Rest of the World Pharma and Biotech Projects

Cambrex Completes Major Expansion of Solid Form Screening Facility in Edinburgh

Pfizer to Halt Biosimilar Output in China, Sell Assets to Wuxi Biologics

ABN Cleanroom Technology Finishes High-Tech Omega Cleanroom

Carverian Completes Lithuanian Design & Build Project for Thermo Fisher

Stridencies Increases Sterilization Capacity with French Facility Expansion

Eisai Plans Drug Delivery Center to Support Biologics Expansion

Daimyo Medical Selects Sytira’s FlexFactory Platform

Aenova Expands Sterile Production Capacity

Cytiva Diagnostics Design Lab Goes Live in China

AMPO Installed New Oxygen Service Cleanroom Facilities

Jacobs Wins Award for Cruiserath Muti Product Cell Culture Facility

Cytiva Opens Asia Diagnostics Advanced Application Center

 

USA Pharma and Biotech Projects 

Navy Yard Chooses Top Engineering Firms for Life Science Hub Expansion

Fujifilm Chooses North Carolina for New $2-Billion Cell Culture Facility

Nexus Moves into Wisconsin Sterile Injectable Manufacturing Facility

Cytovia Inks Two Deals Covering R&D and Biomanufacturing Operations

G-CON PODs Selected by Matica Biotechnology for GMP Viral Vector Facility

SpectronRx Receives NRC Materials License for New Facility

Rentschler and Leukocare Extend Partnership with Joint US Site

Cascade Chemistry Begins Capacity Expansion

 

Aerospace Cleanroom Updates

NASA Practices VIPER Moon Rover Assembly in New Cleanroom

 

Semiconductor Updates

Intel’s $20 billion Arizona Expansion

More on Intel in Arizona

Intel Expansion of Several Campuses

 

Electronics and Nanotechnology

Microfactories, Not Gigafactories, Will Build It Back Better

 

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Rest of the World Pharma and Biotech Projects

 

Cambrex Completes Major Expansion of Solid Form Screening Facility in Edinburgh

Cambrex announced the completion of an expansion of its solid form screening and crystallization process development facility in Edinburgh, Scotland. This major expansion project has seen the facility’s total footprint doubled to 15,000 square feet, with existing laboratory space having been refurbished, and an additional 3,500 square feet of laboratory space added.

“We have seen an increase in demand for services, and specifically for larger-scale crystallization projects, so this expansion increases our efficiency and ability to respond to these requests,” commented Tom Loewald, Chief Executive Officer of Cambrex. He added, “The work we carry out at the Edinburgh site is one part of Cambrex’s integrated drug substance offering, and the investment increases our flexibility to work on projects at all stages of drug development.”

Cambrex’s Edinburgh site is a world-class facility, providing solid form development services for drug substance and drug product. These include solid state investigations such as salt, co-crystal, and polymorph screening, in addition to crystallization process development and GMP analytical services. The expert scientists at the site work on projects both as a standalone service to a range of pharmaceutical innovators, as well as liaising with other Cambrex sites to offer an integrated process development service.

The expansion has added an additional 13 fume cupboards to the laboratory, including three that are “walk-in”, which will allow the Edinburgh team to increase capacity and provide its clients with larger process crystallization development, up to 20-liter scale. The site currently has 50 employees, and the expansion will add additional laboratory space to enable the recruitment of up to 40 more scientists, with the potential for further growth in the future.

About Cambrex:

Cambrex is the leading small molecule company that provides drug substance, drug product, and analytical services across the entire drug lifecycle. The company provides customers with an end-to-end partnership for the research, development, and manufacture of small molecule therapeutics. With over 35 years’ experience and a growing team of over 2,100 experts servicing global clients from sites in North America and Europe, Cambrex is a trusted partner in branded and generic markets for API and dosage form development and manufacturing.

Cambrex offers a range of specialist drug substance technologies and capabilities, including biocatalysis, continuous flow, controlled substances, solid state science, material characterization, and highly potent APIs. Cambrex can also support conventional dosage forms, including oral solids, semi-solids, and liquids, and has the expertise to manufacture specialist dosage forms such as modified-release, fixed-dose combination, pediatric, bi-layer tablets, stick packs, topicals, controlled substances, sterile and non-sterile ointments.

 

Pfizer to Halt Biosimilar Output in China, Sell Assets to Wuxi Biologics

Pfizer Inc has decided to stop producing biosimilar products in China and sell a unit in the eastern city of Hangzhou to WuXi Biologics Inc, the U.S. drugmaker said.

The pharmaceutical industry increasingly relies for its profits on costly biologic drugs, made from living organisms that are tougher and more expensive to make than conventional medicines with chemical ingredients.

"The site was planned to manufacture three biosimilars for the China market," the company said in a response to Reuters.

"Pfizer commercially and technically evaluated other products for the site but none reached the level of activity for the scale of the site."

Neither Pfizer nor WuXi disclosed the deal value, or the products to be made after the transaction closes, which is expected in the first half of this year.

WuXi said the deal would allow it to address surging manufacturing demand for drug substances and drug products.

The facilities are equipped with bioreactors and capable of filing vials and syringes, the Chinese firm said in a statement on the WeChat app.

WuXi also makes vaccine substances for a COVID-19 shot developed by AstraZeneca PLC and the University of Oxford to supply them to Brazil, but did not have immediate comment on whether the plant would turn out such substances.

 

ABN Cleanroom Technology Finishes High-Tech Mogema Cleanroom

ABN has finished the expansion, working with TRU 100% Cleanroom Cleaning for cleaning and validation.

ABN Cleanroom Technology has finished the expansion of Mogema's cleanroom in the Netherlands.

Mogema is a high-tech expert in welding, machining and vacuum technology, also covering high-quality engineering and assembly (also for cleanroom).

ABN's modular circular cleanroom solutions were able to add an additional cleanroom space in accordance with ISO Class 6 and ISO Class 7 standard.

Mogema had planned a 4,300 sq. ft. (400 sqm) expansion of its ISO Class 6 cleanroom. In an update in 2020, ABN talked about the importance of scalability with cleanrooms, which is especially important in expansion cases such as this.

