Animal-free Solutions for Endotoxin and Pyrogen Testing

Product Description

Fujifilm Wako offers following sustainable, animal-free and ELISA-free reagents for endotoxin and pyrogen testing:

1.    PYROSTAR™ Neo+: Instead of using traditional LAL reagents, Fujifilm Wako also offers a new alternative of endotoxin detection reagents developed by recombinant technology. It mimics the traditional LAL reagents cascade of three recombinant factors (Factor C, Factor B, and proclotting enzyme).  The usage of a pNA chromogenic group for detection combined with the recombinant technology provides.

2. LumiMAT™ Pyrogen Detection Kit: Fujifilm Wako provides monocyte activation test (MAT) kit for pyrogen testing as an alternative of Rabbit Pyrogen test. Our LumiMAT™ Kit is used to detect the presence of pyrogenic substances in pharmaceuticals and medical devices without the need for animal testing.

FUJIFILM Wako Chemicals Europe GmbH

  • DE
  • 2022
    On CPHI since
  • 4
    Certificates
  • 1000 - 4999
    Employees
Company types
Distributor/Import Export
Manufacturer/Innovator
Wholesale/Retail
Primary activities
End-product distributor (Wholesale)
Excipients Manufacturer
Fine Chemicals Company
Specifications
  • Details
    1. PYROSTAR™ Neo+
    Key Features:
    a. Colorimetric method, can be used with an absorbance plate reader
    b. Endotoxin-specific reagent eliminates the risk of false positives from (1-->3)ß-D-Glucan
    c. Quantitative range: 0.001 to 50 EU/mLd. High sensitivity with less lot-to-lot variation

    2. LumiMAT™ Pyrogen Detection Kit
    Key Features:

    a. Assay with reporter NOMO-1 cells
    b. Rapid testing (5 hours), ELISA free method
    c. Only add luminescent substrate to the plate after incubation
    d. High reproducibility with less lot-to-lot variation
    e. Stable supply from master cell ban
  • Selling Points
    Product Features; Product Performance; Sustainability
  • Model
    Recombinant Endotoxin Detection Reagent, ELISA and Animal-free Pyrogen Test
  • Supplied from
    Japan
  • Measured In
    piece

FUJIFILM Wako Chemicals Europe GmbH

  • DE
  • 2022
    On CPHI since
  • 4
    Certificates
  • 1000 - 4999
    Employees
Company types
Distributor/Import Export
Manufacturer/Innovator
Wholesale/Retail
Primary activities
End-product distributor (Wholesale)
Excipients Manufacturer
Fine Chemicals Company

More Products from FUJIFILM Wako Chemicals Europe GmbH (6)

  • Sodium Dextran Sulfate 5000

    Product Sodium Dextran Sulfate 5000

    Sodium Dextran Sulfate 5000 suitable for pharmaceutical field with high quality.
  • Sucrose (Low endotoxin 0.2EU/g)

    Product Sucrose (Low endotoxin 0.2EU/g)

    This is high quality Sucrose with low endotoxin (0.2EU/g) originally from Hokkaido Japan. The specification criteria meets Japanese Pharmacopeia that can safely use in Pharma industry.
  • Bioprocessing solution

    Product Bioprocessing solution

    In the biopharmaceutical production realm, a range of solvents are utilized for manufacturing processes and Cleaning in Place (CIP). Over the past few years, single-use bags have gained popularity in the research, development, and production of biopharmaceuticals, particularly antibody drugs. In response t...
  • GMP Pharmaceutical Material

    Product GMP Pharmaceutical Material

    CertiPro are product series of pharmaceutical raw materials manufactured according to GMP guidelines; meeting high quality standards and specifications for increase productivity, process recovery and patient safety.
    FUJIFILM Wako Pure Chemical provides pharmaceutical raw materials that ...
  • Small molecules for Cell Therapy

    Product Small molecules for Cell Therapy

    Y-27632 is a selective and potent inhibitor of ROCK (Rho-associated coiled-coil forming kinase/Rho binding kinase) and it plays various roles including contraction of vascular smooth muscle cells via ROCK signaling pathways. Furthermore, it suppresses the cell death of human embryonic stem cells (hESCs) an...
  • Media for Vaccine Production

    Product Media for Vaccine Production

    WakoVAC is FUJIFILM Wako Pure Chemical's Serum Free Cell Culture Media Series ​for Vaccine Production​.The lineup includes for MDCK cells, Vero cells and Insect cells.A series of media with very high performance in cell growth. We are especially aiming to support vaccine manufacturing with our quality prod...

