Case Studies
From discovery to scalable solutions
Optimizing the Path to Breakthrough Therapies.
At Biolasta Pharmaceutical Inc., we partner with scientific teams to solve complex challenges across drug development, manufacturing, and analytical strategy. We support projects that advance both biologic and non‑biologic therapeutics, optimize critical processes, and establish robust and scalable workflows. The following are selected case studies highlighting our work and achievements.
Process Advisory for Monoclonal Antibody Functional Assay
Expert advisory guided the design of a gene reporter assay to evaluate the functional activity and potency of a monoclonal antibody candidate. By selecting appropriate cell systems, reporter constructs, and readout parameters, the assay aligns with preclinical development goals and regulatory expectations, accelerating decision-making and strengthening the analytical foundation for therapeutic development.
Optimization of Periplasmic Folding for Monoclonal Antibody Expression
Gene modification strategies improved periplasmic folding and expression of a monoclonal antibody candidate. Signal peptide replacements and optimized protein trafficking enhanced folding efficiency and protein quality, supporting reliable upstream expression and downstream characterization while maintaining regulatory alignment.
Consulting Support for Early-Stage Biotech Facility and Material Sourcing
End-to-end advisory helped a new biotech company source critical lab materials, select vendors, and design their research and production facility. Workflow optimization and compliance planning established a functional infrastructure that supports both current R&D and future expansion.
Optimizing Downstream Purification for Monoclonal Antibodies
Affinity chromatography was optimized by shifting from Protein L to Protein A, improving resolution, removing impurities more efficiently, and increasing product purity. This established a robust, reproducible purification workflow that meets regulatory quality standards.
Flow Cytometry Expertise for Monoclonal Antibody Development
Hands-on training and advisory strengthened internal capabilities in flow cytometry, covering panel design, gating strategies, compensation, and troubleshooting. Marker selection, fluorophore pairing, and proper controls ensured accurate cell population identification and reproducible results aligned with scientific and regulatory best practices.
Optimizing Upstream Processing for Recombinant Protein Production
Bioreactor setup and process optimization enhanced cell growth and protein expression for a recombinant protein candidate. Adjustments to feeding strategies, agitation, and aeration improved yield, maintained consistency, and established a reproducible workflow ready for scale-up and downstream processing.
Advisory on Manufacturability of Antibody Candidates
Assessment of monoclonal antibody candidates targeting a viral disease informed process design, upstream and downstream considerations, and scalability potential. The recommendations improved expression, ensured consistent quality, and created workflows suitable for future manufacturing and regulatory compliance.
Comprehensive CMC Support for a Lipid Nanoparticle Therapeutic Candidate
End-to-end CMC support guided experimental design, process development, analytical characterization, and regulatory alignment for an LNP candidate. Formulation strategies, manufacturing considerations, quality control, and documentation practices established a robust, scalable workflow ready for clinical evaluation.