Formulation of biological pharmaceuticals with personal consultation

The field of biologic therapeutics is continuing to grow, and gains significance compared to small molecule drug candidates. The amount of FDA approved biological drug products per year has increased from 7% in year 2000 to 50% in year 2022 out of the total amount, highlighting the growth and importance of biological therapeutics in the future.  

Formulating biologics differs in many aspects compared to formulation of small molecules. The more complex structures demand more complex formulation strategies to maximize their therapeutic efficacy. The optimal formulation strategy needed also differs significantly depending on the type of modality, the individual properties of drug candidate and choice of administration route.    

We will cover new biological modalities, such as nucleotides and peptide/protein-based drug candidates. If you’re working on a biological drug candidate e and want to develop a compliant formulation with improved shelf life, minimized aggregation, enhanced uptake, targeting or easier handling this is the course for you!

Course contents  

• What differs between formulation development for small molecules and biologics 
• Challenges in formulation of biologics 
• Different types of nanoparticles and drug delivery systems for biological drugs 
• Case studies 
• Analysis and quality control 
• Regulatory aspects

Course objective 

After attending this course, the attendee will have: 

• An insight into differences between formulation development for biologics and small molecules 
• Understood some techniques and tools in formulation development to meet a selection of the common challenges for different modalities. 

Individual consulting

In addition to the course content, the fee includes a complimentary one-hour individual session with RISE experts. This session will be tailored to your organization´s specific interests and challanges. If required, we can arrange for a non-disclosure agreement to be signed beforehand. 

Target group

Life-science industry partners, formulation scientists and small SME’s who want to gain insights in important aspects of formulation of biologics and learn more about drug development and analytics required.

Related reading

Senior, M., Fresh from the biotech pipeline: fewer approvals, but biologics gain share. Nature Biotechnology 41, 174–182 (2023).