Parenteral Drug Products

Parenteral drug products for peptides and oligonucleotides present challenges beyond sterile filling. Molecular stability, aggregation behavior, and sensitivity to processing conditions can vary significantly with sequence, chemistry, and formulation composition, directly influencing manufacturability and product performance.

Parenteral drug product services are designed to address these modality-specific considerations, supporting injectable peptide and oligonucleotide programs through phase-appropriate formulation development, manufacturing, and clinical supply.

Parenteral formulation development for peptides and oligonucleotides focuses on understanding molecule-specific stability and degradation pathways and translating those insights into robust injectable formulations.

Services include

• Liquid and lyophilized formulation development

• Excipient and buffer selection based on stability and aggregation behavior

• Formulation screening to support route, dose, and presentation decisions

• Stability and stress studies to inform formulation and process development

Parenteral drug product manufacturing supports injectable peptide and oligonucleotide programs across clinical stages, with processes designed to maintain formulation integrity and ensure consistent execution.

Capabilities include

• Manufacturing of sterile injectable drug products

• Support for vials, prefilled syringes, cartridges, and lyophilized presentations

• Manufacturing processes aligned with formulation characteristics and fill–finish requirements

• In-process controls to support consistency and product quality