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    Pharma Services Category of Lubrizol Life Science Health

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    HTL Biotechnology is the world leader in the responsible development and production of pharmaceutical-grade biopolymers.
    Polpharma is a Polish CDMO of APIs and a significant European API producer, delivering products to companies worldwide.
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    01 API Development (1)

    02 Analytical Method Development (1)

    03 Analytical Testing Services (9)

    04 Biologic Drugs (2)

    05 Early Clinical / Phase I-IIa (1)

    06 Formulation Development (9)

    07 Lyophilization (1)

    08 Materials (1)

    09 Medical Device (1)

    10 Preformulation & Material Science (6)

    11 Stability Studies (2)

    12 Structural Characterization (1)

    13 Technologies (1)

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    01 Lubrizol Life Science Health (36)

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    01 U.S.A (36)

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    Lubrizol Life Science Health

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    SPRAY DRYING

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    Our particle & nanoparticle engineering expertise includes, among others, micronized particulates (eg jet-milling), spray drying, emulsions, suspensions, liposomes, LyoCells®, solid lipid nanoparticles, polymer nanoparticles, PEGPLUS™, coacervates and polyelectrolyte complexes, and micro/nano

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    Pharma Service: API & Drug Product Development

    Category: API Development

    Sub Category: Spray Drying
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    EMULSIONS

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    Our particle & nanoparticle engineering expertise includes, among others, micronized particulates (eg jet-milling), spray drying, emulsions, suspensions, liposomes, LyoCells®, solid lipid nanoparticles, polymer nanoparticles, PEGPLUS™, coacervates and polyelectrolyte complexes, and micro/nano

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    Pharma Service: API & Drug Product Development

    Category: Formulation Development

    Sub Category: Emulsion
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    NANOPARTICLES FORMULATION

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    Our passion for complex drug product development means that we can handle just about project, including dosage forms like nanoparticles, resorbable microspheres, films/patches, and lipid-based systems.

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    Pharma Service: API & Drug Product Development

    Category: Formulation Development

    Sub Category: Liposome / Microsphere / Nanoparticle
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    LIPOSOMES

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    Our particle & nanoparticle engineering expertise includes, among others, micronized particulates (eg jet-milling), spray drying, emulsions, suspensions, liposomes, LyoCells®, solid lipid nanoparticles, polymer nanoparticles, PEGPLUS™, coacervates etc

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    Pharma Service: API & Drug Product Development

    Category: Formulation Development

    Sub Category: Liposome / Microsphere / Nanoparticle
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    HOT MELT EXTRUSION

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    Lubrizol Life Science Health uses this approach for both solid oral dosage forms and drug eluting devices. Combined with our DOSE™ system to quickly hone in on the right polymer choice, HME is an excellent path to increased bioavailability.

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    Pharma Service: API & Drug Product Development

    Category: Formulation Development

    Sub Category: Overview
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    HIGH PRESSURE HOMOGENIZATION

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    At Lubrizol Life Science Health we use Microfluidics'® homogenizers to accomplish this. We have capabilities that span early development to sterile cGMPclinical supply.

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    Category: Formulation Development

    Sub Category: Overview
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    SPECIALIST DOSAGE FORMS - SUSPENSION

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    Our particle & nanoparticle engineering scientific expertise includes micronized particulates (eg jet-milling), spray drying, emulsions, suspensions, powders, liposomes, oral solid lipid nanoparticles, polymer nanoparticles, coacervates, etc.

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    Pharma Service: API & Drug Product Development

    Category: Formulation Development

    Sub Category: Suspension
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    PREFORMULATION

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    Starting with DOSE™, our own preformulation system and proceeding through formulation, production for pre-clinical toxicology, scale up and clinical trial material production,

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    Pharma Service: API & Drug Product Development

    Category: Preformulation & Material Science

    Sub Category: Overview
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    WET MILLING & JET MILLING

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    Lubrizol Life Science Health is a leader in nanomilling (wet milling and jet milling), microfluidization and spray drying. Currently, it is the only for-hire organization that can perform nanomilling under aseptic conditions at a commercial scale.

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    Pharma Service: API & Drug Product Development

    Category: Preformulation & Material Science

    Sub Category: Particle Size Reduction & Micronization
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    PARTICLE SIZE REDUCTION

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    Lubrizol Life Science Health has a complete set of in-house milling technologies including ball, high energy and jet milling (Netzsch® and Dyno®-Mill). It can mill highly potent compounds and can also mill aseptically.

