Delivering Insights & Innovation Tailored to Your Program
Support the analytical, formulation, and process development of your novel molecules with our custom research and development services. Scientific advances continue to spur the creation of innovative molecules and approaches for the treatment of diseases, and our team is ready to help your innovative drug programs success, no matter how unique.
Comprehensive Molecular Support
The following examples outline our recent experience with novel molecules and drug product formulations.
VLPs are assembled in vitro, which enables a greater diversity of cargos and modifications to the protein capsid compared to viruses that are cultured in living cells. Our experience includes analytical method development for the cargo and protein capsid as well as the fully formed particle before and after chemical modification. We then develop the VLP assembly and purification process and transfer it to a GMP facility for scaleup and process validation.
Viruses such as adenovirus, lentivirus, and adeno-associated virus (AAV) are a popular approach for delivering nucleic acid cargos to human cells because of their natural capabilities. Our experience includes analytical method development and characterization of therapeutic viruses.
LNPs are another approach to delivering nucleic acid molecules to human cells that, like VLPs, are assembled in vitro and thus support a wide variety of nucleic acid cargos. Our experience spans across multiple projects and includes analytical method development for both the drug substances (e.g., oligonucleotides, 1 or more RNAs and DNAs) and the LNP drug product. Additionally, we conduct analytical characterization, method validation, stability testing, and GLP release testing. We specialize in developing LNP formulations, including lyophilized formulations, and optimize LNP processes.
Other nanoparticle assemblies are often utilized for therapeutic uses, including nanoparticles formed from metals or the associations of a cationic polymer with a nucleic acid polymer. Our experience spans across multiple projects and includes analytical method development, analytical characterization, and formulation development of diverse types of nanoparticles.
In this method, antibodies selectively bind to a target cell or tissue, allowing for delivery of a drug conjugate to a specific site. In addition to toxic drug or imaging molecule targeting using ADCs, we also have experience characterizing antibodies conjugated with different classes of oligonucleotides.
As nucleic acid-based therapeutics continue to gain commercial approval, novel molecules beyond the currently approved mRNA, antisense oligonucleotide (ASO), and small interfering RNA (siRNA) are being developed as gene therapies. We have experience developing analytical methods and characterizing gene therapies ranging from small nucleotide drugs and highly modified oligonucleotides (e.g., ASO, siRNA, PMO/PPMO, PNA) to larger nucleic acid polymers (e.g., linear, single stranded mRNA, circular RNA, tRNA, gRNA/sgRNA, double stranded RNA, plasmid DNA). We also have experience developing the synthesis process for the enzymatic synthesis of RNA, scaling up, and successfully manufacturing a GMP batch.
Integrated Laboratory Services
When your team needs additional CDMO support, our scientists are ready. Our state-of-the-art facilities and highly trained experts can add power to your project.