Vision is one of the most sought-after and admired qualities of a corporate executive. The

 (online edition) defines vision as “the ability to think about or plan the future with imagination or wisdom;” and as “a mental image of what the future will or could be like” (1).

When a CEO’s vision is aligned with what really happens in the business environment, it can bring great corporate success and great admiration for the CEO. The classic example in recent times of a corporate leader with a spot-on vision is Steve Jobs, whose understanding of the promise of mobile technology yielded some of the most successful product launches of all time.

Vision has become such an admired quality in corporate leadership that it has come to overshadow other qualities, including operating skill. The excitement generated by a corporate vision can drive up the valuation of a company (i.e., its stock price) even when operating results are poor; just look at the performance of Amazon’s stock, which has rocketed up despite marginal earnings. 

With technology companies, the story often trumps the actual performance. That point was driven home when Microsoft CEO Steve Ballmer announced his retirement. Ballmer delivered enormous profits over a 12-year period and successfully positioned the company in some key businesses such as databases, gaming, and Skype. Despite that performance, Ballmer was widely criticized for Microsoft’s late and troubled response to mobile technology, and the company’s stock went up when his retirement was announced. 

The bio/pharmaceutical contract services business has had its share of visionaries, but their track record has not been good. Their efforts to respond to clear trends in the bio/pharmaceutical industry such as the re-engineering of R&D, the growing role of biopharmaceuticals, and the expanding role of emerging markets in the supply chain have often come to naught, overwhelmed by the realities of profitability and cash flow.


  The practical difficulties of realizing a vision were evident when Lonza announced a series of retrenchment moves, most notably its withdrawal from its biosimilar joint venture with Teva, and the restructuring of its microbial fermentation business. Those initiatives were originally set in motion by Lonza’s previous CEO, Stefan Borgas, who clearly had a vision to position Lonza in the forefront of the major biotechnology trends sweeping over the bio/pharmaceutical industry. Borgas engineered the acquisition of Cambrex’s biologics assets in 2006, which gave Lonza significant positions in bioscience-based research tools, microbial fermentation, and cell therapy. Another acquisition gave Lonza capabilities in virus-based products. Borgas established the biosimilars joint venture with Teva, which linked Lonza’s large, mammalian cell-culture capacity with Teva’s experience in developing and marketing generic injectables. He also established Lonza’s presence in China by building a small-molecule manufacturing facility in Nanjing and added capabilities for antibody-drug conjugates at the company’s main manufacturing site in Visp, Switzerland.

Borgas’s strategic moves undoubtedly positioned Lonza directly in the path of major trends driving the bio/pharmaceutical industry, but they were expensive, requiring extensive capital expenditures and investments in R&D and acquisitions. Whatever their long-term promise, the initiatives hurt Lonza’s near-term profitability and the heavy reliance on contract manufacturing made it difficult to hit stated earnings targets. When the EU debt crisis struck and the Swiss franc shot up in value, Lonza’s profitability was severely hurt, and Borgas was replaced. The new executive team has focused on restoring predictable, near-term profitability and retreated from some of those strategic initiatives. 


  In hindsight, Borgas’ vision for Lonza seems well founded: the trends it was based on are in fact reshaping the bio/pharmaceutical industry. The Lonza experience, however, shows that reality has a habit of impinging on the vision, and that pursuing a vision is inherently risky. Reality struck in the form of the European financial crisis and the longer-than-expected time it has taken to clarify a path for biosimilars in the US. 

The risk comes in part because pursuing a vision by definition means being ahead of the market and giving people what they want before they know they want it. Stockholders and investors may run out of patience waiting for the corner to be turned, and the business might actually run out of cash before the vision is realized. Taking those kinds of risks will generally be unpalatable and unwise for otherwise successful businesses. 

