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XECHEM RESEARCH INSTITUTE
Searching Nature's Bounty for New Therapeutics
The Xechem Research Institute is dedicated to finding new drugs from Natural Sources. We screen Natural, Semi-synthetic and Synthetic compounds for therapeutic and biological activity. Natural Products Department
The Natural Products Department has the background, capabilities and state-of-the-art equipment necessary to extract and isolate valuable Natural Products based on bioassay-guided fractionations from a wide variety of Medicinal Plants, Marine And Microbial sources.
Large scale extraction tanks, rotary evaporators (20-L and 50-L) and chromatography equipment are available for extraction and purification of products on almost any scale.
Contract manufacturing and technology transfer services are available.
Technology Development
Xechem has Extensive Technological Experience in: Purification of Natural Products
Process development under current Good Manufacturing Practices (cGMP) and current Good Laboratory Practices (cGLP)
Microbial fermentation
Plant cell culture
Regulatory assistance
Analytical testing
Bioprocessing Department
The Bioprocessing Department has expertise in strain improvement, media development and parameter optimization as well as a pilot plant to address scale-up issues.
The shaker room can handle over 700 shake flask fermentations from 50-mL to 2-L scale to identify initial conditions. Diverse client needs ranging from antibiotic fermentations and rDNA fermentations to primary metabolite and enzyme production can be quickly fulfilled by the availability of over 15 fermentors of various geometrical configurations ranging from 10-L to 70-L.
Process scale equipment is available for recovery and purification. State-of-the-art analytical instrumentation (HPLC, IR, GC, UV-VIS) is also available for in-process and finished product characterization. Culture preservation and maintenance is accomplished by utilization of large scale lyophilizers, ultracold storage freezers (-70?C) and liquid nitrogen facilities, each with its own dedicated resource backup.
U.S. Patent Number
Title of Patent
Date of Issue
#5,654,448 "Isolation and Purification of Paclitaxel from Organic Matter containing Paclitaxel, Cephalomannine and Other Related Taxanes" 1997
#5,840,748 "Dihalocephalomannine and Methods of Use Therefor" 1998
# 5,854,278 "Preparation of Chlorinated Paclitaxel Analogues and Their Use Thereof as Antitumor Agents" 1998
# 5,807,888 "Preparation of Brominated Paclitaxel Analogues and Their Use as Effective Antitumor Agents" 1998
# 5,840,930 "Method for Production of 2",3" Dihalocephalomannine" 1998
Add: Development of Vancomycin
Development of paclitaxel purification process, U. S. Patent #5,654,448 (1997).
Development of second generation paclitaxel analogs
Contract Research
Xechem offers a variety of Contract Research Services including: Fermentation
Custom synthesis and scale-up
Chemical analysis (HPLC, LC-MS, GPC, wet analysis etc)
Biological screening and testing
Formulation
Give the list of SBIR Grants awarded
Preapproval Master Agreements
Paragraph on Hexoid? Plate, EXIST?
Screening for Biological Activities
The Screening Process includes:
Field work with herbologists, Shamens, ethnobotanists, physicians, biologists and chemists
Biological screening and isolation of bioactive compounds and
In vitro microbial, antifungal, anticancer and antiviral and immunomodulators, followed by in vivo testing
The Screening Department has expertise in in vitro biological screening in the areas of bacteriology, mycology, protozoology, immunology, virology, and animal cell culture.
Xechem is well equipped with biological safety cabinets, microscopes, microplate readers, electronic liquid handling systems, water-jacketed CO2 incubators and advanced detection and automated handling systems.
Cell-based and mechanism-based bioassays are developed and quickly implemented into a High-Throughput Screening (HTS) program.
U.S. Patent Number
Title of Patent
Date of Issue
# 5,817,510 "Device and Method for Evaluating Microorganisms" 1998
# Des. 411,308 "Covered, Multi-Well Assay Plate" 1999
Searching Nature's Bounty for New Therapeutics
The Xechem Research Institute is dedicated to finding new drugs from Natural Sources. We screen Natural, Semi-synthetic and Synthetic compounds for therapeutic and biological activity. Natural Products Department
The Natural Products Department has the background, capabilities and state-of-the-art equipment necessary to extract and isolate valuable Natural Products based on bioassay-guided fractionations from a wide variety of Medicinal Plants, Marine And Microbial sources.
