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Technical expertise

We have an impressive track record, safely and successfully delivering projects for facilities covering all aspects of pharmaceutical research, development and manufacture: chemical active pharmaceutical ingredients, bulk biopharmaceuticals, liquid and solid dosage forms, pilot plants, research laboratories, medical devices, consumer health products, and diagnostics.

The growing importance of vaccine production to meet expanding demands and the threats of global pandemics is only underscored by today's news headlines. Newer recombinant-based technologies promise to enhance or replace traditional production methods, such as egg-based flu vaccine production, while greatly speeding up response and development time-to-market.<br />&nbsp;<p>Whether new or traditional, we can provide the process expertise, engineering experience and project execution capability required to meet these new challenges. We marry facility design with process functionality and project delivery expertise to help our clients ensure that global cGMP regulatory compliance is met.</p><p>We offer process solutions for:</p><ul><li>Traditional vaccine production</li><li>Egg-based vaccine production</li><li style="">Recombinant cell culture based processes</li><li style="">Transgenic plant technologies</li><li style="">Vaccine purification, formulation and fill / finish</li><li style="">Process simulation and optimization</li><li style="">Pathogens containment technology</li><li style="">Custom applications<br style="" /></li></ul>

<p>If our clients can't consistently produce products with system efficiency and reliability, then they can't meet the needs and opportunities of the marketplace.<br /><br />With manufacturing becoming ever more competitive and profit margins under strain, the cost of manufacturing your product is increasingly important. Efficient product flows, higher production rates, lower cost of utilities, and greater operational up-time are all critical to improving the utilization of equipment, reducing required capital investment, and driving down the cost of manufacturing products.<br /><br />The time and effort spent in the development of our clients’ products, whether tablets, capsules, or novel oral drug delivery technology, should not be placed in jeopardy by a manufacturing system that doesn't deliver.<br /><br />We can provide the engineering design, equipment, facility expertise and proven project execution capability to help our clients get their products to market, cost-effectively. Our design processes focus on process architecture, ensuring that product, people and material flows are optimized to deliver a cost-effective solution, through a well-coordinated, seamless manufacturing operation, incorporating the “lean manufacturing” concepts.<br /><br />Our experience will help provide our clients with a sustainable operation able to meet the challenges of a constantly changing marketplace and ever evolving regulatory landscape.<br /><br />We offer oral solids dosage solutions for:</p><ul><li style="">Granulation</li><li style="">Fluid bed drying</li><li style="">Powder blending</li><li style="">Tabletting</li><li style="">Blister lines and bottle filling</li><li style="">Tablet coating</li><li style="">Encapsulation</li><li style="">Tablet packaging</li><li style="">Highly-active ingredients containment technology</li></ul>

&nbsp;Small molecule, active pharmaceutical ingredients (API)-based products remain a vital part of global healthcare. It’s key to get the design right the first time, to avoid regulatory and quality issues down the road!<br /><br />The production of small molecule APIs continues to present many challenges to the pharmaceutical manufacturer and developer. A constantly evolving regulatory landscape, increased competition in the marketplace, and shifting environmental factors forcing process changes are just a few. High-potency and highly-reactive compounds present special containment challenges for meeting safety and cGMP requirements.<br />&nbsp;<br />Our acknowledged expertise encompasses both batch and continuous chemical synthesis. We have designed and built a wide variety of facilities, each configured to meet our clients’ needs for operational flexibility and adaptability and the most stringent safety, regulatory and product quality demands.<br /><br />We have engineered facilities to cover the entire range of containment thresholds including some of the lowest design operating exposure limits in the industry.<br /><br style="" /><p style="">We offer process solutions for the API customer:</p><ul><li style="">Specialty chemical process design</li><li style="">Batch chemical reactor design</li><li style="">Recovery and purification operations (distillation, filtration, centrifugation)</li><li style="">Environmental emissions control</li><li style="">Process safety management and HAZOP studies</li><li style="">Containment design for high potency compounds</li><li style="">Process simulation &amp; optimization</li><li style="">Custom applications<br style="" /></li></ul>