Other examples of failed visions in the contract services industry point to the fact that customer behavior often takes much longer to change than the visionary expects. This situation has been especially true for the integrated services model, often referred to as the “one-stop shop.” Companies that have pursued this model did so with the understanding that small companies lacked the sophistication to buy services individually, and that bio/pharmaceutical companies of all sizes are looking to shorten development times and reduce costs.  Those visionaries, however, underestimated the reluctance of the large bio/pharmaceutical companies to change the way they do things, and their reliance on smaller bio/pharmaceutical companies made them vulnerable to the volatility of venture funding and capital markets. 

Many CMO and CRO executives have seen the contract services business model as one that can transform the bio/pharmaceutical industry and help it adapt to new market realities. In the clinical research sector, that has indeed been the case, especially as CROs have leveraged the power of information technology to streamline clinical trials. CROs have been able to make the investment in information technology without undermining their near-term profitability and performance. CMO and CDMO executives will be well served to follow that more incremental approach to pursuing their long-term visions. 

,” (Oxford University Press), online, http://oxforddictionaries.com/us/definition/american_english/vision, accessed Sept. 17, 2013. 


  Jim Miller is president of PharmSource Information Services, Inc., and publisher of Bio/Pharmaceutical Outsourcing Report, tel. 703.383.4903, Twitter@JimPharmSource, info@pharmsource.com,www.pharmsource.com.

Articles

Outsourcing

Practicality of implementation should be a part of vision in the bio/pharmaceutical industry.

The Expense of Vision in Outsourcing

reports that applications for the 2014–2015 school year are now available for the Sixteenth Annual Lilly Reintegration Scholarship.  Since its inception, the program has directed more than four million dollars in tuition, books, and laboratory fees to hundreds of colleges, trade, and vocational schools and high school equivalency programs across the United States to fund educational pursuits of students living with bipolar disorder, schizophrenia, or schizo-affective disorder. This year the program expands to include the diagnosis of major depressive disorder. 

 have launched a new joint initiative to make vaccines more resistant to heat, thus reducing the need for refrigeration. GSK and BMGF will invest a combined $1.8 million in early-stage research into vaccine thermostability. Details of the Vaccine Discovery Partnership (VxDP), under which this initiative falls, were introduced at the Foundation’s Grand Challenges Meeting in Rio de Janeiro, Brazil. In one of the first projects to start under this initiative, GSK researchers will explore how to make adjuvants more heat stable. This project will focus initially on the adjuvant AS01, which is used in GSK’s RTS,S malaria vaccine candidate, currently in late-stage development in partnership with the PATH Malaria Vaccine Initiative. RTS,S has been designed for use in infants and children from sub-Saharan Africa, where maintaining vaccines at an optimum temperature can be challenging. Developing a method of making AS01 more heat stable could bring a significant public health benefit. The results could also have broader applications for all other AS01-containing vaccines, including vaccines in development by GSK against HIV and tuberculosis.

reported results from a large-scale Phase III trial for its malaria vaccine candidate, RTS,S, which is designed to protect young children and infants from clinical malaria up to 18 months after vaccination. Based on these data, GSK now intends to submit, in 2014, a regulatory application to the European Medicines Agency. The World Health Organization has indicated that a policy recommendation for the RTS,S malaria vaccine candidate is possible as early as 2015 if it is granted a positive scientific opinion by EMA.

