OUR SERVICES
Translational research also called 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.
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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.
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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.
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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.
Translational research
Lead Optimization & selection
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…
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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.
CMC and CMC Regulatory
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.
Chemistry, Manufacturing and Controls (CMC) Support
Regulatory
Strategy
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.
Management of overall pharmaceutical drug development programs, or specific aspects of drug development programs, requires skilled professionals who have prior experience with these activities.
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Cross-functional product development teams need to be managed in a way that fosters strategic planning, keeps information flowing, and ensures that timelines and deliverables stay on track. The same applies for the functional area subteams, or other teams created to achieve a particular goal or complete a particular task. BIOTECH provides experienced professionals to oversee
and execute your drug development activities at a project
or program level.
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.
Global Project Management
