European Pharmaceutical Manufacturer - Latest News

Launch of Turnkey Isolated Milling Suite at Interphex Announced by Malvern Instruments

Thu, 02 Feb 2012 00:00:00 GMT

The result of a collaboration between four market leading companies serving the powder processing industries is to be presented on Booth 2443 at Interphex 2012, 1-3 May, New York, US. The new turnkey isolated milling suite encloses the innovative ARTMiS Automated RealTime Milling System within Powder Systems Ltd's (PSL's) containment unit, providing a secure, advanced processing solution for those dealing with highly potent and/or high value materials.

Introduced last year, ARTMiS brings Sturtevant's Micronizer Jet Mill together with a Malvern Insitec particle size analyser and the Schenck AccuRate PureFeed Feeder to deliver a fully automated system for jet milling that according to the companies — according to the companies — offers exemplary process control for optimal manufacturing efficiency. Built on the expertise of all three companies, it simplifies and optimises the jet milling process, reducing operational requirements to the input of a particle size distribution set point and introduction of the feed. ARTMiS then delivers a closely controlled, consistent product with minimal manual intervention, simultaneously maximising process throughput and reducing the need for manual analysis. Its installation within PSL's advanced containment unit extends all of these benefits to those handling toxic or hazardous materials, such as pharmaceutical actives.

The Micronizer Jet Mill at the heart of ARTMiS is a low-maintenance unit that delivers a narrow particle size distribution. With a sanitary design, it is suitable for processing the broadest range of material types, including those that are heat sensitive. The Insitec continuously monitors, in real-time, the particle size of the material exiting the mill, measuring complete particle size distributions in less than one second. These data are used to precisely moderate the feed rate via a simple PID control loop that acts on the Schenck AccuRate PureFeed Feeder, a pharmaceutical industry designed unit that controls feed rates at very precise accuracies.

The PSL isolator is reportedly the optimum solution when containment of the jet milling process is required. The isolator provides full operator protection through high containment to µm levels, and a controlled, safe environment while performing size reduction of active ingredients. It has been designed for enhanced operator viewing, ergonomics and an assured explosion protection system is fully integrated into the design. PSL's nitrogen purge systems are able to achieve less than 1% RH.

Rainbow Medical Director Appointed by King's College London

Thu, 02 Feb 2012 00:00:00 GMT

A director of a Letchworth Garden City-based, leading edge pharmaceutical technology firm has been appointed to a newly created, top post at one of the world's leading medical academic institutions. Professor Luigi (Gino) Martini has been formally presented in his new role as the first Chair of Pharmaceutical Innovation at a King's College London ceremony at the Barbican.

Professor Martini's appointment at King's College London's world-renowned Institute of Pharmaceutical Science will strengthen its ability to transfer new discoveries and inventions that arise within the broad clinical and pharmaceutical community. King's is reportedly the largest centre for the education of healthcare professionals in Europe and is recognised for its cutting-edge research in physical and mental health. Rainbow Medical Engineering, of which Professor Martini is a Director, specialises in advanced ultrasonic systems for a wide spectrum of medical and industrial applications. It has reportedly pioneered the use of the technology in areas that include plastics welding and joining solutions, the manufacture of medical devices and drug dosage forms and the production of pharmaceutical products.

Professor Martini joined Rainbow founder and Managing Director, Alan Profit, at the privately owned company last year, having held a range of senior appointments with some of the world's largest pharmaceutical groups. These included heading up preclinical and pharmaceutical development for emerging markets and the Asia Pacific region, the development of dosage forms and the design and successful implementation of technological platforms.

Professor Martini is a Pharmacist and received his PhD in Drug Delivery from the University of Manchester. He was made visiting Professor at John Moores University of Liverpool in 2006 and designated a Fellow of the Royal Pharmaceutical Society in 2008. He was appointed a member of the UK's Research Excellence Framework (REF) 2014 sub-panel for Pharmacy, Dentistry, Nursing and Allied Healthcare professionals in 2011. He has ten patents and over thirty-five papers published in the field of drug delivery, formulation and innovative technologies.

Professor Martini is believed to be the only industrial teaching practitioner in the School of Pharmacy. His research interests include the use of ultrasonic processing technology to fabricate medical devices and pharmaceutical dosage forms, the design of dosage form concepts for delivering personalised medicines and the development of biopharmaceuticals. He gained his MBA with Distinction from the University of Liverpool, specialising in SME business failures and success.

