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Introduction Biochemize S.L. Biochemize S.L. is a biotechnological company focused in the design and development of processes based on biocatalysis. Our.

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Presentation on theme: "Introduction Biochemize S.L. Biochemize S.L. is a biotechnological company focused in the design and development of processes based on biocatalysis. Our."— Presentation transcript:

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2 Introduction Biochemize S.L. Biochemize S.L. is a biotechnological company focused in the design and development of processes based on biocatalysis. Our technological platform lies in the use of enzymes or microorganisms to perform chemical reactions able to substitute manufacturing processes based on classical organic chemistry.

3 Location We are located in Terrassa, at 20 km from Barcelona. Our office and laboratories are part of the facilities of the Technology Centre of our associate partner Leitat.

4 Our Technology Biochemize S.L. Biochemize S.L. develops bioprocesses using biocatalysts (enzymes or microorganisms) in single or multiple transformation steps. P2B Our technological platform P2B (Platform to Biochemize) is capable to perform high throughput screening of biocatalysts, reaction conditions, suitable substrates and products obtained. The screening can be done in a short period of time and renders information about different possible bioprocesses and conditions that could be further developed at a larger scale.

5 P2B – Platform To Biochemize P2B P2B is the key to determine quickly with low risk and at very small scale if a conceptual biotransformation is technologically viable. Biochemize S.L. Once the succeeding biocatalysts or bioprocesses have been identified, Biochemize S.L. investigates at lab scale the experimental conditions which can lead to the highest yields. Two approaches can be followed: P2B Bioprocess Development of bioprocesses suitable to substitute already established synthetic procedures up to an industrial scale Perform biotransformations that can lead to a (new) chemical entity with improved features compared to the starting molecule P2B Discovery

6 P2B – Discovery P2B Discovery P2B Discovery is an ideal approach for molecules with a complex structure or different functional groups that can be affected when trying to modify them by synthetic procedures. Biocatalysts can be used to obtain new lead, lead optimization, me-too and me-better compounds by modification of already available structures.

7 P2B – Discovery Directed The type of transformation is selected based on the functional group or structure targeted. Exploratory The transformations applicable are diverse in order To test what kind of molecules can be obtained from a given starting structure or what kind of final properties may be achieved. The biotransformation can be: This approach is appropriate to seek new development opportunities (e.g. improved or different pharmacological properties) This approach is suitable when it is well known what feature is conferred by the new functional group or structure in the final molecule (e.g. make it more soluble)

8 P2B – Discovery Biotransformations Oxidations / Reductions Hydration / Dehydration Glycosilations Sulfidations / Sulfoxidations Aromatic Chlorination N-, O-, S-methylation Nitrilation Alkylation / Dealkylation Amide and Ester formation / hydrolysis Potentially, any biotransformation already described…

9 Applications of P2B – Discovery Evaluation of pharmacological properties Improve the solubility Source of building blocks Obtain more stable molecules Increase the IP of the company or the pipeline of products Support in Analytical Methods development More…

10 P2B Discovery The P2B Discovery process consists of the following phases: Biotransform. Screening Biocatalyst Selection & Reproduction Compound Characteriz. Small Scale Production Flexible: Phases can be omitted, merged, delimited or adapted to each project or customer requirements. Step-wise: Each phase is not planned nor quoted until the previous phase is completed and the results presented. Risk-Control: The customer decides the project continuation at each phase depending on results and conclusions obtained so far. Fast: The objective is to provide small amounts of promising (new) molecules in a short time, avoiding setting-up long, difficult and low yield synthetic procedures. Results oriented: The customer is able to decide if full development is a business opportunity according to the properties tests of molecules provided. Tests of Properties by Customer PHASE IIPHASE IIIPHASE IVPHASE V Bibliography Assessment PHASE I Project Management in P2B – Discovery

11 Operations Biochemize S.L. Biochemize S.L. offers the most outstanding and up to date technology options, while maintaining an industrial scope. If necessary, many operations can be outsourced to other companies and research centres under our direction and supervision. We have a powerful network of contacts in biocatalysis and bioprocessing. Several partnership agreements have been established. Austria Bulgaria China Denmark Ireland Italy Korea Netherlands Spain United Kingdom United States Advisors Analytical Services Biocatalyst Suppliers Bioprocessing Services Biotransformation Experts Enzyme Screening Enzyme Immobilization Genetic Engineering Manufacturers Research & Development Scaling-Up Services

12 Why contracting Biochemize? We offer the most outstanding and up to date technology options. Industrial scope guaranteed: productivity, costs and risks are the key drivers of our evaluations. P2B Our technology platform (P2B) is a powerful tool for fast, low risk and small scale proof of concept verifications. P2B We increase the success possibilities through the P2B platform and our network of contacts. Project management based on a development by phases approach. The customer controls the risks and costs associated to the project development.

