Biologics, including antibodies, therapeutic proteins, and vaccines among others, are a critical component of our modern healthcare enterprise. These products can greatly improve the overall quality of life—allowing people to gain protection from many infectious diseases, cancer patients to receive immuno-oncology treatment, and insulin-dependent diabetics to lead normal lives.
The development of Biologics is a highly complex and rigorously regulated process in which scientific discoveries are moved from the laboratory benchtop to preclinical testing, to clinical testing for safety and effectiveness, and ultimately to commercial licensure. In addition, we have specific expertise supporting many of the common manufacturing platforms used to develop Biologics, including many different cell lines, bioreactors, purification, and process optimization technologies.
Our team is comprised of highly trained professionals who have extensive experience working through the development, licensure, and commercialization process, and many of our team members have many years of experience in their specific area of expertise. Our team of experts can effectively and efficiently lead or assist your team in the development of new biological products, and we customize our approach to address your specific needs and requirements.
Our Biologics Services include:
- Functional Product Development Expertise
- Chemistry, Manufacturing and Controls (CMC)
- Drug Discovery
- Nonclinical plan development and execution
- Clinical development and clinical study execution
- Regulatory strategy and guidance
- Quality assurance
- Program Management
- Vendor Selection and Management
- Comprehensive Non-dilutive Funding Support
- Opportunity assessment and strategic outreach/positioning
- Proposal/Solution development
- Contract negotiation
- Program and contract management
- Compliance and cost accounting services
- Product development support/expertise
- Overall Agency/NGO relations
- Strategic Consulting Services
- Strategic Planning
- Financial Modeling
- Market Research
- Supply Chain Network Development & Optimization
- Market Access/Launch
- Due Diligence
- Technology Scouting
For more information about how we can support your Biologics efforts, please contact Robert Huebner, Ph.D.