Biopharmaceuticals constitute a global industry, and biomanufacturers and drug innovators have long recognized the need for a global product strategy. As emerging economies grow, they are beginning to demand domestically produced biologics and vaccines to meet the public health needs of their growing populations, which in turn, has opened strategic opportunities at major biopharmaceutical companies. Biomanufacturing hubs outside the US and Western Europe are providing new options for global operations. In the past, potential cost savings drove many outsourcing decisions, but today, decisions are more complex as drug innovators integrate the demands of a growing global market.  

BioPlan Associates tracked these trends in its 

9th Annual Report and Survey of Biopharmaceutical Manufacturers

 (1). As biologics companies contract out of more sophisticated projects, global outsourcing has moved from a tactical to strategic decision for many companies. The decision calculus surrounding the choice of a global CMO reflects many of these changes. For example, perceptions of offshoring are changing, and drug innovators have become far less concerned about whether their CMO is based locally. Of 19 CMO attributes identified in the BioPlan study, "being local" came in last in terms of importance with only 6.3% of the 302 respondents identifying this attribute as "very important" (1). In 2005, 10.4% of respondents cited a CMO's location as "very important," but only 6.3% did in 2012. This change reflects greater acceptance of offshoring outsourcing activities due to industry globalisation, more production projects being successfully offshored and improved expertise of sponsors in managing offshored outsourcing.

The BioPlan survey asked respondents to reflect on their facility's future international outsourcing (i.e., offshoring) during the next five years. Depending on the outsourcing operation, respondents indicated between 35–42% of their manufacturing operations (process development, biomanufacturing operations and other operations) could be offshored to some extent (see 

), in five years, and 46% of clinical trial-manufacturing operations could be offshored to some degree.

 Figure 1: Percentage of biomanufacturers in BioPlan Associates’ 2012 and 2011 surveys responding that they will offshore at least some biomanufacturing during the next five years (1). 

A large percentage of biomanufacturers in 2012—as much as 36%—expect some manufacturing offshored by their facility during next five years (see 

) although the percentage expecting to offshore more than half of their operations rated only in the single digits. This finding suggests that it may be too soon to assert that offshoring will become a mainstream activity although there are reasons to expect that offshoring will become more accepted, especially as regional operations outside the US and Europe begin to meet regulatory standards and as single-use bioprocessing devices enter commercial-scale manufacturing. These integrated, fully disposable facilities will enable manufacturing in more developing regions as many of the quality-management processes required for traditional facilities can be "built in" to the disposable devices.  

In comparing survey results on offshoring in 2012 and 2011, the survey showed an across-the-board increase in the percentage of respondents who said they expect offshoring of at least some of their operations during the next five years (see 

). Specifically, the survey showed that:   

35.7% said they would offshore at least some process development for biomanufacturing, up from 22.4% in 2011. 

40.5% indicated they would offshore at least some biomanufacturing operations, up from 37.6% in 2011.  

41.7% expected to outsource internationally other operations, up from 29.6% in 2011. 

Top 1000 Global Biopharmaceutical Facilities Index

, 37.5% of global biopharmaceutical manufacturing capacity exists outside of North America and Europe (2). Holding respectively 8.5% and 8.1% of global biomanufacturing capacity, China and India are emerging on the global scene, followed by Japan and other Asian countries, which have 9.6% of global biomanufacturing capacity and Latin America at 6.5%.  

It is no surprise that countries, such as China and India, which are rapidly developing biomanufacturing clusters, appear high on the list of likely country destinations for international outsourcing. Among all industry respondents to the BioPlan annual study, China ranked highest as a potential international outsourcing destination with 26.2% of respondents (up from 17%), indicating that there was a "likelihood" or "strong likelihood" that they would outsource production to facilities there in the next five years. Next on the list was India, cited by 18.4% of respondents, up from 13.2% in 2011.  

To some extent, geographical outsourcing trends tend to reflect availability (perceived or actual) of reputable CMOs in a given country. New facilities coming on line and the limited number of known CMOs can be more important reasons than cultural or political factors while patent and intellectual-property issues also clearly play a role. Nevertheless, China is clearly the top potential destination for future international outsourcing (even when segregating by US and European-based respondents), and India is growing in favour, particularly among US respondents.  