Large scale extraction tanks, rotary evaporators (20-L and 50-L) and chromatography equipment are available for extraction and purification of products on almost any scale.
Contract manufacturing and technology transfer services are available.
Technology Development
Xechem has Extensive Technological Experience in: Purification of Natural Products
Process development under current Good Manufacturing Practices (cGMP) and current Good Laboratory Practices (cGLP)
Microbial fermentation
Plant cell culture
Regulatory assistance
Analytical testing
Bioprocessing Department
The Bioprocessing Department has expertise in strain improvement, media development and parameter optimization as well as a pilot plant to address scale-up issues.
The shaker room can handle over 700 shake flask fermentations from 50-mL to 2-L scale to identify initial conditions. Diverse client needs ranging from antibiotic fermentations and rDNA fermentations to primary metabolite and enzyme production can be quickly fulfilled by the availability of over 15 fermentors of various geometrical configurations ranging from 10-L to 70-L.
Process scale equipment is available for recovery and purification. State-of-the-art analytical instrumentation (HPLC, IR, GC, UV-VIS) is also available for in-process and finished product characterization. Culture preservation and maintenance is accomplished by utilization of large scale lyophilizers, ultracold storage freezers (-70?C) and liquid nitrogen facilities, each with its own dedicated resource backup.
U.S. Patent Number
Title of Patent
Date of Issue
#5,654,448 "Isolation and Purification of Paclitaxel from Organic Matter containing Paclitaxel, Cephalomannine and Other Related Taxanes" 1997
#5,840,748 "Dihalocephalomannine and Methods of Use Therefor" 1998
# 5,854,278 "Preparation of Chlorinated Paclitaxel Analogues and Their Use Thereof as Antitumor Agents" 1998
# 5,807,888 "Preparation of Brominated Paclitaxel Analogues and Their Use as Effective Antitumor Agents" 1998
# 5,840,930 "Method for Production of 2",3" Dihalocephalomannine" 1998
Add: Development of Vancomycin
Development of paclitaxel purification process, U. S. Patent #5,654,448 (1997).
Development of second generation paclitaxel analogs
Contract Research
Xechem offers a variety of Contract Research Services including: Fermentation
Custom synthesis and scale-up
Chemical analysis (HPLC, LC-MS, GPC, wet analysis etc)
Biological screening and testing
Formulation
Give the list of SBIR Grants awarded
Preapproval Master Agreements
Paragraph on Hexoid? Plate, EXIST?
Screening for Biological Activities
The Screening Process includes:
Field work with herbologists, Shamens, ethnobotanists, physicians, biologists and chemists
Biological screening and isolation of bioactive compounds and
In vitro microbial, antifungal, anticancer and antiviral and immunomodulators, followed by in vivo testing
The Screening Department has expertise in in vitro biological screening in the areas of bacteriology, mycology, protozoology, immunology, virology, and animal cell culture.
Xechem is well equipped with biological safety cabinets, microscopes, microplate readers, electronic liquid handling systems, water-jacketed CO2 incubators and advanced detection and automated handling systems.
Cell-based and mechanism-based bioassays are developed and quickly implemented into a High-Throughput Screening (HTS) program.
U.S. Patent Number
Title of Patent
Date of Issue
# 5,817,510 "Device and Method for Evaluating Microorganisms" 1998
# Des. 411,308 "Covered, Multi-Well Assay Plate" 1999
XECHEM FINE CHEMICALS DIVISION
Expertise in Bulk Pharmaceutical Production
The Fine Chemicals Division is dedicated to developing and manufacturing bulk quantities of niche rare antibiotics, orphan drugs, and anti-cancer agents from Medicinal Plants, marine sourced and fermentation processes under current Good Manufacturing Practices (cGMP) and current Good Laboratory Practices (cGLP).