By implementing the company's VIX construction concept, Mogema is guaranteed a cleanroom system with 100% redundancy without plant downtime for maintenance activities as a result of modular & pre-engineered cleanroom design.

As part of the final preparations, ABN and Mogema worked with the TRU 100% Cleanroom Cleaning team to ensure an impeccable cleanroom cleaning of the two new cleanrooms. Specialists from TRU ensured that the validation went smoothly and the cleanroom can be put into use.

 

Caverion Completes Lithuanian Design & Build Project for Thermo Fisher

The new project by Finland-based Caverion has included 24,748 sq. ft. (2,300 sqm) of grade C and D cleanrooms.

Caverion has implemented a turnkey project for a new building of the biotechnology company Thermo Fisher Scientific Baltics.

The project was implemented in Vilnius, Lithuania, in just four months with a total area of 59,180 sq. ft. (5,500 sqm).

Caverion was responsible for the Design & Build phases for all technical building solutions. The project also included grade C and D cleanroom facilities of 2,300 sqm.

"Normally these projects take at least one and a half or even two years. To deliver this project in just four months sounds like a mission impossible, but the Caverion Lithuania team brought together its best know-how and completed this project on time. We are pleased with the results which can serve as the best practice case for future projects. We are proud that the world leader in serving science entrusted us with this special assignment," says Egidijus Šydeikis, Managing Director for Caverion in Lithuania, which is the part of Caverion Finland Division.

Thermo Fisher Scientific Vilnius site (Thermo Fisher Scientific Baltics, UAB) has world-class capabilities in manufacturing products for the life science market and has an outstanding research and development (R&D) center, focused on the development of new products in all aspects of molecular, protein, and cellular biology.

Currently, the Vilnius site employees over 1,300 people in a variety of roles.

 

Sterigenics Increases Sterilization Capacity with French Facility Expansion

Sotera Health subsidiary has expanded its ethylene oxide facility in Rantigny France.

Sterigenics, a subsidiary of Sotera Health and a specialist in comprehensive sterilization services, has expanded its ethylene oxide (EO) facility located in Rantigny, France to increase European sterilization capacity.

The expansion increases the Rantigny facility's total sterilization throughput and diversifies its capabilities with the addition of a 32-pallet chamber.

"Local and regional demand for contract sterilization services has been increasing to meet healthcare needs," said Pontus Rundstrom, VP of Operations EMEAA. "The additional capacity at Rantigny shows our commitment to our sterilization customers by helping to get their products into the market in a fast, flexible and reliable way."

The Sterigenics' Rantigny facility provides routine EO, EOStat rapid processing, cycle development and process validation and offers laboratory testing services through its co-located Nelson Labs facility.

The Rantigny expansion follows Sterigenics' recent acquisition of Iotron Industries, a leading electron beam provider in North America. The acquisition further expands the company's capacity across multiple technologies throughout its global network.

 

Eisai Plans Drug Delivery Center to Support Biologics Expansion

Completion of construction is scheduled for the second quarter of Eisai’s fiscal 2022.

Eisai has started construction of a new building to support the development and manufacturing of injectable formulations. The expansion is intended to support the broadening of Eisai’s focus beyond small molecules and into modalities that are delivered via injection.

Oral formulations are central to the history of Eisai, from the development of Aricept in the 1980s and 1990s through to its continued reliance on products such as Lenvima anti-cancer capsules and Banzel anti-convulsant tablets today. However, like many pharma companies, Eisai is expanding into biologics, establishing a pipeline that features 12 drugs given via injection. The Biogen-partnered Alzheimer’s disease prospect aducanumab is the highest-profile antibody in Eisai’s pipeline.

In drug discovery, Eisai is working on a still-more diverse range of modalities including antibody-drug conjugates and nucleic acid drugs. The diversification of the R&D pipeline has persuaded Eisai that it needs to make use of enhanced injection formulation technologies and drug delivery systems.

Eisai has responded to that realization by starting work on Eisai Medicine Innovation Technology Solutions (EMITS) at a site in Japan that has served as its base for formulation research since 1980. Completion of construction is scheduled for the second quarter of Eisai’s fiscal 2022, at which point the Japanese drugmaker will transfer formulation research from its current building to EMITS.

The construction of EMITS will also enable Eisai to enhance its manufacturing process development capabilities for injectables and establish GMP manufacturing capabilities for injection formulations. Eisai is also planning to install systems that enable it to develop liposomes, lipid nanoparticles and other emerging types of preparations. A space to work with external partners is planned, too.

Eisai framed the facilities as part of the midterm strategy it committed to in 2016. At that time, Eisai outlined plans to grow its neurology and oncology businesses by identifying untapped opportunities, a focus that in modern drug development inevitably led it beyond orally delivered small molecules.

 

Diamyd Medical Selects Cytiva’s FlexFactory Platform

Officials at Diamyd Medical say the company will install a new Cytiva FlexFactory platform in Umeå, Sweden. Once up and running, the clinical-stage biopharmaceutical company will begin manufacturing its precision-medicine type 1 diabetes vaccine, which works to reprogram immune cells to prevent the destruction of pancreatic insulin-producing B cells.

Globally, more than 1.1 million children and adolescents live with the autoimmune disease, type 1 diabetes, according to the International Diabetes Federation. Diamyd Medical develops therapies that target the underlying causes of diabetes.

“The importance of being in control of your own manufacturing process for biologics has never been so apparent as during the present pandemic,” said Ulf Hannelius, president and CEO, Diamyd Medical. “With FlexFactory we will be able to produce the biologic GAD, the active product ingredient in our diabetes vaccine. We chose Cytiva’s solutions thanks to the flexibility. The platform we use today can be transformed tomorrow to meet future growth and demand.”

“We developed our FlexFactory platform to be flexible and scalable so companies like Diamyd can respond to changing demands,” added Olivier Loeillot, vice president of bioprocess, Cytiva.

 

Aenova Expands Sterile Production Capacity

With the new sterile filling line, a total of 100 million ampoules and vials can be produced per year at Aenova in Gronau; here the cleaning and depyrogenation area.

