IND Consulting Services – Analytical (CMC) Support for Gene Therapy & Vaccine Products

Accelerating Development of Transformative Therapies for Biotechnology and Healthcare Providers.

Rated 5 stars by clients.

Contact

★★★★★

Innovating Vaccines, Cell and Gene Therapy Solutions

We specialize in advancing vaccines, cell and gene therapy through research, development, and analytical services, bridging innovation with practical application to transform healthcare.

Two individuals stand on either side of a large banner for the BioPharmaceuticals Academy Masterclass. They both wear name tags and appear to be smiling. The banner lists various topics related to pharmaceuticals, including biologics and cell banks.
Two individuals stand on either side of a large banner for the BioPharmaceuticals Academy Masterclass. They both wear name tags and appear to be smiling. The banner lists various topics related to pharmaceuticals, including biologics and cell banks.

150+

15

Trusted by Experts

Leading Innovators

IND Consulting Services – Analytical (CMC) Support for Gene Therapy & Vaccine Products

Accelerating development and commercialization of transformative cell and gene therapies and vaccine development for healthcare providers.

Analytical Method Development & Validation
A close-up view of cells under a fluorescent microscope, showing bright green and blue colors. The cells have distinct blue nuclei surrounded by an irregular green cytoplasm, all set against a dark background.
A close-up view of cells under a fluorescent microscope, showing bright green and blue colors. The cells have distinct blue nuclei surrounded by an irregular green cytoplasm, all set against a dark background.

  • Phase-appropriate method qualification/validation (ICH Q2)

  • Potency, purity, residual, and safety assays

  • Stability-indicating method design and stress testing

Brightly colored microscopic cells are highlighted against a dark background. The cells display a range of vivid colors including blues, pinks, and greens, indicating fluorescent staining techniques. Various cell structures and organelles are visible, emphasizing the intricate details of the biological samples.
Brightly colored microscopic cells are highlighted against a dark background. The cells display a range of vivid colors including blues, pinks, and greens, indicating fluorescent staining techniques. Various cell structures and organelles are visible, emphasizing the intricate details of the biological samples.
A high-tech laboratory environment featuring multiple digital screens displaying complex graphical data, including a large DNA helix. The room contains advanced laboratory equipment on a sleek table and a chair draped with a white lab coat. Soft lighting and a futuristic aesthetic contribute to the overall ambiance.
A high-tech laboratory environment featuring multiple digital screens displaying complex graphical data, including a large DNA helix. The room contains advanced laboratory equipment on a sleek table and a chair draped with a white lab coat. Soft lighting and a futuristic aesthetic contribute to the overall ambiance.
Product Characterization

  • Design and optimization of identity, potency, and purity assays

  • Full capsid/empty capsid ratio (for AAV), transgene expression (for gene therapy)

  • Antigen quantification and immunogenicity assessment (for vaccines)

  • Analytical specification development (DS/DP)

  • Development of release panels for DS, DP, and intermediates

  • Justification of analytical specifications

  • Establishment of trending and alert limits

Release and In-Process Testing
A microscopic image showcasing a cluster of cells. The cells are vibrant with green, red, and blue fluorescence, indicating various staining or molecular labeling. The majority of the cells are tightly packed in the upper portion, while fewer cells are scattered below against a dark background.
A microscopic image showcasing a cluster of cells. The cells are vibrant with green, red, and blue fluorescence, indicating various staining or molecular labeling. The majority of the cells are tightly packed in the upper portion, while fewer cells are scattered below against a dark background.
Stability Programs

  • Design and execution of stability protocols

  • Storage condition and shelf life determination

  • Excursion studies and risk mitigation

Two scientists in a laboratory, both wearing white lab coats and protective eyewear. The scientist in the foreground is using a pipette, while the one in the background is working on a computer. Various laboratory equipment and supplies are visible around them.
Two scientists in a laboratory, both wearing white lab coats and protective eyewear. The scientist in the foreground is using a pipette, while the one in the background is working on a computer. Various laboratory equipment and supplies are visible around them.
Reference Standards and Controls

  • Development and qualification of reference materials

  • Bridging studies between lots

  • Management of positive/negative controls

A person wearing protective gear, including a face shield, blue gown, and gloves, is holding an egg while using a syringe in a laboratory setting. The individual is focused on a precise task, suggesting a scientific experiment or medical procedure.
A person wearing protective gear, including a face shield, blue gown, and gloves, is holding an egg while using a syringe in a laboratory setting. The individual is focused on a precise task, suggesting a scientific experiment or medical procedure.
A person wearing green gloves is working in a laboratory setting, using a pipette to transfer liquid into small tubes placed in a pink rack. A red biohazard container is visible on the right side, and various lab equipment and documents are scattered around the workspace.
A person wearing green gloves is working in a laboratory setting, using a pipette to transfer liquid into small tubes placed in a pink rack. A red biohazard container is visible on the right side, and various lab equipment and documents are scattered around the workspace.
Safety Testing Integration

  • Planning for mycoplasma, sterility, endotoxin, RCA/RCL, replication-competent virus

  • Residual impurity assay design (e.g., host cell DNA/protein, enzymes)

Regulatory Authoring and Support

Preparation of the Chemistry, Manufacturing, and Controls (CMC) section of the IND, including analytical data and method descriptions

Client Feedback

Hear what our clients say about our innovative services and support.

The support from this team has significantly accelerated our therapy development process.

Emily Carter
An intricate microscopic image of a cell with bright green fibrous structures surrounding a central blue nucleus. Scattered red dots are visible throughout the cell, illustrating a detailed and vibrant internal structure against a dark background.
An intricate microscopic image of a cell with bright green fibrous structures surrounding a central blue nucleus. Scattered red dots are visible throughout the cell, illustrating a detailed and vibrant internal structure against a dark background.

San Diego

Their expertise in cell and gene therapy has been invaluable for our research projects.

Two individuals are wearing blue protective suits, masks, and goggles in a sterile laboratory environment. One is holding a test tube with an orange cap, while the other holds a digital tablet displaying information. A tray with other test tubes is visible, indicating they are involved in some form of scientific or medical research.
Two individuals are wearing blue protective suits, masks, and goggles in a sterile laboratory environment. One is holding a test tube with an orange cap, while the other holds a digital tablet displaying information. A tray with other test tubes is visible, indicating they are involved in some form of scientific or medical research.
John Smith

New York

★★★★★
★★★★★
Innovation

Accelerating development of transformative therapies for all.

Research

Services

contact@cgtbio.com

+1-845-800-5812

© 2024. All rights reserved.