<p>&nbsp;Our experience includes:</p><ul><li>Batch and fed batch cell culture reactors up to 25,000 liters</li><li style="">Perfusion cell culture reactors</li><li style="">Fermentor design up to 200,000 liters</li><li style="">Unique mass transfer, heat removal, and mixing strategies</li><li style="">Reactor design for extremophiles</li><li style="">High biosafety level reactor design<br style="" /></li></ul><p style="">Our experts work with our clients to optimise their bioprocess scale-ups and develop a design that minimizes system complexity while assuring process reliability. No other engineering firm offers our depth of knowledge and experience in the design, construction and troubleshooting of bioreactor and fermentor systems.</p>

We have in-depth knowledge of, and experience in, the design, procurement, installation, start-up and validation of recovery and purification systems for mammalian cell culture, insect cell culture, fermentation, vaccine and transgenic processes. In addition to our process excellence, our facilities design experts are experienced in providing the proper containment, cleanliness classification and viral segregation for recovery and purification areas.<br /><br />Our experience includes working with standard and custom process systems. We have designed and installed both modular skid mounted systems and stick-built systems to meet our clients’ needs. Our designs take all aspects of the manufacturing process into careful consideration including CIP, SIP, cleaning and storage, cGMP operations, sampling, product changeovers, scalability and maintainability.<br />&nbsp;<br />Some of the technologies we have employed on harvest and recovery include centrifugation, homogenization, depth filtration, and tangential follow filtration. We have experience with both disposable and traditional systems.<br /><br />On the purification side of the process, we have experience with ion exchange, affinity, and size exclusion chromatography and tangential and nano filtration for buffer exchange and virus removal.<br style="" />

All of the time and resources that are invested in producing our clients’ products, whether novel vaccines, common analgesics, or diagnostic contrast media, are wasted if our clients don't have the confidence in the final steps to completing the manufacturing process. Amec Foster Wheeler provides the engineering experience to create a solution to help our clients get a product ‘out of the door’. Whether a tablet or a biological parenteral, each filling process requires an experienced approach to achieve a successful production line. We combine the facility with the process and equipment to ensure every step is coordinated and seamless.<br style="" /><br style="" /><p style="">We develop fill / finish solutions for:</p><ul><li>Aseptic liquid filling</li><li style="">Thermally-sterilised liquid forms</li><li style="">Oral solid dosage</li><li style="">Diagnostics</li><li style="">Transdermal products</li><li style="">Powder filling</li><li style="">Potent compounds</li><li style="">Custom applications<br style="" /></li></ul>

Increasingly, the trend in our industry is to reduce operator handling with loading and unloading lyophilizers in order to reduce the risks associated with both product contamination and personnel safety. Although the design of lyophilizers has not changed much over the past 20 years, the automation associated with loading and unloading has. Whether the loading containers are trays, vials, ampoules or cartridges, automating the loading and unloading and integration of the equipment such as the lyo, loading machine, isolator, etc, can be challenging. Add in the cleaning and containment issues and it can truly complicate the process automation of all the components.<br /><br />If sufficient time and engineering is not spent in the design, construction and factory testing phases of the equipment, difficulties can arise with the qualification and operation phases of the equipment once it arrives on site. We have both the technical and design, procurement, and qualification experience to work with equipment suppliers in order to minimize the potential risks and obstacles associated with bringing a complicated piece of equipment to a fully automated, operational and validated system.<br />&nbsp;<br />How do we do this? By developing tight specifications with the equipment suppliers, thoroughly reviewing their documentation and participating in factory testing, ensuring the equipment is not only functional, but meets the requirements established by the owner. We also bring a wealth of experience and solutions when problems arise along the way.