At its Gronau site in Germany, Aenova, a development service provider and contract manufacturer for the pharmaceutical and healthcare industries, has increased its ampoule capacities. With the new ampoule filling and closing line, the sixth sterile line at the Gronau site, a new fully automatic optical control line and a new packaging line, a total of more than 100 million ampoules and vials can now be produced per year. Aenova's strategy is aimed at significantly expanding capacity and optimizing supply availability at several of the Group's sites.

In aseptic manufacturing, safety and hygiene are paramount for product purity and process reliability. The new plant in Gronau is a so-called RABS plant (Restricted Access Barrier System) for the filling of 1ml to 5ml ampoules and offers high safety for products and personnel while at the same time providing high flexibility. In a RABS (Restricted Access Barrier System), the production area and the operating environment are physically separated. The production area provides a highly clean working environment through a special machine housing, securely locked doors, and glove intervention.

The high-performance filling line is supplemented by a new fully automatic optical inspection line and an additional packaging line including labeling and bundling machine to meet capacity requirements throughout the process. In liquid sterile production, the inspection of containers is particularly time-consuming and resource intensive. The new optical inspection machine with camera technology primarily checks for particles and leakage, so-called black burners, head geometry and correct crimping, color and closure of the crimp cap, color of the solution, as well as code rings and OPC points—one point cut for an easy-to-handle predetermined breaking point on the ampoule. It features high speed and can control both aqueous and oil-based ampoules and vials. Throughput times can thus be significantly reduced while simultaneously increasing capacity by around 7%. With this machine network, Aenova will be able to produce over 100 million ampoules and vials per year in Gronau.

"Our site is a center of excellence for sterile production and conventional solids within the Ae-nova Group and can point to more than 100 years of experience in pharmaceutical production This innovation is an important milestone in being able to meet customer needs even better," said Emil Wolf, managing director at Aenova in Gronau.

These new facilities are also an essential component of Aenova's strategy to further develop the company's position as a scalable end-to-end contract service provider for pharmaceutical and healthcare companies. This includes capacity expansions in tablet production at the Tittmoning site for the production of very large volumes and at the Regensburg site for the production of highly potent active ingredients (up to OEB 5), as well as an additional line for aseptic filling at the Italian site in Latina. COVID-19 vaccines can then also be filled there.

Jan Kengelbach, CEO of the Aenova Group, said, "These investments are a major step for Aenova to be able to serve our customers' requirements even more reliably with the highest quality and very good delivery reliability.”

 

Cytiva Diagnostics Design Lab Goes Live in China

Cytiva has opened a new diagnostics design lab in Tonglu, its manufacturing site close to Shanghai in East China, where it has been making filtration products for many years.

The Asia Diagnostics Advanced Application Center has been set up to provide companies with expertise and lab infrastructure to help them overcome technical hurdles and to be ready to apply for regulatory approval, according to the life sciences company.

The China based lab means that local diagnostics companies can now access Cytiva’s diagnostic services without having to rely on the company's other design lab in Germany, it added.

This new lab is part of the spend Cytiva announced in September 2020, with it allocating US$500m to realize its goal of raising overall manufacturing capabilities within five years. With a lot of new companies entering the diagnostics field over the last 12 months to address the challenges of the COVID-19 pandemic, Cytiva has been investing in new and existing sites and services to support that surge in capacity.

Duplicating the European model in Asia

Emmanuel Abate, vice president genomics and cellular research at Cytiva, speaking to BioPharma-Reporter last October, debriefed us on the company’s plans for China and told us that, globally, it had been seeing “a lot of smaller firms – biotech companies and innovators - coming with their kits and asking for help. To that extent, apart from capacity for components, we decided to invest in service labs so that we can partner with those diagnostic companies. While we have been doing that work for many years, it has mostly been in one location; now we are expanding to Germany and duplicating our European model in Asia; in that way, we can get closer to our Asian customers.”​

Lee Jenkins, senior product manager, Cytiva Diagnostic Services, told us today that the design lab in Tonglu can help with the major challenges a diagnostic company will face when developing a test.

Such challenges include the selection of the right components to put in the test.

The lab can also help with optimizing the performance of the test so it can meet the required sensitivity and specificity that regulators require, as well as consultation services to support scale up manufacturing of the test, from a bench-top test to a larger validation batch size.

“With this new lab we meet the needs for local diagnostics capabilities from our Asia customers. They no longer have to send samples to our other lab in Germany. We expect services to be in high demand and already have half a dozen projects in the pipeline,” ​added Jenkins.

The new China lab offers:

Raw material research advice:​ Helping customers decide whether to develop a lateral flow test, dry chemistry/dipstick, or flow through immunoassay test for your diagnostic application.

Scale-up support: Assisting all the way from R&D prototype to manufacture set up, advising how to make the development process as efficient as possible without compromise.

Access to the lab: ​Fitted with sample preparation equipment, bench-top centrifuges and refrigerated centrifuges, electronic scanning microscope, new gold spraying/striping equipment and a lateral flow reader.

 

AMPO Installed New Oxygen Service Cleanroom Facilities

AMPO have recently installed new Oxygen service cleanroom facilities in our valve manufacturing plant in Idiazabal, Spain and are nowadays fully operational. Oxygen is reactive at ambient conditions, and its reactivity increases with increasing pressure, temperature and concentration. Most materials, metallic and non-metallic, are flammable in high-pressure oxygen, and that is why AMPO POYAM VALVES oxygen service valves are designed and manufactured without any ignition hazards.

Our new ISO 7 clean room for oxygen service valves has been built in accordance with ISO 14644 standard and counts with the following areas: an entrance and a changing room, a dark room, an assembly area and a testing and packing area.

Here we assure cleanliness at every manufacturing step.

The successful design, development, and operation of oxygen service valves require special knowledge and understanding of material properties, design, ignition mechanisms, and manufacturing and operational processes, and AMPO has a wide experience on oxygen service valve design and manufacturing.

 

Jacobs Wins Award for Cruiserath Muti Product Cell Culture Facility

Jacobs provided architecture, engineering, construction management and turnover services for a world class biopharmaceutical manufacturing facility, Cruiserath Biologics based in Dublin, Ireland, which, has won the Project Execution category at the International Society for Pharmaceutical Engineering (ISPE) 2020 Facility of the Year Awards (FOYA). The award recognizes innovation in facilities serving the regulated healthcare industry.  The factory, optimized for rapid product changeover and future use as a multi-product facility, will support Bristol Myers Squibb in meeting growing global demand for its medicines.