Workflow Innovations for Life Scientists to be Focus for Rainin Instruments and PhyNexus Joint Venture

Wed, 01 Feb 2012 00:00:00 GMT

Rainin Instruments, a Mettler Toledo company, has launched a joint initiative with PhyNexus, Inc., maker of specialised sample preparation technology. The companies will leverage PhyNexus' patented PhyTip pipette tip column technology to jointly develop products to better serve the research needs of life scientists.

By combining miniaturisation with high-performance, PhyTip columns eliminate many of the sample preparation bottlenecks encountered by researchers in their daily workflows. For protein purification, the technology is a natural fit with Rainin's high performance pipettes and its 40-year record of advancing pipetting technology in ways that improve accuracy, precision, ergonomics and workflow.

"This business initiative with PhyNexus is an important strategic opportunity for Rainin to further develop and expand its liquid handling systems portfolio," said Leonard Pulig, Rainin General Manager. "PhyNexus' stellar reputation for innovation in liquid chromatography is a strong complement to Rainin's considerable presence in the Life Science market and global reach through our parent firm, Mettler Toledo."

Because PhyTip columns can be used with a wide range of chemistries for life science applications, combining them with Rainin's pipetting technology will speed sample preparation, save money by requiring fewer samples and produce higher concentrations of pure protein product. In terms of practical applications, functional assays requiring pure protein, hybridoma screening, formulations and QC, for example, will all benefit from purification solutions that streamline workflows and foster better decision making earlier in the research or discovery process.

"Our PhyTip column technology has added significantly to the arsenal of tools available to many researchers," said PhyNexus CEO, Douglas Gjerde. "Through our collaboration with Rainin, we see an enormous opportunity to profoundly improve and expand the capabilities of research labs by making powerful new sample preparation tools available to all life scientists."

Automatic Tablet Dosing Device Launched by Isopak

Tue, 31 Jan 2012 00:00:00 GMT

Isopak, the UK's exclusive distributor for Dott.Bonapace, is extending its already extensive range of pharmaceutical equipment with the addition of an automatic tablet dosing device. Fully compatible with all Dott.Bonapace capsule filling machines, the new automatic tablet dosing device is designed for applications involving the placement of tablets, oblongs, mini and micro tablets into capsules.

Suitable for a wide range of projects, including clinical trials, R&D applications and blind trials, the automatic tablet dosing device can handle up to 3,000 capsules per hour. It is easy to use and has relatively inexpensive change parts needed for the accommodation of different tablets. A big feature of the dosing device is that Isopak can, if required, produce the change parts using just drawings, which is particularly useful where no tablet samples are available.

Manufactured in high grade stainless steel, the unit can be supplied and fitted to new In-CAP capsule filling machines and also retrospectively to older Dott.Bonapace equipment. As a further bonus, no electrical connections are needed because the In-CAP capsule filling machine powers the automatic tablet dosing device.

The unit is easy to operate and product changeovers can be made in a matter of minutes, thanks to the electro polished and laser marked format disc. Designed for disassembling without any tools, the full dosing cycle is controlled by a Siemens SPS that, thanks to a highly accurate laser beam, is precisely controlled.

Operationally, the user can choose between the automatic dosing mode and manual production. The run cycle is straight forward and comprises the separation of the tablets, oblongs, mini or micro tablets into the feed hopper and the counting of these into the capsule body using a highly accurate laser sensor.

The automatic tablet dosing device works with a cross-section of combinations, including tablets and powders, tablets and pellets, tablets with other tablets and also in combinations involving up to three of the different items.

Supplied with a 12-month warranty, the automatic tablet dosing device is extremely well engineered and therefore highly unlikely to cause problems.

Leak Detector Designed for Optimum Flexibility Required in Today's Pharma Leak Testing Announced by Uson

Thu, 02 Feb 2012 00:00:00 GMT

Pharmaceutical processors and pharmaceutical packagers seeking leak detection equipment that can be custom configured to their unique test application requirements minus the additional costs can now obtain a competitively priced and reportedly first-of-a-kind leak and flow tester from Uson — the Uson Optima vT Leak and Flow Tester. Uson's Optima vT includes one or two test channels with four sensors each, totally customisable pneumatics, multiple built-in automated calculators, myriad data handling and storage options and other features that combine to make the Optima best-match test technology for the greatest number of leak and flow test applications.