FUJIFILM Wako Chemicals Europe GmbH resources (2)

  • News Analytical Standards of Nitrosamines for Pharmaceutical, Food, and Water Environment Analysis

    Nitrosamines are compounds of the chemical structure where hydrogen of the amine nitrogen is substituted with a nitroso group. And these are known to be carcinogenic. 
  • Brochure LAL, SLP Reagents and related products for Endotoxin and Pyrogen Testing

    FUJIFILM Wako provides a line of reagents formulated to perform each of the three endotoxin detection assays: the gel clot assay, the kinetic turbidimetric assay (KTA) and the kinetic chromogenic assay (KCA).
    We have an analysis system that is user friendly and capable of performing all methodologies for LAL testing. Endotoxin-Specific LAL Reagents.Our premiere collection of endotoxin-free accessories includes pipette tips, test tubes, caps and LAL reagent water designed for worry-free endotoxin testing. Our Endotoxin Test-Related Products are additional specialty kits that assist with the successful completion of the bacterial endotoxin test.
    The SLP-HS Single Reagent Set II is able to detect both peptidoglycan (PG) and (1->3)-β-D-glucan (BDG). The product uses a self-defense mechanism of silkworm Bombyx mori which leads to a color change by building a black melanin pigment in the presence of microbial contamination.

Frequently Viewed Together

  • Product Analytical Services

    Actylis performs routine and non-routine analytical testing for various industries, in support of manufacturing processes, QA/QC functions, R&D projects, and environmental applications. Leveraging state-of-the-art instrumentation, extensive knowledge base, as well as internal, cross-functional competen...
  • Product PURA Series Microcrystalline Cellulose (MCC)

    Enhance product performance with sustainable, pure and high quality PURA Series MCC:
    • Nitrite below detection limit • Highest purity • Nitrite below detection level • Negligible black spots • Different particle sizes • Different bulk densities • Ultimate flowability • Spherical par...
  • Product Sucrose(injection)

    Sucrose is a sweetener, we can provide you pharma grade and injection grade.CAS NO.57-50-1
  • Product BioHale® Trehalose Dihydrate

    BioHale® Trehalose Dihydrate is a non-reducing disaccharide consisting of two glucose molecules which are linked by an α, α-1,1 bond. It is used in the pharmaceutical industry as a stabilizer of biologics.

    Trehalose Dihydrate has proven to be highly effective in protecting cell membranes...
  • Product Simaline™ Wo

    SIMALINE™ WO is an excellent water-in-oil emulsifier and effectively stabilizes all types of oils at low concentrations with textures ranging from lotions to thick creams.
    • SIMALINE™ WO is compatible with a wide range of oils • It can be used to formulate water-rich W/O emulsions, with ...
  • Product Propylene Glycol Ph.Eur./USP(JP) (parenteral grade)

    Aug. Hedinger GmbH & Co. KG offers a wide range of products which includes Propylene glycol.
    Manufactured by Dow Deutschland in Stade. Manufacturing complies with requirements of IPEC-PQG GMP.
    A GMP audit will perfomred by Hedinger every three years. A report is available for customer after sign...
  • Product BARETab®Lub - Self Lubricating Excipient

    BARETab® Lub is a combination of Binder and Lubricant, made by using Co-processed technology for Oral Solid dosage forms i.e. direct compressible tablet, Hard Capsule filling and powder mixed formulation. It promotes high speed tableting operations and enhance flowability of the material. It can be used in...
  • Product Calcium Phosphate Excipients

    Innophos manufactures an extensive portfolio of calcium phosphate excipients and co-processed excipients.  Our products are supported by technical experts to assist our customers solve their pharmaceutical, dietary supplement and food product formulation challenges.  Our co-processed A-Tab® M...
  • Product Embo caps®

    Suheung capsules offers a wide range of products which includes embo caps. It belongs to empty hard capsules category.
    By embossing four dimples on the main locking groove of the cap, the exclusive EMBO CAPS® is designed to offer distinct advantages.
    To eliminate premature semi-locking and final...
  • Product Calcium Carbonate IP BP USP EP JP Oyster Coral

    We are considered in the market to be one of the leading manufacturers and suppliers of this commendable Calcium Carbonate IP BP USP EP JP and OYSTER. Processing of this product is done in accordance with the set norms and guidelines of the chemical industry, utilizing the finest ingredients and ...
  • Product Povidone

    The product has high solubility and can be used as a pore forming agent, suspension aid, dispersant, and film forming agent.
  • Product QACS Pharmaceutical services

    QACS Lab is GMP/GLP certified and provides contract laboratory testing for Pharmaceuticals. Methodologies stay in accordance with EMA & FDA. QACS is equipped with Microbiological - Chemical - Molecular - Packaging laboratory premises to provide variety of Pharmaceutical testing solutions &...
  • Product Expansorb