In 2015, biopharmaceutical manufacturer Bristol Myers Squibb engaged Jacobs to reimagine its existing active pharmaceutical ingredients (API) plant in Dublin, Ireland, to enable large-scale production of its vital immuno-oncology medicines. Representing an innovative approach to fighting cancer, immuno-oncology seeks to harness the body's own immune system to combat tumor cells.

Jacobs was tasked with creating a facility of the future for the $1 billion Multi-Product Cell Culture (MPCC) facility. At the time, the project represented the largest pharmaceutical project being undertaken in Europe, with more than 2,200 people on site at peak. The project's fast-tracked 26-month delivery commanded collaboration from Jacobs' global network of expertise across Ireland, the United States and India, working around the clock to meet the ambitious schedule.

The complexity, scale and speed of execution required game-changing project delivery. A detailed and robust project execution plan was developed to address challenges, monitor progress and ensure project success. The facility was delivered within budget, applying state–of–the–art project delivery techniques and tools, and achieving an impressive safety record during the 6.5 million hours worked. The facility was also awarded LEED Silver certification for its sustainability performance in respect of design, construction and operation.

"With growing demands for its immuno-oncology medicine, Bristol Myers Squibb needed to build a facility for the future," said Koti Vadlamudi, Jacobs Senior Vice President, Advanced Facilities. "The project is a huge success for Jacobs, Bristol Myers Squibb, and ultimately the many patients that rely on these medicines produced in the Dublin campus."

The facility met the design intent to be a flexible, multi-product manufacturing operation able to produce biopharmaceuticals for human therapeutic use.  The project repurposed an existing site to design and construct a new manufacturing facility, global laboratory, offices, cafeteria, utility and warehouse buildings as one functional campus. The facility is now in commercial operation, having recently received regulatory approval from both the FDA and the European Medicines Authority.

 

Cytiva Opens Asia Diagnostics Advanced Application Center

The lab is part of Cytiva’s global expansion plans, including an investment of $500 m across five years to raise manufacturing capacity, announced in September 2020.

Cytiva is opening a design lab in Tonglu, the company’s manufacturing site located close to Shanghai in East China. Here, diagnostics companies can access Cytiva’s diagnostic services without having to travel overseas to its Germany lab. Developing a lateral flow diagnostic is a complex process. By offering laboratory infrastructure, technical expertise, and consultation, the company aims to help developers overcome technical hurdles and be ready to apply for regulatory approval.

“In the last year, China has been extremely active. They accelerated the development of their COVID-19 tests and we see a lot of demand for diagnostic components,” says Emmanuel Abate, VP Genomics and Cellular Research at Cytiva.

Cytiva aims to bring expertise in areas such as material science, biochemistry, and virology, as well as manufacturing for scale-up, under the same roof. The company will offer raw material research and advice, scale-up support and access to a lab fitted with sample preparation equipment, bench-top centrifuges and electronic scanning microscopes.

“We have been manufacturing filtration products in Tonglu for many years and are now pleased to apply our assay design expertise to help local companies with their diagnostics projects. The expectations of this new lab are high and there are already a dozen design-in projects in this year’s pipeline.” said Eric Wu, Plant Manager for the Tonglu site.

Powered by 200 associates, the site is ISO-accredited with digital and automation technologies. The design lab will strengthen Cytiva’s commitment to the Tonglu area, an economic development zone.

“We have been supporting the diagnostic industry for over 30 years', helping customers to optimize assays,” said Emmanuel Abate. “With lots of new companies entering the space to meet the challenges of COVID-19 now is the right time to establish a dedicated space to support our customers in Asia to reach their diagnostics development goals.”

 

BioNTech Provides Update on Vaccine Production Status at Marburg Manufacturing Site

BioNTech announced the European Medicines Agency (EMA) approved the manufacturing of the COVID-19 vaccine drug product at the facility in Marburg. As part of the process, EMA has approved the production of the drug substance, the mRNA, at the Marburg site over the course of this week. The approvals make BioNTech’s Marburg manufacturing site one of the largest mRNA vaccine manufacturing sites in Europe as well as worldwide with an annual production capacity of up to one billion doses of our COVID-19 vaccine, once fully operational. Due to optimized operational efficiencies which were initiated last year, BioNTech has been able to increase the expected annual manufacturing capacity by 250 million doses.

A single mRNA batch of the current scale is sufficient to produce around eight million vaccine doses. Currently, 400 BioNTech employees work in Marburg, 200 of them in 24/7 shifts in order to maximize the production’s output. Based on the approval by the EMA, first drug product batches of the vaccine can now be delivered to partner sites for sterile fill and finish, before distribution to the European Union and countries worldwide. The first batches of vaccines manufactured at the Marburg site are expected to be delivered in the second half of April.

In total, 50,000 steps are required from manufacturing the mRNA to the bulk drug substance which then can be handed over for fill and finish. Materials and components for production arrive from a global supply chain that has been dramatically expanded in the last 12 months.

BioNTech’s manufacturing facility in Marburg is a GMP-certified manufacturing facility. Good manufacturing practice (GMP) is a system of regulatory standards for ensuring that products are consistently produced and controlled according to quality standards aiming for a high level of drug quality and patient safety. The GMP regulations have been developed over decades to minimize the risks involved in any pharmaceutical production, including the vaccine production that cannot be eliminated through testing the final product. The production of vaccines under GMP standards are a prerequisite for the validation of the manufacturing processes by the EMA.

Together with Pfizer, the company is working continuously on multiple initiatives to respond to global demand. A key factor in the expansion of our manufacturing network has been the set-up of this new manufacturing site in Marburg, Germany. BioNTech plans to be able to produce up to 250 million doses of BNT162b2 in the first half of 2021. The first vaccines manufactured at the Marburg site are scheduled for distribution in early April.

The vaccine, which is based on BioNTech’s proprietary mRNA technology, was developed by both BioNTech and Pfizer. BioNTech is the Marketing Authorization Holder in the European Union, and the holder of emergency use authorizations or equivalent in the United States, United Kingdom, Canada and other countries in advance of a planned application for full marketing authorizations in these countries.