R&D for the multi-function single or dual channel configured Optima vT Leak and Flow Tester began in 2009 and incorporates Uson's vast and unparalleled knowledgebase of the wide ranging requirements for leak detection and flow testing in medical, automotive, and other industrial parts testing using the unique and adaptable two-channel 8-sensor technology in its core to deliver best-in-class test technology without a premium price tag.

Key features of the Optima vT Leak and Flow Tester include:

capabilities for vacuum decay tests, pressure decay leak testing, differential pressure decay leak tests, mass flow leak detection (including back pressure and differential), upstream and downstream cracking pressure, pressure rise tests, burst tests, laminar flow tests, force decay testing and occlusion testing;
state-of-the-art microcontrollers comparable with those used in the most sophisticated and demanding consumer electronics applications;
two channels with up to four sensors per channel, totalling up to eight sensor inputs;
simultaneous testing on all sensor inputs;
built-in automated calculators to speed testing and data handling;
fully customisable pneumatic controls;
and large, easy-to-read, full colour touchscreen display with intuitive user interface.

Linkam Temperature Controlled Stage Used in Freeze Drying Characterization at University of Iowa

Thu, 02 Feb 2012 00:00:00 GMT

The University of Iowa Pharmaceuticals (UIP) is reportedly the largest and most experienced university-affiliated FDA-registered pharmaceutical manufacturing facility in the US. UIP has been developing formulations, manufacturing products and conducting analytical testing in compliance with cGMPs for over 30 years. The facility claims it is the only one of its kind offering the range and scope of services needed by commercial clients. Additionally, UIP has performed work for numerous government agencies, including the National Cancer Institute, the Centers for Disease Control, the World Health Organization, the National Institutes of Health and the Food and Drug Administration.

One area of interest is the understanding of lyophilisation processes. Key to this is the characterisation instrumentation from Biopharma Technology Ltd. Two systems are in use. The Lyotherm 2 provides integrated Differential Thermal Analyser (DTA) and electrical impedance (Zsinφ) capability in a single instrument. It is designed to measure glass transition (Tg'), eutectic (Teu) and melting (Tm) temperatures relevant to freeze-drying formulations. The Lyostat 2 is a fully integrated freeze-drying microscope that incorporates a Linkam THMS 600 cryo temperature stage. This enables critical events such as collapse and melting to be observed in situ, as well as characteristics such as skin or crust formation to be observed and identified. The coupled Lyostat 2 and Lyotherm 2 units provide valuable information for both formulation and cycle development processes. With UIP's in-house expertise in lyophilisation, this combination will allow quicker and more efficient development of lyophilisation cycles.

The team is led by Professor Lee Kirsch of the College of Pharmacy. His research interests include macromolecular peptide pro-drugs for targeted drug delivery, the kinetics and mechanisms of the chemical instability of drugs, the kinetics and mechanisms of the physical instability of dispersed and colloidal systems and pharmaceutical package integrity technologies. One of his team described the main work with the Lyostat 2 system: "We use the system to find out the collapse temperature for various clients' freeze drying formulations." Until the arrival of the Lyostat 2, determining the collapse temperature would take hours in the lab in an attempt to understand the critical temperatures needed to produce the best product. The ability to provide accurate thermal characterisation right down to -196˚C significantly reduced the time and complexity in the process, enabling scientists to determine these key temperatures and so create the best product quickly and simply.

The collaboration between BTL and Linkam has enabled a practical solution to questions on freeze drying previously only answered with difficulty. Adding the temperature stage has brought benefits to BTL through being able to provide quality pictures to illustrate the process at varying precisely controlled temperatures and pressures while, for Linkam, it has introduced the company to an exciting and growing market.

Medal for Research into New Materials to be Awarded to University of Reading Academic

Wed, 11 Jan 2012 00:00:00 GMT

A scientist at the University of Reading, whose research into novel materials could provide new ways of administering vital drugs, is to be presented with an award for his work.

Dr. Vitaliy Khutoryanskiy, Reader in Pharmaceutical Materials at Reading's School of Chemistry, Food and Pharmacy, has won the 2012 McBain Medal for his ‘visionary' work in the field of colloid, polymer and interface science.

