DR ANTHONY MELVIN CRASTO Ph.D ( ICT, Mumbai), INDIA, worlddrugtracker, 25Yrs Exp. in the feld of Organic Chemistry,Working for GLENMARK GENERICS at Navi Mumbai, INDIA. Serving chemists around the world. Helping them with websites on Chemistry.Million hits on google, world acclamation from industry, academia, drug authorities for websites, blogs and educational contribution, सुकून उतना ही देना प्रभू, जितने से जिंदगी चल जाये।औकात बस इतनी देना,कि औरों का भला हो जाये।...........P.S. : The views expressed are my personal and in no-way suggest the views of the professional body or the company that I represent.
DR ANTHONY MELVIN CRASTO
DR ANTHONY MELVIN CRASTO
Ph.D,Org Chem,ICT, Mumbai,India, [email protected],+91 9323115463, 25+ years in industry( API), mostly multinationals, process development in companies like Hoechst Marion Roussel(Sanofi aventis), Searle, RPG, Innovassynth, Glenmark, with exposure to basic research at SEARLE under Dr Nagarajan (Director Ciba), Tech transfer in plant eg deltamethrin 3 tonnes in RPG, bulk drug gmp (7 months) in Hoechst Marion Roussel(SANOFI AVENTIS), Custom syn in Innovasynth(SANDOZ, Basel, BASF Germany), exposure to natural pdts, drugs int, vet drugs, and some exposure in agro.speciality chemicals, flavours and fragrances, nutraceuticals and mettalocenes. ability to deliver products in the production plant(atleast 35 in career).
highlights
1. Felt proud to spend millenium night (2000) in RPG Panoli, ankleshwar plant
2. Added personally a 25 kg sodium cyanide charge in a reactor at 2 in night, carried it to the reactor, tied a handkerchief on my nose and charged, at panoli, RPG.life sciences in 90'decade, not to be attempted again
3. Did not run away and controlled an exotherm in panoli plant batch of RPG life sciences, due to accidental addn of acid.Cl into NaCN rxn . The temp went upto 59 deg cent and came down......imagine what would have happened if the reactor exploded
4. Similar. case when a thin film high vacuum distilation exploded in a pilot plant in Nasik for RPG/lifesciences/CBZ chem. UK, still was able to despatch 100 kg material, Award recieved was a london trip
5. High vac. distilled 25 kg of drug int in the night using 3 pumps for a pilot plant trial intermediate, SANDOZ Basel, award bottle of wine from switzerland
6. Personally worked after lab work in evenings with Dr Ralph Stapel , director.Hoechst pilot plant at Mulund Mumbai, in 80'
7. Assisted Dr Yatendra khandelwal, Head Asia pacific, QA for TGA audit at Aventis plant ankleshwar
8 Slept for 3 hrs in morning in first aid room in Panoli during Deltamethrin process demo at panoli Gujarat, then afternoon 2 hrs at guest house during 6 months campaign
9 Reached Innovasynth lab in khopoli at 9 morning from mumbai,100 km, using trucks, ricks after july monsoon deluge in Mumbai 2005.........LOCALS coudnt reach in time
10 Got an opportunity to write a DMF in 90', hoechst, Got a chance to work in tablets,large vol parenterals, inj, vaccines in Hoechst mulund plant
Specialties
To carry out research and devpt, motivate, guide & lead a team of scientists,conduct lit.search,identify and execute new/novel routes for the synth,scale up from grams to kg levels in lab,conduct pilot trials/assist in prodn.upto ton levels. Carry out impurity profiles and assist in dossier writing. To keep in mind IPR issues and draft patents, file DMFS in US/EU, file patents and contribute to intellectual property,Ability to develop novel routes for API,s, well versed with polymorphism issues
Currently working with GLENMARK GENERICS LTD research centre as Principal Scientist, process research (bulk actives) at Mahape ,Navi Mumbai,and leading a team of scientists in developing APIs for regulated markets, this involves visualization and execution of novel routes, polymorphs, and developing intellectual property to protect the invention. This involves all aspects of synthesis in lab and commercialization on plant , support for DMF filing.