<p style="">In these uncertain times with limited capital available, pharma companies are looking for ways to achieve flexible, lower cost, manufacturing operations. Amec Foster Wheeler can perform an objective process-specific analysis and recommend which of the following disposable solutions would best fit our clients’ needs:</p><ul><li style="">Cell culture/fermentation utilizing single-use bioreactors </li><li style="">Filtration steps that include depth filtration, tangential filtration and dead-end filtration</li><li style="">Centrifugation with disposable product contact inserts</li><li style="">Liquid chromatography with disposable, pre-packed columns</li><li style="">Product hold utilizing disposable bioprocess containers with various mixing options in optional jacketed outer containers</li><li style="">Solution prep and hold utilizing single-use mixing systems with or without solids/liquid addition ports and bioprocess containers&nbsp;</li><li style="">Cold product storage<br style="" /></li></ul>

Packaging in today's healthcare manufacturing environment is more than the traditional bottle in a carton. Our clients’ product investment value is at its peak when the product reaches the packaging operation. Our clients’ reputation is travelling &quot;down the line&quot; along with the vials, syringes, bottles and cartons. The right packaging equipment, integrated into a complete system, supports the quality of the product all the way to the end-user.<br style="" />&nbsp;<br />Amec Foster Wheeler has the experience to develop and execute a comprehensive plan for implementation of any kind of packaging line system. We have hands-on experience with the full range of packaging solutions whether it's a semi-automatic highly flexible line or an automated operation incorporating the latest track-and-trace capability. <br /><br style="" /><p style="">We offer fill / finish solutions for:</p><ul><li style="">Automated particulate inspection</li><li style="">Online print and apply labelling</li><li style="">Form / fill / seal packaging</li><li style="">Thermoform kit assembly</li><li style="">Cartooning, bundling, and case packing</li><li style="">Robotic pick and place</li><li style="">Custom applications<br style="" /></li></ul>

<p style="">Responding to the needs of a demanding market with:</p><ul><li>Decreased construction time</li><li style="">Decreased commissioning time</li><li style="">Combining subject-matter experts with skilled labor</li><li style="">Smaller footprint</li><li style="">Standardized design</li></ul><p style="">Who doesn't want to get something that performs as needed, at the right time, at the right price, that fits into the intended space? How do our clients make sure that modules perform as required and are integrated into the&nbsp; construction and facility plan - not to mention the budget? </p><p style="">We have a library of proven designs and specifications that meet the latest cGMP standards.<br style="" /><br />Amec Foster Wheeler can ensure that the process module is fit for purpose by sizing and selecting the proper equipment and instrumentation that fits the facility space requirements in a 3D design environment. We have complete knowledge of the biopharmaceutical equipment supply chain and can tailor it to meet the cost and schedule demands of our clients’ projects. We know where the suppliers add value and where they don't so that equipment is not &quot;over-specified&quot;. We can develop a test plan that will ensure that all user requirements are met and facilitate a smooth transition to system qualification.<br style="" /><br style="" /></p>

Evaluation of facilities and campuses is a challenge, balancing cost, flexibility and operability, with key areas of uncertainty in support systems and root utilities.<br />&nbsp;<br />When it comes to providing high value to our clients, we believe we have a significant extra advantage: our K-TOPS® process simulation and optimization tool. Our goal, on behalf of our clients, is to maximise capacity at fixed capital costs while designing in easy flexibility - to identify opportunities to increase production capacity with small cost increases.<br />&nbsp;<br />K-TOPS® is our award-winning* dynamic process simulation and optimization tool. Its power lies in the delivery of alternative scenarios and ideas for staged implementation, which allows clients to do a truly in-depth evaluation of the alternatives as part of a robust decision-making process.<br />&nbsp;<br />The alternatives can be deployed, visually, at the push of a button. A multi-layered view with multiple scenarios is automatic. And it’s fast: K-TOPS® deploys solutions with twice the detail, in half the time.<br />&nbsp;<br />K-TOPS® adds visible value at all levels, whether it’s addressing a CFO’s concerns over supply chain issues, supporting the plant manager with anticipated capacity increases and a shortage of clean water, or just to evaluate the possible bottlenecks in a unit operation.<br />&nbsp;<br />K-TOPS® can be used to simulate any process and can be used worldwide. A dedicated Amec Foster Wheeler team, along with our dynamic K-TOPS® software, working in partnership with you, is the best recipe for optimizing success.<br /><em><br />* Pharmatex Product Innovation Award, voted by a panel of judges for a product that showed significant innovation in both engineering and excellence towards pharmaceutical applications</em>.

