As a reliable partner for new drug developers, medicinal chemistry service provided by biomaxlab encompasses a broad breath of chemistry services. We meet our clients’ needs using our strong expertise in organic and medicinal chemistry, extensive experience in industrial drug discovery and excellent managerial skills acquired from working experience at CRO. Each of our R&D services can be contracted as part of an integrated program or as a stand-alone project.

Medicinal Chemistry

biomaxlab’s medicinal chemistry experts can help devise medicinal chemistry strategies for clients’ need from hit identification, hit to lead generation to lead optimization. With our flexible tactics, we help start-up drug discovery units swiftly address their needs in medicinal chemistry and execute the medicinal chemistry strategies using our strong knowledge and experience in industrial drug discovery and managing CRO resources.

  • Novel scaffold design and comparative analysis for hit identification
    • Competitive landscape analysis for new programs
    • Route design and exploration of structural diversity within new scaffolds
    • IP analysis
  • Assess HTS hit sets and design library for SAR profiling
  • SAR analysis based on both in vitro and in vivo data
  • Design initial leads from competitors‘ patents
  • Focused library design for lead generation and optimization
  • Design SPR-guided analogs with better drug-likeness
  • Studies flow design and project consultation
  • Help client identify and manage CRO resources
  • Assisting patent filing for/by clients

Modern Synthetic Chemistry

  • Organometallic chemistry (Highly reactive metal catalysis, reaction under inert atmosphere)
  • Organoboron chemistry (Hydroboration and coupling, widely applied in material science and medicinal chemistry)
  • Organofluorine chemistry
  • Asymmetric synthesis (Catalysis and Resolution)
  • Glycosylation (Important chemistry for biologically active compounds)
  • Natural products modification( Common method to improve the medicinal and biological properties of natural products)

Custom Synthesis

Our chemists are experts in the latest technologies in synthetic organic chemistry, including asymmetric synthesis. We have a strong track-record and expertise in designing and preparing multi-step targets on scales ranging from milligrams to several hundred grams. Using this experience, we can handle custom syntheses of small molecules with novel scaffolds and functions.

  • Bioassay substrates
  • Building blocks and intermediates
  • Chiral compounds
  • Heterocyclic chemistry and scaffolds
  • Multi-step synthesis
  • Pharmaceutical reference standards (APIs, impurities, metabolites and parent compounds)
  • Stable isotope labeled compounds (Deuterium, carbon-13, nitrogen-15 and oxygen-18)
  • Synthesis route design
  • Reaction condition optimization
  • Scale-up (milligrams to kilograms)

biomaxlab screening service utilizes tailored assays to meet the demands of your screening strategies. We have the capacity and expertise to maximize your library screening efforts. Our services can be used for target validation, hit identification and lead optimization, or follow-up studies, choosing from our broad portfolio of assays for targets such as profiling of the cancer pathways, GPCRs, and ion channels. For these target screenings, we offer the flexibility of multiple readouts for luminescence assay and/or second messenger detection.

biomaxlab carries over 150 human and animal cell lines, see Table. Our assays can therefore be readily customized in primary, stably transfected, immortalized, cancer, and other cell types to meet your needs.

Assay Validation

Our assays are validated based on the NIH Chemical Genomics Center Assay Guidance Manual. Appropriate controls are included on every plate and Z' values and signal to noise calculations are determined for the entire screening process. Any assay that does not meet our specifications or specific criteria set by the customer will be repeated.

Our services deliver

  • Bioanalytical screening of library compounds
  • Final lead compounds
  • High quality data
  • Extensive validation and appropriate controls included
  • Fast turnaround time depending on the size of the project
  • Competitive pricing
  • Complete confidentiality

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The seven-transmembrane α-helix structure of a GPCR

G-protein-coupled receptors (GPCRs) draw much attention as drug targets because more than 40% of the approximately 500 clinically marketed drugs are targeting GPCRs. Functional assays for GPCRs are indispensable platforms for drug screening and ligand hunting. We provide assay systems which cover calcium flux, cAMP level and reporter assay for our customers to carry out high-throughput screening (HTS).

