IDIX » Topics » Manufacturing

These excerpts taken from the IDIX 10-K filed Mar 4, 2009.
Manufacturing
 
We have developed the capacity to synthesize compounds in quantities ranging from milligrams, and in the case of telbivudine, to metric tons. Our medicinal chemists focus on small-scale synthesis that leads to the discovery of new compounds and the analysis of structure-activity relationships for each identified compound series. In addition, these scientists aim to design efficient synthetic routes suitable for process chemistry scale up to the level of one-kilogram batches of the lead molecule. This material supports key preclinical studies, including proof-of-principle studies in animal models, early pharmacokinetic assays, initial toxicology studies and formulation development. The process chemistry facility we maintain in Cambridge, Massachusetts allows us to accelerate these key studies. This facility also allows us to provide non-current good manufacturing practices materials in quantities up to one kilogram to support early toxicological studies and the initial development of formulations. Clinical materials are then manufactured using current good manufacturing practices, or cGMP, by third-parties.
 
To reduce costs and preserve manufacturing proprietary rights, we provide these manufacturers with only the required portion of the synthetic method and a sufficient quantity of the starting or intermediate material to prepare the quantity and quality of material necessary for the conduct of our clinical trials and related nonclinical toxicology studies. We currently rely upon a number of third-party manufacturers for the supply of our drug candidates in bulk quantities.
 
We have selected manufacturers that we believe comply with cGMP and other regulatory standards. We have established a quality control and quality assurance program, including a set of standard operating procedures, analytical methods and specifications, designed to ensure that our drug candidates are manufactured in accordance with cGMP and other domestic and foreign regulations.
 
Manufacturing
 
We have developed the capacity to synthesize compounds in quantities ranging from milligrams, and in the case of telbivudine, to metric tons. Our medicinal chemists focus on small-scale synthesis that leads to the discovery of new compounds and the analysis of structure-activity relationships for each identified compound series. In addition, these scientists aim to design efficient synthetic routes suitable for process chemistry scale up to the level of one-kilogram batches of the lead molecule. This material supports key preclinical studies, including proof-of-principle studies in animal models, early pharmacokinetic assays, initial toxicology studies and formulation development. The process chemistry facility we maintain in Cambridge, Massachusetts allows us to accelerate these key studies. This facility also allows us to provide non-current good manufacturing practices materials in quantities up to one kilogram to support early toxicological studies and the initial development of formulations. Clinical materials are then manufactured using current good manufacturing practices, or cGMP, by third-parties.
 
To reduce costs and preserve manufacturing proprietary rights, we provide these manufacturers with only the required portion of the synthetic method and a sufficient quantity of the starting or intermediate material to prepare the quantity and quality of material necessary for the conduct of our clinical trials and related nonclinical toxicology studies. We currently rely upon a number of third-party manufacturers for the supply of our drug candidates in bulk quantities.
 
We have selected manufacturers that we believe comply with cGMP and other regulatory standards. We have established a quality control and quality assurance program, including a set of standard operating procedures, analytical methods and specifications, designed to ensure that our drug candidates are manufactured in accordance with cGMP and other domestic and foreign regulations.
 
Manufacturing
 
We have developed the capacity to synthesize compounds in quantities ranging from milligrams, and in the case of telbivudine, to metric tons. Our medicinal chemists focus on small-scale synthesis that leads to the discovery of new compounds and the analysis of structure-activity relationships for each identified compound series. In addition, these scientists aim to design efficient synthetic routes suitable for process chemistry scale up to the level of one-kilogram batches of the lead molecule. This material supports key preclinical studies, including proof-of-principle studies in animal models, early pharmacokinetic assays, initial toxicology studies and formulation development. The process chemistry facility we maintain in Cambridge, Massachusetts allows us to accelerate these key studies. This facility also allows us to provide non-current good manufacturing practices materials in quantities up to one kilogram to support early toxicological studies and the initial development of formulations. Clinical materials are then manufactured using current good manufacturing practices, or cGMP, by third-parties.
 