    Poly(lactic acid co-glycolic acid) and poly(caprolactone) copolymers used as functional excipients for controlled and slow drug release (weeks to months) with a single injection.
  • Product DTPA (Pentatic Acid)

    ROUTE OF ADMINISTRATION: Injectable

    REGULATORY STATUS: GMP, TECK PACK

  • Product Scientific Support

    Selectchemie AG provides a wide range of services including scientific support. Our experienced professionals are at your service at locations in 18 countries to deliver tailor-made solutions according to your needs. Contact us for more information.
  • Product Silicified Microcrystalline Cellulose

    High Quality Silicified Microcrystalline Cellulose
  • Product CLEANROOM PRODUCTS

    sterile and non sterile
  • Product InhaLac 500 - micronized Lactose for DPI

    InhaLac® 500 is MEGGLE’s first micronized grade and is specifically designed for inhalation. This inhalation grade lactose exhibits extremely small particles. In combination with the high quality and safety it will meet your individual dry powder inhalation formulation requirements.
    ...
  • Product STANPURE - ZINC OXIDE

    STANPURE - ZINC OXIDE

    ·         DMF Available

    ·         FDA License available in BP /USP/ NF

    ·         EXCiPACT, GMP Certi...
  • Product Contaminants

    Neotron Pharma, thanks to its many years of experience in the Food department, is able to quantify the presence of contaminants such as Pesticides, Aflatoxins, Mycotoxins under GMP regime. This type of analysis can be fundamental for all those suppliers of raw materials and Erbal intended for the supplemen...
  • Product Impurities and contaminants analysis

    Impurities and contaminants analysis in biotechnology products from SGS – a range of services providing impurities and contaminants characterization in biotechnology derived products and microbial contamination control.To help you meet ICH Q6B guidelines, you need accurate impurities and contaminants analy...
  • Product Sodium Hyaluronate - Injection grade

    Hyature® is a pharmaceutical grade sodium hyaluronate which can be used as an API or excipient for drugs and medical devices in ophthalmic preparations, intra-articular injections, anti-adhesive preparations, topical preparations for wound healing and soft tissue filler, etc. Hyature® sodium hyalur...
  • Product Potassium Hydroxide Pellets (Eka Pellets™)

    Your benefits
    - Expertise in alkali production since 1904
    - produced in Sweden in accordance to IPEC-GMP
    - fine and laboratory chemicals (synthesis and analysis)                  &...
  • Product UTPVision BlynX

    UTPVision BlynX is a custom-configurable vision inspection system that can be used inline for real-time production quality monitoring or offline for statistical process control.
    Discover more: https://www.utpvision.com/en/news/blynx
  • Product Trace Metals Testing and Elemental Analysis

    Our experienced analysts apply a strategic approach to sample preparation for difficult samples and a range of analytical technology, relevant to your needs, including inductively coupled plasma – mass spectrometry (ICP-MS) or inductively coupled plasma – optical emission spectroscopy (ICP-OES) or ion chro...
  • Product Lactalpha 50

    Lactalpha 50 is a 50 Mesh pharmaceutical grade sieved lactose conforming with the lactose monohydrate monograph of the current Pharmacopoeias (Ph. Eur., USP-NF and JP). The flowability of Lactalpha 50 makes it efficient as a diluent in capsule or sachet formulation.

    Manufactured in Retiers,...
  • Product Residual Solvents and OVI Testing

    We provide expert determination and identification of residual solvents in pharmaceutical articles, helping customers ensure that residual solvents have been reduced to acceptable levels in drug products, drug substances and excipients. Often it is prudent to ensure residual solvents are controlled for all...
  • Product Excipients for Gel Capsules

    Enhance your oral formulations with high quality ingredients. Contact us to learn about the excipients in development.
  • Product MICCEL 102

    Ankit Pulps & Boards Pvt Ltd offers a wide range of products which includes MICCEL 102.Feature: Direct Compressible and large particle size.LOD %: NMT 6.0/7.0;BD g/ml: 0.28 to 0.37;+60 #, %: NMT 8;+200 #, %: NMT 45;Contact us for more information at sales@celluloseankit.com
  • Product Compressible Sugar


    Customized compressible sweetener

    Compressible Sugar is made by boiling granulation  process with the good tableting performance. It meets the current standards of compressible sugar in every pharmacopoeia and CP. Less moisture absorbing and hardening during long-term...
  • Product Sunvidone ® CL/Crospovidone Type A and Type B

    CRACTERISTICSSUNVIDONE CL series are supplied as fine white or almost white powders. They have a slight characteristic odour and are practically tasteless. They are insoluble in all the usual solvents.
    APPLIICATIONS
    SUNVIDONE CL series possess a number of useful properties for pharmaceutical products...
  • Product Primary Pharmaceutical Reference Standards and Reference Material Manage...