It is worth keeping in mind that China was a late starter in the area of contract manufacturing. The few internationally based CMOs in China are working hard to establish a global presence, and legal and regulatory aspects continue to hinder commercial-scale contract manufacturing. Nevertheless, there continues to be excess pharmaceutical production capacity in China, so outsourcing may permit improvements as the idle capacity of many production facilities is addressed. It may take years for Chinese CMOs, however, to come up to full cGMP standards and to be permitted to operate at commercial scale. The BioPlan survey data shows that by 2017, between one-third and almost one-half of the industry will be outsourcing some form of operations internationally, with China a key component of future plans. Assuming that acceptance of offshoring continues to increase and that key emerging destinations, such as China, reach the necessary regulatory standards, it is reasonable to assume that by the end of this decade, offshoring will have become a mainstream activity.  

  is president of BioPlan Associates and a periodic contributor to Outsourcing Outlook. 

9th Annual Report and Survey of Biopharmaceutical Manufacturers (

, Top 1000 Global Biopharmaceutical Facilities Index 

Articles

Outsourcing

Will international biomanufacturing outsourcing become mainstream in this decade?

Offshoring Biomanufacturing

As fine-chemical producers, contract manufacturers, and pharmaceutical companies gather this month for Informex, being held Feb. 19-22 in Anaheim, California, custom manufacturers face improving conditions. Certain CMOs report improving business conditions in 2012, and although overall capacity expansions are few, CMOs continue to invest in specialized technological capabilities, such as high-potency API (HPAPI manufacturing).  


Lonza, a bellwether in the custom-manufacturing arena, reported improvements in this business in 2012 following a weak 2011. In 2012, Lonza reported that it strengthened its chemical manufacturing product pipeline in all clinical phases to more than 350 active projects and its manufacturing capacity utilization to above 75%. The improvement reflects a recovery from 2011, when the business unit recovered from various product delays and project cancellations. In 2013, the chemical manufacturing business will be part of the company’s “Visp Challenge,” a program initiated in 2011 to improve the efficiency and economic viability of its Visp, Switzerland, manufacturing site, the largest site in Lonza’s manufacturing network. 

On the expansion side, Lonza reported on the first two build-out phases of its large-scale multpurpose cGMP API plant in Nansha, China, following FDA approval of several customer projects in late 2011. Also, a new cGMP kilo-laboratory in Nansha and an additional small-scale manufacturing train were successfully brought on line. The company’s large-scale antibody drug conjugates project in Visp was finalized on schedule and the plant received FDA approval in the third quarter of 2012. A second expansion phase has started and will be finalized toward the end of the first half of 2014. Five additional HPAPI labs in Visp, with capabilities for cytotoxic substances, are operational and utilized, and new investment in additional cytotoxic API manufacturing capacity in Visp was started up, according to the company. Lonza also increased peptide-manufacturing capabilities at it site in Braine, Belgium. 

On the biologics manufacturing side, Lonza raised its mid- and large-scale asset utilization in 2012, which included a new facility in Singapore, to above 70% with its mammalian and microbial services and manufacturing offerings increasing to more than 340 active projects. Some key highlights in 2012 included the new Singapore facility successfully performing its first validation campaigns for multiple customers and approval by FDA in the fourth quarter of 2012. Expansion of the laboratories and manufacturing suites at its Slough, United Kingdom, is on track. The company’s Hopkinton, Massachusetts, site is fully operational, manufacturing multiple early-phase products for various customers following recent quality-control problems. Lonza reported that in cooperation with  FDA and customers, the Hopkinton site made significant progress with its quality systems and equipment performance, and the company expects the lifting of the FDA Warning Letter ban in 2013 after a final FDA inspection. The harmonization programs for all mid- and large-scale mammalian manufacturing facilities are continuing. These programs enable its facilities to provide capacity from 20 to 20 000 liters.

Other companies are proceeding with investments and alliances to build HPAPI capabilities. In 2012, Carbogen Amcis and ADC Biotechnology announced a partnership to provide customers with development and manufacturing services for antibody drug conjugates. ADC Bio will provide access to proprietary solid-phase immobilization technologies for conjugation and long-term storage of antibody drug conjugates, and Carbogen Amcis will focus on small- to large-scale GMP supply and on the formulation of antibody drug conjugate. In October 2012, Fujifilm Diosynth Biotechnologies formed a strategic alliance with Piramal for antibody drug conjugate production, whereby the two parties will offer contract development and manufacture of ADCs. Piramal offers antibody drug conjugate production at its site in Grangemouth, Scotland. Fujifilm recently announced an expansion of its cGMP manufacturing facilities at its sites in Research Triangle Park, North Carolina, and Billingham, United Kingdom. Novasep announced in 2012 a $3.9-million (EUR 3 million) investment to expand its highly potent API manufacturing capabilities at its Le Mans, France, facility. The plant expansion is expected to be fully operational by the beginning of 2013. The new Le Mans facility adds to Novasep’s strategy for total synthesis of antibody drug conjugates.