To reduce costs and preserve manufacturing proprietary rights, we provide these manufacturers with only the required portion of the synthetic method and a sufficient quantity of the starting or intermediate material to prepare the quantity and quality of material necessary for the conduct of our clinical trials and related nonclinical toxicology studies. We currently rely upon a number of third-party manufacturers for the supply of our drug candidates in bulk quantities.
 
We have selected manufacturers that we believe comply with cGMP and other regulatory standards. We have established a quality control and quality assurance program, including a set of standard operating procedures, analytical methods and specifications, designed to ensure that our drug candidates are manufactured in accordance with cGMP and other domestic and foreign regulations.
 
Manufacturing


 



We have developed the capacity to synthesize compounds in
quantities ranging from milligrams, and in the case of
telbivudine, to metric tons. Our medicinal chemists focus on
small-scale synthesis that leads to the discovery of new
compounds and the analysis of structure-activity relationships
for each identified compound series. In addition, these
scientists aim to design efficient synthetic routes suitable for
process chemistry scale up to the level of one-kilogram batches
of the lead molecule. This material supports key preclinical
studies, including proof-of-principle studies in animal models,
early pharmacokinetic assays, initial toxicology studies and
formulation development. The process chemistry facility we
maintain in Cambridge, Massachusetts allows us to accelerate
these key studies. This facility also allows us to provide
non-current good manufacturing practices materials in quantities
up to one kilogram to support early toxicological studies and
the initial development of formulations. Clinical materials are
then manufactured using current good manufacturing practices, or
cGMP, by third-parties.


 



To reduce costs and preserve manufacturing proprietary rights,
we provide these manufacturers with only the required portion of
the synthetic method and a sufficient quantity of the starting
or intermediate material to prepare the quantity and quality of
material necessary for the conduct of our clinical trials and
related nonclinical toxicology studies. We currently rely upon a
number of third-party manufacturers for the supply of our drug
candidates in bulk quantities.


 



We have selected manufacturers that we believe comply with cGMP
and other regulatory standards. We have established a quality
control and quality assurance program, including a set of
standard operating procedures, analytical methods and
specifications, designed to ensure that our drug candidates are
manufactured in accordance with cGMP and other domestic and
foreign regulations.


 




Manufacturing


 



We have developed the capacity to synthesize compounds in
quantities ranging from milligrams, and in the case of
telbivudine, to metric tons. Our medicinal chemists focus on
small-scale synthesis that leads to the discovery of new
compounds and the analysis of structure-activity relationships
for each identified compound series. In addition, these
scientists aim to design efficient synthetic routes suitable for
process chemistry scale up to the level of one-kilogram batches
of the lead molecule. This material supports key preclinical
studies, including proof-of-principle studies in animal models,
early pharmacokinetic assays, initial toxicology studies and
formulation development. The process chemistry facility we
maintain in Cambridge, Massachusetts allows us to accelerate
these key studies. This facility also allows us to provide
non-current good manufacturing practices materials in quantities
up to one kilogram to support early toxicological studies and
the initial development of formulations. Clinical materials are
then manufactured using current good manufacturing practices, or
cGMP, by third-parties.


 



To reduce costs and preserve manufacturing proprietary rights,
we provide these manufacturers with only the required portion of
the synthetic method and a sufficient quantity of the starting
or intermediate material to prepare the quantity and quality of
material necessary for the conduct of our clinical trials and
related nonclinical toxicology studies. We currently rely upon a
number of third-party manufacturers for the supply of our drug
candidates in bulk quantities.


 



We have selected manufacturers that we believe comply with cGMP
and other regulatory standards. We have established a quality
control and quality assurance program, including a set of
standard operating procedures, analytical methods and
specifications, designed to ensure that our drug candidates are
manufactured in accordance with cGMP and other domestic and
foreign regulations.