 

 

USA Pharma and Biotech Projects 

 

Navy Yard Chooses Top Engineering Firms for Life Science Hub Expansion

CRB and IPS-Integrated Project Services are among the companies that have been chosen to work on the project by Philadelphia's public-private economic development corporation PIDC.

PIDC, Philadelphia's public-private economic development corporation and master developer of the Philadelphia Navy Yard, in partnership with Ensemble Real Estate Investments and Mosaic Development Partners, has announced the execution of an agreement.

The agreement provides Ensemble/Mosaic with the exclusive development rights for 109 acres at the Navy Yard and launches a $2.5 billion development plan that will create thousands of construction and permanent jobs.

The $400 million first phase includes the development of two advanced life sciences buildings followed by significant residential and hospitality initiatives.

It will support interior ceiling heights up to 16' and provide floor heights designed to facilitate cGMP manufacturing with walkable cleanroom ceiling systems.

Ensemble/Mosaic will construct a +/-100,000 sq. ft. speculative laboratory and office development at 1201 Normandy Place with anticipated delivery by the close of 2022. The partners will concurrently market 333 Rouse Boulevard, which can accommodate a 120,000 sq. ft. build-to-suit facility, for opportunities with cGMP manufacturers.

Upon completion of these buildings, the Navy Yard will eclipse one million sq. ft. of life sciences space.

"Expanding this vibrant life sciences hub will bring high-quality jobs to the Navy Yard, support growing companies in the advanced life sciences sector, and contribute to development of this dynamic campus that is already home to 15,000 employees," said Kate McNamara, Senior VP at PIDC. "Equally exciting, our agreement includes one of the most intentional and inclusive economic opportunity initiatives in the history of this city."

The agreement, which was initially announced last July, will guide the growth and expansion of the former military base and will further establish the Navy Yard as a vibrant and inclusive mixed-use community. Ensemble/Mosaic ultimately envisions approximately 3,000 residential units and nearly three million sq. ft. of life science manufacturing, R&D, office, hotels, makerspace and retail space when complete.

The building at 1201 Normandy Place is designed by DIGSAU, an award-winning contemporary architecture firm, in collaboration with CRB, a global architecture and engineering firm, which together aims to set a new standard for innovation.

Philadelphia-based DIGSAU has designed five buildings in the Navy Yard. CRB is a preeminent designer for life science manufacturing and laboratory environments.

The four-story facility targeting LEED Gold certification is conceived with flexibility at the forefront. Its 30,000 sq. ft. floor plates with 16' floor-to-floor heights will provide lab and clinical manufacturing-ready environments for ATMP (advanced therapy medicinal products) and life science companies.

Spaces between 5,000 to 100,000 sq. ft. will be available, maximizing both efficiency and optionality for the company's operations.

Mark Seltzer, Senior VP of Development - East at Ensemble, said: "Our new buildings will create much-needed inventory for the incredible demand for space in this sector."

The preliminary concept for 333 Rouse Boulevard is a 120,000 sq. ft. facility providing office, laboratory space, cGMP manufacturing, warehousing and conditioned indoor mechanical space for plant and critical utilities. The manufacturing area will support interior ceiling heights up to 16' and provide floor heights designed to facilitate cGMP manufacturing with walkable cleanroom ceiling systems.

The project provides for a balance of short-term efficiency and long-term flexibility, making it an ideal home to life sciences companies seeking immediate functionality and the ability to grow in place.

This project is being designed by DIGSAU and IPS-Integrated Project Services, a locally founded company that ranks as one of the top biologics, cell and gene therapy design firms in the world solely dedicated to designing, constructing and qualifying cGMP facilities.

 

Fujifilm Chooses North Carolina for New $2-Billion Cell Culture Facility

Fujifilm announced on March 19, 2021 that it has selected Holly Springs, NC, as the location for its new $2-billion North American large-scale cell culture production site.

The new facility, which is expected to be operational by spring 2025, will feature 8 x 20,000-L bioreactors with the potential to add further 24 x 20,000-L bioreactors based on market demand, Fujifilm said in a company press release. The facility will also offer commercial scale, automated fill-finish and assembly, packaging, and labeling services.

“Holly Springs, North Carolina is a suitable location for us, as it is one of the most active communities in the [United States] in addressing environmental and social issues,” said Kenji Sukeno, president of Fujifilm, in the press release. “Fujifilm will contribute to realizing a sustainable society by collaborating with the Holly Springs community and stimulating the local economy. The new site is strategically important to accelerate the growth of our bio CDMO [contract development and manufacturing organization] business.”

“We are passionate about the tremendous value that this new facility will bring to our partners in producing life-impacting therapies. To build what will be the largest end-to-end cell culture CDMO facility in North America requires commitment and partnership. We are delighted to have received the strong support from the town of Holly Springs and the state of North Carolina. This is building for the future, both in infrastructure and in talent, as part of the vibrant North Carolina biotech hub,” added Martin Meeson, CEO of Fujifilm Diosynth Biotechnologies, in the press release.

 

Nexus Moves into Wisconsin Sterile Injectable Manufacturing Facility

The company is anticipating completion of commissioning and qualification activities by summer 2021.

Nexus Pharmaceuticals has received authorization to occupy its pharmaceutical manufacturing facility from the Village of Pleasant Prairie, Wisconsin.

The company, which specializes in developing processes to manufacture specialty and generic injectables drugs, first announced plans in 2019 to build Project Tomorrow, a sterile injectable manufacturing facility to support the production and supply of injectable drugs in various therapeutic areas including anesthesiology, oncology, cardiology, and neurology.

Project Tomorrow, in which Nexus plans to invest $250 m, is projected to be completed in three phases within the next ten years. Phase one, which began in August 2019 and includes a three-story manufacturing facility with an isolator filling system and a large capacity lyophilizer, is nearing completion, the company says. Nexus and the Village of Pleasant Prairie partnered with Integrated Project Services and Turner Construction on the design and construction of the 84,000 sq. ft. structure. Phases two and three will include cytotoxic and highly potent manufacturing suites, increased warehousing, and expanded secondary packaging.