has formed a new collaboration with the São Paulo Research Foundation (FAPESP) to create a new Center of Excellence for Sustainable Chemistry in Brazil. The agreement emerged from a meeting with Rogerio Ribeiro, senior vice-president, Emerging Markets & Asia Pacific, GSK, and Geraldo Alckmin, Governor of São Paulo State, and Celso Lafer, president of FAFESP. The center is part of a larger goal by GSK to be carbon neutral by 2050. The center will be located in the state of São Paulo and will focus on sustainable chemistries most relevant to the discovery and development of medicines. GSK has agreed in principle to cofund the center with FAPESP, investing approximately £400,000 (640,000) per year during a 10-year collaboration that will be matched by FAPESP. GSK is already supporting a Center of Excellence for Sustainable Chemistry in the UK based at the University of Nottingham. Once the new center in São Paulo is established, it will form scientific links with GSK and the University of Nottingham to facilitate the sharing of knowledge and expertise between Brazilian and UK researchers. Through the collaboration, the new center in Brazil will take a multidisciplinary approach to exploring all aspects of more sustainable chemistry, including improving synthetic efficiency, sustainable solvents, and renewable feedstocks from agricultural waste. The project work seeks to develops alternatives for processes and reagents used in the pharmaceutical industry that will allow the company to embed new sustainable chemistries within GSK and directly contribute to its carbon-neutral goals. 

 announced the debut of the Power of One campaign,  which is designed to encourage people around the world to help end child deaths from malaria. Novartis will support the campaign financially and donate up to three million Coartem  (artemether lumefantrine) dispersible treatments to match antimalarials funded by the public. It is estimated that over 300 million additional treatments will be needed to treat malaria patients across Africa between now and the end of 2015.

The Power of One campaign aims to address this treatment gap through direct donations and existing government commitments. Every dollar donated to the campaign will buy and deliver a treatment to a child diagnosed with malaria. Novartis is the exclusive treatment sponsor of the Power of One campaign, joining other innovative companies. Additional sponsors include Alere Inc., which will provide malaria rapid diagnostic tests, 21st Century Fox, AHAlife.com, Causes.com, Time Warner, Twitter, Venmo and others. Zambia will be the first country to receive deliveries of treatments and tests as a result of the Power of One campaign. 

 Former US President Jimmy Carter joined 

to commemorate the fifteenth anniversary of the 

, an independent, not-for-profit program dedicated to the elimination of blinding trachoma as a public health concern.  Trachoma is an infectious eye disease that is a leading cause of blindness in the developing world.  Pfizer has provided hundreds of millions of doses of the antibiotic Zithromax (azithromycin) to help the global campaign wipe out blinding trachoma by the year 2020. Pfizer, through the ITI, has donated more than 340 million doses of the antibiotic to date to prevent and treat trachoma in support of the World Health Organization(WHO)-led Global Alliance for the Elimination of Trachoma by the year 2020. ITI has managed the distribution of the antibiotic to 28 countries in Africa and Asia since 1998. Approximately 320 million people worldwide are at risk for contracting trachoma, with about 7 million suffering from the advanced, blinding stage of the disease.

 On Nov. 10, 2013, the 100 millionth Carter Center-assisted dose of Zithromax is expected to be distributed in the Amhara Region, Ethiopia, during a celebration with the Ethiopian government, Pfizer, ITI, the Lions Clubs International Foundation, Lions of Ethiopia, and other partners.  The Amhara Region is thought to be the most trachoma-endemic area in the world, and the partners are working to demonstrate that blinding trachoma can be eliminated from a highly endemic country. The Carter Center, together with the Ministry of Health and other partners in Ethiopia, has helped demonstrate that community-directed infrastructures for preventing trachoma can mobilize millions of people to accept treatment and adopt behavior changes to improve their own lives, even in remote areas where there is limited access to basic medical care, water, and sanitation. The international trachoma campaign uses the SAFE strategy, approved by the WHO, to prevent and treat trachoma. SAFE stands for:  Surgery to prevent blindness; Antibiotics to treat active infections; Facial cleanliness; and Environmental improvements, such as latrines to reduce the breeding grounds of flies that help spread the disease. Using these interventions, Ghana, Morocco, Oman, Vietnam, Iran, and The Gambia have all achieved great success against this debilitating infection.  Mali, Niger, and Sudan also are on track to make significant inroads in their fight against blinding trachoma by 2015. 