Four major routes of the GPCR Signaling Pathway

GPCRs transmit extracellular signals across the plasma membrane via intracellular coupling with heterotrimeric G proteins. Heterotrimeric G proteins are classified into four subfamilies based on their Gα subunits, Gs, Gi, Gq and G12. Current methods employed in GPCR screening assays measure G protein signaling by determining change in second messengers such as cAMP, inositol trisphosphate (IP3), and intracellular Ca2+ mobilizations, which demands different assay platforms and requires specialized instrumentation for each pathway which could be costly. Our proprietary GPCR assay platform is designed to report GPCR activation. These assays are used for potency rankings of GPCR modulators and for high throughput screening. The advantage of our GPCR screening assays is that they give you a cost-effective screening approach before you spend time and resource to narrow down individual GPCRs before you are not sure which subtypes of GPCRs are involved.

Intracellular/extracellular free ions, such as Ca2+, H+ and Mg2+ concentrations are important for vital cell functions, such as excitability, membrane potential, cell volume regulation, cell proliferation and apoptosis. Under physiological conditions, intracellular and extracellular free ion concentrations are fine controlled; however, they are dysregulated in a number of diseases. Utilizing digital cell imaging, high throughput screening (HTS) and ion sensitive electrodes, we offer measurements of intracellular and extracellular free ion, such as Ca2+, H+ and Mg2+concentrations to test effects of lead compounds on these free ions, and further elucidate the mechanisms underlying action of the compounds on the ions.

(TGFβ (TGF-beta), Wnt, NF-kB, MAPK)

BioMaxLab Reporter Assays provide a HTS for rapid, sensitive, and quantitative assessment of signal transduction pathway activation by measuring the activities of downstream transcription factors in cultured cells. We transfect the HEK-293 cells with the reporter and run services for the following signaling pathways to provide a comprehensive coverage for potential mechanism of action of drug candidates based on:

	Monitor how the signaling pathway is regulated by your compounds.
	Evaluate how potent the effect of tested compound is on activity of the pathway.
	Delineate the potential biological targets for your drug candidates.

We have experimentally optimized the number of response elements as well as the intervening sequence between response elements to maximize the signal to noise ratio for each pathway.

In addition to the positive and negative controls included in each run, we also cotransfect the reporter with Renilla luciferase as an internal control for normalizing transfection efficiencies, monitoring cell viability and producing a ratiometric readout, thus to ensure the validity and the comparability of the data over time.

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In vitro ADME provides a set of parameters that predict how a drug will behave in the human body. BioMaxLab conducts custom drug absorption, distribution, metabolism research that can assess drug permeability, metabolic stability and clearance, drug-drug interaction, metabolite identification, CYP and UGT phenotyping and identification, CYP and UGT induction and/or inhibition, and protein binding.

Absorption Study (CaCo-2):

Our absorption study model is designed to classify the absorption potential of our customers' compounds. We use Caco-2 cell monolayers to predict intestinal drug absorption. We routinely run assays for our customers that determine active and passive transport of a compound across cell monolayers.

Distribution Study: Cell permeability and efflux assays (MDR1-MDCKII):

The P-gp transporter is an efflux transporter that is encoded by the ABCB1 gene. P-gp is also known as P-glycoprotein and the Multi-Drug Resistance transporter 1 (MDR1). P-gp (MDR1) is expressed in many tissues of the body including in the kidney on the apical side of the intestinal lumen, the apical side of the bile canaliculus in liver hepatocytes, the apical membrane of proximal tubule epithelial cells and the apical side of the capillaries in the blood brain barrier (BBB). P-gp (MDR1) serves to limit the absorption of substrates, protect them from entering the brain and also to mediate their renal and hepatic elimination.

Human P-gp (MDR1) is known to be a determinant of drug absorption, distribution, and excretion of a number of clinically important drugs. P-gp is widely expressed in major organs, and, more specifically, P-gp is highly expressed in the capillaries of the blood brain barrier (BBB) and poses a barrier to brain penetration of its substrates. Given that P-gp efflux liability can be a major hurdle for CNS therapeutic drugs to cross the BBB and reach the target, the interactions of CNS compounds with P-gp may lead to the lack of CNS activity as a result of the decreased brain penetration. Thus, the prediction and understanding of the relevance of P-gp-mediated efflux transport have become important activities in the discovery and development of CNS drugs. Transwell-based assays using polarized MDCKII and MDR1-MDCKII cell lines provide a great tool to classify compounds as P-gp substrates. Comparison of the efflux ratios between MDR1-MDCKII and MDCKII transwell assays can provide a measure of the specific human P-gp-mediated efflux activity.