“We at Nexus Pharmaceuticals are very pleased with the issuance of the occupancy authorization for the site,” said President and CEO, Mariam S Darsot. “This is a critical milestone and brings us one step closer to manufacturing critical and essential medications in the United States. I would like to thank all of our vendors and especially our Project Tomorrow team here at Nexus for their tireless efforts in reaching this tremendous juncture.”

Now the staff are able to relocate into the manufacturing facility, Nexus anticipates a forthcoming inspection by the FDA, completing the four-year journey from concept to completion. Pending approval, commercial pharmaceutical production is hoped to begin as early as 2022.

Meanwhile, Nexus is continuing its commitment to supporting the Wisconsin economy by creating over 400 new local jobs long-term. The company anticipates completing phase one of hiring and operations by the beginning of the third quarter of 2021, which will create 77 jobs in the fields of high-tech manufacturing and scientific research. Phase two of hiring is expected to commence in 2022.

 

Cytovia Inks Two Deals Covering R&D and Biomanufacturing Operations

Cytovia Therapeutics, a biopharmaceutical company developing allogeneic “off-the-shelf” gene-edited chimeric antigen receptor (CAR)-NK cells derived from induced pluripotent stem cells (iPSCs) and NK-engager bispecific antibodies, entered into two agreements for R&D and manufacturing operations in Massachusetts and Puerto Rico. The deals are intended to accelerate the company’s universal iPSC NK cells towards clinical trials beginning in Q4 2021 and gene-edited iPSC CAR-NK cells by 2022.

Cytovia will move into new lab space at the ABI-LAB facility in Natick, MA, this month, and has started recruiting R&D and process development personnel to its existing team. Cytovia’s existing cell therapy operation under the New York Stem Cell Foundation and antibody GMP manufacturing with STC Biologics will continue.

Cytovia also signed a long-term joint collaboration manufacturing and operations agreement with BioSciencesCorp to integrate Cytovia’s manufacturing processes within an existing 95,000-sq-ft cGMP facility, including more than 40,000-sq-ft of cleanroom and biomanufacturing, located in Aguadilla, Puerto Rico. The company will recruit manufacturing personnel beginning in summer 2021.

“We’re excited to rapidly expand our R&D team with the best talent in the Boston area. The combination of advanced laboratory space and cost-effective cGMP manufacturing capability represents a highly significant milestone as Cytovia’s NK off-the-shelf cell therapies and bispecific products accelerate towards the market,” said Wei Li, CSO of Cytovia Therapeutics. “The integration of Cytovia’s two new facilities is designed to allow the company to take each of our products rapidly and seamlessly into clinical and commercial production.”

The Natick laboratories will comprise four activities: NK cell biology, gene-editing, antibody and CAR development, and NK cell pilot manufacturing. The NK cell technology will then transfer directly to larger-scale but matching production operations in Puerto Rico.

Cytovia’s first cell product is scheduled to be in the clinic in 2021 with up to three additional CAR-NK cell products following in 2022.

“The new facility gives Cytovia streamlined control over cGMP production in a facility that has been designed to meet global regulatory expectations and readiness for FDA, EMA, and global regulatory audits,” noted Robert Salcedo, the president of BioSciencesCorp and acting head of Cytovia manufacturing.

“By operating multiple cell modular clean rooms and bioreactors scaled to 25 L, the cGMP facility will provide best-in-industry capacity to support clinical and commercial operations. The facility has been designed to allow multi-product manufacturing, enabling Cytovia to produce iPSC-derived CAR NK therapeutics for thousands of patients and positioning it as a leading cell therapy company with full clinical and commercial manufacturing capabilities.”

“We are delighted to welcome Cytovia Therapeutics to the Boston biotech ecosystem,” added Raphael Nir, PhD, co-founder, managing partner, and CSO of ABI-LAB. “Cytovia brings some of the most advanced R&D capabilities in cell therapy and antibody development, with vast potential to provide a breakthrough anticancer treatment. We are thrilled to be part of this important journey and will provide any help to expedite Cytovia development efforts towards clinical trials.”

 

G-CON PODs Selected by Matica Biotechnology for GMP Viral Vector Facility

G-CON Manufacturing (G-CON), the leader in prefabricated, flexible cleanroom solutions, announced today that it has been selected by Matica Biotechnology (Matica Bio), a contract development and manufacturing organization (CDMO) specializing in the clinical and commercial production of cell and gene therapies, to support the cleanroom build out for its new GMP production facility in College Station, TX. The 25,000 sq. ft. facility will be dedicated to the production of viral vectors used in cell and gene therapies, vaccines and oncolytic products.

G-CON will provide the engineering design, build and delivery of 8 prefabricated cleanroom PODs. The 7,900 sq. ft. POD system will serve as Matica Bio's seed preparation suite, upstream and downstream processing suites, fill finish suite and other auxiliary GMP areas. Each POD will also feature dedicated air handling units, a fire protection system, an integrated automation system, and process utility distribution. G-CON will commission the units after delivery as part of the overall project validation effort.

"We are very excited that Matica Bio chose to partner with G-CON in building their initial personalized medicine facility," said Tim Vickers, Executive Director of Business Development at G-CON Manufacturing. "This project requires high quality, rapid delivery and optimal life cycle economics and we are honored to be Matica Bio's partner for this project. The College Station area is important to both organizations as it becomes an established corridor for biologics research and manufacturing. We welcome Matica Bio to the area and to the growing number of critical base of suppliers for vital therapies."

Tim Lutz, Chief Manufacturing Officer of Matica Bio commented, "Our clients require a flexible and efficient production operation that meets the stringent requirements of global GMP regulatory agencies. The G-CON POD system of modular cleanroom construction helps us better meet our demands with decreased timelines compared to standard construction."

Matica Bio celebrated the groundbreaking of its facility on February 23, 2021 with local officials, community members and G-CON in attendance. The GMP facility is scheduled to open in the third quarter of 2021 with client access to GMP production slots beginning in early 2022.

About G-CON Manufacturing:

G-CON Manufacturing designs, builds and installs prefabricated G-CON POD® cleanrooms. G-CON's POD portfolio provides cleanrooms in several dimensions for a variety of uses, from laboratory environments to personalized medicine and production process platforms. G-CON POD® cleanroom units surpass traditional cleanroom structures in scalability, mobility and the possibility of repurposing the PODs once the production process reaches its lifecycle end. For more information, please visit G-CON's website at http://www.gconbio.com.