 Other companies are proceeding with investment or recently made investments in 2012. Almac expanded its API manufacturing facility at its European Headquarters in Craigavon, United Kingdom, with a scheduled completion for end of 2012. This upgrade includes installation of two 1000-L reactors and a pressure-filter dryer, which allows production of GMP APIs up to 150-kg batch. Cambridge Major Laboratories (CML) is planning an expansion of its large-scale API manufacturing facility in Germantown, Wisconsin. The expansion comes three years after commissioning the new site. The expansion will include additional reactor capacity as well as isolation equipment. Alongside capacity additions, CML has made additional investments in engineering controls to ensure the sustainability of the business. Cedarburg Hauser Pharmaceuticals expanded the capacity of its Wisconsin-based API manufacturing plant as a result of an increased demand for contract manufacturing of commercial APIs as well as additional upgrades for improving safety and GMP systems. Dr. Reddy’s eports expansion in the areas of activated mPEG manufacturing and in the development and manufacture of APIs for use in preclinical through to commercial development at its manufacturing facility in Mirfield, United Kingdom. Also,in addition to its HPAPI capacity expansion, Novasep is investing EUR 30 million ($39 million) to build a chromatography plant for the production of large volumes of commercial APIs. The plant will be built on Novasep’s existing site in Mourenx, France, and is expected to be operational and validated within 18 months. The new plant will contain Varicol continuous chromatography systems with 1200-mm diameter columns operated at up to 70 bars. SAFC, part of Sigma-Aldrich, is expanding its operations in Scotland by investing in the development of a new powder-manufacturing facility on its Irvine site. SAFC’s new facility in Irvine is its second powder manufacturing facility, which will support SAFC’s risk-management program, providing an internal back-up supplier for its customers. The new facility will be used to service customers across Europe.

APIs

As contract API manufacturers, fine-chemical producers, and pharmaceutical companies prepare to attend Informex in Anaheim this month, the state of the industry shows improving conditions in certain sectors.

Cautious Times for Fine-Chemical Producers and Contract API Manufacturers

Swiss researchers have discovered a method that allows for the controlled release of an active agent on the basis of a magnetic nanovehicle. The research was conducted as part of the National Research Program "Smart Materials,” a cooperation between the Swiss National Science Foundation and the Commission for Technology and Innovation. The specific work was conducted by researchers at ETH Lausanne, the Adolphe Merkle Institute, and the University Hospital of Geneva in Switzerland.

The researchers demonstrated the feasibility of using a nanovehicle to transport drugs and release them in a controlled manner, as explained in a Jan. 24, 2013, press release from the Swiss National Science Foundation. The nanocontainer used was a liposome witha diameter of 100 to 200 nm. The membrane of the vesicle was composed of phospholipids and the inside of the vesicle offered room for the drug. Superparamagnetic iron oxide nanoparticles (SPIONs) were integrated into the liposome membrane; the SPIONs become magnetic in the presence of an external magnetic field. Once they are in the field, the SPIONs heat up. The heat makes the membrane permeable, and the drug is released. SPION are also a contrast agent in magnetic resonance imaging (MRI). A simple MRI shows the location of the SPION and allows for the release of the drug once it has reached the targeted spot.

In their study, the researchers noted that liposomes have been characterized by cryogenic electron microscopy (CryoTEM) as well as in combination with nanoparticles in SPIONs incorporated inside the liposomal membrane. CryoTEM maintains the native state of the liposomes. The quick freezing of the sample immobilizes particles and liposomes exactly at their position in the suspension, which allows localization information to be extracted from the images. The researchers reported on the analysis of cryoTEM images of liposome-particle hybrids, including the estimation of the contrast transfer function (CTF) and electron dose as well as the correct positioning of the sample holder and tomography for accurate localization (1).

 Another another challenge was to reach a temperature sufficiently high to open up the liposomes, according to the release. This problem was addressed by increasing the size of the SPION from 6 to 15 nm. The membrane of the vesicles had a thickness of only 4-5 nm. The researchers regrouped the SPION in one part of the membrane, which made the MRI detection easier. Before starting 

 tests, the researchers plan to study the integration of SPION into the liposome membrane in greater detail, according to the release. 