The medal, a joint award of Royal Society of Chemistry (RSC) and Society of Chemical Industry (SCI), will be presented to Dr. Khutoryanskiy at a one-day symposium in January 2013, at which he will deliver a keynote lecture.

Dr. Khutoryanskiy's research is focused on the development of new materials to help in the administration of drugs, the treatment of wounds, and technology to contain innovative treatments such as proteins, bacteria and living cells such as stem cells, which could all help in the fight against disease.

His research of the behaviour of water-soluble polymers in solution mixtures has resulted in a number of advances leading to the formulation of nanomaterials, soft and superabsorbent hydrogels, thin films and microcapsules. His research team has extensively studied the ability of various pharmaceutical polymers to stick to mucosal surfaces, such as are found in the mouth, stomach or on the surface of the eye, allowing new ways to administer drugs.

This sticking property allows drugs to be retained more easily where they are needed in the body. In the eyes, for example, conventional eye drops are quickly washed away by tears and blinking, but a ‘sticky' dose allows more drugs to penetrate the eye, making treatments dramatically quicker and more effective.

Hydrogels are also very promising for wound care applications, where their ability to absorb large amounts of biological fluids is used to develop wound dressings that can aid the healing process, provide protection for the newly formed tissue, and can be easily removed without causing a trauma. Dr. Khutoryanskiy's group has recently developed hydrogels that have excellent potential in this area, which are in development with a range of industrial partners.

Dr. Khutoryanskiy's team has also developed different approaches for the encapsulation of proteins, probiotic bacteria and living cells, potentially leading to new approaches for the development and delivery of therapeutic treatments.

Opportunity to Dramatically Enhance Patients' Lives with Albumin Conjugation Solution from Novozymes Biopharma and Upperton

Fri, 13 Jan 2012 00:00:00 GMT

Novozymes Biopharma, part of Novozymes A/S, has announced that it has expanded its partnership with Nottingham-based R&D company Upperton Ltd to offer customers a new albumin conjugation solution. By linking drugs to Novozymes' new Recombumin Flex recombinant human albumin (rAlbumin), using conjugation, their pharmacokinetic and pharmacodynamic properties can be dramatically enhanced. As a result, manufacturers can benefit from the ability to tailor and control the half-life of drugs to fit patients' medical needs.

"Novozymes is delighted to unveil Recombumin Flex along with our new conjugation solution in partnership with Upperton," said Dave Mead, Business Development Director at Novozymes Biopharma. "Novozymes has enjoyed a successful relationship with Upperton over the past 10 years and its expertise and experience in the conjugation of proteins, combined with our experience of protein engineering and production, will help customers to design drugs with tailored serum half-life and fewer side-effects. This will result in improved dosing regimes for the patient and a reduction in overall costs for the healthcare provider."

By manipulating the interaction of albumin with its receptor, the neonatal Fc receptor (FcRn), Novozymes can produce modified albumins that bind with greater or lesser affinities, meaning a flexible half-life. Increasing the serum half-life of a drug may reduce the frequency of injections a patient receives or even reduce the amount of drug delivered, thereby significantly reducing toxic side-effects and increasing patient acceptance.

Upperton has demonstrated that proteins, peptides and small molecule APIs can be covalently attached to recombinant human albumin using a range of chemistries. Additionally, once drugs have been linked to the recombinant human albumin carrier, they exhibit dramatically improved pharmacokinetic and pharmacodynamic properties. According to the companies, combining Novozymes' unique IP and know-how around the albumin molecules themselves with Upperton's rP-conjugateT albumin conjugation chemistry knowledge, enables the companies to work closely with customers to design and implement the best chemical linking approach for their molecule. As a result, Novozymes can provide partners with a unique service from initial product concept through to in vivo testing for developing novel drugs.

Richard Johnson, founder and CEO of Upperton, commented: "By combining Novozymes' and Upperton's unmatched expertise in our respective fields, we have developed a solution that solves industry challenges by enabling a tunable half-life that offers control and flexibility and has the potential to improve overall treatment efficacy."

High Precision Climate Chambers Announced by CIK Solutions

Fri, 13 Jan 2012 00:00:00 GMT

According to CIK Solutions, its Kambic climate chambers are top class units benefiting from innovative design and decades of experience. Their metrological performance is highly praised and their operation is intuitive and flexible.

