"We have been using SmartChem for the past four years and I am sure that it will continue to be our most dependable reliable data source in the coming years. We congratulate ROW2 on completing five years of providing SmartChem and we wish them all the success in the future."

- Head Procurement, Leading manufacturer of API’s and intermediates, Italy

"The web seminar sponsored by ROW2 Technologies gave us an overview of developments in the field of Pd catalysts. It helped us in keeping up-to-date with the technical developments in the field. I will be looking forward to such seminars in the field of organic synthetic chemistry."

- R&D Manager, One of the top US based Agro Companies

Welcome to CI2E Quarterly, Process Research Special! We are delighted to bring you the second issue for the year 2007. The Process Research fraternity contributes greatly in creating a better and healthier life for all. As a token of our appreciation, we have dedicated this newsletter to Process Research and advancements being made in Process Chemistry!

The CI2E Quarterly is appreciated as a true Compendium of Information, Interaction and Entertainment, so read more on its sections below. CI2E Quarterly continues to be shared with over 5000 "select" industry professionals in the Life Sciences and Chemical Industries!

In this issue:

• ROW2 World: ROW2 in the spotlight

• Featured Article: Solvents and Sustainability by Dr. Lalitha Krishnan

• Links: to various other articles published on Process Chemistry.

• MyForum: Jim Ryan of ACS gives an insight to two ACS Process Chemistry programs.

• Entertainment: Wimbledon Fun Trivia and gags to help relax a little during your busy day.

ROW2 World - Quarter 2 Highlights

ROW2 News

• Reigning Media Attention: ROW2’s unique offerings, which cater to the core need of global Life Sciences companies and create Intellectual Property for them, has started catching the attention of not just industry professionals but the media as well. This year ROW2 featured in some of the internationally reputed Life Sciences Publications.
  
  ROW2 Featured in World Pharmaceutical Frontiers    - 2007 Vol. 1 Issue
     Keith Talent of World Pharmaceutical Frontiers, U.K.    discovers a new and effective process chemistry-   partnering model with ROW2’s offerings. Click here to    read this interesting article titled "Effective Process    Chemistry Partnering".
  
  Srini Gopalan’s thoughts on the Future Trends in    Strategic Collaboration featured in Specialty    Chemicals Magazine, U.K. (May 2007 - Issue 31):
     Srini, Chief Executive Officer, ROW2 Technologies,    shares his thoughts on how the Life Sciences Industry is    moving towards partnering concepts rather than    outsourcing concepts to meet today’s challenges. He    also gives an insight to the new emerging partnering    model coined as Cerebral Process Partnering in the    article titled CPP: An emerging trend in intellectual    partnering in the Outsourcing section of Specialty    Chemicals.
  
  ROW2 featured in Chemspec Europe Special issue    of Chemical Weekly, India - June 2007
     In a personal interview, the Editor of Chemical Weekly    is apprised of the unique position that ROW2 has been    able to carve for itself in the Life Sciences Industry in    the article titled “ROW2 Technologies: Catering to    ‘cerebral outsourcing’ needs in synthetic organic    chemistry”.
  
  ROW2’s Press Conference featured in Chemistry    Today: May/June 2007 issue
     ROW2’s successful Press Conference “CPP: An    emerging trend in intellectual partnering” at Informex    USA 2007 featured in Chemistry Today, one of the    leading magazines from Italy.
  
  

• Successful Webseminar: On June 14, 2007 ROW2 hosted a web seminar entitled “Overcoming Challenges in Coupling Reactions with Robust Catalysts for Pharmaceutical and Fine Chemical Applications” for the benefit of Process Research fraternity. The event featured Dr. Thomas Colacot, Development Manager in the Catalysis and Chiral Technologies Division at Johnson Matthey, USA who introduced powerful solutions to Cross-Coupling Reactions. ROW2 received an overwhelming response to this webseminar and had over 45 Process Research professionals attend this webseminar.
  
  "The ROW2 Technologies seminar provided Johnson Matthey an ideal forum to educate the Pharmaceutical and Fine Chemicals R&D community on our latest developments in the area of Coupling Catalysis. The participating audience generated quite an interest in our products and services. The entire process was very well managed and well received" - Connie Schlegel, Market Analyst, Johnson Matthey Catalysts, USA
  
  Click here to view the webseminar recording.
  
  If you wish to Register for the “Speaker Position” for our future webseminars, please send us a synopsis here.
  
  

• Events: ROW2 attended Chemspec India, Mumbai on April 18-19, 2007; CPhI Japan, Tokyo on April 18-20, 2007; OPR&D, Jersey, Channel Islands on May 14-17, 2007; Chemspec Europe, Amsterdam on June 27-28, 2007.
  