 Grantmakers In Aging (GIA), a national association of funders, and the 

 have announced a second year of funding totaling $1.3 million for Community AGEnda, an initiative aimed at helping American communities become more age-friendly, meaning great places to grow up and grow old. The award will support grants up to $140,000 from GIA to each of the five participating Community AGEnda communities, in Arizona, Florida, Georgia, Indiana, and greater Kansas City. Funding for Community AGEnda is provided to GIA by the Pfizer Foundation. 

has been recognized by the Dow Jones Sustainability Index as the Group Leader in sustainability within the pharmaceutical, biotechnology, and life-sciences Industry, based on an analysis of economic, social, and environmental performance.  This year’s DJSI assessment emphasized a number of Roche’s efforts, such as how the company manages innovation, especially the development of new medical products that create value, management of the supply chain, and engagement with stakeholders. Roche’s programs on managing talent and developing future leaders received the highest points, as did customer relationship management. Roche also scored highly in the areas of marketing practices, human rights, environmental reporting and its contribution to improve health outcomes. In 2009 Roche introduced a number of five-year corporate goals, using key performance indicators to measure progress. Among these, Roche introduced a diversity objective to increase the percentage of women in key positions by at least 50% as well as an energy-efficiency goal of reducing energy consumption and increasing energy efficiency by 10% by the end of 2014. Roche is well on track with these and other goals. 

Sanofi Pasteur, the vaccines division of 

 to explore and develop new platforms and methods intended to accelerate vaccine R&D, particularly in areas of global health. The announcement was made at the Grand Challenges  in Global Health meeting in Rio de Janeiro, Brazil during a session focused on  affordable technologies for the developing world. The Vaccine Discovery Partnership (VxDP) is a newly created, formal mechanism by which the Gates Foundation can directly collaborate with Sanofi Pasteur and other vaccine and pharmaceutical companies across disease areas of interest.It provides an integrated, straightforward and sustained relationship based on a memorandum of understanding (MOU). Sanofi Pasteur has already been working with the Gates Foundation on other projects such as HIV vaccine development and distributing inactivated (as opposed to oral) polio vaccines globally to eradicate the disease. 

CSR and Sustainability Forum

A roundup of developments in global health and sustainability from the bio/pharmaceutical industry, its suppliers, and other public and private organizations.

Pharma News in Global Health and Sustainability

A recent analysis of the Chemical Pharmaceutical Generic Association (CPA), which represents Italian generic API manufacturers, points to strong growth for the pharmaceutical contract research and manufacturing services (PCRAMS) industry. The overall world PCRAMS industry, which includes revenues from both contract research organizations (CROs) and contract manufacturing organizations (CMOs), was valued at $72 billion in 2012, up from $21 billion in 2000. Contract manufacturing accounted for two-thirds of the  2012 market, or $47 billion, and contract research the remaining $25 billion, according to the CPA report, 

Of the global contract manufacturing business, contract manufacturing of APIs and intermediates accounted for the largest sector for contract manufacturing  at 64% or $30 billion. Contract manufacturing of finished dosage forms accounted for 9.6% or $4.5 billion, according to the CPA analysis. Development of finished dosage forms accounts for approximately 15% of the contract manufacturing market, or $7 billion, and packaging/labeling and other services represent the remainder or $5.5 billion. 

Of the  market for contract manufacturing of APIs and intermediates, custom synthesis (mainly focused on new, branded APIs) accounts for 40% or $12 billion, and toll manufacturing for  the remaining 60% or $18 billion. For purposes of the analysis, “custom synthesis” denotes when a company outsources the manufacturing of an intermediate or API without indicating the operational modalities. “Toll manufacturing” denotes when the production of the intermediate or API is carried out by the external suppler according to operational modalities established by the sponsor company. 

Overall, the global PCRAMS market is forecast to grow at an average of 13.6% yearly over the next five years to reach $136 billion by 2017 from $72 billion in 2012, according to the CPA analysis. The global CRO business is expected to increase from $25 billion to $43 billion in 2017, representing average yearly growth of 11.4%, according to CPA. The global CMO business is projected to increase from $47 billion in 2012 to $93 billion in 2017, an average of 14.6% in yearly growth, according to CPA estimates. 

