Below is a great response I received from dreamer0 as to questions concerning Evonik/Core:
Petemantx: please see my complete responses in bold/red. In addition, please refer to what georgejjl had pointed out as well. Thank You -G!!!
Want to make sure I am getting this correct as my following questions shows how confused I am at the current time:
Evonik only makes the Brilacidin active ingredient at the API level and it is in its commercial grade form per your post
Is the commercial form a liquid? Sorry. I cannot confirm this if it’s in liquid or solid state. It will be laid out in the Inter Company Quality Agreement (icQAG) .
Will this product be used in ALL indications for Brilacidin and thus be used by the DP mfr for each indication such as for making the pills needed for IBD indications, topical creams for dermatologic applications, changing the active ingredient into a polymer for industrial applications, etc? Very likely- as stated in the article …it’s a Scale Up process for the entire B franchise. API or DS (inter changeable). In some cases API undergoes additional steps such as (un-milled and milled) based on route of administration (oral- unmilled or IV- milled). Now going back to DP mfg (CoreRx), their specialty is to formulate and Package in Sachet Form for B-OM only IMO. For other dosage forms, if CoreRx has the capability then they might go with them or else you need to find a diff DP manufacturer. Need to find out what’s in the icQAG.
Is it usually typical for DP mfrs to use the API product rather than trying to make the API product themselves should a drug look like it is going to be a large volume drug? now a days in commercial world the combinations are so many………here few examples:
Company-A = NDA holder / Patent holder
I) Option 1: All under one roof: where company-A will produ5ce API/DP/Packaging under one roof.
Ii) Option 2: where company-A will produce API/DP and outsource Packaging to a CMO.
Iii) Option 3: where company-A will produce API and outsource DP activity at CMO-1 and then Packaging activity at CMO-2
Iv) Option 4: CMO2 (CoreRx)will purchase API from CMO1(Evonik) and perform DP/PKG activities
I don’t think CoreRx has the specialty/capability to synthesize B. Hence we need Evonik.
I take it then this product would be shipped to the various DP mfrs in containers that could be of any size (litre, gallon, drum, larger?)limited by the handling/life cycle requirements of the API product. -
yes and no. If CoreRx has the specialty/ capability to produce ALL dosage forms, then it’s one stop shop. IF NOT, then you’re correct…the API needs to be shipped to various DP manufacturing sites.
What ingredients would/could go into Brilacidin other than the active ingredient? I have been thinking that Brilacidin was strictly the small molecule synthetic product with no other ingredients involved.
Good question. What I see from the CoreRx responsibilities …… they formulate granules and package in sachet form correct? Are they receiving this API in liquid or crystalline form? IDK. In order to makes granules with a specific granule size you need to have other excipients [inert material(s)- binding agents etc] or could be wrong…… there are some latest tech gadgets out there that can achieve the desired state.
Core will produce the sachets for B-OM at the Drug Product level.
Does this mean they have to process the API active ingredient to change it into a powder form and would any additional ingredients have to be added other than the active ingredient made by Evonik?
If it gets changed from powder to granules then YES. Possibility for an excipient or excipients will be involved to achieve granule state.
Would Core be purchasing all the active ingredient from Evonik or could they make that themselves?
Evonik is the sole API scaleup producer. Yes. CoreRx will have to buy from Evonik.
I hope it’s not confusing… any additional questions please feel free to ask!
iHub NewsWire
Petemantx: please see my complete responses in bold/red. In addition, please refer to what georgejjl had pointed out as well. Thank You -G!!!
Want to make sure I am getting this correct as my following questions shows how confused I am at the current time:
Evonik only makes the Brilacidin active ingredient at the API level and it is in its commercial grade form per your post
Is the commercial form a liquid? Sorry. I cannot confirm this if it’s in liquid or solid state. It will be laid out in the Inter Company Quality Agreement (icQAG) .
Will this product be used in ALL indications for Brilacidin and thus be used by the DP mfr for each indication such as for making the pills needed for IBD indications, topical creams for dermatologic applications, changing the active ingredient into a polymer for industrial applications, etc? Very likely- as stated in the article …it’s a Scale Up process for the entire B franchise. API or DS (inter changeable). In some cases API undergoes additional steps such as (un-milled and milled) based on route of administration (oral- unmilled or IV- milled). Now going back to DP mfg (CoreRx), their specialty is to formulate and Package in Sachet Form for B-OM only IMO. For other dosage forms, if CoreRx has the capability then they might go with them or else you need to find a diff DP manufacturer. Need to find out what’s in the icQAG.
Is it usually typical for DP mfrs to use the API product rather than trying to make the API product themselves should a drug look like it is going to be a large volume drug? now a days in commercial world the combinations are so many………here few examples:
Company-A = NDA holder / Patent holder
I) Option 1: All under one roof: where company-A will produ5ce API/DP/Packaging under one roof.
Ii) Option 2: where company-A will produce API/DP and outsource Packaging to a CMO.
Iii) Option 3: where company-A will produce API and outsource DP activity at CMO-1 and then Packaging activity at CMO-2
Iv) Option 4: CMO2 (CoreRx)will purchase API from CMO1(Evonik) and perform DP/PKG activities
I don’t think CoreRx has the specialty/capability to synthesize B. Hence we need Evonik.
I take it then this product would be shipped to the various DP mfrs in containers that could be of any size (litre, gallon, drum, larger?)limited by the handling/life cycle requirements of the API product. -
yes and no. If CoreRx has the specialty/ capability to produce ALL dosage forms, then it’s one stop shop. IF NOT, then you’re correct…the API needs to be shipped to various DP manufacturing sites.
What ingredients would/could go into Brilacidin other than the active ingredient? I have been thinking that Brilacidin was strictly the small molecule synthetic product with no other ingredients involved.
Good question. What I see from the CoreRx responsibilities …… they formulate granules and package in sachet form correct? Are they receiving this API in liquid or crystalline form? IDK. In order to makes granules with a specific granule size you need to have other excipients [inert material(s)- binding agents etc] or could be wrong…… there are some latest tech gadgets out there that can achieve the desired state.
Core will produce the sachets for B-OM at the Drug Product level.
Does this mean they have to process the API active ingredient to change it into a powder form and would any additional ingredients have to be added other than the active ingredient made by Evonik?
If it gets changed from powder to granules then YES. Possibility for an excipient or excipients will be involved to achieve granule state.
Would Core be purchasing all the active ingredient from Evonik or could they make that themselves?
Evonik is the sole API scaleup producer. Yes. CoreRx will have to buy from Evonik.
I hope it’s not confusing… any additional questions please feel free to ask!
iHub NewsWire
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