Services

Chamow & Associates offers services from experienced consultants with specialized knowledge and technical expertise in biopharmaceutical drug development. While the primary focus of our business is preclinical development through to IND, we partner with biotechnology companies across all phases of drug development, providing strategic advice and solutions to skillfully navigate through both technical and regulatory challenges.

Companies developing biotechnology products are often faced with the need to balance cost, time and probability of success. Fundamentally, we help our clients to understand and manage risk, and in doing so, manage time and costs and ensure their success. Our services include:

Consulting

Provide strategic advice and guidance on the stages and costs of biopharmaceutical drug development. Assist management in planning:

  • 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
  • Supervise 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 / Optimization

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

  • Cell line development
  • Upstream development
  • Downstream development
  • Formulation development
  • Product and process characterization

Outsourcing

Identify, evaluate, select and manage contract manufacturing organizations (CDMO’s) for all CMC tasks. Provide assistance to:

  • Identify and recommend CDMOs based on “fit” for project and client
  • Review and help to negotiate master services agreements
  • Manage CDMOs on behalf of client to achieve desired outcome and deliverables
  • Cell line, process and assay development
  • Process and assay transfer
  • Clinical manufacturing of bulk drug substance
  • Clinical filling of drug product
  • Clinical packaging, labeling and distribution
  • Commercial manufacturing
  • Process validation
  • Facility design

Quality and Regulatory

Assist with quality and regulatory processes:

  • Design quality management system
  • Write SOP’s
  • Perform vendor audits
  • Author CMC sections of pre-IND briefing documents, IND and IMPD filings and BLAs
  • Approve manufacturing and quality documents of CDMO’s

Project Integration

  • Integrate development activities with manufacturing processes; partner with clients and CDMO’s to form an integrated CMC team
  • Coordinate activities of integrated CMC team
  • Develop timelines and budgets for IND/BLA activities
  • Coordinate authors to prepare pre-IND briefing package and CMC section of IND/IMPD/BLA

Training

On-site CMC, quality and regulatory compliance training. In-depth training that 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.

Please contact us to discuss how we can help you
Download our brochure
Steven M. Chamow, Ph.D., Principal Consultant |
San Mateo, CA
|
650-345-1878
| info@chamowassociates.com
© 2019 Chamow & Associates |