Biotimize
What we do
End-to-End Biopharmaceutical CDMO Solutions
From early-stage host cell engineering to scalable bioprocessing and non-clinical GxP batch production—de-risking complex biologics for global commercialization.
Core Capabilities &
Deliverables
High-Throughput Cell Line Development & RCB
Development of high-expression host cell systems (mammalian CHO & microbial platforms) utilizing High-Throughput (HTP) screening technologies for rapid clone selection, monoclonality isolation, and generation of characterized Research Cell Banks (RCB).
High-Yield Upstream & Downstream Development
End-to-end process development for high productivity—achieving titers up to 13 g/L for recombinant proteins in mammalian cell systems. Complete media optimization, bioreactor scale-up, multi-step chromatography, and viral clearance parameters.
Techno-Economic Feasibility & Process Simulation
Advanced bioprocess modeling and cost-of-goods analysis utilizing industry-standard software SuperPro Designer® and SchedulePro® (Intelligen). De-risk your pipeline early through rigorous CAPEX/OPEX evaluation, debottlenecking, and facility occupancy scheduling.
Non-Clinical Batch Supply (Toxicology & PK/PD)
Production of representative biomanufactured material for early-stage non-clinical evaluations, toxicology studies, and PK/PD testing, ensuring structural integrity and target concentration requirements.
Phase-Appropriate Readiness for Phase 1 Entry
Process development from scratch built under phase-appropriate regulatory practices (ANVISA, ICH Guidelines), preparing your therapeutic pipeline for a seamless transition into Phase 1 clinical trial manufacturing.
Strengthening the Global and Brazilian Biopharma Ecosystem
By offering cost-effective and high-quality CDMO services, Biotimize is not only democratizing access to cutting-edge biopharmaceutical development but also strengthening Brazil’s Health Economic-Industrial Complex.
Biotimize’s work fosters local innovation, reduces dependence on imported biologics, and positions Brazil and Latin America as an emerging biopharma hub for both national and international markets.
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Mammalian Cells
Process and cell line development across versatile mammalian platforms, leveraging industry-standard licensed systems with expression yields reaching up to 13 g/L. We deliver end-to-end solutions in serum-free, animal-component-free media—covering upstream/downstream optimization, analytical method validation, and API formulation.
Mammalian Cells
Process and cell line development across versatile mammalian platforms, leveraging industry-standard licensed systems with expression yields reaching up to 13 g/L. We deliver end-to-end solutions in serum-free, animal-component-free media—covering upstream/downstream optimization, analytical method validation, and API formulation.
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01.
Cell Line Development
Cell Line Development
Design of plasmids and vectors, the transformation of cells, and selection of clones by evaluating the production and quality of the expressed protein. Production and storage of cell banks under Good Laboratory Practice conditions.
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02.
Upstream Development
Upstream Development
Definition of unit operations involved in the production step of the protein of interest, characterization of cell growth, and production of the protein of interest in shake-flasks systems and in benchtop bioreactors.
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03.
Downstream Development
Downstream Development
Definition of the purification steps for the protein of interest to reach the appropriate purity and quality parameters. Filtration, chromatography (by affinity, by ion exchange, by hydrophobic interaction, among others), dialysis, ultrafiltration, and viral inactivation are evaluated.
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04.
Process Optimization
Process Optimization
Through the technical-economic feasibility study, the technical stages related to production costs and the productive capacity of the process are mapped and, thus, optimization strategies are outlined. In the upstream stage, for example, different culture media and supplementation strategies are evaluated, as well as process parameters (pH, temperature, controlled oxygen, among others) to increase the expression of the protein of interest or adjust quality parameters (glycosylation, aggregates, etc.). In the purification steps, different resins and membranes are tested, fluxes are adjusted, mobile phase composition, buffer composition, etc., are evaluated to increase the recovery, quality, and purity of the protein of interest.
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05.
Analytical Development
Analytical Development
As important as the unit operations for the production and purification of the protein of interest are the analytical methodologies used for its quantification and characterization. In this way, we carry out the complete life cycle of the analytical methods in an adequate way for each stage of drug development: development, optimization, validation, and transfer. In doing so, we ensure that analytical methods evolve in the most appropriate way from the various clinical stages to commercialization.
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06.
Product Formulation
Product Formulation
We perform final product formulation to maintain API quality attributes such as purity, integrity, safety, and potency. During the development of the presentations, we search for formulations that allow their processing efficiently, avoiding the generation of oxidized variants and aggregates, among other forms of degradation, and with consistent stability information.
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07.
PoC and Pre-Clinical Material Production
PoC and Pre-Clinical Material Production
In our structure, we can absorb the stages of cell culture, filtration, clarification, chromatography, and tangential filtration of sufficient volumes to generate quantities of biopharmaceuticals for the stages of pre-clinical studies. Through quality controls, according to the Good Laboratory Practices (GLP), we issue certificates of analysis for the main quality attributes of the protein of interest, recognized by the OECD and INMETRO.
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01.
