Spray Drying of Biologics
Spray Drying of Biologics
Serán supports both formulation development and particle design of biologics for improved stability and to enable alternative routes of delivery. From protein therapeutics to lipid nanoparticles (LNPs) carrying RNA, Serán specializes in comprehensive design of solid-state formulations for optimal long-term stability while considering the unique requirements of each target product profile. Spray drying enables the creation of a free-flowing powder and the ability to engineer particle properties. The ability to intentionally design these particles is critical for downstream incorporation and performance in drug delivery systems, including inhalable powders, injectable suspensions, or long-acting implants.
Spray Drying Expertise Expanding Biotherapeutic Innovation
Spray dried biotherapeutic formulations enable the creation of advanced products such as high-concentration protein suspensions, pulmonary delivery of peptides, proteins, and nucleic acids, and targeted oral delivery.
Serán is experienced in working with a wide variety of biologic modalities, including peptides, proteins, phages, and nucleic acids. Solid-state formulations for these biologic modalities have the potential to significantly improve product stability and enable integration into advanced drug delivery systems. Our deep scientific knowledge, formulation and dosage form experience, and technical expertise form the bedrock of our particle engineering leadership.
Capabilities
- Particle design & engineering
- Formulation development & optimization
- Lipid nanoparticle formulation & spray drying
- Phage formulation development & spray drying
- Protein formulation development & spray drying
- Peptide formulation development & spray drying
- High concentration injectable protein suspensions (up to 500 mg/mL)
- Oral solid dosage forms for targeted local delivery to the GI tract
- Pulmonary product development
- Manufacturing & process engineering
- 50 mg – 20 kg scale
Technologies
- Spray drying (50 mg – 20 kg scale, aqueous & organic spray solvent compatible, many types of atomization supported)
- Fluid-bed coating
- Dry granulation, tablet compression, tablet coating
- Encapsulation
- High concentration injectable protein suspensions
- Lipid nanoparticle formulation & process development
- Oral solid dosage forms, inhalation products, and subcutaneous/intramuscular injectables