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    Pharma Service: API & Drug Product Development

    Category: Preformulation & Material Science

    Sub Category: Particle Size Reduction & Micronization
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    SOLUBILIZATION

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    Lubrizol has developed a proprietary approach to solubilization using a combination of computational tools and empirical data. DOSE has resulted in several clinical products already and is the basis for much of Lubrizol's work.

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    Pharma Service: API & Drug Product Development

    Category: Preformulation & Material Science

    Sub Category: Solubility Assessment & Enhancement
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    ODOR & TASTE MASKING BY ENCAPSULATION

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    Employed to protect a given API, taste masking or to facilitate targeted drug delivery, encapsulation is a proven drug taste & odor masking strategy that Lubrizol has been practicing for over 20 years.

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    Pharma Service: API & Drug Product Development

    Category: Preformulation & Material Science

    Sub Category: Taste Masking
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    ANTIBODY-DRUG COMPLEXES

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    Using Lubrizol's proprietary approach, a targeting ligand or therapeutic large molecule is attached to a nanoparticle that is loaded with an API(s).

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    Pharma Service: Drug Product Manufacturing

    Category: Biologic Drugs

    Sub Category: Antibody Drug Conjugate
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    DRUG & DEVICE COMBINATION PRODUCTS

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    We are the world's leading drug/device combination product development CRO. Whether it's a new chemical entity, a line extension or generic, we are equipped to handle the complete design, formulation and production of our client's drug eluting devices.

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    Pharma Service: Drug Product Manufacturing

    Category: Medical Device

    Sub Category: Overview
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    POLYMER PROCESSING

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    Our polymer processing capabilities include hot melt extrusion, co-extrusion, and injection molding. We have also established preferred relationships with the world’s leading polymer suppliers.

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    Pharma Service: Packaging

    Category: Materials

    Sub Category: Polymer
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    BET SURFACE AREA

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    Lubrizol Life Science Health has various Analytics and Characterization Equipments for analytical services.

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    Pharma Service: Analytical

    Category: Analytical Testing Services

    Sub Category: BET Surface Area
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    LYOPHILIZATION

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    We have a 120 ft2 lyophilizer that builds upon our existing R&D and clinical lyophilization capability (2 R&D and 2 small-scale clinical lyophilizers). Our commercial lyophilizer is supported with both Clean-In-Place and Steam-In-Place capabilities.

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    Pharma Service: Drug Product Manufacturing

    Category: Lyophilization

    Sub Category: Overview
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    SOLID SOLUTIONS

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    Used to modify bioavailability, solid solutions are another go-to technology. We offer several systems for preparing solid solutions including Hot Melt Extrusion and spray drying.

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    Pharma Service: API & Drug Product Development

    Category: Preformulation & Material Science

    Sub Category: Solid State Characterization
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    HPLC ANALYSIS

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    Lubrizol Life Science Health runs the full gamut of testing including, among others, ELISA, SDS-PAGE, Western blots, image analysis, HPLC, LC, LC-MS, ligand-receptor binding assays, cellular proliferation, cytotoxicity and cellular activation assays.

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    Pharma Service: Analytical

    Category: Analytical Testing Services

    Sub Category: Chromatography (TLC / LC / HPLC / UPLC / GC)
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    DISSOLUTION TESTING

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    In vitro dissolution testing of oral dosage forms measures the dissolution rate of an amount of drug substance going from the solid state into solution per unit time under standardized conditions.

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    Pharma Service: Analytical

    Category: Analytical Testing Services

    Sub Category: Dissolution
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    FTIR / NIR

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    Lubrizol Life Science Health has various Analytics and Characterization Equipments for analytical services.

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    Pharma Service: Analytical

    Category: Analytical Testing Services

    Sub Category: FTIR / NIR
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    MASS SPECTROMETRY AND LC/MS

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    Our LC/MS/MS bioanalytic services include Bioanalytical method development and validation, Nonclinical and cGLP/cGMP clinical sample analysis, Non-GLP discovery support, TK/PK sample analysis, Dried blood spot analysis, 96-well sample processing and analysis

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    Pharma Service: Analytical

    Category: Analytical Testing Services

    Sub Category: Mass Spectrometry and LC / MS
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    METHOD DEVELOPMENT AND VALIDATION

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    The work in Analytic Services ranges from early method development through and onto validation and clinical and commercial support. With decades of experience, our staff will help you design and successfully execute a phase-appropriate analytical strategy

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    Pharma Service: Analytical

    Category: Analytical Method Development

    Sub Category: Method Development and Validation
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    GEL ELECTROPHORESIS

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    Lubrizol Life Science Health provides bioanalytic serives by using various instrumentation.

