plant, we produce custom reagents and several off-the-shelf ELISA kits, including our commercial product portfolio of gold standard ELISA kits. These capabilities strengthen our capacity to tailor assay development to the needs of individual customers at all stages of drug development, from design to routine use.”

A customer-centric approach

“Our knowledge of study design allows us to help customers by developing the right bioanalytical strategies, including the choice of assays and reagents,” Carlsson explains. “We also understand the relevant regulatory requirements based on the customer’s current phase of development and work proactively to provide the most efficient solutions for each project that comes our way.” In addition, with magnetic bead-based ELISAs (MBeads), Mercodia offers advance solutions for biomarker detection by increasing the binding surface and maintaining the antibody specificity, turning methods more high throughput. MBeads also open the possibility for hybrid detection methods. As Carlsson says, “with MBeads, we can couple our reagents to beads or plates and detect the relevant molecules via liquid chromatography-mass spectrometry.”

Annika Carlsson
Director of the Bioanalysis and Services team at Mercodia

Mercodia also provides a dedicated project manager for each project, giving customers a singular point of contact who is familiar with each project and its scope. “Clients love our approach because we provide a personalized service that is easily accessible and attuned to the needs of each individual project,” Carlsson explains. “Our project managers work closely with internal experts to deliver the analyses that customers need on time and at any given stage of their product lifecycle.”

How Mercodia ensures regulatory adherence

With over 30 years of experience in bioanalysis, Mercodia is a leading expert in the analysis of large molecules such as biologics, biosimilars, peptides, and oligonucleotides. Their comprehensive range of analytical platforms includes ELISA, Meso Scale Discovery (MSD), SPR (Biacore™), and MBeads. Mercodia offers cost-effective solutions that include assay development and optimization, PK/PD analysis, immunogenicity assessments, LC-MS/MS services, and biomarker testing. With extensive experience in regulatory compliance and project management, Mercodia holds certification in Good Laboratory Practice (GLP) and adheres to Good Clinical Practice (GCP), aligning with guidance from the European Medicines Agency, US Food and Drug Administration, and ICH standards.

Annika Carlsson
Director of the Bioanalysis and Services team at Mercodia

“Our GLP certificate is audited every second year and we have been compliant since 2012,” Carlsson says. “This reflects the high standard of virtually all aspects of our labs, from staff training to equipment validation and data reporting. Of course, GLP covers the preclinical work, but we apply the same standards to our GCP work.” Carlsson continues, “Mercodia works quickly and flexibly. We typically work with lead times of less than three months from the first meeting to beginning a project, and we understand the need for adaptability in the fast-paced world of clinical development. Our optimized resource management approach ensures that projects stay on track in the face of challenges, and we strive to combine the speed and flexibility of a small company with the experience and quality of a larger one.”

Expanding our services

“Looking ahead, we want to focus on expanding our services while maintaining our innovative approach to commercial assay development,” Carlsson says. “It’s a real testament to the company that we can evolve while providing such a dedicated service. And that’s not all, we are also growing, with the acquisition of a new site in the US and continued expansion in Uppsala, Sweden. All in all, the success of our first 30 years looks set to continue for some time – I look forward to seeing what we help our customers to achieve in the not-so-distant future.”