BIOLOGICS

Development to Commercialization

Project Success Begins with CMC Considerations

DSI Biologics consultants are partners with our clients and provide expert knowledge to resolve complex challenges. DSI consultants provide support and recommendations for your process development, lab-scale design and execution, process design and execution, equipment selection, technical transfers, scale-up, and commercialization. Our Biologics experts have a wealth of knowledge based on education and experience and have maintained knowledge current with leading industry practices. DSI consultants have supported and led many successful product and facility submissions and have the diverse knowledge to help with any submission challenges. We use a client-focused philosophy to ensure the best service in a professional and timely manner.

Our mission is to provide guidance and value at every step of the drug development process, from product conception through commercialization.

Regardless of the stage of your product’s development, the DSI team brings the technical expertise and industry experience necessary to step in and provide immediate hands-on support to your team. We are one of the most experienced biologics consulting companies.

Process Development and Manufacturing

Our consultants are skilled in every aspect of Biologics CMC from concept through Agency approval. Unencumbered process development is achieved when CMC requirements are considered early and kept as a priority. Some Keys to success include:

  1. Obtaining high quality, commercially available materials early in the Development stage will avoid supply and qualification issues later on. We can assist you with securing available high quality materials.
  2. Selecting equipment fit for small scale and that is also scalable leads to commercially viable processes. We can assure equipment fit for purpose at all scales, that is dependable and has adequate vendor support for maintenance, repairs and parts.
  3. Identifying and contracting with GMP compliant development and manufacturing organizations smooths the pathway to regulatory submission and approval. We can provide a list of capable and GMP compliant CMO/CDMOs, author requests for proposals, evaluate proposals and recommend best choice(s), assist in selecting and contracting with a CMO/CDMO.

Scale Up and Commercialization

DSI consultants are highly experienced in scaling up processes and getting projects to commercial stage. This includes support in the areas of:

Materials Management

  • Shipping and receiving operations
  • Warehouse operations
  • Materials and components purchasing
  • Inventory Management

Upstream Operations (Cell Culture and Fermentation)

  • Process Development and Control
  • Process Scale Up
  • Batch Record Authoring and Reviewing
  • Support for setting of specifications
  • Media formulation and preparation
  • Design of Agency required studies
  • Master and working cell bank management
  • Vial thaw, expansion, Bioreactor scaleup and product production
  • Harvest operations

Downstream Operations (Purification)

  • Process Development and Control
  • Process Scale Up
  • Batch Record Authoring and Reviewing
  • Support for setting of specifications
  • Buffer formulation and preparation
  • Filtration Operations
  • Chromatography
  • Viral Clearance
  • Drug Substance final formulation
  • Filling Operations
  • Design of Agency Required studies

End-to End-Biologic Services

  • Analytical
  • QA
    • QA systems
    • QA metrics
    • quality management representative (QMR) support
    • vendor qualifications and audits
    • internal audits
    • inspection preparation
  • Regulatory
    • IND
    • BLA/MAA
  • Supply Chain
    • ERP
    • MRP assessment and implementation
    • space planning
    • incoming outgoing PFD creation and/or review