Asia Pacific will show the strongest growth in the global PCRAMS market, with particularly strong growth for India and China. The share held by India in the world PCRAMS market will nearly triple in the next five years, and by 2017, India will be the second largest market for PCRAMS, accounting for 21.3% of the global market compared to only 8.3% in 2012. India will only be surpassed by the United States, which is expected to hold almost 25% (24.9%) of the global PCRAMS market in 2017 compared to a share of 33.7% in 2012. Just as the US market’s share in the global PCRAMS market will decline so will the share of Western Europe from 25.0% in 2012 to 17.1% in 2017. China’s share of the global PCRAMS  market will increase from 12.2% in 2012 to 19.2% by 2017, according to the CPA analysis. 

Global Feature

Overall growth in the market for pharmaceutical contract research and manufacturing is strong although growth in established markets erodes at the expense of emerging markets.

A Strong Outlook for Global Pharma Outsourcing

A review of activity thus far in 2013 shows measured investment by fine- chemical companies, contract manufacturers of APIs and intermediates,  CDMOs, and CMOs of finished product manufacturing. High-potency manufacturing continues to be an active area of investment on both the API and finished product side. For CDMOs and CMOs of finished product manufacturing, there have been several partnerships in drug-solubilization as well as investments in lyophilization and sterile manufacturing and aseptic processing. 

Fine-chemical companies and contract API manufacturers expand 

Among recent developments, Siegfried is proceeding with a new 300-m

 production plant in Nantong, China. The company broke ground for the new facility in July 2013. The plant will begin commercial production in mid-2014 and employ a workforce of about 300 by 2015. Siegfried is also proceeding with the construction of a new 100-m

 chemical plant in Zofingen, Switzerland. The new building will replace several older plants at the Zofingen site that no longer comply with efficiency requirements and generate high maintenance expenses. The two plants in Nantong and Zofingen are based on an identical technical concept to facilitate product transfers from a regulatory and technical perspective. A new administration building also will be erected in Zofingen. The new offices will be ready for occupation in the second half of 2015. 

Cedarburg Hauser Pharmaceuticals upgraded its API plant in Grafton, Wisconsin. The upgraded facilities are expected to increase API production by 20–25%. Improvements to the plant include the addition of a 30-ton process chiller, an additional 200-kilowatt backup generator, and an industrial vacuum pump. The company also tripled its filtration capacity through the addition of new, large Aurora filters. 

In September 2013, International Chemical Investors Group (ICIG) agreed to acquire Allessa, a manufacturer of fine chemicals intermediates and specialty chemicals, headquartered in Frankfurt with production sites in Frankfurt’s vicinity in Fechenheim, Griesheim, and Hoechst. Allessa has more than 890 employees and an internal training center of more than 70 apprentices employed by the company.  The WeylChem Group, ICIG’s non-GMP fine chemicals platform, operates its plants in Griesheim and Hoechst as well, which also used to belong to the former Hoechst conglomerate, and any future cooperation between Allessa and the WeylChem Group, under one ownership, would result in additional synergies. 

Earlier in 2013, ICIG agreed to acquire from the Solvay Group Peptisyntha SA, the Brussels-based custom manufacturer of peptides. Upon closing of the deal, expected this fall, Peptisyntha will become a member of ICIG’s CordenPharma platform as its third site offering peptide manufacturing. Although the US sister company Peptisyntha Inc., located in Torrance, California, is not part of the transaction, certain customer relationships will be assumed by Peptisyntha in Brussels. 