  • Apical vs. Basolateral permeability (Caco-2, pH 6.5/7.4)
  • Apical vs. Basolateral permeability (Caco-2, pH 7.4/7.4)
  • Apical vs. Basolateral permeability (Caco-2, pH 7.4/7.4 + verapamil)
  • Apical vs. Basolateral permeability (MDCKII, pH 7.4/7.4)
  • Apical vs. Basolateral permeability (MDR1-MDCKII, pH 7.4/7.4)
  • Apical vs. Basolateral permeability (MDR1-MDCKII, pH 7.4/7.4 + verapamil)
  • Basolateral vs. Apical permeability (Caco-2, pH 6.5/7.4)
  • Basolateral vs. Apical permeability (Caco-2, pH 7.4/7.4)
  • Basolateral vs. Apical permeability (Caco-2, pH 7.4/7.4 + verapamil)
  • Basolateral vs. Apical permeability (MDCKII, pH 7.4/7.4)
  • Basolateral vs. Apical permeability (MDR1-MDCKII, pH 7.4/7.4)
  • Basolateral vs. Apical permeability (MDR1-MDCKII, pH 7.4/7.4 + verapamil)

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BioMaxLab is expertise in performing studies on drug metabolic stability and clearance. While metabolic stability is helpful when trying to determine the potential half-life of a compound, the intrinsic clearance of drug candidates can help to confirm whether metabolism is the main clearance pathway when it is compared with the total body clearance in vivo. Our in vitro ADME metabolic stability and intrinsic clearance assays are conducted in liver microsomes, liver S9, cryopreserved hepatocytes from human, Cynomolgus monkey, Beagle dog, Sprague-Dawley rat, and CD-1 mouse. We also determine metabolic stability when a compound is dosed to animals DRUG METABOLISM & PHARMACOKINETICS. The time points are customized for each project, and the deliverables include raw data, percent remaining, and half-life values.

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BioMaxLab is able to identify, generate, and compare metabolite profiles to assist with species selection for toxicology studies. We will use the state-of-the-art mass spectrometry to analyze samples from in vitro metabolic stability assays or in vivo dosing studies. We search the data sets for potential metabolites, and compare the time profiles of parent compound loss and metabolite formation using enzyme sources from various animal species. Metabolite identification and profiling studies can also be specifically designed to look for unique or disproportionate human metabolites. We determine possible major metabolites using HPLC-UV detection and identify major metabolites using LC-MSn and NMR methods.

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CYP and UGT phenotyping, or identification, determines the CYP and/or UGT enzymes that are involved in the metabolism of a compound. BioMaxLab will use FDA-approved criteria in this study including specific chemical inhibition, and/or recombinant enzymes. We also perform correlation analysis that involves a donor bank of liver microsomes of at least 10 donors. Pilot studies will be conducted to determine the appropriate reaction conditions for each project.

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Drug-drug interactions involves inhibition and/or induction of drug metabolizing enzymes. Inhibition of drug metabolizing enzymes is a major mechanism of drug-drug interactions. The majority of these enzymes are CYPs.

CYP Inhibition Studies

These studies are conducted with HLM or recombinant enzymes, FDA-accepted probe substrates, and control inhibitors. Both IC50 and Ki values can be determined, and the pre-incubation of the test article with microsomes and NADPH are used to assess time-dependent inhibition. Alternatively, we can use recombinant CYP450 enzymes with fluorogenic probe substrates in screening assays.

UGT Inhibition Studies

Recombinant UGT enzymes are used to assess the IC50 values of a test article with respect to the most common isoforms.

CYP Induction Studies

Enzyme induction following drug administration can lead to enhanced clearance of co-medications or itself, causing a drug-drug interaction, therapeutic failure, patient management, and potentially other safety issues. Cryopreserved human hepatocytes from one or more donors are used to assess the potential of a compound to induce the activity of a drug metabolizing CYP. In addition to directly studying enzyme activity, we are also able to determine CYP mRNA or protein expression induction using RT-PCR or Western Analysis, respectively (two FDA-accepted validation methods) upon request by the clients.

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Drug efficacy and disposition are influenced by binding of a drug to plasma proteins, primarily human serum albumin, or α1-acid glycoprotein. High drug-protein binding can both reduce the fraction of free drug available for target sites and prolong the duration of drug activity. BioMaxLab will use equilibrium dialysis , ultrafiltration using Thermo rapid equilibrium dialysis (RED) device and HTDialysis 96-well micro-equilibrium dialysis device. Multiple concentrations can be tested to obtain Kd estimates. We can also use in vivo samples to assess binding values.

