Highly potent APIs: can lean manufacturing ever be safe?
By Fiona Barry +, 09-Oct-2014
The phrase “lean manufacturing” conjures up job cuts and not much more for many people, but managers can use the method to drastically simplify HPAPI (highly potent active pharmaceutical ingredients) production, says an expert.
Green chemistry makes ‘cents’ for cost-focused API firms says expert
By Gareth MacDonald+, 07-Oct-2014
Making drugs generates a huge amount of waste but industry is showing signs of cleaning up its act according to Paul Anastas, the Yale scientist who coined the phrase “green chemistry.”
Global Biotech Marketer, Serial Entrepreneur, Academician, Chair of Bioinfomedical Ltd.
| CURRENT |
|---|
Started and built entrepreneurial venture that began as a consulting firm and grew into a successful business engaged in the global transfer of medical/gerontological technologies and software, marketing of research cytokines, and strategic alliances with bio-similar producers. Fostered relationships in Hawaii, Central/Southeast Asia, Oceania, Central Europe, Middle East, and East Africa, to accelerate growth of the business and further its objectives. Created differentiation strategies designed to cope with competitive marketing pressures primarily in long-term healthcare, specialty medical institutions and pharmaceutical distributors in the U.S. and Southeast Asia.
ABOUT HIM BY HIM
Over the course of my 20+ year career as an interdisciplinary and multicultural university educator, social scientist, marketer, entrepreneur and administrator, I have directed organizations, programs and initiatives that promote academic excellence, improve student performance, and strengthen educational outcomes. I have taught at Professor levels in the disciplines of healthcare administration, healthcare management information systems, sociology, global marketing and more. I have a track record in leading and participating in accreditation requirements, and in driving the design and development of curriculum and course offerings, at both graduate and undergraduate levels. My international experience encompasses five continents and I have an in-depth understanding of geopolitical contexts of business and effects on global and local economy and education.
Complementing my teaching and administrative background is executive and research experience in healthcare, geriatrics, entrepreneurship, and marketing, including the conceptualization, startup, and growth of a successful firm engaged in the global transfer of medical/gerontological technologies and software, marketing of research cytokines, and strategic alliances. InfoMedical Biotechnology (www.bioinfomedical.com) satisfies customers’ demand for high quality cytokine products. The use of medical diagnostics is growing in importance, as bigger proportion of the world’s population age and the cost of healthcare continues to rise. The company provides scientists with tools to investigate the genetic and molecular basis for human development and disease; knowledge that is applied in development, discovery and manufacture of new drugs.
Specialties: Education Program Development; Teaching; Student Recruitment-Retention; Distance Learning Modalities; Research & funding; Community Health; Sustainable Entrepreneurship; Strategic Planning; Sociology; Disruptive Innovation; and Global Business Strategies.
Senior project presentations at University of Hawaii Entrepreneurship Baccalaureate
Live Life Aloha Obesity Reduction
More about him
– Present (10 months)Honolulu, HawaiiDr. Rafi conducts the weekly broadcast of Boritzer’s Bio Briefings. The hourly show focuses on the Biotechnological, Health and Medical sectors that are changing the way we live, eat, work, and socialize in the 21st Century. www.thinktechhawaii.com (live streaming on Mondays @ 15:00 Hawaiian Standard Time). Available after 24 hours (http://tinyurl.com/lnulduz).
From New York to Singapore, “Hospitals I’ve Learned to Love” with Dr. Rafi Boritzer
Dr. Rafi Reveals IUI, IVF & Transactions at the Sperm Bank
Live, Life with Aloha – Obesity Reduction MadeEasy- Dr. Rafi Boritzer
The Health Care Highway -From Kolkata to Kapolei with Dr. Rafael Boritzer
Tele Medicine Systems – Dr. Rafi Boritzer with Dr. Dan Davis
In Telomere Research, SIZE is Everything-Dr. Rafi and Prof. Richard Allsopp
If You Are A Baby Boomer, The Future is Now
Dr. Rafi chats with Prof. Tom Huang, Lab Director @ Pacific InVitro Fertilization
Dr. Rafi and Prof. Clair Wright discuss “Pregnancy Dangers and Outcomes”
Islands of Health- Dr Rafi on Fiji, Timor-Leste, Singapore, Madagascar, and Sicily
Dr. Rafi Chases Ambulances from Honolulu to Tahrir Square
Who is following you when you check into a long term care facility – Boritzer’s Bio Briefings
Cuban Healthcare: Can you achieve more with less?
As as an academic and consultant, I am available for year round consulting projects and visiting professor assignments. Contact: boritzer@bioinfomedical.com , LinkedIn messages, Facebook messages.
