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.

“We are able to follow all the necessary steps to obtain biopharmaceutical molecules”.
  • 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.

    Illustrative image for Mammalian Cells
    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.

    • 01. 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.

    • 02. 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.

    • 03. 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

      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.

    • 05. 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.

    • 06. 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.

    • 07. 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.

  • 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.

    Illustrative image for Microbial
    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.

    • 01. 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

      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

      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

      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.

    • 05. 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.

    • 06. 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.

  • 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
    Illustrative image for 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).

  • Molecule
    Specification
    Therapeutic area
    Stage
    BTZ01
    Novel
    Oncology
    Clone and PoC
  • Molecule
    Specification
    Therapeutic area
    Stage
    Omalizumab
    Biosimilar
    Oncology
    Clone and PoC

LGPD

Rigorous company in relation to the general data protection law (LGPD)

Biotimize - Biotechnology as a Service is committed to complying with the laws that protect the privacy of the data of its employees, partners and the general public.
See how we deal with the information collected:

What are the data types? Personal data:
”Information related to the identified or viral person”, for example: first name, last name, date of birth, personal documents, home or business address, telephone, email and IP address.

Sensitive Personal data:
These are the data that refer to racial or ethnic origin, religious conviction, political opinion, union affiliation or organization of a religious, philosophical or political nature. Sensitive personal data as well are those related to health or sex life, genetic or biometric data.

What data does our Company collect? Our company handles data from employees, partners and service providers, being duly compliant with the LGPD.
On the website, the company collects data through the voluntary and consensual completion of forms, e-books and contact to receive the newsletter.

Is there automatic data collection? Biotimize - Biotechnology as a Service does not automatically collect data in each access to the website.

How do they use my data? The personal data provided by users who fill in the forms are used solely to provide feedback at the user's request (individual or legal entity interested in our company's products and services).
Once the service is completed, such data is deleted.

Have you got any questions? Talk to the Data Protection Manager (DPO) by email: dpo@biotimize.com.br
You will be able to clarify doubts related to the processing of personal data.