Currently, involved in development of several targets for regulated markets. Provide support to US/European marketing team for developing and execution of new projects
Process Development :-
• Providing guidance and support for process development for challenging of patents in regulated market.
• Design patent non-infringing scalable synthetic routes/process and scale-up of API’s
• Bench and Pilot scale synthesis transformations in hands on
• Optimization of the process, ie,developing industrially feasible process.
• Preparation of PDR, filing of patent and DMF
• Lead a group of Scientists and Group Leaders(for docs).
Skill sets:- Technical skills:
Synthesis:
• Development of novel synthetic routes/process for pharmaceuticals and successful implementation of the technology in pilot plant
• Conducted various reactions at laboratory and production scales.
• Synthesized various classes of compounds.
• Experienced to work under cGMP condition
Documentation:
• Literature survey: well conversant with the use of Sci Finder and Internet search techniques.
• Operating Instruction: Preparation of scale up report (process, yield, costing, quality, specification etc.).
• Setting of specifications: Supported analytical section for method development and establishment of specification for Raw Material, Intermediate and finished products.
Soft skills:-
• Creativity in problem solving, Highly motivated and Self-starting individual, Excellent communication skill,Team leader with good listening
RESEARCH ACTIVITIES COVERED IN THE ENTIRE CAREER
1) Extensive range of chemistry and scale of manufacture from laboratory, scale up laboratory, pilot plant, plant scale including third party activity.
Applied intellectual and synthetic skills to the process development of pharmaceutical drugs/their intermediates, and natural products, neutraceuticals, mettalocenes, speciality chemicals, flavours and fragrances in the laboratory and monitor them during plant trials.
Act as a technology transfer man and provide all data required for transfer from lab to commercialization.
Use of Internet and manual literature search methods to decide on non infringing route
Write DHR for API before implementation of novel route in the plant and assist for all batches for the DMF purposes, very well versed with IPR issues
Ability to develop novel routes for API,s and draft patents,well versed with polymorphism issues.several patents filed in US/EU
total exp25+ in industry, Currently working as principal scientist and leading a team of scientists in developing APIs for regulated markets, this involves novel routes, polymorphs, and developi
ng intellectual property to protect the invention. This involves all aspects of synthesis and commercialization and assist in providing support for DMF filing.
Currently involved in development of several targets for regulated markets. The job involves visualization of novel routes and its execution , simultaneously develop intellectual property and generate data in the process,. Provide support to US/European marketing team for developing and execution of new projects
INNOVASSYNTH
led a team of 30 chemists for the custom synthesis business in the area of drugs, organic intermediates, speciality chemicals, flavours and fragrances, nutraceuticals and mettalocenes. (25 projects) This included rapid development, scale up and commercialization as per the needs of the foreign clients with a time frame.customers were Sandoz Basel, BASF Germany,
RPG LIFE SCIENCES
1 Donepezil : Manufactured 4 kilos on pilot plant scale as R & D demonstration, the process was developed from scratch. Plans are to make 25 kilos with 300% profit margins
2) Pantoprazole : Process is being modified continuously to cope-up with price crash
3) PZL Chloride an intermediate of Pantoprazole : Multi step process is being continuously modified / developed to meet cost demands
4) Manufactured 3 tonnes deltamethrin on plant scale as R & D demonstration at an commercially viable cost, the process was developed from scratch ie lit,lab work, scale-up, pilot trials and also included third party work for one bromination step,which needed 8 reactors. Later on annually about 25 tonnes were manufactured. later on the company was taken over by a multinational for deltamethrin. the price in market crashed to half.
5) Acetamiprid : Developed a process from scratch. Process was handed over to isagro for commercialization in 2001 during hiving of the company from RPG
6) M-alcohol an intermediate of Tetra conazole : During isagro transition period in 2001, the process from Italy was adapted to Indian plant conditions, scaled up with some modification and handed over for commercialization. This is being produced on a regular basis.