Johnson Matthey’s Catalysis and Chiral Technologies business unit is expanding its existing specialty ligand manufacturing capability to include commercial-scale manufacturing up to 100 kg. The expansion is largely focused on the Buchwald ligands from the Massachusetts Institute of Technology.The Buchwald ligands are a class of bulky and electron-rich dialkylbiaryl monophosphine ligands, which are used for the 

generation of active catalysts. These ligands are used for coupling reactions in the manufacture of both pharmaceuticals and specialty chemicals and are more commonly offered at a research scale for use in the laboratory, according to the company. This is the third recent investment by the company, which has made investments at facilities in Taloja, India, last year and has further expansion underway in Royston, United Kingdom. 

In February 2013, Albemarle announced that its fine-chemistry services  business approved and began construction on another expansion of its Tyrone, Pennsylvania custom manufacturing facility. The $30-million expansion adds new capacity to the site for custom manufacturing projects, but also improves the infrastructure to allow for future expansions. The expansion follows an earlier expansion that began operation in November 2012. The first increment of new capacity will be operational late in the first quarter of 2014. 

Saltigo reported that it successfully passed a FDA inspection for its API production unit in Leverkusen, Germany and all the associated facilities. Also, Saltigo moved its corporate headquarters from Langenfeld to Leverkusen. The relocation of Saltigo’s corporate headquarters is part of a series of moves following the transfer of its parent company, Lanxess, headquarters to Cologne. In Leverkusen, business units and group functions from 11 different office buildings will move into four buildings belonging to Lanxess by the end of January 2014. 

In October 2013, DSM opened a new cGMP facility for biopharmaceutical contract manufacturing in Brisbane, Australia. The facility was built in partnership with Biopharmaceuticals Australia with cooperation from the government of Queensland and the Commonwealth of Australia. 

Companies also are partnering to expand capabilities. Cambridge Major Laboratories, a provider of pharmaceutical API development and manufacturing, and the CDMO/CMO AAIPharma Services agreed to merge in October 2013. Patrick D. Walsh was named as the CEO of the merged company. The combined company forms a supplier of integrated chemistry manufacturing and control (CMC) services, including process chemistry, solid state chemistry, API manufacturing, formulation development, analytical development and testing services, clinical and commercial finished dosage-form manufacturing (oral solid and sterile), and packaging and stability services.

Earlier this year, DSM Pharmaceutical Products signed a collaboration agreement with Chemtrix in the field of continuous flow chemistry. The collaboration is intended to provide equipment, development, and manufacturing services to the pharmaceutical industry. Also, Almac completed its knowledge-transfer partnership with Queens University Belfast, which was intended to develop, improve, and embed bioprocesses to facilitate the delivery of products for its biocatalysis business. The overall partnership aim was to allow technology transfer of fermentation and molecular/microbiology expertise from Queens University to Almac. Almac met the specific partnership objectives by not only sharing a program of work with academics at Queens, but also by attending training courses organized through University College London and embedding key learning back into the company. 

In February 2013, AMRI and Codexis formed  a SMARTSOURCING partnership. The collaboration will provide opportunities to combine the two companies’ capabilities and technologies for specific customer projects. Under the nonexclusive, two-year agreement, the companies will align their respective strengths to identify and implement new and improved manufacturing routes for select APIs with Codexis contributing directed evolution technology that enables enzyme discovery and optimization with AMRI’s process development and manufacturing capabilities, including using AMRI’s proprietary microbial strains.

Several companies are expanding capabilities in high-potency manufacturing, including antibody-drug conjugates (ADCs). For example, Sigma-Aldrich's custom-manufacturing services business unit, SAFC Commercial is expanding two of its manufacturing facilities in the United State: The company is  investing in commercial-scale manufacturing capacity for ADCs at its facility in St. Louis, Missouri and is expanding its high-potency API (HPAPI) manufacturing and storage capacity at its facility in Verona, Wisconsin. Additional commercial-scale manufacturing capacity has also been designed to accommodate future growth in demand for ADC production. 

