Biotimize
What we do
Biotechnology as a service
Through the Biotechnology as a Service (BTaaS) model, Biotimize provides biotechnology and bioprocess engineering-based services to global companies or institutions.
BTaaS allows our customers to have access to a structure composed of high-quality equipment, duly calibrated and qualified according to regulatory agencies, and a specialized team with more than 15 years of experience in the development of biopharmaceuticals. The solutions are of a personalized nature and can range from advisory support in projects developed by the client to the complete development of a product by our team. We are able to follow all the necessary steps to obtain biopharmaceutical molecules. In doing so, we can speed up the arrival of new technologies to the market.
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Mammalian Cells
We have a CHO cell lineage that allows the expression of an average of 5 g/L of recombinant protein in suspension cultures and in culture media free of animal components. We operate in the establishment of cell lines for the stable expression of recombinant proteins, in the development of processes (Upstream and Downstream), in the development and validation of analytical methods, and in the formulation of APIs and finished products. Through our services, the client will have all the necessary information to start the production of clinical batches.
Mammalian Cells
We have a CHO cell lineage that allows the expression of an average of 5 g/L of recombinant protein in suspension cultures and in culture media free of animal components. We operate in the establishment of cell lines for the stable expression of recombinant proteins, in the development of processes (Upstream and Downstream), in the development and validation of analytical methods, and in the formulation of APIs and finished products. Through our services, the client will have all the necessary information to start the production of clinical batches.
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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
We provide services for a variety of products obtained from microbial, E. coli, or yeast cultures, which include soluble intracellular products, inclusion bodies and extracellular secreted products. Our platform is structured to provide integrated solutions for strain development and clone evaluation, process development (Upstream and Downstream), analytical methods, API formulation, and finished products for use in preclinical studies.
Microbial
We provide services for a variety of products obtained from microbial, E. coli, or yeast cultures, which include soluble intracellular products, inclusion bodies and extracellular secreted products. Our platform is structured to provide integrated solutions for strain development and clone evaluation, process development (Upstream and Downstream), analytical methods, API formulation, and finished products for use in preclinical studies.
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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.
-
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.
-
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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Technical-economic analysis
Through in-silico simulations, using the SuperPro Designer and Schedule Pro softwares (Intelligen, INC.), we assess the economic and technical viability of the processes proposed by our clients or under development by our team. It is very common to question the unit value of the product, its production cost, and how this information correlates with the scalability of the process to meet a certain demand.
Technical-economic analysis
Through in-silico simulations, using the SuperPro Designer and Schedule Pro softwares (Intelligen, INC.), we assess the economic and technical viability of the processes proposed by our clients or under development by our team. It is very common to question the unit value of the product, its production cost, and how this information correlates with the scalability of the process to meet a certain demand.
Through our evaluation, it is possible to design a process on an industrial scale to meet an identified demand and, through this definition, obtain data on annual production capacity, the unit production cost, return on investment, internal rate of return, return time and other parameters used for decision making.
In addition, this tool identifies the operational limitations of the process about yields, costs, scales, and equipment that can be more assertively solved in laboratory-scale studies.
Bioproduct - Development
Biotimize is developing innovative monoclonal antibodies and biosimilars that will help treat people suffering from chronic diseases, following the highest quality standards required by regulatory agencies worldwide (ANVISA, FDA, EMA).
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MoleculeSpecificationTherapeutic areaStageBTZ01NovelOncologyClone and PoC
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MoleculeSpecificationTherapeutic areaStageOmalizumabBiosimilarOncologyClone and PoC