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    Pharma Service: Analytical

    Category: Analytical Testing Services

    Sub Category: Native Gel Electrophoresis
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    CUSTOM STABILITY STUDIES

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    Lubrizol Life Science Health pharmaceutical stability programs operate under ICH guidelines, supplemented by custom programs that are designed as needed

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    Pharma Service: Analytical

    Category: Stability Studies

    Sub Category: Overview
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    PHOTOSTABILITY ANALYSIS

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    Our services include Development of stability indicating methods, photostability, accelerated and long-term stability programs.

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    Pharma Service: Analytical

    Category: Stability Studies

    Sub Category: Photostability
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    PHYSICAL CHARACTERIZATION

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    We are the leading particulate and device based drug product physical characterization company. With growing frequency, regulators are requiring tight control over physical parameters such as particle or droplet size, viscoelastic properties

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    Pharma Service: Analytical

    Category: Analytical Testing Services

    Sub Category: Physical Characterization
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    RAMAN MICROSCOPY

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    Category: Analytical Testing Services

    Sub Category: Raman
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    THERMOGRAVIMETRIC ANALYSIS

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    Lubrizol Life Science Health has various Analytics and Characterization Equipments for analytical services.

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    Pharma Service: Analytical

    Category: Analytical Testing Services

    Sub Category: TGA
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    PHARMACOKINETIC SERVICES

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    Frequently, our Clients find their commercial dosage form is not appropriate for non-clinical testing. For developers in need of formulations specifically for toxicology and/or pharmacokinetic studies, we have the solution.

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    Pharma Service: Clinical Trials

    Category: Early Clinical / Phase I-IIa

    Sub Category: Pharmacokinetics / Pharmacodynamics / Pharmacometrics
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    BIOPHARMACEUTICAL ANALYTICAL DEVELOPMENT

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    These analytic methods are used to assay the biological products being formulated and to measure the in vitro potency of the final product formulations. Our services include Biopharmaceutical characterization, sizing and stability.

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    Pharma Service: Analytical

    Category: Biologic Drugs

    Sub Category: Biopharmaceuticals
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    FORMULATION DEVELOPMENT & PROCESS DESIGN

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    Since 1991, we have been designing liquid, suspension, powder, solid solution, semisolid formulations and even drug eluting devices. From drug nanoparticles to multiphasic emulsions to solid lipid nanoparticles we have created & commercialized products.

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    Pharma Service: API & Drug Product Development

    Category: Formulation Development

    Sub Category: Overview
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    LIPID AND CARBOHYDRATE ANALYSIS

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    The LyoCell technology combines a lipid based approach with nanoparticles. Leveraging the power of reverse cubic phase geometry, the hydrophobic and hydrophilic domains in these nanoparticles are never more than a few nanometers apart giving the particles unique solubilization properties.

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    Pharma Service: Analytical

    Category: Structural Characterization

    Sub Category: Lipid Formulation
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    POWDER FORMULATION DEVELOPMENT

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    Lubrizol Life Science Health can develop powder formulations for all routes of administration, including sterile powders for reconstitution and injection, nasal inhalation, and oral.

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    Pharma Service: API & Drug Product Development

    Category: Formulation Development

    Sub Category: Powder
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    STEROID & HORMONE TOPICAL FORMULATIONS

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    Lubrizol has worked on dozens of topical formulations with a wide variety of APIs including Highly potent APIs (hormones, steroids, cytotoxics), small molecules (insoluble compounds, new chemical entities), Large molecules (peptides, nucleotides.

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    Pharma Service: API & Drug Product Development

    Category: Formulation Development

    Sub Category: Steroid / Hormone
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    Lubrizol Life Science Health

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    ORAL DOSE TECHNOLOGIES

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    LLS Health has OSD drug development technologies such as Nano-milling & Hot melt extrusion (HME) offering advantages like bioavailability enhancement of poorly soluble compounds and good compatibility with other sustained & modified release components.

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    Pharma Service: Drug Product Manufacturing

    Category: Technologies

    Sub Category: Oral Dose Technologies
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