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Cytotoxicity is a critical area of concern for drug candidates. Hepatocyte cytotoxicity is a major cause of drug candidate failure, both pre- and post-market launch. BioMaxLab will conduct cytotoxicity assays for testing the potential of drug candidate-induced cytotoxicity both in liver cell lines, such as Hep G2 or Hep 3B, or using human or rat hepatocytes. We will use XTT as well as LDH assays.

In Vivo Pharmacokinetic/ADME Screening

Whether you have one compound or a library of compounds requiring DMPK assessment, our well-trained and proficient scientists at BioMaxLab can design, conduct, and interpret the DMPK components of your program as part of our streamlined screening services. Quick study initiation, multiple species, resident animal colonies with chronic surgical models included, and various dose regimens and administration routes plus bioanalytical support provide the necessary tools you need to rapidly identify and optimize your potential drug candidates.

Available services:

  • Tissue distribution

  • Metabolite profiling and identification

  • Single/multiple/cassette dosing

  • Bioavailability and bioequivalence

Approximately one third of compounds in pre-clinical development exhibit some levels of cardiac risks. Unfortunately, many of these compounds are not identified until they are in clinical trials after millions of dollars and years of effort have been invested. As a result, the vast majority of investigational products that enter clinical trials fail. Therefore, for the sake of saving time and money, it is critical to assess the preclinical cardiac safety of these investigational products before they enter clinical trials.

The hERG channel plays a significant role in cardiac repolarization and acute hERG block alone will prolong QT and induce Torsades de Pointes. Compounds routinely affect The hERG channel influencing the effect of hERG block. BioMaxLab provides a fast, comprehensive preclinical cardiac safety assessment for full resolution of potential cardiac risk prior to IND submission. Multiple assays are employed to assess a compound's effect on preclinical cardiac safety at molecular, cellular, tissue and system levels. We enable you to achieve nearly 100% predictivity of cardiac risk with our preclinical cardiac safety assessment. BioMaxLab provides the most complete preclinical cardiac safety package presently available.

 

Molecular structure of hERG

hERG Channel Electrophysiology Overview

Drug-induced delayed cardiac repolarization has associated with block of hERG (a functionally prominent ventricular repolarizing potassium current) and is linked to cardiac proarrhythmia (Torsades-de-Pointes). However, hERG current block is not always associated with delayed repolarization, and preclinical cardiac safety studies evaluating only hERG current provide a focused but narrow perspective. Additional cardiac ion channels represent numerous potential off-target effects that may modulate the effects of hERG current block, affect impulse initiation (chronotropic effects), conduction (dromotropic effects), or contractility (inotropic effects). Routine hERG screening in early discovery efforts should be supplemented with additional studies to avoid unduly discarding hERG blocking drugs not affecting delayed repolarization and to ensure overall cardiac safety.

Assessing hERG Channel Inhibition

  • BioMaxLab uses manual patch clamp (a gold standard) to assess hERG channel inhibition on HEK293 cells or CHO cells stably transfected with the hERG ion channel.
  • BioMaxLab uses manual patch clamp (a gold standard) to assess hERG channel inhibition on HEK293 cells or CHO cells stably transfected with the hERG ion channel.
  • Protocols include exploratory non-GLP screening of single high concentration or IC50.
  • Validated with a number of agents known to affect the hERG current, including terfenadine, cisapride and E-4031.

