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.
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.
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.
“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
Expertise in biologics, advance therapies and small molecules including
- Antibodies and derivatives
- Monoclonal antibodies
- Bispecific antibodies
- Antibody drug conjugates
- Radiolabeled antibodies
- Fusion proteins
- Recombinant enzymes
- ATMPs including cell and gene therapies
- Small molecules
Manufacturing Strategy and Operations
Provide strategic advice and guidance on the stages and costs of biopharmaceutical drug development including expression systems and analytical methods.
- Develop budget and timeline estimates for preclinical development
- Conduct due diligence on an asset as potential acquisition
- Design and oversee implementation of manufacturing processes
- Support assay development and phase appropriate validation, including potency
- Plan and oversee execution of formulation development and stability
- Manage reference standard preparation
- Oversee production of toxicology and cGMP lots
- Provide technical oversight of operations at CDMOs including PIP
Process Development and Optimization
Work with client to 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
- Titer and yield improvement
- Studies to demonstrate product comparability
- Analytical method development
Quality and Regulatory
- Design quality management system
- Write SOPs
- Perform vendor audits
- Create and recommend regulatory strategies
- Generate responses to agency requests, comments and questions
- Author and maintain global regulatory dossiers
- Generate and maintain Quality Agreements
- Author CMC sections of pre-IND briefing package and IND/IMPD/BLA
- Design and deliver CMC, quality and regulatory compliance training
- Identify and recommend CDMOs based on fit for project and client
- Review and help negotiate master services agreements
- Provide technical oversight of CDMOs on behalf of the client:
- Partner with clients and CDMOs as an integrated CMC team
- Cell line, process, formulation development, and tech transfer
- 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
- Quality review and release of GMP documentation
GMP Facility Design
Partner with client and engineering firm to advise on facility design, construction and commissioning.
- 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
- Lead equipment specification and selection process
- Regulatory toxicology strategy
- Nonclinical study design consistent with ICH Guidance
- Nonclinical study monitoring and on-site visits
- Nonclinical regulatory briefing package preparation
- Regulatory meeting representation for toxicology
- Due diligence review of toxicology data
- Performance of technical due diligence in support of in licensing or acquisition activities
- Serve as expert witness for biologics manufacturing
- Develop CMC strategies to support raising investment capital
In addition to CMC, Alira Health provides multiple services in support of the Pharmaceutical and Biotech industries.