7) Pyrazosulfuron ethyl : Developed a process from scratch. Process was handed over to isagro for commercialization in 2001 during hiving of the company from RPG
MANY PROJECTS ON CUSTOM SYNTHESIS FOR CBZ, PFIZER, AVENTIS, ETC WERE DONE DURING THIS TENURE IN RPG LIFE SCIENCES
Ph.D,Org Chem,ICT, Mumbai,India, [email protected],+91 9323115463, 25+ years in industry( API), mostly multinationals, process development in companies like Hoechst Marion Roussel(Sanofi aventis), Searle, RPG, Innovassynth, Glenmark, with exposure to basic research at SEARLE under Dr Nagarajan (Director Ciba), Tech transfer in plant eg deltamethrin 3 tonnes in RPG, bulk drug gmp (7 months) in Hoechst Marion Roussel(SANOFI AVENTIS), Custom syn in Innovasynth(SANDOZ, Basel, BASF Germany), exposure to natural pdts, drugs int, vet drugs, and some exposure in agro.speciality chemicals, flavours and fragrances, nutraceuticals and mettalocenes. ability to deliver products in the production plant(atleast 35 in career).
highlights
1. Felt proud to spend millenium night (2000) in RPG Panoli, ankleshwar plant
2. Added personally a 25 kg sodium cyanide charge in a reactor at 2 in night, carried it to the reactor, tied a handkerchief on my nose and charged, at panoli, RPG.life sciences in 90'decade, not to be attempted again
3. Did not run away and controlled an exotherm in panoli plant batch of RPG life sciences, due to accidental addn of acid.Cl into NaCN rxn . The temp went upto 59 deg cent and came down......imagine what would have happened if the reactor exploded
4. Similar. case when a thin film high vacuum distilation exploded in a pilot plant in Nasik for RPG/lifesciences/CBZ chem. UK, still was able to despatch 100 kg material, Award recieved was a london trip
5. High vac. distilled 25 kg of drug int in the night using 3 pumps for a pilot plant trial intermediate, SANDOZ Basel, award bottle of wine from switzerland
6. Personally worked after lab work in evenings with Dr Ralph Stapel , director.Hoechst pilot plant at Mulund Mumbai, in 80'
7. Assisted Dr Yatendra khandelwal, Head Asia pacific, QA for TGA audit at Aventis plant ankleshwar
8 Slept for 3 hrs in morning in first aid room in Panoli during Deltamethrin process demo at panoli Gujarat, then afternoon 2 hrs at guest house during 6 months campaign
9 Reached Innovasynth lab in khopoli at 9 morning from mumbai,100 km, using trucks, ricks after july monsoon deluge in Mumbai 2005.........LOCALS coudnt reach in time
10 Got an opportunity to write a DMF in 90', hoechst, Got a chance to work in tablets,large vol parenterals, inj, vaccines in Hoechst mulund plant
Specialties
To carry out research and devpt, motivate, guide & lead a team of scientists,conduct lit.search,identify and execute new/novel routes for the synth,scale up from grams to kg levels in lab,conduct pilot trials/assist in prodn.upto ton levels. Carry out impurity profiles and assist in dossier writing. To keep in mind IPR issues and draft patents, file DMFS in US/EU, file patents and contribute to intellectual property,Ability to develop novel routes for API,s, well versed with polymorphism issues
Currently working with GLENMARK GENERICS LTD research centre as Principal Scientist, process research (bulk actives) at Mahape ,Navi Mumbai,and leading a team of scientists in developing APIs for regulated markets, this involves visualization and execution of novel routes, polymorphs, and developing intellectual property to protect the invention. This involves all aspects of synthesis in lab and commercialization on plant , support for DMF filing.
Currently, involved in development of several targets for regulated markets. Provide support to US/European marketing team for developing and execution of new projects
Process Development :-
• Providing guidance and support for process development for challenging of patents in regulated market.
• Design patent non-infringing scalable synthetic routes/process and scale-up of API’s
• Bench and Pilot scale synthesis transformations in hands on
• Optimization of the process, ie,developing industrially feasible process.