There is an environmental aspect to just about every project that we execute, whether it’s at the concept, FEED or EPC phase. We work closely with our people, clients, partners, suppliers and contractors to ensure that we work in an environmentally responsible way.<br /><br />As well as providing a service which integrates the environmental component as part of the overall project, we also apply our environmental expertise in many other ways.<br /><br />These include addressing our own environmental performance in our offices, helping to protect the natural environment, important artefacts or local wildlife around project sites, working with clients to increase energy efficiency or energy integration, providing specialist environmental consultancy or remediation services, or working with our clients on exciting new technology solutions.<br /><br style="" /><p>Here are just a few examples of our expertise at work:</p><ul><li style="">We have leading expertise in the increasingly important areas of water management and waste water treatment</li><li style="">We work with clients to increase the energy efficiency of their facilities</li><li style="">We are at the forefront of the application of continuous processing in the pharma industry</li><li style="">We’re also training engineers to become LEED-accredited professionals and are supporting clients to achieve LEED certification</li></ul>

Some people ask, &quot;Do you see the glass as half empty, or half full?&quot; Here at Amec Foster Wheeler we ask &quot;How clean is the glass?&quot;<br /><br />We have the expertise to implement the optimal CIP / SIP philosophy tailored to your process and your facility. Our engineers are experts at all facets of CIP / SIP design, from concept through system design, automation, installation, start-up and qualification. Our engineers have designed CIP systems that cover the spectrum: portable and fixed systems, one tank, two tank, or multiple tank systems, and centralized CIP systems. We have implemented SIP philosophies to meet various client needs, whether your goal is sterilization, sanitisation, or bioburden reduction.<br />&nbsp;<br />But more importantly, we recognize that CIP and SIP do not begin and end with your CIP system and clean steam distribution. Cleanability and sterility need to be engineered into your process to be effective. If done correctly, CIP is not a system, it is a methodology that permeates throughout and is integrated into your process.

<p>Clean steam for the SIP of process equipment. Purified water for cleaning operations. WFI for media and buffer preparation.<br /><br />The backbone of every production facility are the critical utilities that feed its operations. The generation, storage, and distribution of critical utilities are just as important to the success of your facility as the process itself. The design, installation, optimisation, and validation of clean steam, WFI, purified water, and clean compressed gas systems each present unique challenges that we are uniquely positioned to solve.<br /><br />We have years of experience in every aspect of clean utility design:</p><ul><li>Utility sizing and distribution schematics and simulations</li><li style="">P&amp;ID development and purchase specifications</li><li style="">Generation and execution of commissioning and qualification protocols</li><li style="">Start-up and maintenance support</li><li style="">Evaluation and troubleshooting of installed critical systems&nbsp;</li></ul><p style="">We can design, build, optimize, and validate all your critical systems to help ensure your process and your product are never jeopardised.</p>

<p>Batch production costs are rising as more sophisticated molecules are demanded by the market. These molecules are expensive but needed in smaller quantities: plants need to have greater manufacturing flexibility and reduced inventory.<br />&nbsp;<br />Continuous processing can provide the answer. We have a unique place amongst worldwide contractors in being able to offer real project execution experience in this new technology area. We have the best people and tools to help our clients realize the opportunities offered by continuous processing.<br />&nbsp;<br />Our recent experiences show that early involvement in a project by our specialists pays big dividends in the final project investment cost. We have been involved in laboratory R&amp;D studies, consultancy, front-end designs, engineering, procurement, construction management and validation, safely delivering successful projects for our clients.<br />&nbsp;<br />Our team can deliver the advantages of continuous processing to our clients’ projects, and help our clients decide what is exactly right for their business.&nbsp;</p><ul><li>Identify continuous processing opportunities</li><li style="">Help our clients develop the business case for continuous processing</li><li style="">Provide specialist capability to convert batch to continuous processing</li><li style="">We deploy a toolbox of proprietary techniques including Britest, used with our clients’ data to optimize the design</li><li style="">Experience of many other industries to maximize synergistic interactions</li><li style="">Continuous processing uses very different equipment from batch processing. We have been through the learning curve and have developed unrivalled and unbiased knowledge of specialist equipment, instruments and manufacturers<br style="" /><br /></li></ul>