    Discover our extensive range of high-quality pharmaceutical reference standards:
    - Over 6,000 APIs, excipients and impurities for qualitative and quantitative applications
    - Many APIs & excipients ISO 17034 accredited
    - 95% ready to ship
    - Comprehensive CoA...
  • Product Glycofurol

    Status: Commercial Production plant: Ceriano (Italy)
  • Product ERYLITE® Erythritol

    ERYLITE® Erythritol • Sweetener • Bitterness masking agent • Bulking agent or carrier • Tablet disintegrant • Tablet or capsule diluent
    Jungbunzlauer’s products support the development of drugs and supplements in the pharamceutical industry and play an important role in the composition of a var...
  • Product galenIQ™ 800/801

    BENEO-Palatinit GmbH provides the pharmaceutical excipients galenIQ™ 800 and 801for granulation and agglomeration processes. Contact us for more information.
  • Product Sodium Stearyl Fumarate

    Appearance:
    White to off-white powder or granule.
    Almost insoluble in water, slightly soluble in methanol, insoluble in acetone and anhydrous ethanol.
    Application: 
    As lubricants for tablets and capsules with a concentration of 0.5 ~ 2.0% (w/w).
    It can form a ...
  • Product SANAL® P+ Pharmaceutical Sodium Chloride (API)

    SANAL® P+ Sodium Chloride Pharmaceutical Quality is for specific market requirements (eg. the Chinese and Russian markets) as active ingredient in both parenteral and peritoneal solutions and a base material for hemodialysis and hemofiltration solutions as well as other pharmaceutical applic...
  • Product Pharmaceutical Grade Polyethylene Glycol 4000

    Polyethylene glycol is widely used in various preparations, such as injection, local preparation, eye preparation, oral and rectal preparations.
    At the solid level, Polyethylene glycol can be added to the liquid polyethylene glycol to adjust the viscosity for local ointments.
    Polyethylene glycol ...
  • Product Batch release and import from no-EU countries

    We possess a manufacturing authorization for batch release

    We provide the following services:

    1. Batch release by a Qualified Person.
    2. Adoption of responsibility as external Qualified Person.
    We serve our partners with:

    • Method transfer ...
  • Product LECIVA-SNF

    Pulmonary surfactant rich lecithin 
  • Product Povidone(PVP K30)

    Povidone(PVP K30) 

  • Product PALMSTAR AL PHARMA-MB

    PALMSTAR AL PHARMA-MB is one of our Aluminium Stearates with the best gelling performance capabilities. It is very suitable as an emulsion stabilizer and viscosity increasing agent for creams and ointments. Additionally, pharmaceutical applications use it as an anti-caking agent or suspending agent. PALMST...
  • Product L-Asparagine 1-hydrate (Ph. Eur.) pure, pharma grade code A1668

    https://www.itwreagents.com/iberia/en/product/l-asparagine-1-hydrate-ph-eur-pure-pharma-grade/A1668
  • Product Factory Direct Pharmaceutical Intermediates 2-Hydroxypropyl-Beta-Cyclode...

    Product Name: 2-Hydroxypropyl-β-cyclodextrin
    CAS No: 128446-35-5

    Appearance:white powder
    Assay: 99.0%
    Package: 10kgs/drum
    Storage: room temperature,in sealed tight container
    usage:increasing water solubility,get rid of terrible smell
    Usage:
    2-Hydroxypropyl-β-cy...
  • Product Quality Services

    At Tjoapack, we use our expertise and experience to ensure the highest level of quality across all of our operations. Our in-house qualified persons (QPs) test and check the entire production process before releasing a finished product to the market for sale. Fully approved by the EMA and the FDA, among o...
  • Product DELASOL®

    DELASOL® is a gelatin product for the one-step production of truly enteric capsules that open in the intestine (instead of the stomach, as with traditional gelatine capsules).
    Most enteric delivery systems are produced by applying an acid-insoluble coating to freshly produced soft cap...
  • Product Pemulen™ polymeric emulsifiers

    These pharmaceutical excipients provide effective emulsification properties to form stable oil-in-water emulsions. Pemulen™ polymeric excipients contain both hydrophilic and hydrophobic portions and serve as excellent gel forming polymers, creating a network around suspended oil droplets and prov...
  • Product MANNITAB™ F2

    Mannitol fine Powder
    Filler
    USP/NF, Ph. Eur. , BP, IP
    Particle size: 50