About Matica Biotechnology:

Matica Bio, an affiliate of CHA Biotech, provides viral vector GMP manufacturing services for cell and gene therapies, vaccines, oncolytic vectors and other advanced therapy products. Matica Bio's GMP facility in College Station, TX is designed for the rapid development, scale-up and production of Lentivirus and AAV products for clinical supply. Matica Bio offers process development, production, product release and stability assessment of viral vector products; together with the quality oversight and regulatory guidance necessary to ensure our clients' success.

 

SpectronRx Receives NRC Materials License for New Facility

SpectronRx announced the U.S. Nuclear Regulatory Commission (NRC) has issued a Materials License for its new Indianapolis, IN headquarters. The license also expands SpectronRx’s roster of authorized nuclear pharmacists and authorized users. The news comes as SpectronRx continues to scale its early-stage development and commercialization services for leading pharmaceutical companies working to develop and deploy radiopharmaceutical compounds for the treatment and detection of certain cancers and other diseases.

“Securing Nuclear Regulatory Commission materials licensing for our new headquarters and additional staff is a significant milestone for the growth of SpectronRx,” said John Zehner, CEO of SpectronRx. “We now have the necessary approvals to scale our newly opened 60,000 square foot Indianapolis facility. This is great news for both patients and the State of Indiana alike, as it means a bigger pipeline for life-saving therapies and more jobs for medical professionals specializing in radiopharmaceuticals.”

SpectronRx now has two Indiana locations; a 6,300 sq. ft. facility located in South Bend, and a new 60,000 sq. ft. facility at 9550 Zionsville Rd. in Indianapolis. SpectronRx opened its South Bend facility in 2016, and has now relocated its headquarters to the new Indianapolis location. SpectronRx also has plans to expand into the European Union.

“In response to increased demand for early phase therapeutic and diagnostic development services, SpectronRx has experienced significant growth as an early-stage contract developer for global and domestic life sciences companies,” said Anwer Rizvi, President of SpectronRx. “The scope of our new location and materials license gives us the ability to operate as a large-scale developer, manufacturer and nuclear pharmacy.”

The NRC materials license authorizes that SpectronRx can receive, acquire, possess and transfer byproduct, source, and special nuclear material in chemical and/or physical form. This includes any byproduct material with Atomic Numbers 1 through 83 with a half-life less than or equal to 120 days, with some exceptions. The license lists more than 25 different isotopes, ranging from Lutetium-177, Actinium-225, Iodine-131, and Iodine-123. Authorized uses include the preparation and distribution of radioactive drugs and radiochemicals for medical use to authorized recipients.

 

Rentschler and Leukocare Extend Partnership with Joint US Site

The alliance has completed projects for companies around the globe since it was established in 2017.

Rentschler Biopharma and Leukocare are celebrating the fourth anniversary of their strategic alliance. Established in 2017 and recently expanded into the US, the alliance is designed to integrate tailored formulation development into the manufacturing process and help to address the challenges of increasingly complex biopharmaceuticals. Clients benefit from this alliance, the companies say, through shorter development timelines, cost savings and potentially additional patent protection.

During these four years, the alliance has completed projects for companies around the globe, ranging from established monoclonal antibodies to multispecific formats, as well as novel enzymes and scaffolds. They include both early- and late-stage development programs.

Formulation development projects within the alliance have included adjustment of existing formulations and creation of novel formulations for improving stability or extension of storage time at room temperature.

With the recent opening of Leukocare’s US development labs and offices at Rentschler Biopharma's facility in the Greater Boston area, the two companies will work together closely in the US as well as in Europe.

Dr Frank Mathias, CEO of Rentschler Biopharma, said: “Our strategic alliance with Leukocare is a great success for our two companies and, importantly, for our clients. Formulation issues often lead to the failure of drug development projects or significant delays both in early and late clinical stage, making formulation a critical success factor. Drug development and formulation need to cooperate, and, together, our two companies can address client needs in early- or late-stage development, as well as in commercial manufacturing optimization. We are delighted that this alliance now has a solid footprint in both Europe and the U.S.”

Michael Scholl, CEO of Leukocare, said: “Both of our companies are highly focused on not just meeting but exceeding client expectations. Already four years ago, we recognized an increasing demand for advanced and accelerated formulation development services combined with excellent CDMO services. We are excited to expand our presence into the U.S., enabling us to work closely with Rentschler Biopharma on both sides of the Atlantic to provide optimal solutions and customized services for each joint project. We very much look forward to continuing this strong and highly fruitful partnership.”

 

Cascade Chemistry Begins Capacity Expansion

Will triple floor space and increase manufacturing capacity for APIs for clinical trial materials and ultimately commercial production.

Eugene, OR-based Cascade Chemistry initiated construction of a $14 million facility to significantly increase its cGMP manufacturing capacity.

Cascade Chemistry, a pharmaceutical CDMO, began construction of new facilities to increase capacity to manufacture APIs under cGMP.

The new facilities, expected to be operational in 1Q22, will increase floor space almost three-fold and significantly add to its cGMP manufacturing capacity and scale. The $14 million expansion also includes 2,200 sq.-ft. of new analytical labs, a robust quality system and additional office space.

The 28,000-sq.-ft. building currently under construction will initially include five suites for Phase 1 and 2 cGMP manufacturing with flow hydrogenation and reactors up to 400 liters. Additional capacity for API Phase 3 and commercial scale cGMP manufacturing up to 1,000 liters will be added in 2022. The second 7,000-sq.-ft. building is reserved for future expansion.

“This expansion reflects our growing success as a reliable, experienced and flexible outsourcing partner with exceptional chemistry problem-solving expertise,” said Jeremiah Marsden, PhD, President of Cascade Chemistry. “Our customers are increasingly requesting our assistance in producing APIs for their clinical trials, and demand has outstripped our cGMP manufacturing capacity. We were fortunate to acquire two suitable buildings just 10 minutes from our current facility, and construction of new cGMP manufacturing suites that will greatly increase our clinical trial API production capacity is now underway.