Xechem has developed proprietary technology (U.S. Patent #5,654,448) to extract, isolate and purify paclitaxel from the bark and needles of the yew tree (Taxus brevifolia and other related Taxus species). A Drug Master File (DMF) was submitted (1996) to the U.S. Food and Drug Administration (FDA) for the manufacture of bulk paclitaxel for use in injectables.
Xechem is also a consulting resource for development and pilot-plant production of clinically important pharmaceuticals for companies lacking such capabilities. Research Chemicals
Xechem provides many important research chemicals, some of which are listed below. For more information on these or on products not shown, please write to us directly. Vancomycin HCl
Bleomycin A2
Bleomycin B2
N-Acetyl Amphotericin B
Amphotericin B
Daunomycin HCl
Mycosamine
Paclitaxel (PAXETOL?)
Cephalomannine
Baccatin III
10-Deacetyl Baccatin III
Podophyllotoxin
Expertise in Bulk Pharmaceutical Production
The Fine Chemicals Division is dedicated to developing and manufacturing bulk quantities of niche rare antibiotics, orphan drugs, and anti-cancer agents from Medicinal Plants, marine sourced and fermentation processes under current Good Manufacturing Practices (cGMP) and current Good Laboratory Practices (cGLP).
Xechem has developed proprietary technology (U.S. Patent #5,654,448) to extract, isolate and purify paclitaxel from the bark and needles of the yew tree (Taxus brevifolia and other related Taxus species). A Drug Master File (DMF) was submitted (1996) to the U.S. Food and Drug Administration (FDA) for the manufacture of bulk paclitaxel for use in injectables.
Xechem is also a consulting resource for development and pilot-plant production of clinically important pharmaceuticals for companies lacking such capabilities. Research Chemicals
Xechem provides many important research chemicals, some of which are listed below. For more information on these or on products not shown, please write to us directly. Vancomycin HCl
Bleomycin A2
Bleomycin B2
N-Acetyl Amphotericin B
Amphotericin B
Daunomycin HCl
Mycosamine
Paclitaxel (PAXETOL?)
Cephalomannine
Baccatin III
10-Deacetyl Baccatin III
Podophyllotoxin
XECHEM THERAPEUTICS DIVISION
Proprietary Drugs
Our expertise in drug development started with our first project: the successful launch of vancomycin in a remarkably short time - within 3 and 1/2 years, from culture in the test tube through final active drug substance to the finished dosage form marketed with FDA approval. This occurred when Xechem was affiliated with the LyphoMed Pharmaceutical Company.
An emphasis is now on our PAXETOL? brand of paclitaxel for treating refractory ovarian and breast cancer.
Generic Drugs
The generic drugs produced include: Vancomycin
Paclitaxel (PAXETOL?)
Bleomycin
PAXETOL? Brand of Paclitaxel
Currently, our PAXETOL? brand of paclitaxel for injection is being prepared for marketing, via strategic manufacturing, distribution, sales and alliances in Domestic and International markets
On June 3, 1996, Xechem announced the findings of a comparison study between TAXOL? (a registered trademark of Bristol-Myers Squibb) and PAXETOL? for antitumor activity in vitro and in vivo.
Proprietary Drugs
Our expertise in drug development started with our first project: the successful launch of vancomycin in a remarkably short time - within 3 and 1/2 years, from culture in the test tube through final active drug substance to the finished dosage form marketed with FDA approval. This occurred when Xechem was affiliated with the LyphoMed Pharmaceutical Company.
An emphasis is now on our PAXETOL? brand of paclitaxel for treating refractory ovarian and breast cancer.
Generic Drugs
The generic drugs produced include: Vancomycin
Paclitaxel (PAXETOL?)
Bleomycin
PAXETOL? Brand of Paclitaxel
Currently, our PAXETOL? brand of paclitaxel for injection is being prepared for marketing, via strategic manufacturing, distribution, sales and alliances in Domestic and International markets
On June 3, 1996, Xechem announced the findings of a comparison study between TAXOL? (a registered trademark of Bristol-Myers Squibb) and PAXETOL? for antitumor activity in vitro and in vivo.