Carbogen Amcis is investing $4 million to expand its cleanroom clinical-supply facility at its Bubendorf, Switzerland. The Bubendorf facility features a new 100-m

 ADC cleanroom suite for the development and production of ADC clinical material under cGMP and contains Grade D and Grade C areas to allow aseptic and safe handling of highly potent material at occupational exposure limit values (OELs) below 1 µg/m

 at 8-hour time weighted average (8h-TWA). In 2012, Carbogen Amcis and ADC Biotechnology (ADC Bio) partnered for ADC development and manufacturing services. 

In January 2013, Lonza announced plans to invest CHF 14 million ($15 million) to expand ADC manufacturing capacity at its site in Visp, Switzerland. The expansion of the ADC facility will double the company's existing large-scale manufacturing capacity in Visp. The expansion is expected to be completed in the second quarter of 2014.

In October 2012, Fujifilm Diosynth Biotechnologies formed a strategic alliance with Piramal for ADC production, whereby the two parties will offer contract development and manufacture of ADCs. Piramal offers ADC production at its site in Grangemouth, Scotland. Piramal recently invested $2.5 million at is Grangemouth site to upgrade one of its ADC manufacturing sites from clinical phase to commercial grade. The upgrade gives Piramal two commercial grade ADC suites at the Grangemouth facility while retaining clinical phase manufacturing capacity in other suites on site. 

 Investment in formulation development and finished product manufacturing

Dow Chemical and Cambrex have opened a new facility for Dow’s hydroxypropyl methylcellulose acetate succinate (HPMCAS) for drug solubility enhancement at Cambrex’s site in Karlskoga, Sweden. The Cambrex Karlskoga expansion began in early 2013. The facility completion and start of the HPMCAS product validation is part of the solubilization partnership between Dow and Bend Research, announced in October 2012. Beginning in 2014, Dow will be able to commercially supply solubility enabling excipients. 

Colorcon and Evonik have formed  a cooperation agreement for the market promotion and technical support of the Acryl-EZE aqueous acrylic enteric system. The Acryl-EZE system, used for the application of an enteric film coating for oral solid dosage forms, was originally codeveloped by the two companies. It combines Evonik’s enteric polymer, EUDRAGIT L 100-55, with a fully or partially formulated coating system from Colorcon. Prior to this new cooperation agreement, the product was produced, distributed, marketed, and supported solely by Colorcon to the pharmaceutical industry. From now on, customers with enteric coating projects will have access to nine technology centers of Evonik and twenty technical services laboratories of Colorcon globally.

The Controlled Release Alliance between Colorcon and Dow Pharma and Food Solutions has introduced new grades of flowing METHOCEL Premium Cellulose Ethers for direct compression and dry-granulation applications. METHOCEL DC2 is the latest addition to cellulose ethers manufactured by Dow. It is designed to enhance material flow from the blender to the tablet press through a proprietary technology to change the fibrous morphology of traditional METHOCEL materials to a more spherical shape to form an easy-flowing powder. 

Capsugel’s Dosage Form Solutions business unit will upgrade and expand three of its manufacturing facilities in the United States and Europe. The multimillion-dollar investments broaden the company’s global capabilities to handle hormonal as well as high-potent compounds for soft gelatin and liquid-fill hard capsules. The expansions are part of the implementation of its Lipidex technology platform, which was launched in June 2013. 

. Financial terms were not disclosed, and the deal is expected to close at the end of 2013. The merger will add areas such as sterile manufacturing and the production of special active ingredients, including hormones, antibiotics and cytostatics, to Aenova’s existing range of solid, semisolid, and liquid dosage forms. The Aenova Group’s existing production network will increase from eight to 21 sites. In addition to new production facilities in Germany (Berlin, Brackenheim, Münster, Gronau, Regensburg, and Wolfratshausen) and in Europe, Aenova will also acquire its first site in Asia (Japan). The number of employees will increase from 2500 to more than 4000. 