This was my tribute to a great living legend
READ AT http://newdrugapprovals.org/2014/10/02/lanoconazole/
Nihon Nohyaku (Originator), Tsumura (Licensee)
| Synonym: | 2-[4-(2-Chlorophenyl)-1,3-dithiolan-2-ylidene]-2-imidazol-1-yl-acetonitrile |
| Application: | An antifungal compound |
| CAS Number: | 101530-10-3 |
| Molecular Weight: | 319.83 |
| Molecular Formula: | C14H10ClN3S2 |
| Appearance: | Crystalline |
| Physical State: | Solid |
| Solubility: | Soluble in chloroform, and methanol. Insoluble in water. |
| Storage: | Store at -20° C |
| Melting Point: | 129-132 °C |
| Boiling Point: | ~477.6 °C at 760 mmHg (Predicted) |
| Density: | ~1.4 g/cm3 (Predicted) |
| Refractive Index: | n20D 1.73 (Predicted) |
| pK Values: | pKb: 3.76 (Predicted) |
| WGK Germany: | 3 |
| RTECS: | NI3393500 |
| PubChem CID: | 3002820 |
| Merck Index: | 14: 5357 |
| MDL Number: | MFCD00865590 |
| Beilstein Registry: | 4819111 |
| Salt | ATC | Formula | MM | CAS |
|---|---|---|---|---|
| – | D01 | C 14 H 10 ClN 3 S 2 | 319.84 g / mol | 101530-10-3 |
| Synthesis a) |
|---|
  |
| Country | Trade name | Manufacturer |
|---|---|---|
| Japan | Astatine | Tsumura |
| Ukraine | No | No |
1. Oka, H., et al., 1992. Therapeutic efficacy of latoconazole in formulations of clinical use on experimental dermatophytosis in guinea pigs. Arzneimittel-Forschung. 42(3): 345-9. PMID: 1497697
2. Niwano, Y., et al., 1994. Therapeutic efficacy of lanoconazole, a new imidazole antimycotic agent, for experimental cutaneous candidiasis in guinea pigs. Antimicrobial agents and chemotherapy. 38(9): 2204-6. PMID: 7811048
3 http://aac.asm.org/content/38/9/2204.full.pdf
References 1. Seo, A., Kanno, H., Hasegawa, N. et al. (Nihon Nohyaku Co., Ltd.). Antimycotic agent and fungicidal agent. US 4738976. 2. Seo, A ., Sugano, H., Hasegawa, C., Ikeda, K., Munechica, Y., Konoe, T., Konaka, M. (Nihon Nohyaku Co., Ltd.). Antifungal agent. JP 87093227. 3. Seo , A., Sugano, H., Hasegawa, C., Ikeda, K., Nishimura, A., Miyashiro, Y. (Nihon Nohyaku Co., Ltd.). Non-medicinal bactericidal agents and method for their preparation. JP 87093204. 4. Seo, A., Sugano, H., Hasegawa, C., Miyashiro, Y., Nishimura, A., Ikeda, K. (Nihon Nohyaku Co., Ltd.). Ketene S, S-acetals. JP 85218387. 5. Seo, A., Kanno, H., Hasegawa, N. et al. (Nihon Nohyaku Co., Ltd.). A novel ketene S, S-acetal deriv., a process for manufacturing thereof and a method for curing mycosis by administering it. EP 218736.
MAKE IN INDIA
http://makeinindia.com/sector/pharmaceuticals/
Read all about Organic Spectroscopy on ORGANIC SPECTROSCOPY INTERNATIONAL 
WEBSITE http://www.scientificupdate.co.uk/
TRAINING COURSE 2-3 DEC 2014
Process Development for Low Cost Manufacturing
When:02.12.2014 – 03.12.2014
Tutors:
Where: National Chemical Laboratory – Pune, India
Brochure:View Brochure
Register http://scientificupdate.co.uk/training/scheduled-training-courses.html
Chemical process research and development is recognised as a key function during the commercialisation of a new product particularly in the generic and contract manufacturing arms of the chemical, agrochemical and pharmaceutical industries.
The synthesis and individual processes must be economic, safe and must generate product that meets the necessary quality requirements.
This 2-day course presented by highly experienced process chemists will concentrate on the development and optimisation of efficient processes to target molecules with an emphasis on raw material cost, solvent choice, yield improvement, process efficiency and work up, and waste minimisation.
Process robustness testing and reaction optimisation via stastical methods will also be covered.
A discussion of patent issues and areas where engineering and technology can help reduce operating costs.
The use of engineering and technology solutions to reduce costs will be discussed and throughout the course the emphasis will be on minimising costs and maximising returns.
