Biotimize

Biotimize provides personalized biotechnology and bioprocess engineering-based services (non-GMP) to biopharmaceutical companies.

Biotechnology as a service

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Biotimize is developing innovative monoclonal antibodies and biosimilars as well as providing biotechnology and bioprocess engineering-based services (non-GMP) to biopharmaceutical companies.

CDMO

Coming soon

Biotimize has a wet lab for bioprocess development for pre-clinical material production in Piracicaba - São Paulo. An expansion plan will begin to build the #1 biological R&D Center and CDMO in Brazil.

Selected Cases

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projects
  • Cristália

    We are performing a cell line development (CHO) of an innovative biological for Cristália.

    We were also directly linked to the structuring and start of activities of the Biotechnology Platform of the company Cristália:

    We solved an existing CHO cell growth limitation in wave bioreactor through changes in the process control so that it was possible to reach 30e7 cell/mL, the concentration necessary to carry out the scaling of the process to 500 L (SUB) under GMP certification;

    We perform all process parameter calculations for scale-up production and perform staggered cultures in order to maintain the productivity and growth kinetics found in laboratory and pilot scales;

    We developed a process for the production of recombinant protein from BHK21, since the clone selection and stable production, and we increased the production from 0.6 mg/L to 60 mg/L by applying statistical tools (DoE);

    We diagnosed the cause of variations in the Somatropin production process by E. coli and with the solution proposal based on process control, the process became predictive and stable.

  • PHP Biotech

    We are developing the production process of a recombinant protein to obtain material for proof of concept studies in vitro and in animal models. Activities include:

    Design of plasmids/vectors for the desired expression system: definition of the type of plasmid/vectors to be purchased from the supplier;

    Transformation and cloning: obtaining up to 5 clones for each processing system expression (P. pastoris, E. coli, and CHO);

    Creation of the Research Cell Bank (1-18 cryovials of 1-1.5 mL);

    Definition of growth kinetics in shaken flasks;

    Protein initial expression test;

    Purification initial test;

    Production of material for in vitro and in vivo studies: production of up to 200 mg of purified protein in the systems defined in the previous steps.

  • Crop Biolabs

    We are developing and producing an innovative biological drug for Crop Biolabs in yeast.

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  • Vyro Biotherapeutics

    We guided the design of the experiments for the development of processes for the production of oncolytic viruses for the company Vyro Biotherapeutics, through activities such as:

    Adaptation of adherent cells for suspension in fetal bovine serum-free medium;

    Creation of cell and virus banks (WCB and MCB);

    Characterization of viral production (MOI/POI);

    Obtaining kinetic parameters and process validation;

    Optimization of culture medium, MOI/POI, purification and formulation;

    Scale-up and validation in benchtop bioreactors.

  • Bio-Manguinhos

    We offer technical consultancy for the elaboration of Conceptual, Basic and Executive Projects for the company Architectus/Bio-Manguinhos to produce 8 biopharmaceuticals on an industrial platform, with the services:

    Requirements of the production process of a multipurpose platform to define the architectural design and layout criteria;

    Definition of cleaning requirements (CIP and SIP);

    Process flow block diagrams (BFD), based on operations production units, for a multipurpose platform;

    Mass balance estimation, based on unit operations of the production, for a multipurpose platform;

    Equipment organization studies to propose layouts of architecture;

    Study of definition of campaigns and suites of different products.

  • Eurofarma

    We offered technical-regulatory consultancy to comply with ANVISA's requirements for the company Eurofarma through the following activities:

    Critical review of the risk analysis of the drug production process in question;

    Critical review of the validation report of the production process of the drug in question;

    Critical review of the control methods used in the production, purification and formulation process of the drug in question (instrumental and analytical);

    Critical review of statistical process control (CEP);

    Critical review of the critical process parameters (CPPs) of the unit operations used in the production of the drug in question;

    Critical review of the critical quality attributes (CQAs) used;

    Critical review of the inquiries made by ANVISA;

    Assessment of process and product impurities profile;

    Elaboration of a list of actions containing process improvements and strategies to confirm the safety of batches already in stock to be presented at the meeting with ANVISA.

  • UFRJ

    We carried out a Manufacturing Instruction review and elaboration for the Federal University of Rio de Janeiro in a project for the production of clinical material for a vaccine against COVID19.

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  • Funed

    We offered technical consultancy to Fundação Ezequiel Dias (FUNED) for the optimization and scale-up of the process for the production of SARS-Cov-2 antigen to produce diagnostic kits through the following activities:

    Technical guidance on the development of the biotechnological process (standardization, optimization, validation and scale-up);

    Technical guidance on the development of analytical methodologies.

Latest News

Bioprocess CDMO Institutional
10, Apr 2024
Biotimize’s R&D Center inauguration

In an unprecedented model in the country, Biotimize opens a laboratory to development of active biological inputs in Brazil Company is the first to work under GLP certification in Brazil to operate in the “as a service” model (CDMO) and will be the only one in South America to offer an end-to-end production service from… Continue reading Biotimize’s R&D Center inauguration

Bioprocess CDMO Institutional
05, Mar 2024
Good Laboratory Practice (GLP)

We are used to talk about Good Manufacturing Practice (GMP), however, have you thought the importance of the Good Laboratory Practice (GLP)? While GLP and GMP serve different purposes and address different stages of product development and manufacturing, they are both essential components of the regulatory framework governing the biopharmaceutical industry. GMP ensures the consistent… Continue reading Good Laboratory Practice (GLP)

Bioprocess CDMO Institutional
03, Nov 2023
Partnership with PQE Group

We are pleased to announce that the development of our CDMO’s conceptual, basic and executive projects has begun! Last month we closed a partnership with PQE Group to develop the Conceptual, Basic and Executive projects of our CDMO. PQE Group is an ISO 9001 certified technology solutions and compliance consulting services company with global capabilities… Continue reading Partnership with PQE Group

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Biotimize provides personalized biotechnology and bioprocess engineering-based services (non-GMP) to biopharmaceutical companies.

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.