Process research overview

Ad

Ad

Ad

Ad

Ad

Ad

Ad

Ad

Ad

Ad

Ad

Ad

DR ANTHONY M CRASTO (Ph.D) PRINCIPAL SCIENTIST PROCESS RESEARCH DEC 2011 “ A SHORT PRESENTATION”

<ul><li>What is Process Research ? </li></ul><ul><li>Its 12 Principles </li></ul><ul><li>Definition </li></ul><ul><li>Obje...

Net Cost: $802 Million Invested Over 15 Years 5,000–10,000 Screened 250 Enter Preclinical Testing 5 Enter Clinical Testi...

<ul><li>Objective : </li></ul><ul><li>To design elegant, practical, efficient, environmentally benign and economically vi...

<ul><li>Plant :- It is a place were the 5 M’s like money, material, man, method and machine are brought together for the ...

<ul><li>To carry out research and development activity in the field of Organic Chemistry, to make profit for the organizat...

<ul><li>To try the process on a model of proposed plant before committing large sum of money on a production unit. </li></...

<ul><li>Scientists with experience in lab, 20 litre scale, pilot plant operations as well as in actual production area are...

<ul><li>“ The ideal chemical process is that which a one-armed operator can perform by pouring the reactants into a bath t...

<ul><li>An amalgam of: </li></ul><ul><li>Modern synthetic organic methodology </li></ul><ul><li>Physicochemical properties...

<ul><li>Chemical Engineering principles: mixing, heat transfer, vessel configuration </li></ul><ul><li>Practical Process A...

<ul><li>Equipment qualification </li></ul><ul><li>Process validation </li></ul><ul><li>Regularly schedule preventative mai...

<ul><li>Adequate provision for training of personnel </li></ul><ul><li>A well-defined technology transfer system </li></u...

Med Chem Clinical Chem E R&D Pharm R&D Safety Analytical Process

responsible for developing In-process assay and critical evaluation of drug substance and intermediates Med Chem Clinical...

responsible for toxicity studies: (carcinogen, teratogen, gene toxicity ) Med Chem Clinical Chem E R&D Pharm R&D Safety...

responsible for formulating drug substance (API) into drug product Med Chem Clinical Chem E R&D Pharm R&D Safety Analyti...

Oversee process transfer into Pilot plants Med Chem Clinical Chem E R&D Pharm R&D Safety Analytical Process

Conducts clinical trials (Ph I-III) and evaluates data Med Chem Clinical Chem E R&D Pharm R&D Safety Analytical Process

Discovers new chemical entities (NCE’s) and prepares intitial quantities Med Chem Clinical Chem E R&D Pharm R&D Safety...

<ul><li>Patent : drafting, inventorship, litigation </li></ul><ul><li>Outsourcing : work with vendors on tech transfer;...

<ul><li>Prevention : It is better to prevent waste than to treat/clean up after its created. </li></ul><ul><li>2. Atom Ec...

<ul><li>5 Design Safer Products: </li></ul><ul><li>Products should be designed to effect their desired function while min...

<ul><li>7. Design for Energy Efficiency: </li></ul><ul><li>Energy requirements for a process should be recognized for env...

<ul><li>9. Minimize Derivatization : </li></ul><ul><li>Avoid the use of protecting groups when possible as it add steps, ...

<ul><li>11. Design for Degradation: </li></ul><ul><li>Ideally, process products and by-products should breakdown into inn...

<ul><li>Process Economics - Minimize inventory cost of API via: </li></ul><ul><li>Low cost RM </li></ul><ul><li>Productiv...

<ul><li>Remoxipride-----schizophrenia </li></ul><ul><li>2-Synthesis of Pyrazine Carboxamide a CHIRAL PIPERAZINE –Ingredie...

Selective Dopamine-2 Antagonist Indication: Anti-psychotic (Depression/Schizophrenia) Clinical Trials: halted in 1993 due ...

Auerbach, Weissman Tet Letters 1993, 931

Drawbacks: 1. Use of costly Oxalyl Chloride 2. CO and CO 2 by-products 3. Lengthy time cycle due to exothermic amination ...

A: 179/[124+127+73+73] = 45 % B: 179/[105 + 98 +74 +18] = 61%

<ul><li>Increased Regulatory controls (FDA, EPA) </li></ul><ul><li>Downward Pricing Pressure </li></ul><ul><li>Greater Com...

<ul><li>Process Development as a Competitive Weapon/Leveraging Capabilities </li></ul><ul><li>“ The power of process devel...

<ul><li>“ A firm that can develop sophisticated process technologies more rapidly and with fewer development resources has...

<ul><li>Practical Process Research & Development; Neal Anderson </li></ul><ul><li>The Merck Druggernaut: The Inside Sto...

<ul><li>THANKS </li></ul>

Share Slideshare

LinkedIn
Facebook
Twitter

Embed

Size (px)

Show related Slideshows at end

WordPress Shortcode

Link

Share
Email

Powerpoint presentation parvez1 by Anthony Melvin Cr... 508 views
Anthony crasto glenmark scientist, ... by Anthony Melvin Cr... 1330 views
IDC Launch in India by IntelliAssist 1985 views
Drug discovery and development by rahul_pharma 7464 views
IPR NDA and ANDA by mahender Kotte 3233 views
What is IP, Patents in Pharma Industry by Anthony Melvin Cr... 8994 views

View on Slideshare

1 of 42 Ad

View on Slideshare

1 of 42 Ad