Empower clients to accelerate drug development with tailored, premium-quality bioassays
Deliver strategic excellence, robust science, and expedited solutions as your trusted partner for bioassays
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About Cellentia Lab
What is Bioassays
Drug’s biological function or effect
Body’s responses to drugs
Our Goals
Collaborating with clients to advance their drug development through comprehensive expertise in harnessing bioassays across development cycles.
We wholeheartedly dedicate ourselves to delivering unparalleled and highly efficient bioassay services, encompassing everything from designing a bioassay strategy and developing/validating assays to conducting sample testing and providing regulatory filing support. Our aim is to empower clients in swiftly developing novel drugs and cutting-edge medical devices, ensuring their rapid journey to market approval, so they can provide them to the patients in need.
Bioassay Innovation
Explore Our Comprehensive Bioassay Mastery
Our bioassay development and services can help to accelerate your biologic drug discovery and development workflow. These comprehensive services include new assay development, modification of existing assays, bioassay optimization and qualification, biologic drug profiling and custom cell manufacturing.
Our Services
The spectrum of our activities and services
Cytotoxicity
Cytotoxicity plays a crucial role in assessing the potential of a drug to selectively target and destroy cancer or specific cells while minimizing harm to healthy cells. It is widely used throughout the drug development cycles.
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Potency
Potency assays are the most critical component of the drug lot release process because they assess the strength and effectiveness of a drug product, ensuring that each batch consistently meets requirement for quality, safety, and therapeutic efficacy. Each drug's uniqueness makes developing a specific potency assay challenging
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Immunogenicity
Immunogenicity involves the body's immune system reacting to biological drugs, potentially affecting their effectiveness and safety. Pre-existing immunity due to prior exposure to similar or related substances or antigens also would impact drug’s efficacy and safety.
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Single cell functionality
Single cell functionality analysis assesses individual behavior and attributes of these cells, enabling a deeper comprehension of cell-based therapies. Post-drug administration, comprehending the body's cellular-level responses to the drug is essential for a complete understanding of its effectiveness.
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Frequently asked questions
What Types of Bioassays Do You Offer?
We provide an extensive array of bioassays across diverse analytical platforms.
What types of drugs are you having bioassays for?
Our expertise lies in conducting bioassays to support biological drugs, cell therapies, and gene therapies. In therapeutic areas such as oncology, we extend our support to assays measuring the biological effects of small molecule drugs.
Can You Customize Bioassays to Meet Our Specific Requirements?
Certainly. We firmly believe in the uniqueness of each drug concerning its indication, necessitating customization for optimal function monitoring of the drug and the biological responses.
What Quality Control Measures Do You Have in Place?
Our rigorous quality control measures encompass assay qualification at the conclusion of development. We integrate controls into each assay to monitor their long-term performance. Additionally, we conduct validation for GMP/GLP assays and institute comprehensive qualification plans for critical assay reagents.
What Is the Turnaround Time for Bioassay Results?
Turnaround times vary depending on the specific assays. While some assays yield results in a matter of hours, others may require a more extended duration. For instance, we successfully developed a cell-based assay with a one-month timeline, involving four passages of cells to achieve heightened sensitivity. Regardless of the assay complexities, we are dedicated to delivering results with efficiency and reliability.
Specialized Assay for AAV
QPCR for AAV titration
Total antibody for AAV
Neutralizing antibody for AAV
Our mission
Our mission is to empower clients to accelerate drug development through our unmatched bioassay services. We deliver excellence across strategy, assay development and validation, sample testing, and regulatory filing, ensuring the highest quality and swift execution every step of the way.
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