Drug Product Development

Intellective Bio provides in-house drug product development services for a wide variety of therapeutic proteins including antibodies (monoclonal, bispecific, trispecific), nanobodies, fusion proteins, ADCs, and protein-based vaccines. Our in-house experts are experienced in overcoming therapeutic protein formulation challenges such as thermal and light sensitivity, phase separation, and high protein concentration formulations.

Formulation development
- Based on the QbD concept, we use our in-depth knowledge of the properties of buffers and excipients to develop a customized formulation suitable for the most common dosage forms: glass vials (liquid or lyophilized), prefilled syringes, cartridges, and other delivery systems such as inhalers or nasal sprays.
- Our process begins with pre-formulation screening and lyophilized product feasibility assessments, as appropriate for your molecule. Protein stability is assessed early in our development process by using our proven strategies to evaluate the suitability of liquid formulations and, if necessary, the feasibility of lyophilized formulations. Rational design of pH/buffers and screening of excipients is standard. To date, we have developed formulations for various products with protein concentrations ranging from 0.1 mg/mL to 180 mg/mL.

Aseptic fill finish process development
- Aseptic fill finish usually involves the following unit operations: bulk DS thawing, pooling (if needed), sterile filtration, filling, lyophilization (if needed), stoppering, capping and visual inspection. Our experts evaluate equipment and materials with product contact to ensure compatibility and to identify critical process parameters. For lyophilized products, additional lyo cycle and scale-up studies are performed. The goal is simple: develop a robust manufacturing process with regulatory and commercial success in mind.