Typical applications include long-term stability tests, calibration laboratories, material test laboratories, material conditioning, accelerated ageing and many more.

The standard product programme features an impressive lineup, letting the customer select from 12 models, including four different chamber volumes with three different temperature ranges each. Beyond that, individual and customised solutions are available, right through to walk-in chambers.

More information is available at http://www.cik-solutions.com/en/catalog/climatic-chambers/

Protection and Transparency Across Pharma Supply Chain with tesa's Sealing Solutions

Thu, 12 Jan 2012 00:00:00 GMT

For the pharmaceutical sector, the need for transparency and reliable protection for consignments across the whole logistics chain to the customer is of vital importance.

tesa has responded to this challenge in developing the tesa Security concept and SecuritySeal adhesive tapes and labels thatclearly show whether a shipment has completed its previous journey in the logistics chain intact and in its original packaging.

Providing a secure seal and reliable protection, tesa's SecuritySeal products undergo a physical and visual change when they are opened. Such changes are irreversible, meaning that any attempted tampering is clearly evident. When the seal on the tape or label is opened, a warning appears and remains visible when closed again.

tesa SecuritySeal labels can be printed with logos, serial numbers and item-specific barcodes. As a result, the labels can be used for track and trace purposes. If label barcodes are scanned every time goods are delivered, manufacturers and retailers can immediately see that boxes and pallet packaging have been delivered intact and logistics partners can consistently prove that shipments have been delivered in full and in the original packaging.

The label material can be supplied in different formats, colours and sizes and customised to the customers' needs to ensure protection against imitations.

Additional benefits include:

ease of application allows the creation of a smooth packaging process for shippers;
barcode scanning features offer fast inventory control during stock-taking;
the identification of weak points in the logistics chain;
security and quality assurance at each point of transfer;
complete delivery reinforces customer trust and satisfaction;
StretchSeal and SecuritySeal tags provide security closure for reusable containers and can be quickly attached and easily removed without leaving residue.

The tesa Security concept guarantees maximum security as a result of tailored advisory services, solutions and comprehensive guidance.

tesa SecuritySeal products ensure that unauthorised access is immediately detected. However, employees, logistics partners and customers need to be aware of the security concept and need to report any irregularities immediately. For this reason, tesa offers guidance at the customer's location and provides relevant information to all those concerned.

Werum's MES Part of Novo Nordisk's First Combined ERP/MES System

Fri, 06 Jan 2012 00:00:00 GMT

In the framework of the global PS@ SAP programme, Accenture, Werum Software & Systems and NNE Pharmaplan have rolled out the first combined ERP/MES system at Novo Nordisk's site in Denmark.

The main objective of the programme is to implement a globally standardised ERP/MES solution on the basis of SAP and Werum's PAS-X. The programme is intended to be rolled out later to most of Novo Nordisk's worldwide manufacturing sites.

Novo Nordisk decided on Werum's PAS-X because it provides essential functionalities out-of-the-box. Another factor that convinced Novo Nordisk to choose Werum's manufacturing execution system is the fact that PAS-X has a proven record of successful installations throughout the industry.

The programme started with the development of a standalone PAS-X pilot system in Denmark in 2008 and with some other implementations throughout the organisation. Since then, Novo Nordisk, Werum and NNE Pharmaplan have been cooperating closely and have designed and implemented a MES PAS-X Core system.

iPhone App for Selecting Bottles and Carboys Launched by Thermo Fisher

Thu, 12 Jan 2012 00:00:00 GMT

Thermo Fisher Scientific has created a free iPhone and Android app for the selection of Thermo Scientific Nalgene bottles, carboys and vials. Based on their specific laboratory needs, users simply insert a Nalgene catalogue number or search terms and the intuitive app recommends the most appropriate container from Thermo Fisher's extensive inventory of almost 700 choices. Results are based on the specific properties for chemical resistance, autoclavability, inertness, temperature tolerance and a host of other parameters and certifications for the customers' individual laboratory activity.

To further refine product recommendations, users can change search criteria and view technical drawings and dimensional outputs to assess product suitability before purchase. Results can be saved for further study or sent to an email address.