The BioMaxLab Difference

  • A customer focused approach, delivering beyond your expectations.
  • Scientific excellence with over 20 years combined experience in in vitro pharmacology and a technical team with the same high standards as yours.
  • A quality service.
  • A flexible service; we support a cross-section of global clients, from small biotech to large pharmaceutical companies, and academia, providing both validated assays and tailored protocols.
If your drug has a positive effect on hERG channel, does it have a QT risk? The follow-up studies to the heart models in vitro can provide greater depth of understanding or additional knowledge regarding the potential of test substance for delayed ventricular repolarization and QT interval prolongation in humans. BioMaxLab offers a heart model in vitro QT service to characterize a drug's potential to affect ventricular repolarization and contractility. Early testing for multiple effects on key cardiac ion channels fully resolves discordances and prevents advancement of cardiotoxic drug candidates. Using isolated rat or rabbit hearts, BioMaxLab offers Langendorff perfused heart ECG and contractility assessment so that drugs can be tested on isolated animal hearts. We can identify effects of your compounds on the ECG (QT interval, QRS), heart contractility (LVDP, dP/dt) and coronary flow. Three hearts will be used per concentration. Final reports of the in vitro QT service include drug effects on the study parameters including a summary of the results, description of methods used, statement of quality standard, and any amendments or deviations included as an appendix
The in vivo QT Service is a component of BioMaxLabs preclinical cardiac safety assessment, a comprehensive cardiac safety assessment package for full resolution of potential cardiac risk prior to IND submission. Using rat, rabbit or dog, BioMaxLab can determine the effects of drugs on ECG in vivo, such as QT/QTc interval, QRS duration, RR interval, PR interval. Three animals will be used per concentration. Final reports of the in vivo QT service include drug effects on the study parameters including a summary of the results, description of methods used, statement of quality standard, and any amendments or deviations included as an appendix.
Cardiac hemodynamic assessment is another component of BioMaxLabs preclinical cardiac safety assessment. Using rat, rabbit or dog, BioMaxLab can determine the effects of drugs on cardiac hemodynamic parameters, such as heart rate, arterial blood pressure (including systolic, diastolic and mean arterial blood pressure), heart contractility (LVDP, dP/dt) and coronary flow. Three animals will be used per concentration. Final reports of the cardiac hemodynamic assessment include drug effects on the study parameters including a summary of the results, description of methods used, statement of quality standard, and any amendments or deviations included as an appendix.

BioMaxLab offers Cancer Cell Line Screening of over 150 Cancer Cell Lines Table. Cell lines are of human origin and are well characterized. You can also select cancer cells from our cancer cell-58 panel (CCP-58) that is similar to those included in the NCI-60 Panel of cancer cell lines or clients are welcome to design a special panel of cells that is most relevant to their specific research need. We will assist you with the selection of cell lines by tissue of origin or for the presence of specific gene mutations responsible for cancer induction or responsible for drug resistance.

CCP-58 panel

The CCP-58 panel is a set of 58 representative human cancer cell lines derived from diverse tissues; brain, blood and bone marrow, breast, colon, kidney, lung, ovary, prostate and skin. Researchers across the world have employed these cell lines to characterize drug effectiveness.

Flexibility

BioMaxLab has adopted a very flexible, screening approach with multiple end point parameters available including proliferation or other assays (e.g. ion channels) in the medium conditions of interest.

  • 96-well screening plate format
  • 3 to 4 weeks data turnaround time
  • Choice of proliferation assay method (Alamar blue, CyQuant, XTT, MTS)

 

Molecular structure of hERG

hERG Channel Electrophysiology Overview

Drug-induced delayed cardiac repolarization has associated with block of hERG (a functionally prominent ventricular repolarizing potassium current) and is linked to cardiac proarrhythmia (Torsades-de-Pointes). However, hERG current block is not always associated with delayed repolarization, and preclinical cardiac safety studies evaluating only hERG current provide a focused but narrow perspective. Additional cardiac ion channels represent numerous potential off-target effects that may modulate the effects of hERG current block, affect impulse initiation (chronotropic effects), conduction (dromotropic effects), or contractility (inotropic effects). Routine hERG screening in early discovery efforts should be supplemented with additional studies to avoid unduly discarding hERG blocking drugs not affecting delayed repolarization and to ensure overall cardiac safety.

Assessing hERG Channel Inhibition

  • BioMaxLab uses manual patch clamp (a gold standard) to assess hERG channel inhibition on HEK293 cells or CHO cells stably transfected with the hERG ion channel.
  • BioMaxLab uses manual patch clamp (a gold standard) to assess hERG channel inhibition on HEK293 cells or CHO cells stably transfected with the hERG ion channel.
  • Protocols include exploratory non-GLP screening of single high concentration or IC50.
  • Validated with a number of agents known to affect the hERG current, including terfenadine, cisapride and E-4031.

The BioMaxLab Difference

  • A customer focused approach, delivering beyond your expectations.
  • Scientific excellence with over 20 years combined experience in in vitro pharmacology and a technical team with the same high standards as yours.
  • A quality service.
  • A flexible service; we support a cross-section of global clients, from small biotech to large pharmaceutical companies, and academia, providing both validated assays and tailored protocols.
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