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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

Mar 26, 2015

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Slide 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. Slide 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. Slide 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. Slide 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 Slide 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. Slide 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) Slide 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 Slide 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 Slide 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 Slide 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 Slide 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. Slide 13 Contact Jaume Mir Founder CEO and Commercial Director E-mail:[email protected] Telephone:++34 686 441 120 Address:C/. de la Innovaci, 2 (Leitat Centre Tecnolgic) 88225 Terrassa (Barcelona) SPAIN Slide 14 Slide 15 Back-up slides Applications of P2B Discovery Slide 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 Slide 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 Slide 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 Slide 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 Slide 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 Slide 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 Slide 22 Back-up slides Project Management in P2B Discovery Slide 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 Slide 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 Slide 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