Services

Advancing your biologics development with comprehensive CMC solutions

What We Offer

Developing biotechnology products requires the need to balance cost, time, and probability of success. Our team of experienced consultants partners with you to navigate the complex processes of biopharmaceutical drug development. Get strategic advice and solutions to ensure your success across any or all phases of biotherapeutic drug development. 

 

Our comprehensive services include manufacturing, quality, regulatory, and project management to integrate your CMC packages into successful IND and BLA filings. 

Our Services

Manufacturing Strategy & Operations

Provide strategic advice and guidance on the stages and costs of biopharmaceutical drug development.

Process Development & Optimization

Develop technical design for biotherapeutic production and optimize manufacturing processes.

Quality & Regulatory

Design management systems for filing documentation and regulatory approval.

Outsourcing Support

Identify, evaluate, select, and manage CDMOs (contract development and manufacturing organizations) for all CMC tasks.

GMP Facility Design

Assist with design validation efforts for manufacturing, segregation and ancillary spaces.

Project Integration

Coordinate development activities with manufacturing processes.

Technical & GMP Training

Design and deliver on-site CMC, quality and regulatory compliance training.

“Chamow & Associates has made a significant impact on our therapeutic antibody program in taking responsibility for much of our early stage CMC development.

Xiaodong Yang, President & CEO at Apexigen

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Manufacturing Strategy and Operations

Provide strategic advice and guidance on the stages and costs of biopharmaceutical drug development including potency methods, such as binding assays and bioassays.

  • Develop budget and timeline estimates for preclinical development
  • Conduct due diligence on an asset as potential acquisition
  • Design preclinical proof-of-concept studies
  • Design and oversee implementation of manufacturing processes
  • Support assay development and qualification
  • Plan and oversee execution of formulation development and stability
  • Manage reference standard preparation
  • Oversee production of toxicology and cGMP lots

Process Development and Optimization

Develop technical design for biotherapeutic production. Optimize manufacturing processes with respect to the following.

  • Cell line development
  • Upstream development
  • Downstream development
  • Formulation development
  • Product and process characterization
Additional support for small molecule therapeutics. 

Quality and Regulatory

Assist with quality and regulatory processes.

  • Design quality management system
    • Write SOPs
    • Perform vendor audits
  • Lead and participate in global regulatory interactions
  • Create and recommend regulatory strategies
  • Generate responses to agency requests, comments and questions
  • Author and maintain global regulatory dossiers
  • Generate and maintain Quality Agreements

Outsourcing Support

Identify, evaluate, select, and manage contract manufacturing organizations (CDMOs) for all CMC tasks.

  • Identify and recommend CDMOs based on fit for project and client
  • Review and help negotiate master services agreements
  • Manage CDMOs on behalf of client to achieve desired outcome and deliverables
  • Oversee and support the following processes.
    • Cell line, process, and formulation development
    • Development and validation of analytical methods for in-process, release and stability
    • Design and specification for release of bulk drug substance and product
    • Clinical filling of drug product
    • Clinical packaging, labeling and distribution
    • Commercial manufacturing
    • Process validation
    • Facility design

GMP Facility Design

Assist with design, development and approval for cGMP manufacturing spaces.

  • Facilitate design validation efforts for manufacturing, segregation and ancillary spaces
  • Plan the design validation needs for critical equipment and a personnel training program
  • Assist with process flow and creating the process flow diagram 
  • Identify and recommend waste systems and storage needs
  • Oversee design elements for validation and regulatory compliance

Project Integration

Integrate development activities with manufacturing processes. Partner with clients and CDMOs to form an integrated CMC team.

  • Coordinate activities of integrated CMC team

  • Develop timelines and budgets for global regulatory dossiers

  • Coordinate authors to prepare pre-IND briefing package and CMC section of IND/IMPD/BLA

Technical and GMP Training

Design and deliver on-site CMC, quality and regulatory compliance training. In-depth training teaches clients to plan and execute product development and manufacturing strategies, and to integrate CMC activities with regulatory requirements to ensure quality and compliance throughout the product life cycle.

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