Conference 4-5 DEC 2014
TITLE . Organic Process Research & Development – India
Subtitle:The 32nd International Conference and Exhibition
When:04.12.2014 – 05.12.2014
Where:National Chemical Laboratory – Pune, India
Brochure:View Brochure
Register..http://scientificupdate.co.uk/conferences/conferences-and-workshops.html
for
Benefits
The efficient conversion of a chemical process into a process for manufacture on tonnage scale has always been of importance in the chemical and pharmaceutical industries. However, in the current economic and regulatory climate, it has become increasingly vital and challenging to do so efficiently. Indeed, it has never been so important to keep up to date with the latest developments in this dynamic field.
At this Organic Process Research & Development Conference, you will hear detailed presentations and case studies from top international chemists. The hand-picked programme of speakers has been put together specifically for an industrial audience. They will discuss the latest issues relating to synthetic route design, development and optimisation in the pharmaceutical, fine chemical and allied fields. Unlike other conferences, practically all our speakers are experts from industry, which means the ideas and information you take home will be directly applicable to your own work.
The smaller numbers at our conferences create a more intimate atmosphere. You will enjoy plenty of opportunities to meet and network with speakers and fellow attendees during the reception, sit-down lunches and extended coffee breaks in a relaxed and informal environment. Together, you can explore the different strategies and tactics evolving to meet today’s challenges.
This is held in Pune, close proximity to Mumbai city, very convenient to stay and travel to either in Pune or Mumbai. I feel this should be an opportunity to be grabbed before the conference is full and having no room
Hurry up rush
References
1 http://newdrugapprovals.org/scientificupdate-uk-on-a-roll/
2 http://scientificupdate.co.uk/conferences/conferences-and-workshops.html
3 http://en.wikipedia.org/wiki/Pune
PROFILES
Dr Will Watson gained his PhD in Organic Chemistry from the University of Leeds in 1980. He joined the BP Research Centre at Sunbury-on-Thames and spent five and a half years working as a research chemist on a variety of topics including catalytic dewaxing, residue upgrading, synthesis of novel oxygenates for use as gasoline supplements, surfactants for use as gasoline detergent additives and non-linear optical compounds.
In 1986 he joined Lancaster Synthesis and during the next 7 years he was responsible for laboratory scale production and process research and development to support Lancaster’s catalogue, semi-bulk and custom synthesis businesses.
In 1993 he was appointed to the position of Technical Director, responsible for all Production (Laboratory and Pilot Plant scale), Process Research and Development, Engineering and Quality Control. He helped set up and run the Lancaster Laboratories near Chennai, India and had technical responsibility for the former PCR laboratories at Gainesville, Florida.
He joined Scientific Update as Technical Director in May 2000. He has revised and rewritten the ‘Chemical Development and Scale Up in the Fine Chemical & Pharmaceutical Industries’ course and gives this course regularly around the world. He has been instrumental in setting up and developing new courses such as ‘Interfacing Chemistry with Patents’ and ‘Making and Using Fluoroorganic Molecules’.
He is also involved in an advisory capacity in setting up conferences and in the running of the events. He is active in the consultancy side of the business and sits on the Scientific Advisory Boards of various companies.
………………………………………………………………………………………………….
Dr John Knight gained a first class honours degree in chemistry at the University of Southampton, UK. John remained at Southampton to study for his PhD in synthetic methodology utilizing radical cyclisation and dipolar cyloaddition chemistry.
After gaining his PhD, John moved to Columbia University, New York, USA where he worked as a NATO Postdoctoral Fellow with Professor Gilbert Stork. John returned to the UK in 1987 joining Glaxo Group Research (now GSK) as a medicinal chemist, where he remained for 4 years before moving to the process research and development department at Glaxo, where he remained for a further 3½ years.
During his time at Glaxo, John worked on a number of projects and gained considerable plant experience (pilot and manufacturing). In 1994 John moved to Oxford Asymmetry (later changing its name to Evotec and most recently to Aptuit) when it had just 25 staff. John’s major role when first at Oxford Asymmetry was to work with a consultant project manager to design, build and commission a small pilot plant, whilst in parallel developing the chemistry PRD effort at Oxford Asymmetry.
The plant was fully operational within 18 months, operating to a 24h/7d shift pattern. John continued to run the pilot plant for a further 3 years, during which time he had considerable input into the design of a second plant, which was completed and commissioned in 2000. After an 18-month period at a small pharmaceutical company, John returned to Oxford in 2000 (by now called Evotec) to head the PRD department. John remained in this position for 6.5 years, during which time he assisted in its expansion, established a team to perform polymorph and salt screening studies and established and maintained high standards of development expertise across the department.