13 Contact Jaume Mir Founder CEO and Commercial Director E-mail:jmir@biochemize.com Telephone:++34 686 441 120 Address:C/. de la Innovació, 2 (Leitat Centre Tecnològic) 88225 – Terrassa (Barcelona) SPAIN

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15 Back-up slides Applications of P2B – Discovery

16 Evaluation of pharmacological properties Changes in the structure of the original molecule can influence the pharmacological properties: More specific action (i.e. less side effects) Increase the potency New activity Applications of P2B – Discovery

17 Improve the solubility A small change in the structure of a Drug Substance can modify the solubility without affecting the pharmacological activity. The solubility can be modified by introducing polar or hydrophobic groups, as needed. Possible applications: better formulability during the pharmaceutical processing, improvement of the ADME profile. R= OH, Cl Applications of P2B – Discovery

18 Source of building blocks The cleavage of some functional groups or parts of the molecule can lead to a building block that can be further modified by synthetic or biotechnology approaches. This option is specially useful in compounds with a (poly)glycosyl group, that can be removed to render the aglycone part. Applications of P2B – Discovery

19 Obtain more stable molecules Physical, chemical and microbiological stability can be improved by the new properties conferred by the structural changes induced in the original molecule: Physical: crystalline form, particle morphology Chemical: hydrophobization, steric hindrance Microbiological: prevention of enzyme attack, 3D conformation, anti-microbial activity Applications of P2B – Discovery

20 Increase the IP of the company or the pipeline of products Providing new molecules that can be potentially developed, licensed or marketed can increase the value of your company and open new business opportunities. Applications of P2B – Discovery

21 Support in Analytical Methods development Obtain metabolites or impurities difficult to synthesize, but necessary to develop suitable control testing procedures. The technical information in your DMF and dossier submissions will be strongly supported with a solid characterization package. If you are a Drug Substance manufacturer, you can give support to your customers in their Drug Product development, by supplying these special molecules. Applications of P2B – Discovery

22 Back-up slides Project Management in P2B – Discovery

23 Biotransform. Screening Biocatalyst Selection & Reproduction Compound Characteriz. Small Scale Production Biochemize The Bibliography Assessment comprises preliminary evaluations, some of them optional, that can be performed by Biochemize or by the customer. The scope of the assessment includes: Biochemize Theoretical evaluation of suitable biotransformations according to the original structure (Biochemize) Qualitative estimation of possible structure-activity relationships (QSAR) in order to select appropriate biotransformations (optional) Verification of intellectual property opportunities and already protected structures (optional) Tests of Properties by Customer PHASE IIPHASE IIIPHASE IVPHASE V Bibliography Assessment PHASE I Project Management in P2B – Discovery

24 Biotransform. Screening Biocatalyst Selection & Reproduction Compound Characteriz. Small Scale Production The biotransformations selected in the Phase I evaluation are confirmed or discarded during the Phase II with an Experimental Screening. The aim of this phase is to afford evidence that the substrate is transformed and what kind of general biotransformations occur. The final product isolation is not possible in this phase, because of the very small scale experiments. Thus, the characterization is not attained, although some hints about the resulting structure may be obtained. Tests of Properties by Customer PHASE IIPHASE IIIPHASE IVPHASE V Bibliography Assessment PHASE I PHASE II Project Management in P2B – Discovery

25 Biotransform. Screening Biocatalyst Selection & Reproduction Compound Characteriz. Small Scale Production A selection of the biotransformations and the corresponding biocatalysts is done among those succeeding in Phase II. The experiments are reproduced in different experimental conditions in order to meet the requirements leading to a higher productivity at a laboratory scale. The aim at this stage is to obtain enough amount of the resulting product isolated for its characterization in the next phase. Tests of Properties by Customer PHASE IIPHASE IIIPHASE IVPHASE V Bibliography Assessment PHASE I PHASE III Project Management in P2B – Discovery

26 Biotransform. Screening Biocatalyst Selection & Reproduction Compound Characteriz. Small Scale Production The compound characterization is an optional phase. Biochemize It can be led by Biochemize or performed by the customer, as required. Tests of Properties by Customer PHASE IIPHASE IIIPHASE IVPHASE V Bibliography Assessment PHASE I PHASE IV Project Management in P2B – Discovery

27 Biotransform. Screening Biocatalyst Selection & Reproduction Compound Characteriz. Small Scale Production P2B-Discovery The final stage of P2B-Discovery is the small scale production of the final product (mg to g) in order to allow the customer to test the properties. If a full development of the product is finally decided, the manufacturing process at higher scale can be set-up by: The customer: according to in-house procedures, synthetic chemistry, out- sourcing to contractors or partners, etc. BiochemizeP2B-Bioprocess P2B-Discovery Biochemize: using the P2B-Bioprocess approach and according to the knowledge gained with the P2B-Discovery experience, or through technology provided by own partners, etc. Tests of Properties by Customer PHASE IIPHASE IIIPHASE IVPHASE V Bibliography Assessment PHASE I PHASE V Project Management in P2B – Discovery


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