Biologics are complex molecular entities that require extensive planning and development strategies to control development costs, ensure compliance with regulations, 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.
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.
Developing a biologic drug is a complex process that is both expensive and time-consuming. There are key advantages to hiring a biologics consulting service, some of which include making sure you are complying with regulatory requirements and minimizing risk along the development pathway to commercialization. Other key benefits include:
Whether your company needs support with initial product design or have made it to the validation stage, our biologics experts are able to provide support to 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.
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.
Our experts provide support and knowledge throughout every aspect of CMC to ensure:
Scaling up and commercialization processes can be complex. Therefore, having a highly experienced consultant can minimize risk as a program moves forward 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. Not only will we help you improve the quality of your processes, but we will also help with project management, regulatory submissions, and clinical manufacturing as your product moves thru the development process.
Contact us today to learn how our biologics consultants can support your company’s CMC development process.