SmartChem News

• SmartChem Jubilee: ROW2 is celebrating 5 years of providing the SmartChem service to the Life Sciences Industry. To celebrate this occasion, ROW2 has planned various initiatives such as the SmartChem Jubilee Offer. Many of its customers and new subscribers have already benefited from this Offer. Your organization too can benefit from the SmartChem 5 Years Jubilee celebration.

RouteDesign News

• RouteDesign Continues to make Strides: ROW2 continues to enter into long-term partnerships with top Life Sciences companies worldwide for its RouteDesign service and is currently working towards building strategic alliances with some of its customers.
  
  “This is a great achievement for ROW2 and is a wonderful reward for the work the entire team has put in the last few years. We have dedicated teams working for these customers. Having worked on diverse projects with different R&D Locations of these companies, we now understand their needs, expectations and confidentiality norms very well. This will definitely help us in adding more value to their business.” says Dr. Dhananjay Rane, Executive Director – Process Chemistry Solutions, ROW2 Technologies
  
  “We have critically evaluated the depth and breadth of ROW2’s RouteDesign service over the past two years and are convinced with their expertise, consistency, professionalism and flexibility. I am now confident that the ROW2 team is competent to act as an extension of our research team. We believe this collaboration will be very fruitful in contributing to the generation of our IP,” adds Head of Process Research of one of the top 10 Pharmaceutical companies.

• Interesting Survey: Our team recently conducted an interesting survey with our customers to understand which type of projects benefit maximum from RouteDesign service. The responses we received elaborated diverse process research challenges such as various types of structural complexities, route complexities etc. where companies derive maximum value from RouteDesign.
  Get details of this interesting survey by clicking here.

• Process Research Chemists Day: After witnessing the immense joy of celebrating this event with research chemists in 2006, ROW2 will celebrate “Process Research Chemists Day” on November 10, 2007.

Important Events from Jul to Sep 2007:

Jul:
10-11: PBOEC 2007, Savoy Place, London
11-13: Modern Synthetic Methods, Philadelphia, USA

Aug:
29-31: Scale-Up of Chemical Processes, Boston, USA

Sep:
10-11: ChemOutsourcing, New Jersey, USA
24-27: LogiChem USA 2007, Arizona, USA

Featured Article

Some Solvent-Selection Considerations in Designing a More Environment-Friendly API Manufacturing Process

Solvents play a crucial role and are integral components of manufacturing processes of active pharmaceutical ingredients (API). Over the past decade, it has been repeatedly reported that many of the commonly used volatile organic solvents (VOCs), like dichloromethane pose serious waste-management issues as well as human health and eco-toxicity hazards. Since solvents account for the largest proportion by mass and volume of chemicals used in most batch processes, they contribute significantly to the overall toxicity profile of a given manufacturing sequence. In response to this issue, major pharmaceutical companies are beginning to invest in developing and integrating “green” practices into the design of commercial syntheses.

Moving towards more sustainable and environmentally friendly chemical syntheses and processes is very complex. A key factor in developing a cleaner process and significantly reducing its environmental impact is to select the most appropriate solvent early in the discovery process while minimizing its adverse health, environmental and safe-handling concerns.

To read the full article click here

ROW2 picks of the quarter

Total R&D Projects – plateauing out
Published by: PharmaProjects

This interesting 2006 Annual Review of the Pharmaceutical Industries provides insight into the total number of drugs in R&D, examinations of R&D drugs by status, company, therapy etc. over a ten-year period.

Chemistry Highlights 2006
Published by: C&E News

Learn more about the top chemistry research developments in the year 2006. Selected based on novelty and breakthrough nature this article covers advances in various chemistry sub-disciplines.

Tweaking Process Chemistry
Published by: Drug, Discovery and Development

Read all about how bench-top equipment and increased collaboration between industry and academia is starting to create a renaissance in the field.

Featured Article Cont'd.

Alternative Solvents in Chemical Syntheses:

The drive to develop cleaner technology with minimized environmental impact and recognition of the problems associated with VOCs has led to a substantial research effort worldwide on widely varying portfolio of alternatives¹ such as:

1. ionic liquids² (involatile systems)

2. fluorous solvents and super-critical CO₂ (easily recyclable)

3. water and super critical-water ³(inorganic system) and

4. solventless reactions⁴.

Despite extensive research in the aforementioned areas, traditional VOCs continue to dominate in the manufacturing of pharmaceutical actives. The reason is that research on modifying the properties of the previously mentioned alternatives and making them economically viable is still in its infancy leaving open many options in this area.

Some “Green” Considerations for Solvent Selection in API Manufacturing:

• Process chemists in pharmaceutical companies, in addition to being guided by intuition need to be educated about the new solvent alternatives and should stay abreast of literature pertaining to the newest developments in the field.