 




Manufacturing


 



We have developed the capacity to synthesize compounds in
quantities ranging from milligrams, and in the case of
telbivudine, to metric tons. Our medicinal chemists focus on
small-scale synthesis that leads to the discovery of new
compounds and the analysis of structure-activity relationships
for each identified compound series. In addition, these
scientists aim to design efficient synthetic routes suitable for
process chemistry scale up to the level of one-kilogram batches
of the lead molecule. This material supports key preclinical
studies, including proof-of-principle studies in animal models,
early pharmacokinetic assays, initial toxicology studies and
formulation development. The process chemistry facility we
maintain in Cambridge, Massachusetts allows us to accelerate
these key studies. This facility also allows us to provide
non-current good manufacturing practices materials in quantities
up to one kilogram to support early toxicological studies and
the initial development of formulations. Clinical materials are
then manufactured using current good manufacturing practices, or
cGMP, by third-parties.


 



To reduce costs and preserve manufacturing proprietary rights,
we provide these manufacturers with only the required portion of
the synthetic method and a sufficient quantity of the starting
or intermediate material to prepare the quantity and quality of
material necessary for the conduct of our clinical trials and
related nonclinical toxicology studies. We currently rely upon a
number of third-party manufacturers for the supply of our drug
candidates in bulk quantities.


 



We have selected manufacturers that we believe comply with cGMP
and other regulatory standards. We have established a quality
control and quality assurance program, including a set of
standard operating procedures, analytical methods and
specifications, designed to ensure that our drug candidates are
manufactured in accordance with cGMP and other domestic and
foreign regulations.


 




These excerpts taken from the IDIX 10-K filed Mar 14, 2008.
Manufacturing
 
We have developed the capacity to synthesize compounds in quantities ranging from milligrams to metric tons. Our medicinal chemists focus on small-scale synthesis that leads to the discovery of new compounds and the analysis of structure-activity relationships for each identified compound series. In addition, these scientists aim to design efficient synthetic routes suitable for process chemistry scale up to the level of one-kilogram batches of the lead molecule. This material supports key preclinical studies, including proof-of-principle studies in animal models, early pharmacokinetic assays, initial toxicology studies and formulation development. The process chemistry facility we maintain in Cambridge, Massachusetts allows us to accelerate these key studies. This facility also allows us to provide non-current good manufacturing practices, or cGMP, materials in quantities up to one kilogram to support early toxicological studies and the initial development of formulations. These formulations could then be manufactured using cGMP material. We also contract with third parties, including Novartis, for the synthesis of material used in our toxicology studies and for formulation development.
 
We contract with third parties, including Novartis, for the synthesis of cGMP material used in our clinical trials. To reduce costs and preserve manufacturing proprietary rights, we provide these manufacturers with only the required portion of the synthetic method and a sufficient quantity of the starting or intermediate material to prepare the quantity and quality of material necessary for the conduct of our clinical trials and related nonclinical toxicology studies. We currently rely upon a number of third-party manufacturers for the supply of our product candidates in bulk quantities.
 
We have selected manufacturers that we believe comply with cGMP and other regulatory standards. We have established a quality control and quality assurance program, including a set of standard operating procedures, analytical methods and specifications, designed to ensure that our product candidates are manufactured in accordance with cGMP and other domestic and foreign regulations.
 
The process used for the manufacture of Tyzeka®/Sebivo® was robust and had been repeated by different manufacturers on a multiple kilogram scale. We are currently pursuing the same result with respect to the other product candidates we currently have in clinical development.
 
We rely upon Novartis as well as other third-party manufacturers for the dosage form of our product and product candidates. We do not expect to internally manufacture material for our clinical trials or undertake the commercial-scale manufacture of our drug products.
 
Manufacturing


 



We have developed the capacity to synthesize compounds in
quantities ranging from milligrams to metric tons. Our medicinal
chemists focus on small-scale synthesis that leads to the
discovery of new compounds and the analysis of
structure-activity relationships for each identified compound
series. In addition, these scientists aim to design efficient
synthetic routes suitable for process chemistry scale up to the
level of one-kilogram batches of the lead molecule. This
material supports key preclinical studies, including
proof-of-principle studies in animal models, early
pharmacokinetic assays, initial toxicology studies and
formulation development. The process chemistry facility we
maintain in Cambridge, Massachusetts allows us to accelerate
these key studies. This facility also allows us to provide
non-current good manufacturing practices, or cGMP, materials in
quantities up to one kilogram to support early toxicological
studies and the initial development of formulations. These
formulations could then be manufactured using cGMP material. We
also contract with third parties, including Novartis, for the
synthesis of material used in our toxicology studies and for
formulation development.