When research shows that 90% of manufacturing inefficiencies are locked in during development, then maximising the efficiency of process development is essential to accelerate time to market, rapidly ramp up to production, enhance acceptance of new products and develop a stronger economic position.<br />&nbsp;<br />We have been at the forefront of the application of the Lean approach to pharma manufacturing, focusing on achieving ‘design for manufacture’, where a lab process can be scaled up to pilot- and full-scale production without the waste-ridden scale-up iterations often currently required at each stage.<br />&nbsp;<br />Lean thinking can be applied to many areas of pharma development and manufacturing to gain significant benefit. However, some pharmaceutical operating practices are inherently so far removed from the basic Lean principles, that the full benefit of Lean Thinking will only be achieved by radically changing the whole operational practice.

We have a proven track record in the custom design of pre-assembled process modules for the pharma and other FDA-regulated industries, covering the full range of pilot and manufacturing scales of operation. These include individual “skidded” unit operation systems, as well as entire pre-assembled process trains and suites.<br />&nbsp;<br />Modular fabrication of process and utility systems allows us to separate the fabrication and testing of these systems from the building construction activities, so these activities can be completed in parallel to compress the project schedule.<br />&nbsp;<br />A modular approach also allows the process to adapt to changes. Purification schemes, for example, may need to adapt to changes that result from increased protein yields in the bioreactor or introduction of new products.<br />&nbsp;<br />We are experienced in transforming a process design concept into fully operational and tested process modules. Utilising state-of-the-art design and productivity software, we ensure that equipment is delivered on time and meets all customer requirements. Our modular approach also extends to critical utility systems, such as pumping / cooling / heating skids for WFI and purified water systems.<br />&nbsp;<br />We may also consider the need to add or replace modules after the facility has been completed, with minimal impact on current operations. Design of access panels in exterior walls, interior walls and roof, and proper sizing of access corridors would enable us to reap the full benefits of a modular approach.<br /><br style="" /><p style="">Our modular system designs include:</p><ul><li>Fermenters and bioreactors</li><li style="">CIP / SIP systems</li><li style="">Media and buffer prep systems</li><li style="">Bio-waste inactivation and neutralization systems</li><li style="">Chromatography systems</li><li style="">Filtration and other product purification systems</li><li style="">Custom blending and formulation systems</li><li style="">High-purity stainless-steel tanks and vessels</li><li style="">USP and WFI water systems<br style="" /></li></ul>

&nbsp;Wherever significant amounts of organic solvents are used for a pharmaceutical process, it is important to focus on not just the safety aspects, but also minimising the environmental implications and the associated costs.<br /><br />Disposal by incineration, at one time the only strategy adopted by pharmaceutical firms on the basis of claimed cross-contamination concerns, can no longer be considered as the ‘default’ approach.<br /><br />Taking advantage of technological competencies based on our deep knowledge of state-of-the-art commercial simulation tools (e.g. Aspen HYSIS®, Invensys PRO/II®), we can provide our clients with reliable engineered alternative solutions, based, for example, on batch distillation technology.<br /><br />This allows comparative analysis of different approaches, aimed at achieving cost-effective and environmentally friendly installations, while meeting quality and regulatory expectations.<p>We deliver benefits for our clients, including:</p><ul><li>Use of sophisticated tools with in-depth hands-on knowledge and competence</li><li style="">Improved plant sustainability and safe-guarded public image</li><li style="">Reduced facility running costs</li><li style="">Provision of physical parameters to validate and control solvent quality</li></ul>

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