Presentation on theme: "Introduction Biochemize S.L. is a biotechnological company focused in the design and development of processes based on biocatalysis. Our technological."— Presentation transcript:
2IntroductionBiochemize 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.
3Location 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.
4Our TechnologyBiochemize S.L. develops bioprocesses using biocatalysts (enzymes or microorganisms) in single or multiple transformation steps.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.
5P2B – Platform To Biochemize P2B is the key to determine quickly with low risk and at very small scale if a conceptual biotransformation is technologically viable.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 BioprocessDevelopment of bioprocesses suitable to substitute already established synthetic procedures up to an industrial scaleP2B DiscoveryPerform biotransformations that can lead to a (new) chemical entity with improved features compared to the starting molecule
6P2B – DiscoveryP2B 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.
7P2B – Discovery The biotransformation can be: Directed The type of transformation is selected based on the functional group or structure targeted.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)ExploratoryThe transformations applicable are diverse in orderTo test what kind of molecules can be obtained froma given starting structure or what kind of final properties may be achieved.This approach is appropriate to seek new development opportunities (e.g. improved or different pharmacological properties)
9Applications of P2B – Discovery Evaluation of pharmacological propertiesImprove the solubilitySource of building blocksObtain more stable moleculesIncrease the IP of the company or the pipeline of productsSupport in Analytical Methods developmentMore…
10Project Management in P2B – Discovery The P2B Discovery process consists of the following phases:BibliographyAssessmentBiotransform.ScreeningBiocatalystSelection &ReproductionCompoundCharacteriz.Small ScaleProductionTests ofPropertiesby CustomerPHASE IPHASE IIPHASE IIIPHASE IVPHASE VFlexible: 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.
11OperationsBiochemize 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.AdvisorsAnalytical ServicesBiocatalyst SuppliersBioprocessing ServicesBiotransformation ExpertsEnzyme ScreeningEnzyme ImmobilizationGenetic EngineeringManufacturersResearch & DevelopmentScaling-Up ServicesAustriaBulgariaChinaDenmarkIrelandItalyKoreaNetherlandsSpainUnited KingdomUnited States
12Why 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.Our technology platform (P2B) is a powerful tool for fast, low risk and small scale proof of concept verifications.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.
13Contact Jaume Mir Founder CEO and Commercial Director Telephone:Address: C/. de la Innovació, 2(Leitat Centre Tecnològic)88225 – Terrassa(Barcelona) SPAIN
15Applications of P2B – Discovery Back-up slidesApplications of P2B – Discovery
16Applications of P2B – Discovery Evaluation of pharmacological propertiesChanges in the structure of the original molecule can influence the pharmacological properties:More specific action (i.e. less side effects)Increase the potencyNew activity
17Applications of P2B – Discovery Improve the solubilityA 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
18Applications of P2B – Discovery Source of building blocksThe 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.
19Applications of P2B – Discovery Obtain more stable moleculesPhysical, 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 morphologyChemical: hydrophobization, steric hindranceMicrobiological: prevention of enzyme attack, 3D conformation, anti-microbial activity
20Applications of P2B – Discovery Increase the IP of the company or the pipeline of productsProviding new molecules that can be potentially developed, licensed or marketed can increase the value of your company and open new business opportunities.
21Applications of P2B – Discovery Support in Analytical Methods developmentObtain 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.
22Project Management in P2B – Discovery Back-up slidesProject Management in P2B – Discovery
23Project Management in P2B – Discovery PHASE IBiocatalystSelection &ReproductionTests ofPropertiesby CustomerBibliographyAssessmentBiotransform.ScreeningCompoundCharacteriz.Small ScaleProductionPHASE IPHASE IIPHASE IIIPHASE IVPHASE VThe 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: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)
24Project Management in P2B – Discovery PHASE IIBiocatalystSelection &ReproductionTests ofPropertiesby CustomerBibliographyAssessmentBiotransform.ScreeningCompoundCharacteriz.Small ScaleProductionPHASE IPHASE IIPHASE IIIPHASE IVPHASE VThe 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.
25Project Management in P2B – Discovery PHASE IIIBiocatalystSelection &ReproductionTests ofPropertiesby CustomerBibliographyAssessmentBiotransform.ScreeningCompoundCharacteriz.Small ScaleProductionPHASE IPHASE IIPHASE IIIPHASE IVPHASE VA 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.
26Project Management in P2B – Discovery PHASE IVBiocatalystSelection &ReproductionTests ofPropertiesby CustomerBibliographyAssessmentBiotransform.ScreeningCompoundCharacteriz.Small ScaleProductionPHASE IPHASE IIPHASE IIIPHASE IVPHASE VThe compound characterization is an optional phase.It can be led by Biochemize or performed by the customer, as required.
27Project Management in P2B – Discovery PHASE VBiocatalystSelection &ReproductionTests ofPropertiesby CustomerBibliographyAssessmentBiotransform.ScreeningCompoundCharacteriz.Small ScaleProductionPHASE IPHASE IIPHASE IIIPHASE IVPHASE VThe 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.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.