you are successful
then starts the cmc obstacle course
Bringing a new drug from the lab to the clinic is a completely different
process from identifying the target and molecule in the first place.
CMC is the most underappreciated aspect of the whole drug development process, but it can make or break development.
Grounded in science and regulated by governments, health care is a challenging sector. In the life of any startup, there are plenty of opportunities for fatal missteps.
But that doesn’t mean your company has to make one.
How to maintain pharmaceutical industry’s high-level standards ?
Each stage in drug development is key, not only demonstrating
proof of concept : 3biotech will support you day after day.
We are your first crash-test:
challenging, then supporting and accelerating
A stronger valuation of your innovation : #challenging to avoid drug development failures and get a clear Chemistry Manufacturing and Control strategy.
Define the best path from beginning to end : # supporting step by step from scientific ideas to innovative drugs.
Go faster from discovering drug candidate until clinical proof of concept : # accelerating the entire drug development
3Biotech development strategy
relies on 3 major pillars
Before administering the drug to human subjects for the first time (First in Human), it is crucial to evaluate the safe dosing limits and potential adverse effects of the drug candidate. This assessment is essential in minimizing risks to clinical subjects and program development.
We assist in the design and execution of pharmacology, drug metabolism and pharmacokinetics (DMPK), and toxicology studies to evaluate the potential adverse effects of the drug candidates related to the intended use of the product.
The prudent selection of a drug candidate relies not only on the expected therapeutic efficacy of the product but also on the toxicology and pharmacology assessments that contribute to the safety package. safet package.
The lack of therapeutic efficacy is a leading cause of drug development failure, especially during the clinical phases. However, a significant reduction in this figure can be achieved by emphasizing nonclinical efficacy studies.
in vitro assessments, including in vitro assessments, including target engagement, tissue cross-reactivity, immune-mediated cell killing, and other specific ex-vivo and in-vivo assays related to the Mechanism of Action (MoA). These studies are referred to as "translational studies" as they translate potential drug candidates' on- and off-target nonclinical properties to clinical consequences.
By conducting translational studies, the best drug candidates for early clinical testing can be identified based on their efficacy and safety profile. This approach can help to minimize the risk of failure during clinical development and optimize the drug development process.
In drug development, safety and efficacy are not the only important factors to consider. It is also essential to develop a robust manufacturing process that can consistently produce high-quality drugs.
The Chemistry, Manufacturing
and Controls (CMC) section
is a critical aspect of any pharmaceutical clinical trial or marketing application. Lack of a comprehensive CMC strategy is a common reason for market authorization denials, accounting for 25% of such cases in the US. This can result in processes and products that fail to meet the regulatory standards.
Regulatory authorities require assurance that there is consistency between the product tested during clinical trials and the batches produced for commercialization years later. Therefore, it is crucial to establish an exhaustive CMC strategy to ensure that the drug product is not only safe and effective but also consistent between batches.
Key assets for success
"Disruptive science is the basis of any innovative company. But impeccable CMC operations and regulatory records
are also key assets for success.
They are of the highest importance for pharmaceutical companies, potential partners of startups"
Olivier Bogillot, President Sanofi
Plan Health-Tech 2021