Biologics are complex molecular entities that require extensive planning and development strategies to control development costs, ensure regulation compliance, and speed up a product to commercialization. Hiring a biologics consultant ensures you receive expert advice and support throughout the entire chemistry, manufacturing, and controls (CMC) development process. Continue reading to learn why you should consider a biologics consulting service and how this could benefit your company.
What are Biologics?
Biologics include products, blood and blood components, antibodies, cell & gene therapies, proteins, and other drugs manufactured in a living system, such as animal cells or microorganisms. Biologic drugs are widely used to treat numerous cancer, immune-related, and inflammatory diseases, such as multiple myeloma, Crohn’s disease, and rheumatoid arthritis.
What Are The Benefits Of A Biologics Consulting Service?
Developing a biologic drug is a complex, expensive, and time-consuming process. There are key advantages to hiring a biologics consulting service, including ensuring you comply with regulatory requirements and minimizing risk along the development pathway to commercialization. Other key benefits include:
- End-to-end support on biologics processes
- Expert advice on regulatory compliance
- Ensuring robust QC/QA systems are in place
- Providing management support
DS InPharmatics: Biologics Consulting Service
Whether your company needs support with initial product design or has made it to the validation stage, our biologics experts can support biotechnology and pharmaceutical companies at every step of our product development process. We offer expert advice on regulatory compliance, QA/QC, and other areas of CMC.
End-to-End Biologic Services
Our end-to-end biologic services include several analytical, quality assurance, regulatory and supply chain options. This range of services can ensure your processes meet regulatory requirements through internal audits and MRP assessment and implementation.
Process Development and Manufacturing
Our experts provide support and knowledge throughout every aspect of CMC to ensure:
- Sourcing of high-quality materials
- That the correct equipment is available for development and clinical manufacturing
- Regulatory compliance is met throughout the entire process
Scale-up and Commercialization
Scaling up and commercialization processes can be complex. Therefore, having a highly experienced consultant can minimize risk as a program progresses toward commercialization. Services in these areas include materials management, such as inventory management and shipping operations; upstream operations, such as bioreactor and harvest operations; and downstream operations, like buffer formulation and filtration operations.
Our consultants will work with you to provide hands-on experience, support and training to ensure compliance with regulatory requirements. We will help you improve the quality of your processes and help with project management, regulatory submissions, and clinical manufacturing as your product progresses through the development process.
Contact us today to learn how our biologics consultants can support your company’s CMC development process.
