Improved process for oral suspension in late stage pharmaceutical development, original process time was 4 days; process was neither scalable nor robust. Resultant process was scalable and robust with a total processing time of 6 hours. Saved the company $ 32MM.
Successfully managed and coordinated a pharmaceutical technology transfer of a biotech drug-device combination product from a site in Europe to a robotic green field facility in Singapore.
Used Process Excellence (six sigma) approach to reduce the variability associated with the elution test for a drug/device combination medical device. Saved the company $7.8 MM
Successfully used Process Excellence approach to data mine and analysis to resolve an outstanding FDA observation without performing further processing and lab work. Saved the company $ 1.4 MM
Have successfully built technical groups that have supported technology transfers, scale-ups and provided technical support (life cycle management and product support) to products ranging from oral to sterile liquids and semisolid products.
The following table is a list of some of the projects that have been successfully completed over these past 22 years. No FD 483 were ever received for the work that was performed by our Principal Consultant who participated in these projects.
|Compound or Product||Combination Product||Dosage Form|
|Iontophoretic Patch (Peptide)||Yes||Transdermal|
|Collagen/Chondroitin||Yes||Artificial Skin (lyophilized)|
|Ceftriaxone||No||Sterile Dry Powder Fill|
|Cefazolin||No||Sterile Dry Powder Fill|
|Cephadrin||No||Sterile Dry Powder Fill|
|Ofloxacin||Yes||Vial & Prefilled Minibag|
|L-Ofloxacin||Yes||Vial & Prefilled Minibag|
|peptide||Yes||Vial / Pump|
|Protein/phospholipids||No||Multi-laminate Liposome in Vial|
|3rd generation cephalosporin||No||Sterile Dry Powder Fill|
|Haloperidone Deconoate||No||Oil Based in Vial|
|Exelon Oral Solution||No||Oral Liquid|
|Bupivacaine CR||Yes||Dry Powder Fill of a sterile microsphere|
|Chirocaine||Yes||Vial and Prefilled Minibag|
|Temodar IV||No||Lyophilized Vial|
|Redipen||Yes||Lyophilized syringe (specialty delivery device)|
|Noxafil (Posaconazole)||No||Oral Suspension|
|Cypher||Yes||Drug Coated Stent|
|Cypher Xtend||Yes||Drug Coated Stent|
|Cypher Select Plus||Yes||Drug Coated Stent|
|Monocryl Plus||Yes||Drug Coated Sutures|