Services
3Biotech Services - Comprehensive Drug Development Solutions
Translational Research: Bridging Preclinical Discoveries to Human Trials
Translational research, also referred to as translational medicine or translational science, refers to the “bench-to-bedside” process that harnesses knowledge from basic scientific research into clinical research to create novel treatments.
The main objective of the translational research is to make sure that the discoveries that advance into human trials have the highest possible chances of success in terms of both safety and efficacy in human studies.
The success of the translation from basic science to clinical science and eventually to the patient requires extensive collaboration between basic scientists involved in discovery research, assay developers, statisticians, clinical scientists and clinicians who conduct the human studies, it also involves better communication and collaboration among other organizations including funding agencies, the industry and regulatory agencies (e.g., EMA, FDA)
and other stakeholders including journals, and patients and related advocacy groups.
3BIOTECH provides experienced professionals in Translational research with track records in managing multidisciplinary sciences team and inter-organizational collaborative models to facilitate the application of basic scientific discoveries in clinical and community settings to prevent and treat human diseases.
Lead Optimization and Selection for biotech and Pharmaceutical Companies
Lead optimization and selection play a crucial role to determine the quality of drug candidates. Lead characterization typically includes in vitro efficacy studies for confirmation of binding and functional activities as well as biochemical and biophysical analyses.
Common molecular analysis includes determination of expression levels from mammalian expression systems, aggregation analysis by SEC, SDS-PAGE, Western blot analysis, determination of target protein binding affinity by Biacore, Manufacturability.
3BIOTECH will support you in all the steps of the lead optimization and selection including : Protein production ; humanization (in case of rodent or other non-human protein) : affinity maturation ; Fc engineering ; characterization of biochemical properties ; in vitro and in vivo pharmacology ; protein production in eukaryotic and prokariotic systems via transient expression or stable cell lines ; in vivo pharmacology including PoC efficacy, Mechanism Of Action (MOA), Pharmacokinetics (PK)/Pharmacodynamic (PD) and preliminary toxicological studies.
3BIOTECH’s highly experienced staff can manage your cross-functional project team to optimize your drug development program, ensuring quality, on time, and on-budget deliverables.
Chemistry Manufacturing and Controls Strategy & Development
Chemistry, Manufacturing and Controls (CMC) involves defining manufacturing processes, molecule critical quality attributes, and intermediate testing through each phase of the molecule’s lifecycle to ensure continued quality, consistency, and regulatory compliance. Regulatory authorities require CMC submissions to validate product and process quality as an API moves through clinical trials.
At 3Biotech, our Chemistry, Manufacturing and Controls (CMC) team works closely with customers from preclinical through to post-launch, providing guidance and expertise on technical and regulatory considerations. From sourcing starting materials to formulating your drug product, we provide the expertise you need in chemistry, biology, formulation, and manufacturing of both small and large molecules. Experts in each arena of CMC assure not only the quality of your product but constituency
of the drug product that will be manufactured from pilot to industrial scale.
CMC Support offered by 3Biotech
Good Manufacturing Practice (GMP)
Drug Substance Process Development
Drug Product Formulation
Regulatory Strategy & Global Project Management: Ensuring a Seamless Path to Market
Assist client in global CMC development and strategic planning for drugs and biologics including cell/gene therapies and vaccines, in order to determine which development strategies and regulatory submissions are appropriate and conform to policies, regulations and guidance for manufacturing process and analytical methodologies (Europe and USA).
3BIOTECH’s highly experienced staff can manage your cross-functional project team to optimize your drug development program, ensuring quality, on time, and on-budget deliverables.
Frequently Asked Questions
What is lead optimization in drug development?
Lead optimization is the process of refining drug candidates, whether small molecules or biologics, to improve their efficacy, safety, and manufacturability before advancing to clinical development. For small molecules, this involves structure-activity relationship (SAR) studies, absorption, distribution, metabolism, excretion, and toxicity (ADME-Tox) profiling.
For biologics, optimization includes protein engineering, immunogenicity assessment, expression system refinement, and stability evaluation. Comprehensive preclinical assessments are performed to ensure the highest likelihood of success in human trials.
What is translational research in drug development?
Translational research bridges preclinical discoveries to human trials by optimizing drug candidates for clinical evaluation. It includes dose selection, biomarker identification, and first-in-human study design to ensure successful clinical translation.
What is Chemistry, Manufacturing, and Control (CMC) in pharma?
Chemistry, Manufacturing, and Controls (CMC) encompasses all activities related to the development of drug substances and products. This includes formulation, process optimization, analytical testing, and ensuring regulatory compliance.
CMC ensures the physical and chemical characteristics of drug products are assessed to maintain quality and consistency throughout manufacturing.
What is continued process verification (CPV) and why is it required?
Continued Process Verification (CPV) is the ongoing monitoring of a manufacturing process to ensure it consistently produces products with the desired quality attributes throughout the product lifecycle.
CPV is required for regulatory compliance and helps maintain product quality and consistency during commercial production.
What are accelerated regulatory pathways (e.g., Fast Track, Priority Medicines [PRIME])?
Accelerated regulatory pathways, such as Fast Track (FDA) and Priority Medicines (PRIME, European Medicines Agency), are programs designed to speed up the development and approval of drugs for serious conditions or those addressing unmet medical needs.
These pathways aim to provide patients with faster access to potentially life-saving therapies.