• Solvent selection should be included as an important design factor in route selection and scientists should be encouraged to think about minimizing environmental impact even as early as the Discovery phase synthesis. In the currently fast-paced pharmaceutical development timeline models, it might be difficult to incorporate “green” features early on in the process but there are many economic advantages to doing so. It is well-known that the expense involved and time required for regulatory filings that are needed for solvent changes in an established manufacturing process are huge and hence a major deterrent



• Reducing the number of synthetic steps and isolations of key intermediates is a relatively more straightforward strategy that would optimize solvent use since fewer steps means lower solvent use, recovery and recycling



• Pharmaceutical companies, environmental research companies and laboratories should collaborate to modify the existing solvent databases and develop a comprehensive database of solvents and solvent alternatives that includes more current examples of different categories of large-scale successful chemical reactions run in “green” alternatives



• Chemical engineers, synthetic chemists and university researchers should collaborate to develop technologies such as microreactors, microencapsulation and continuous processing techniques at a meaningful scale to enable telescoping multi-step reactions and consequently minimizing solvent use



• Pharmaceutical companies should invest in research on the use of water as a solvent for various reactions especially in combination with biocatalysts, which have a greater advantage over chemical reactions due to their mild reaction conditions, higher selectivity and environmental compatibility. Biocatalytic steps in combination with synthetic steps have the potential for improving the efficiency of the process in relation to solvent use

In conclusion, finding a suitable solvent that is environmentally preferable is no doubt a challenge since many competing issues such as compatibility with the chemistry, reaction efficiency, cost, safe-handling and disposal need to be considered. Solvents will continue to be subjected to greater regulatory scrutiny because of their environmental health and safety impact. In today’s global pharmaceutical marketplace, economies in developing countries are facing serious environmental problems caused by air and water pollution from toxic substances. Hence, pharmaceutical along with other chemical companies will increasingly gravitate towards selecting solvents based on environmental demands. The importance of planning ahead in incorporating green solvent considerations early into the API manufacturing process cannot be over-emphasized.

1. R.A. Sheldon, Green Solvents for Sustainable Organic Synthesis: State of the Art. Green Chem. 7,267-278, 2005. 2. C. Chiappe, et al, J.Phys. Org. Chem.18, 275-297 2005. 3. P.G. Jessop P.g. Leitner Eds, Chemical Synthesis Using Super-critical Fluids, Wiley-VCH: Weinheim, Germany, (1999) 4. G.W. Kabalka et al., Tetrahedron 62,857-67(2006)

About Dr. Lalitha Krishnan

Dr Lalitha Krishnan MSc. (Chemistry), Indian Institute of Technology, Madras and PhD Indian Institute of Science, Bangalore recently resigned as Project Leader from Wyeth, USA after having worked in Chemical and Bioprocess Development for 20 years. During her tenure at Wyeth she developed the process for the manufacture of Tygacil® a first-in-class broad-spectrum glycylcycline antibiotic and served as CMC expert on the project team. In 1991, she received the American Cyanamid Scientific Achievement Award for developing a simple and novel process for isolating Vancomycin® from fermentation broths. Dr. Krishnan has a wide range of experience in process development and coordinating CMC technology transfer activities. Dr. Lalitha Krishnan is available as a consultant to Pharmaceutical companies.

Contact: krishnan1@optonline.net

To sponsor future newsletters, write to us here.

Jim Ryan, Director of ACS’s Continuing Education division, describes ACS Process Chemistry programs coming soon:

Process Research in the Pharmaceutical Industry: The Design and Development of Practical Syntheses/Boston, August 19 & 20: This short course will focus on the design and development of practical syntheses for product candidates. Participants will be exposed to all phases of drug process development from preclinical to new drug application filing. Taught by two former Merck scientists, many real-life examples are used illustrate key aspects of research.

Process Chemistry in the Pharmaceutical Industry/Boston, Sept. 30 – Oct.3: This ACS ProSpectives Conference will feature six top academics presenting the latest in their research, 10 senior scientists from big pharma giving case studies of their work, and a former FDA executive, who will conduct a regulatory roundtable that will also address Quality By Design and getting an API from phase I - phase III.

1. The very first    Wimbledon    Championship took    place in 1877.

2. Slazenger has    provided every    tennis ball for    The Championships    Wimbledon since    1902.

3. During World War    II, a bomb ripped    through Centre    Court at the All    England Club and    1,200 seats were    lost.

4. A wooden racket    was last used at    Wimbledon in    1987.


Fun Trivia:

Who will win the Wimbledon 2007 Male and Female finals respectively?

Send us your answer here and you could WIN A PRIZE!

Process Chemistry Specials