 



We contract with third parties, including Novartis, for the
synthesis of cGMP material used in our clinical trials. To
reduce costs and preserve manufacturing proprietary rights, we
provide these manufacturers with only the required portion of
the synthetic method and a sufficient quantity of the starting
or intermediate material to prepare the quantity and quality of
material necessary for the conduct of our clinical trials and
related nonclinical toxicology studies. We currently rely upon a
number of third-party manufacturers for the supply of our
product candidates in bulk quantities.


 



We have selected manufacturers that we believe comply with cGMP
and other regulatory standards. We have established a quality
control and quality assurance program, including a set of
standard operating procedures, analytical methods and
specifications, designed to ensure that our product candidates
are manufactured in accordance with cGMP and other domestic and
foreign regulations.


 



The process used for the manufacture of
Tyzeka®/Sebivo®
was robust and had been repeated by different manufacturers on a
multiple kilogram scale. We are currently pursuing the same
result with respect to the other product candidates we currently
have in clinical development.


 



We rely upon Novartis as well as other third-party manufacturers
for the dosage form of our product and product candidates. We do
not expect to internally manufacture material for our clinical
trials or undertake the commercial-scale manufacture of our drug
products.


 




This excerpt taken from the IDIX 10-K filed Mar 14, 2007.
Manufacturing
 
We have developed the capacity to synthesize compounds in quantities ranging from milligrams to metric tons. Our medicinal chemists focus on small-scale synthesis that leads to the discovery of new compounds and the analysis of structure-activity relationships for each identified compound series. In addition, these scientists aim to design efficient synthetic routes suitable for process chemistry scale up to the level of one-kilogram batches of the lead molecule. This material supports key preclinical studies, including proof-of-principle studies in animal models, early pharmacokinetic assays, initial toxicology studies and formulation development. The process chemistry facility we maintain in Cambridge, Massachusetts allows us to accelerate these key studies. This facility also allows us to provide non-good manufacturing practices materials in quantities up to one kilogram to support early toxicological studies and the initial development of formulations. These formulations could then be manufactured using current good manufacturing practices, or cGMP, material. We also contract with third parties, including Novartis, for the synthesis of material used in our toxicology studies and for formulation development.
 
We contract with third parties, including Novartis, for the synthesis of cGMP material used in our clinical trials. To reduce costs and preserve manufacturing proprietary rights, we provide these manufacturers with only the required portion of the synthetic method and a sufficient quantity of the starting or intermediate material to prepare the quantity and quality of material necessary for the conduct of our clinical trials and related nonclinical toxicology


13


Table of Contents

studies. We currently rely upon a number of third-party manufacturers for the supply of our product candidates in bulk quantities.
 
We have selected manufacturers that we believe comply with cGMP and other regulatory standards. We have established a quality control and quality assurance program, including a set of standard operating procedures, analytical methods and specifications, designed to ensure that our product candidates are manufactured in accordance with cGMP and other domestic and foreign regulations.
 
All of the materials that we require for manufacture of Tyzeka®/Sebivo® are currently available from more than one qualified source. The process used for the manufacture of Tyzeka®/Sebivo® is robust and has been repeated by different manufacturers on a multiple kilogram scale. We are currently pursuing the same result with respect to the other product candidates we currently have in clinical development.
 
We rely upon Novartis as well as other third-party manufacturers for the dosage form of our product and product candidates. We do not expect to internally manufacture material for our clinical trials or undertake the commercial-scale manufacture of our drug products. Accordingly, we are using Novartis as our current manufacturer for the supply of Tyzeka® in the United States and we are in discussions with Novartis about finalizing the manufacturing rights for the long-term supply of Sebivo® in the rest of the world.
 
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