The CDMO Aesica plans opening a new inhalation Lead Technical Center by the end of 2014. Aesica also extended its aseptic capabilities at its site in Nottingham, the United Kingdom with the acquisition of new prefilled-syringes manufacturing equipment capable of processing 5000 units/batch. This latest addition is undergoing validation via process simulation, and validation is expected to be completed by January 2014.

Aesica is expanding its aseptic capabilities at its site in Nottingham, United Kingdom with new prefilled syringes manufacturing equipment capable of processing 5000 units/batch. The equipment is currently undergoing validation through process simulation trials. The company’s total investment is more than £500,000 ($797,395), and  completion of the validation process is expected to be completed by January 2014. The company’s new equipment also enables production of other product forms, such as pen and cartridge syringes and nasal devices. Over the next three years, Aesica is targeting production of 900,000 units and is in advanced discussions with one company for the scale-up of a clinical trial product for which a joint validation is pending.

Almac reported several recent developments. In January 2013, Almac completed the doubling of its pharmaceutical development service capabilities with the opening of a new dedicated non-GMP facility and two analytical laboratories at its UK headquarters. In parallel to the new non-GMP facility, Almac doubled its analytical capacity with new analytical laboratories for processing large sample sets that result from non-GMP process development work for clients who seek to better understand their processes in line with the principles of quality by design. Additionally, in response to increased demand for preclinical and early-phase clinical GMP supply, Almac added to its pharmaceutical development offering with an investment in additional Xcelodose technology, which provides the capability to dose potent APIs directly into capsules. Also, Novozymes Biopharma, part of Novozymes, has formed a new collaboration with Almac to provide a combined service for drug-development applications in the field of drug targeting and pharmacokinetic improvements. The collaboration will combined Almac’s manufacturing assets and protein conjugation capability to link Novozymes’ Recombumin Flex technology to peptide and small-molecule drugs. Collaborations with commercial partners have already begun and will continue to expand in early 2014.

IDT Biologika, a producer of proprietary and third-party biopharmaceuticals and viral and bacterial vaccines, and Oncotec Pharma Produktion announced investments for increasing their respective production capacities. IDT will invest an additional EUR 40 million ($55 million) in its vaccine and parenteral sterile fill-and-finish capacities in syringes, vials, lyophilization and packaging at its BioPharmaPark, located in Dessau-Roβlau. Among the upgrades are serialization and anticounterfeiting capabilities. In September 2013, IDT started up its new production capacity dedicated to sterile parenteral drug products, including vaccines and biologics, having completed an expansion project announced in 2011. Capacity to manufacture vial-based products in liquid and lyophilized form will increase to 60 million units per year. Oncotec Pharma Produktion, a pharmaceutical manufacturing partner of aseptically produced cytostatic drug products, recently announced an EUR 30-million ($41-million) investment to expand sterile parenteral oncology drug manufacturing capacity within IDT’s BioPharmaPark. The expansion projects are expected to be completed in 2016. 

Vetter is investing more than $100 million across its production sites in Germany and the United States to expand and upgrade its facilities to expand filling capacity. Two new filling lines are currently being designed for Vetter's Ravensburg South facility in Germany. The new lines will fill liquid cartridges and vials and will add to the production site’s current lines, one of which is a syringe line that was launched in the spring of 2013. At Vetter’s US clinical manufacturing facility in Chicago, a third filling line for prefilled syringes is nearing completion. Expected to be operational in 2014, the new clinical line will have a maximum batch size of 30,000. 

A roundup of expansion activity of manufacturing capacity and service offerings from fine-chemical producers, CDMOs, and CMOs.

PTSM: Pharmaceutical Technology Sourcing and Management-11-06-2013

The Expense of Vision in Outsourcing

Pharma News in Global Health and Sustainability

A Strong Outlook for Global Pharma Outsourcing

Fine-Chemical Companies, CDMOs and CMOs Expand