Cell Line Development
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Microbial
Comprehensive bioprocess development for recombinant proteins, enzymes, and plasmid DNA expressed in microbial systems (E. coli and yeast). Integrated CDMO solutions covering strain development, high-density fermentation, inclusion body refolding, downstream purification, analytical validation, and API formulation for preclinical batch supply.
Microbial
Comprehensive bioprocess development for recombinant proteins, enzymes, and plasmid DNA expressed in microbial systems (E. coli and yeast). Integrated CDMO solutions covering strain development, high-density fermentation, inclusion body refolding, downstream purification, analytical validation, and API formulation for preclinical batch supply.
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01.
Strain Development
Strain Development
Design of plasmids and vectors, the transformation of cells, and selection of clones by evaluating the production and quality of the expressed protein. Production and storage of cell banks under Good Laboratory Practice conditions.
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02.
Upstream Development
Upstream Development
Definition of unit operations involved in the production step of the protein of interest, characterization of cell growth, and production of the protein of interest in shaken flasks and benchtop bioreactors.
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03.
Downstream Development
Downstream Development
Definition of the purification steps for the protein of interest to reach the appropriate purity and quality parameters. Filtration, chromatography (by affinity, by ion exchange, by hydrophobic interaction, among others), dialysis, ultrafiltration, and viral inactivation are evaluated.
-
04.
Process Optimization
Process Optimization
Through the technical-economic feasibility study, the technical stages related to production costs and the productive capacity of the process are mapped and, thus, optimization strategies are outlined. In the upstream stage, for example, different culture media and supplementation strategies are evaluated, as well as process parameters (pH, temperature, controlled oxygen, among others) to increase the expression of the protein of interest or adjust quality parameters (glycosylation, aggregates, etc.). In the purification steps, different resins and membranes are tested, fluxes are adjusted, mobile phase composition, buffer composition, etc., are evaluated to increase the recovery, quality, and purity of the protein of interest.
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05.
Analytical Development
Analytical Development
As important as the unit operations for the production and purification of the protein of interest are the analytical methodologies used for its quantification and characterization. In this way, we carry out the complete life cycle of the analytical methods in an adequate way for each stage of drug development: development, optimization, validation and transfer. In doing so, we ensure that analytical methods evolve in the most appropriate way, from the various clinical stages to commercialization. We perform final product formulation to maintain API quality attributes such as purity, integrity, safety, and potency. During the development of the presentations, we search for formulations that allow their processing efficiently, avoiding the generation of oxidized variants, and aggregates, among other forms of degradation, with consistent stability information.
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06.
Production of Pre-Clinical Material
Production of Pre-Clinical Material
In our structure, we can absorb the stages of cell culture, filtration, clarification, chromatography, and tangential filtration of sufficient volumes to generate biopharmaceutical supplements for the stages of pre-clinical studies. Through quality controls, according to the Good Laboratory Practices (GLP), we issue certificates of analysis for the main quality attributes of the protein of interest, recognized by OECD and INMETRO.
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01.
Strain Development
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Virotherapy
Scalable bioprocess development for viral vector vaccines, gene therapies, and oncolytic viruses. We offer end-to-end CDMO solutions using adherent and suspension mammalian systems—from host cell adaptation and bioreactor scale-up to downstream chromatographic purification, analytical titration (TCID50/PFU), and formulation for preclinical batch supply.
Virotherapy
Scalable bioprocess development for viral vector vaccines, gene therapies, and oncolytic viruses. We offer end-to-end CDMO solutions using adherent and suspension mammalian systems—from host cell adaptation and bioreactor scale-up to downstream chromatographic purification, analytical titration (TCID50/PFU), and formulation for preclinical batch supply.
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01.
Cell Line & Media Optimization
Cell Line & Media Optimization
Selection, adaptation, and characterization of host cell lines (adherent & suspension) in serum-free media to maximize viral yield and stability.
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02.
Bioreactor Scale-Up
Bioreactor Scale-Up
Transition from static/flask cultures to scalable bioreactors, optimizing critical parameters including Multiplicity of Infection (MOI) and harvest timing.
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03.
Downstream Purification
Downstream Purification
Multi-step purification utilizing ion exchange, affinity, and size-exclusion chromatography coupled with TFF/ultrafiltration for impurity clearance and concentration.
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04.
Formulation & Stability
Formulation & Stability
Development of optimized buffer formulations and real-time/accelerated stability testing to ensure viral particle integrity during storage and transport.
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05.
Analytical Assays & Titration
Analytical Assays & Titration
Comprehensive analytical testing including viral titration (TCID50, PFU, FFA), ELISA, and identity, purity, and potency characterization.
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06.
Non-clinical Batch Supply
Non-clinical Batch Supply
Biomanufacturing of pilot-scale representative batches for in vitro, toxicology, and in vivo preclinical safety and efficacy evaluations.
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01.
Cell Line & Media Optimization
Partner with Us to Accelerate Your Biomanufacturing Pipeline
Connect with our technical executives to evaluate your bioprocess roadmap, scale-up strategy, or non-clinical batch requirements.