John has managed the chemical development and transfer of numerous NCE’s into the plant for clients and been involved in process validations. He joined Scientific Update in January 2008 as Scientific Director.
Pune images
From top:1 Fergusson College, 2 Mahatma Gandhi Road, Shaniwarwada 3 the HSBC Global Technology India Headquarters, and the 4National War Memorial Southern Command
NCL PUNE
The National Chemical Laboratory is located in the state of Maharashtra in India. Maharashtra state is the largest contributor to India’s GDP. The National Chemical Laboratory is located in Pune city, and is the cultural capital of Maharashtra. Pune city is second only to Mumbai (the business capital of India) in size and industrial strength. Pune points of interest include: The tourist places in Pune include: Lal Deval Synagogue, Bund Garden, Osho Ashram, Shindyanchi Chhatri and Pataleshwar Cave Temple.
MAKE IN INDIA
http://makeinindia.com/sector/pharmaceuticals/
Read all about Organic Spectroscopy on ORGANIC SPECTROSCOPY INTERNATIONAL
KEYWORDS
JOHN KNIGHT, WILL WATSON, SCIENTIFIC UPDATE, PROCESS, COURSE, CONFERENCE, INDIA, PUNE, PROCESS DEVELOPMENT, LOW COST, MANUFACTURING, SCALEUP
Cancer, Chemistry, and the Cell: Molecules that Interact with the Neurotensin Receptors
R.M. Myers,* J.W. Shearman, M.O. Kitching, A. Ramos-Montoya, D.E. Neal, S.V. Ley, ACS Chem. Biol.2009, 4, 503-525.
see
http://pubs.acs.org/doi/abs/10.1021/cb900038e
The literature covering neurotensin (NT) and its signalling pathways, receptors, and biological profile is complicated by the fact that the discovery of three NT receptor subtypes has come to light only in recent years. Moreover, a lot of this literature explores NT in the context of the central nervous system and behavioral studies. However, there is now good evidence that the up-regulation of NT is intimately involved in cancer development and progression. This Review aims to summarize the isolation, cloning, localization, and binding properties of the accepted receptor subtypes (NTR1, NTR2, and NTR3) and the molecules known to bind at these receptors. The growing role these targets are playing in cancer research is also discussed. We hope this Review will provide a useful overview and a one-stop resource for new researchers engaged in this field at the chemistry−biology interface.
Agonist: A molecule that binds to a specific receptor and triggers a response in the cell mimicking the action of an endogenous ligand.; Antagonist: A molecule that binds to a specific receptor yet does not provoke a biological response itself upon binding but blocks or dampens the agonist-mediated response.; Homology and identity: Measures of similarity between protein sequences. Homology implies an evolutionary link and is qualitative, whereas identity is quantifiable.; Site-directed mutagenesis: A process where specific single nucleotide changes within a gene can be made resulting in the change of a specific amino acid within a protein sequence.; Prognostic factor: A biomarker that can be used to estimate the chance of recovery from a disease or the chance of the disease recurring.; Predictive factor: A biomarker used to predict the response of a cancer to a given therapy.
DELTAMETHRIN PROJECT, 1999-2000 Panoli Gujarat India
I Was trying to add acid chloride into an aldehyde at zero degrees cent using PTC conditions and one of ingredient was sodium cyanide, cooling was done by brine
I Did not run away when instead of adding acid chloride in 2 hrs the operator added it on 10 min…………..I waited at the reactor and controlled an exotherm in plant by switching off brine supply to other reactors,
The reaction got controlled at 59 deg cent and luckily was ok…………the exotherm was fearful.
Despite all odds God saves us
MAKE IN INDIA
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http://makeinindia.com/sector/pharmaceuticals/
CLICK…….http://www.sciencedirect.com/science/article/pii/S0960894X1400866X
Volume 24, Issue 19, 1 October 2014, Pages 4664–4666
DOI: 10.1016/j.bmcl.2014.08.035
Lisa M. Eubanks, Beverly A. Ellis, Xiaoqing Cai, Joel E. Schlosburg, Kim D. Janda
Cocaine abuse remains prevalent worldwide and continues to be a major health concern; nonetheless, there is no effective therapy. Immunopharmacotherapy has emerged as a promising treatment strategy by which anti-cocaine antibodies bind to the drug blunting its effects. Previous passive immunization studies using our human monoclonal antibody, GNCgzk, resulted in protection against cocaine overdose and acute toxicity. To further realize the clinical potential of this antibody, a recombinant IgG form of the antibody has been produced in mammalian cells. This antibody displayed a high binding affinity for cocaine (low nanomolar) in line with the superior attributes of the GNCgzk antibody and reduced cocaine-induced ataxia in a cocaine overdose model.
