Points Of View - Depending on who you ask the list of trends in the pharmaceutical industry grows from using bigger and more complicated synthesis components, and bioconjugation all the way to trends in full life cycle management and external technology partnerships. CHEManager Europe took a closer look at what the industry is talking about.

Naturally one topic that has been unavoidable for the past year is the current economic climate and what this has meant for various industry sections. Dr. Andreas Meudt, MD New Business Development/Global R&D Director at Archimica, spoke about 2009 as a "transition year for most of the Top 20 global pharmaceutical innovators and a very difficult year for the smaller innovative firms". He went on to stress the fact that most of the big players were still restructuring and that these focused on various cost reduction initiatives. When questioned Lukas von Hippel, AllessaChemie, also commented on economic pressures on the industry: "we have seen over the last years, additionally forced by the economical crisis, a shortage in venture capital, reducing the number of available projects and delaying some projects. The pipelines from other companies often did not develop as expected, again reducing the number of projects available for outsourcing. As a consequence, some companies face challenges and have to decommission plants, sometimes whole sites." Furthermore, von Hippel said the pressure was also increased due to health system changes which are being implemented.
On a more technology based level Gilles Cotier, President of SAFC Global said that "Bioconjugation is a rapidly-emerging complex technology offering a new array of highly targeted ‘smart therapy' solutions to combat diseases. Particularly exciting, is antibody-drug conjugate (ADC) technology, which uses monoclonal antibodies to deliver conjugated HPAPIs to specific cancer tumors," and explain that "in its conjugated form, the HPAPI exhibits more selective cytotoxicity, thereby sparing non-target cells many of the toxic effects. One drug using this technology has already been commercialized, with dozens of ADC products also currently in clinical trials. Other potential applications for conjugated HPAPIs, such as chronic heart disease, muscoskeletal problems and central nervous system diseases, are also generating a lot of interest in the research community."
Another interesting topic was pointed out by Dr. Andreas Meier, Solvay Fluor, who said Solvay was "observing an increased requirement for synthesis components that also provide their own functionality". In order to accommodate this trend the company is expanding its portfolio of fluorine-containing synthesis components. Meier explained that "fluorine in the molecule increases efficacy because it makes molecules more stable and increases membrane possibility. Fluorine chemistry requires very special know-how and equipment".
According to William DuBay, VP Technology and Business Development, AMPAC, the past few years have shown a change in the manufacturing approach of the pharmaceutical industry. The need to produce faster at lower cost initially pushed the industry to Asia and India where manufacturing capacity is still growing and where manpower is relatively inexpensive. "This is still on-going, but we now see a growing interest for developing processes that are intrinsically more efficient. Typically, pharmaceutical processes are based on manufacturing batches using stirred tank reactors. But recently, thanks to positive views from the FDA on continuous processes through process analytical technology and Quality by Design, the pharmaceutical industry has been seriously evaluating continuous processes as a means to lower API costs. These processes have been around for many years in other industries, but the common belief was that they were only worth implementing when quantities were in the 100s of metric tons. With the development of new technologies and improvements in equipment, the manufacturing of smaller quantities (in the 10s of metric tons range) using continuous processes is attractive," DuBay said.
On a more general not, Gaudenz von Cappeler, CEO of Carbogen Amcis, stated that he felt the main focus areas in the next few years would be "an increased need to provide API and drug products for clinical trials and more support in polymorph and crystallization studies."
David Hipkiss, Prosonix said he believed "that Big Pharma will have to take an increasing and earlier interest in the full life cycle management of their products by acquiring or smart partnering with leading Generic companies". He also commented that "Novartis are already well placed to do this with their ownership of Sandoz, and Sanofi-Aventis will accelerate their plans following their recent acquisition of Xentiva. GSK also concluded a recent marketing deal with Dr Reddy's of India. Underpinning this trend will be a continuation of the recognition for external technology partnerships to deliver excellence in innovation and best in class product performance, such as true multi-component particles for ideal synergistic effect in Asthma and COPD."

Technology To Meet Trends?

According to Martin Widmann, Head of BASF's Global Business Unit Pharma Ingredients & Services, another challenge for the pharmaceutical industry comes from technical boundaries of the new active ingredients in the pipeline of customers e.g. less soluble molecules. "We at BASF can help to solve this challenge, by leveraging our expertise in polymer chemistry. With our continuous development program for new excipients, we are enabling new solutions for our customers," said Widmann, and also pointed out that "the pharmaceutical industry concerns for efficiency and security in the entire supply chain have increased in the last years. As a partner, BASF stands for full compliance to all operating standards and transparency for their customers." Gilees Cotier also commented on this saying that "Experience has shown conclusively that maintaining control on API and key intermediates quality throughout the development pipeline is critical and failure to do so has proven disastrous".
"We have identified organofluorine chemistry as an important technology in the expansion of our provision for the pharmaceutical industry. In addition to our existing fluorine capabilities at Dalian (PR China) we have built a new laboratory in Germany to support our production facilities and to expand the range of fluorine chemistry that we can offer on an industrial scale. We are also working closely with noted academics in the field of fluorine chemistry to increase the scope of our offering," said Dr. Hans-Josef Ritzert, Head of Business Line Exclusive Synthesis & Amino Acids, Evonik and also told CHEManager Europe of the importance of crystal formation and morphology: "We have invested in laboratory and analytical equipment to measure and control the particle size and crystal morphology of our pharmaceutical products. In addition we are developing melt crystallization (zone refining) as an industrial method for the purification of high value solids, for example for the electronics industry."
Guy Tiene, Director Marketing and Communications at DSM Pharmaceutical Products spoke about "pharmaceutical companies looking at alternative production methods that are cost-effective and more sustainable to produce their active pharmaceutical ingredients". DSM's green chemistry toolbox offers technology-based cost efficiencies with reduced environmental impact. Tiene explained that "DSM are in commercial scale production using micro reactor technology, and offer other innovative processes for the sustainable production of pharma chemicals. These process intensification methods, including micro reactor technology, biocatalysis and homogeneous catalysis can provide shorter and more efficient scale up routes. We have successfully scaled-up more than thirty industrial enzymatic processes, speeding up development, driving down costs and securing supply at large scale with the expertise to address quality and regulatory factors for these applications under cGMP."
The pharmaceutical industry is a complex and multifaceted industry hence it should surprise no one that the topics of discussion vary so greatly. The different sectors will react differently to the varying pressure points such as economic fluctuations, decreasing number of drug approvals, competition from emerging markets and new regulations enforced at different stages of the pharmaceutical supply chain.