• Preparation of PDR, filing of patent and DMF
• Lead a group of Scientists and Group Leaders(for docs).
Skill sets:- Technical skills:
Synthesis:
• Development of novel synthetic routes/process for pharmaceuticals and successful implementation of the technology in pilot plant
• Conducted various reactions at laboratory and production scales.
• Synthesized various classes of compounds.
• Experienced to work under cGMP condition
Documentation:
• Literature survey: well conversant with the use of Sci Finder and Internet search techniques.
• Operating Instruction: Preparation of scale up report (process, yield, costing, quality, specification etc.).
• Setting of specifications: Supported analytical section for method development and establishment of specification for Raw Material, Intermediate and finished products.
Soft skills:-
• Creativity in problem solving, Highly motivated and Self-starting individual, Excellent communication skill,Team leader with good listening
RESEARCH ACTIVITIES COVERED IN THE ENTIRE CAREER
1) Extensive range of chemistry and scale of manufacture from laboratory, scale up laboratory, pilot plant, plant scale including third party activity.
Applied intellectual and synthetic skills to the process development of pharmaceutical drugs/their intermediates, and natural products, neutraceuticals, mettalocenes, speciality chemicals, flavours and fragrances in the laboratory and monitor them during plant trials.
Act as a technology transfer man and provide all data required for transfer from lab to commercialization.
Use of Internet and manual literature search methods to decide on non infringing route
Write DHR for API before implementation of novel route in the plant and assist for all batches for the DMF purposes, very well versed with IPR issues
Ability to develop novel routes for API,s and draft patents,well versed with polymorphism issues.several patents filed in US/EU
total exp25+ in industry, Currently working as principal scientist and leading a team of scientists in developing APIs for regulated markets, this involves novel routes, polymorphs, and developi
ng intellectual property to protect the invention. This involves all aspects of synthesis and commercialization and assist in providing support for DMF filing.
Currently involved in development of several targets for regulated markets. The job involves visualization of novel routes and its execution , simultaneously develop intellectual property and generate data in the process,. Provide support to US/European marketing team for developing and execution of new projects
INNOVASSYNTH
led a team of 30 chemists for the custom synthesis business in the area of drugs, organic intermediates, speciality chemicals, flavours and fragrances, nutraceuticals and mettalocenes. (25 projects) This included rapid development, scale up and commercialization as per the needs of the foreign clients with a time frame.customers were Sandoz Basel, BASF Germany,
RPG LIFE SCIENCES
1 Donepezil : Manufactured 4 kilos on pilot plant scale as R & D demonstration, the process was developed from scratch. Plans are to make 25 kilos with 300% profit margins
2) Pantoprazole : Process is being modified continuously to cope-up with price crash
3) PZL Chloride an intermediate of Pantoprazole : Multi step process is being continuously modified / developed to meet cost demands
4) Manufactured 3 tonnes deltamethrin on plant scale as R & D demonstration at an commercially viable cost, the process was developed from scratch ie lit,lab work, scale-up, pilot trials and also included third party work for one bromination step,which needed 8 reactors. Later on annually about 25 tonnes were manufactured. later on the company was taken over by a multinational for deltamethrin. the price in market crashed to half.
5) Acetamiprid : Developed a process from scratch. Process was handed over to isagro for commercialization in 2001 during hiving of the company from RPG
6) M-alcohol an intermediate of Tetra conazole : During isagro transition period in 2001, the process from Italy was adapted to Indian plant conditions, scaled up with some modification and handed over for commercialization. This is being produced on a regular basis.
7) Pyrazosulfuron ethyl : Developed a process from scratch. Process was handed over to isagro for commercialization in 2001 during hiving of the company from RPG
MANY PROJECTS ON CUSTOM SYNTHESIS FOR CBZ, PFIZER, AVENTIS, ETC WERE DONE DURING THIS TENURE IN RPG LIFE SCIENCES
HOECHST MARION ROUSSEL TEAM, MULUND, MUMBAI, INDIA
