Consultant for Biologics Process Development and CMC Operations
  
BioProcess Solutions LLC serves the Biopharmaceutical Industry providing technical and operational consulting to support activities from R&D through clinical manufacture, in preparation for Commercial Launch.   

We taylor our services to your needs, offering support for small time-limited as well as long-term projects spanning various stages of the product development cycle.  With our help you can extend your organization  in terms of resources and expertise without the longterm commitment of adding headcount.  

HOW CAN WE HELP?
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  1. OPTIMIZATION AND SCALE-UP
    Process development and optimization of Biologics including proteins, vaccines,and cell-based therapies. Our expertise includes cell recovery, purification, cell encapsulation and liposome based drug delivery. Scale-up from R&D or PD to clinical manufacturing scale.
  2. TECHNOLOGY TRANSFER
    Moving to a new Contract Manufacturer? We can help in this transition, translating a new or existing process from one facility to the next to ensure as smooth a transfer as possible.
  3. CMO VENDOR AND MANAGEMENT
    Managing CMOs and other vendors on your behalf to ensure the quality manufacture of material needed at each stage of the product life cycle..
  4. REGULATORY SUPPORT
    In support of your regulatory submissions we write CMC sections and provide technical review of IND and CTA modules.