Drug Delivery

Heated magnetic nanoparticles consisting of a liposome nanocontainer with superparamagnetic iron oxide nanoparticles are among the recent advances in nano-based drug delivery.

Advances in Nanotechnology-Based Drug Delivery

The International Federation of Pharmaceutical Manufacturers & Associations (IFPMA) released its 2012 status report on pharmaceutical R&D to address neglected diseases that disproportionately affect people in low- and middle- income countries. Representing a 40% increase over 2011, the 132 R&D projects in the 2012 update focus on the following diseases prioritized by the World Health Organization's (WHO) Special Program for Research and Training in Tropical Diseases (TDR): tuberculosis, malaria, human African trypanosomiasis (sleeping sickness), leishmaniasis, dengue, onchocerciasis (river blindness), American trypanosomiasis (Chagas disease), schistosomiasis, leprosy, and lymphatic filariasis.

 "We take a comprehensive approach to tacking neglected diseases," said IFPMA Director General Eduardo Pisani, in a Jan. 14, 2013 press release. "Donations of 14 billion treatments this decade address patients’ near-term needs while these 132 R&D programs will bring innovative vaccines and treatments to meet future needs and hopefully stop these dreaded diseases." 

 Of the 132 R&D projects listed in the IFPMA status report, 112 (85%) are product-development partnerships (PDPs) while the remaining 20 (15%) projects are company-only undertakings. As part of the 2012 London Declaration on Neglected Diseases, the research-based pharmaceutical industry pledged continued R&D and donations of 14 billion treatments by 2020 to control or eliminate nine neglected diseases. . The number of medicine and vaccine R&D projects has increased by more than 40%, from 93 in 2011 to 132 in 2012, according to the IFPMA report. 

 The IFPMA report points to data from the fifth annual G-FINDER report “Neglected Disease R&D: A Five-Year Review,” which shows total R&D funding for neglected diseases as $3.05 billion in 2011. The public sector provides nearly two-thirds ($1.9 billion, 64%) of global funding for R&D followed by the philanthropic sector contributions ($570.6 million, 18.7%) and the pharmaceutical industry ($525.1 million, 17.2%). In 2011, the largest sectoral increase came from the pharmaceutical industry which rose by $20 million (+ 4.2%). In terms of five-year trends, both public and philanthropic sector funding have dropped since the global financial crisisalthough both still reached higher levels in 2011 than in 2007. Meanwhile, multinational pharmaceutical company investment increased by $193.6 million since 2008. 

 In January 2013, WHO issued a report to provide and update on the status of 17 neglected tropical diseases. The publication charts progress in controlling, eliminating and eradicating these diseases. Two are targeted for global eradication, dracunculiasis (guinea worm disease) in 2015 and yaws in 2020. The report outlines six targets set for the elimination of five diseases in 2015 and a further 10 targets for nine diseases for 2020, either globally or in selected geographical areas. 

“With this new phase in the control of these diseases, we are moving ahead towards achieving universal health coverage with essential interventions,” says WHO Director-General Margaret Chan, in a Jan. 16, 2013 WHO press release.  “The challenge now is to strengthen capacity of national disease programs in endemic countries and streamline supply chains to get the drugs to the people who need them, when they need them.” 

 WHO reported that donation of medicines and funding through an alignment of international partners have helped fast-track actions and initiatives that are now having a measurable impact in affected countries with considerable scale-up of preventive chemotherapy interventions. This involves the widespread delivery of safe, single-dose, quality-assured medicines as preventive treatment against five helminthiases and trachoma (chlamydial infection). In 2010, 711 million people received treatment for at least one of the four diseases (lymphatic filariasis, onchocerciasis, schistosomiasis and soil-transmitted helminthiases) targeted for preventive chemotherapy, which involves the widespread delivery of safe, single-dose, quality-assured medicines as preventive treatment. 

 During the next five years, WHO projects that treatment for schistosomiasis (bilharzia) will reach 235 million people. This will be achieved by increasing availability of medicines by using donated medicines and improved distribution at a country level. WHO also reports that a reduction in reported cases of dracunculiasis (guinea-worm disease) with only 521 cases between January and September 2012 compared with 1006 confirmed cases for the same period in 2011 and of human African trypanosomiasis (sleeping sickness) to less than 7000 in 2011 from a high of 30 000 annual cases at the turn of the century. 