Nalgene bottles have reportedly set the standard for quality and superior performance for more than 50 years. Each Nalgene bottle comes with a leak-proof guarantee to protect valuable liquids. Sizes range from 4 to 50 l and small quantity to bulk packs, so scale-up can occur without the need to revalidate materials as projects progress from research into production. Nalgene bottles and containers are available in a wide range of certified materials for laboratory, food and pharmaceutical use.

To download the free Thermo Scientific Nalgene bottles and carboys app, go to the iTunes store or Android Market and search for Nalgene Bottles. Visit www.thermoscientific.com/nalgenecontainers for more information or to try the Bottles and Carboys selection guide before downloading it.

iPhone is a registered trademark of Apple Inc.

Director Sales and Business Development for Latin America Appointed by GEA Pharma

Fri, 06 Jan 2012 00:00:00 GMT

GEA Pharma Systems has appointed Z�imo L�ez Moreno as its Director Sales and Business Development for Latin America.

Z�imo will have direct management responsibility for all GEA Pharma Systems' product lines. These include: Courtoy tablet presses; high shear granulation and fluid bed processing from Aeromatic-Fielder; ConsiGma continuous processing and Single Pot processing from Collette; Lyophil freeze dryers and loading and unloading systems; Buck high containment and materials handling technology; and fermentation and liquid formulation from Diessel.

Z�imo has been involved in the supply of capital equipment to the global processing industry for most of his career and has qualifications in Mechanical Engineering and an MBA in International Business. For the last 12 years he has worked in the pharmaceutical, cosmetic, dairy, beverage and food industries to devise and implement appropriate technology for the Latin American market.

"I am delighted to have joined this rapidly growing organisation and am looking forward to using the strength of the worldwide GEA Group to help our Latin American customers," he said. GEA Pharma Systems is already recognised in Latin America for the quality and tradition of its equipment. The organisation is supported in Brazil by STEQ (www.steq.com.br), in Mexico by Rasch (www.rasch.com.mx) and in Argentina by Vanyrelco. "It is this quality and the strength of our local partners that is the key to successfully meeting anticipated customer demands and expectations."

Frans K.A. Maas, Vice President Sales and Marketing for GEA Pharma Systems, is equally pleased with the new appointment. "With the addition of Z�imo Lopez we're bringing a breadth of market experience to our team," he said. "We are enforcing our message that GEA Pharma Systems is delivering top-line technologies and integrated systems, at the right price-performance level, to this fast growing market — and we plan on being there for the long run."

GEA Pharma Systems' return on performance in Latin America is based on local presence, widespread customer references, in-depth pharmaceutical process knowledge, a competitive manufacturing portfolio of products, all supported by a strong global service network.

The GEA Group has a long tradition of supplying high quality capital equipment for the global processing industry, with over 22,000 employees worldwide. The main factories for pharmaceutical industry are in Switzerland, the UK, Belgium, Germany, Denmark, the US, India and China.

Manager of Business Development Appointed by Process Automation Systems Manufacturer Key Technology

Wed, 04 Jan 2012 00:00:00 GMT

Key Technology has announced the promotion of Bret Larreau to the new position of Manager of Business Development. Larreau is responsible for building new business alliances and developing acquisition opportunities that will expand Key's range of customer product solutions within the food and pharmaceutical manufacturing industries.

"The appointment of Bret to this new position illustrates Key's commitment to developing new business opportunities that add value to customers while helping Key grow and diversify," said Louie Vintro, Senior Vice President of Business Development and Global Operations at Key Technology. "Bret is ideally suited to manage our business development activities. His deep understanding of our industries and what our customers need will help him extend our technology strategically into new arenas."

Larreau has been with Key Technology for eight years and brings 25 years of automated food processing equipment experience to his position. Prior to this promotion, he was the Product Marketing Manager responsible for Key's optical sorters. Before joining Key, he was a Senior Project Manager for Integrated Packaging Systems and prior to that, he worked in engineering, manufacturing management, sales support management and product management for DSI/Stein, part of FMC FoodTech. He holds a bachelor's degree in Agricultural Engineering from Washington State University.

"It's exciting to make this shift, leveraging my experience in the industry and recent market development activities, to focus on finding new opportunities to improve customers' operations and grow Key's business," noted Larreau. "We've got the resources and the personnel to make new partnerships, acquisitions, and licensing a high priority, while continuing to work closely with existing partners on ongoing projects."