 Rabies has been eliminated in several countries, with WHO eyeing regional elimination of this preventable disease by 2020. A new strategy, which involves the early detection and use of antibiotics to treat Buruli ulcer, has drastically reduced suffering and disability from this chronic and debilitating skin condition. An evaluation of WHO’s new strategy, which aims at eradicating yaws by 2020 using a new oral antibiotic treatment designed to replace those developed in the 1950s (which mainly centered on delivering injections of benzathine benzylpenicillin).In 2012, dengue ranked as the fastest spreading vector-borne viral disease, with an epidemic potential in the world, registering a 30-fold increase in disease incidence during the past 50 years. The WHO report cites sustainable preventive measures as a key for addressing this area. 

CSR and Sustainability Forum

Pharma companies intensify R&D efforts to address treatments for neglected tropical diseases in the developing world.

Pharma Companies Increase R&D for Neglected Tropical Disease

 announced that its coalition companies have collectively hired 51,835 veterans through 2012. The coalition, which includes 

, among others; was launched in March 2011 by 11 private-sector companies, and is currently more than halfway to its goal of hiring at least 100,000 US military veterans by 2020.

, a community of action that connects social entrepreneurs around the world to share ideas, are launching Transforming Health Systems: Gamechanging Business Models, an online competition to discover innovative business models that are solving critical problems in health systems around the world. Transforming Health Systems also seeks business models that confront problems in emerging markets where governments, businesses, and nonprofit organizations often lack the resources or commitment to serve communities in need. Winners will receive awards totaling $85,000 plus support from Boehringer Ingelheim to help advance their business models. They will be matched with Boehringer Ingelheim’s local country offices, and will be able to explore the potential for partnerships or further support. Individuals, organizations, or partnerships are eligible to enter from now until Apr. 10, 2013, at 

 has formed a joint venture with the India-based vaccines company 

 to research and develop a six-in-one combination pediatric vaccine to help protect children in India and other developing countries from certain infectious diseases. If the vaccine is approved, it will combine GSK’s injectable polio vaccine and Biological E’s pentavalent vaccine for diphtheria, tetanus, whooping cough, hepatitis B and hemophilus influenza Type B. The vaccine is intended to reduce the number of injections for children and to improve compliance with immunization schedules. Space at local storage facilities would also be freed up because the vaccine is intended to be a fully liquid, ready-to-use formulation with no need for additional ingredients or materials. Phase I development is expected to start in the next two years. Each company will have a 50% stake in the joint venture and will bear the development costs. A small cash investment will be made by both companies to cover the start-up costs and further development costs will be split equally.

A roundup of developments in corporate social responsibility (CSR) and sustainability from the bio/pharmaceutical industry, its suppliers, and other public and private organizations.

CSR and Sustainability in the News

Effective management of manufacturing facilities is an important consideration for pharmaceutical/biopharmaceutical companies, particularly in an era of plant consolidation, restructuring, and a need to maintain of achieve higher returns on capital. Patricia Van Arnum, executive editor of 

, recently spoke to Rakesh Kishan and Eric Grey, senior consultant, both at UMS Advisory to gain a perspective on best practices in facilities management. 

 The pharmaceutical industry as a whole has undergone and continues to undergo restructuring, including manufacturing plant rationalization. In managing an evolving manufacturing and supply network, what would you identify as the key requisites in facilities management to facilitate product transfer and potential ownership changes in a given facility. What are some of the main pitfalls arising in facilities management that may impede those changes in product transfer and ownership changes? 

 A key priority for facilities management in today’s changing manufacturing supply network is to shift to variable cost and a flexible structure. Flexibility in the workforce and contracts are vital in a manufacturing environment characterized by product transfer and ownership changes. These changes can be impeded by a fixed cost structure that offers little variability. 

As plants rationalize or reposition their missions, facilities management should align facilities-management asset-management strategy in light of the manufacturing strategy. Today, it is still possible to find facilities-management asset-maintenance strategiesthat are designed around redundancy for assets whose criticality to production has been downgraded. As plant strategies change, facilities management needs to re-align its approach and the delivery model and risk-acceptance profile that needs to filter right through to facilities-management standards and procedures. 

 A key area for facilities-management contribution to the business will be through strategic portfolio planning. As plant networks change, facilities management can offer strategic space and capacity-planning solutions through new “site of the future” concept models, different asset-ownership structures, and new, flexible delivery models based on analytic visibility into lifecycle costs. Although portfolio planning is important, facilities management also needs to address the important requirements of the site heads and other site stakeholders. This they can do by engaging stakeholders in site master planning to further hone and refine the site- level strategy for facilities-management operations. In sum, facilities management needs to align the portfolio strategy both financially and operationally with the business while keeping a clear site-level focus on asset strategy, workplace services, as well as site master planning.

The pharmaceutical industry is intensifying its product development in biologic-based drugs. Given the higher capital costs associated with biopharmaceutical manufacturing facilities, what would you identify as some best practices inoptimizing facilities management at a biopharmaceutical manufacturing facility? What are some of the unique considerations that need to be taken into account? 

 Facilities-management equipment and systems are more closely connected with product in biologic facilities. High-purity systems and their operations and maintenance are far more closely linked to production in a biologic facility. Consequently, biologic-based drug-manufacturing facilities-management organizations need to have very strong planning and scheduling processes that are tightly integrated into production planning and scheduling. 

The yield-driven biologics production environment can be by far very dynamic when compared with a fixed-schedule pharmaceutical manufacturing environment. Consequently, facilities-management can create value by ensuring effective interfaces with manufacturing and shifting their maintenance and engineering support based on real-time information. Facilities management’s ability to provide reliable utilities and operational solutions for advanced cleaning and maintenance technologies designed specifically for sterile and high-corrosion environments is a source of value in biologics sites. Facilities management’s should also become operationally more cross-functional and flexible to enable quicker equipment shifts across multiple product-recipe trains while maintaining production environment integrity.

 With the pharmaceutical industry facing increased cost pressures, what metrics do you think best evaluate plant performance and operation? Can you be specific in terms of either traditional or new metrics relating to return on capital and asset optimization? 

 Most companies use several measures to gauge plant performance and operations. Any time one thinks about measurement, one has to be mindful of three key facts: No single measure is perfect; not everything important can be measured (for example, shop floor leadership is a strong predictor of plant uptime); and hence, it’s a balance of measures that count the most. Too many measures typically suggest a lack of focus on what truly matters. The measures we typically see are:

: A bottom-line efficiency metric, important particularly in light of competition from low-cost countries;

: A measure of production-material effectiveness and waste
• 

: Measures working-capital effectiveness 
 • 

): Measures equipment utilization, productivity, and effectiveness.

It is very important to recognize interdependencies across the measures. A single- minded focus on solving for a particular measure can end up creating problems in other parts of the operation. For example, a site that may focus on cost/unit may reduce the expertise required to solve problems both on the floor and in the offices, which in turn creates more material and transactional waste.Or a site may use inventory to buffer against operational issues at the expense of working capital rather than address root causes. Alternatively, a site may add labor to improve right-first-time but drive up the cost/unit, which may also be influenced by the regulatory environment at the site.

But there are instances where a single overarching measure can drive improvements in another hierarchy of metrics. For example a site focused on improving OEE found it had to also get the right-first-time improved to prevent paperwork delaying production and also reduce its inventory (increasing inventory turns) in order to achieve sustained results. OEE drove maintenance and facilities groups to work more closely together in order to ensure the assets were available for production when needed.

 Emerging markets are a growth area for the pharmaceutical industry, where pharmaceutical companies may partner with domestically domiciled companies or seek to build their own manufacturing base in a country. What are some of the buy/partner decision points that a company should take into consideration?

: Overseas manufacturing and laboratories are being positioned as the “lab of the future” or as the “manufacturing plant of the future,” as new sites are designed and configured in emerging markets. In these environments, facilities-management services and delivery models can be designed and configured to offer flexible, high-performing solutions without facing legacy constraints. Facilities management has the opportunity to pursue different “make or buy,” “partner/own” choices in their delivery models from the outset. 

For example, one pharmaceutical site elected to bring in an operating facilities-management supplier during the design phase to ensure that operability and maintenance perspectives were incorporated into the design phase of the facility. As the facility started to come on line, the site also then purchased a new service solution from the supplier to provide an integrated set of facilities-management services at the site, where the supplier could leverage their knowledge and input from the design, commissioning, and equipment warrantees into their maintenance and service delivery solution.

Global Feature

In the era of manufacturing capacity rationalizaton, tighter return on assets, and re-alignment of manufacturing assets to meet changing product demand, strategies for cost-effectively managing manufacturing and other facilities become ever-more crucial. A Q&A with UMS Advisory.

PTSM: Pharmaceutical Technology Sourcing and Management-02-06-2013

Offshoring Biomanufacturing

Cautious Times for Fine-Chemical Producers and Contract API Manufacturers

Advances in Nanotechnology-Based Drug Delivery

Pharma Companies Increase R&D for Neglected Tropical Disease

CSR and Sustainability in the News

Optimizing Facilities Management in the Pharma Industry