 

 

Aerospace Cleanroom Updates

 

NASA Practices VIPER Moon Rover Assembly in New Cleanroom

The year leading up to this was spent turning an ordinary workspace into a controlled workspace, or cleanroom.

NASA structural engineer Aristeo Rios performs final torqueing of one of the riser capture brackets during the VIPER assembly pathfinder work at NASA’s Johnson Space Center in Houston in February 2021. A full-scale model of the rover will be built, securely attached to risers installed on a lift table.

NASA's water-hunting lunar robot now has a workspace prepped and ready at the agency's Johnson Space Center in Houston, where it will be built for its upcoming mission to the Moon. The Volatiles Investigating Polar Exploration Rover, or VIPER, has a new 1,000+ sq. ft. cleanroom, called the Surface Segment Integration and Test Facility, where engineers will assemble and outfit the rover.

Located in a corner of the center’s Space Vehicle Mock Up Facility, the VIPER team recently launched the assembly of a full-scale replica of the rover. The "assembly pathfinder" activity will last roughly three months and serve as a dress rehearsal for the flight version.

Faced with a pile of mock components and a heap of requirements for cleanliness and safety, documentation and protocols, the team is blazing a trail toward a rover that is ready for launch. This way, NASA will be as efficient as possible when the real flight equipment arrives – and avoid any unwanted surprises.

"We need to work out the bugs now," said David Petri, VIPER's system integration and test lead at Johnson. "That could mean a lot of things, from discovering there is not enough clearance in one corner of the rover to turn a wrench, to realizing team members need additional training to get the job done. These are the kind of unforeseen challenges that could slow development down."

NASA's VIPER will be built in the summer of 2022, bound for the lunar South Pole in 2023, where it will search for ice in deep, dark craters and other places to create the first water resource maps of the Moon for future space exploration. This work will help advance the Artemis program to establish a sustainable human presence on the Moon.

Since this work is focused on assembly, not a functioning rover, there are no moving parts. Instead, the parts are precision-made from VIPER's designs - mostly 3D-printed, and some made out of sheet metal. The real test comes when determining the order in which the parts are put together. Should they screw part A to part B, then bolt that to part C - or join B and C, first? That is the kind of detail to know before getting too far into assembling a bookshelf, much less a spacecraft.

If there is no easy solution for the assembly team, they may ask the rover's designers for small but essential changes. The current test will make that kind of adjustment possible.

The year leading up to this dry run of VIPER's assembly was spent turning an ordinary workspace into a controlled workspace, or cleanroom.

New air filtration units and particle counters help keep the space extremely clean. This was necessary to prevent any debris or contamination from getting into the spacecraft, where it could potentially interfere with the scientific instruments' measurements or make the solar arrays or radiator work less efficiently, for instance.

A highly sensitive video fire-detection system keeps the hardware safe from flames. And everything inside the room has mitigations against creating sparks, which could damage circuit boards in the rover's sensitive electronics.

There are so many things to think of when building something to meet NASA's rigorous requirements for spaceflight. How will you keep the parts super clean on their way to the workspace? Are the wrenches calibrated? Do you have every necessary nut and bolt? Has someone scheduled the quality inspectors? And so on. The assembly team works long hours to make sure all the bases are covered, but it is worth it.

"You get to work on something that's going to the Moon, and you're doing it with people who will do whatever it takes to be successful," said Petri. "You don't want to let them or the mission down. And it is mutual. So, that makes it exciting!"

VIPER? VIPER is a collaboration within and beyond the agency. VIPER is part of the Lunar Discovery and Exploration Program and is managed by the Planetary Science Division of NASA's Science Mission Directorate at NASA Headquarters in Washington. NASA's Ames Research Center in California's Silicon Valley is managing the project, leading the mission's science, systems engineering, real-time rover surface operations and flight software.

The hardware for the rover is being designed and built by NASA's Johnson Space Center in Houston, while the instruments are provided by Ames, NASA's Kennedy Space Center in Florida, and commercial partner Honeybee Robotics in Altadena, California.

The spacecraft, lander and launch vehicle that will deliver VIPER to the surface of the Moon will be provided by Astrobotic in Pittsburgh, Pennsylvania, who was selected through NASA's Commercial Lunar Payload Services, or CLPS initiative, delivering science and technology payloads to and near the Moon.

 

 

Semiconductor Updates

 

Intel’s $20 billion Arizona Expansion

Intel announced a substantial expansion of its Arizona-based manufacturing capacity with a $20 billion investment – the largest private sector investment in state history. The expansion will see the construction of two new semiconductor fabrication facilities, or fabs, which will produce advanced semiconductor chips used in modern electronics.

The investment will lead to the direct creation of 3,000 new high-tech, high-wage jobs and 3,000 construction jobs, while supporting an estimated 15,000 additional indirect jobs in our community.

“Today’s announcement means jobs, jobs, and more jobs for the state of Arizona,” said Governor Doug Ducey. “It also proves once again that Arizona is at the cutting-edge of advanced chipmaking and manufacturing. No company has been such an instrumental partner in Arizona’s growth and transformation over the years as Intel, and my sincere thanks goes out to CEO Pat Gelsinger and the entire Intel team. I also want to recognize the U.S. Department of Commerce, Arizona Commerce Authority, City of Chandler, President Fann and Speaker Bowers for their partnership to bring this project here. Today, when people think of semiconductor production, they think of Arizona, and that means tremendous things for our state, country and future generations of Arizonans.”

“I’m thrilled to announce plans for Intel’s first large-scale foundry operation, which will be in Arizona,” said Intel CEO Pat Gelsinger. “This represents an investment of approximately $20 billion dollars, which will create over three thousand permanent high-tech, high-wage jobs, over 3,000 construction jobs, and 15,000 local long-term jobs in Arizona. To make our new expansion in Arizona possible, we are excited to be partnering with the state of Arizona and the Biden Administration on incentives that spur this type of domestic investment.”

“Intel’s selection of Arizona for this historic investment is a testament to our vibrant and growing technology ecosystem – one powered by our streamlined regulatory environment, low cost of doing business, world-class higher education institutions and highly skilled and talented labor force,” said Sandra Watson, President and CEO, Arizona Commerce Authority. “We are so grateful to Intel for their unrivaled commitment to our state. We look forward to continuing to partner in their success for decades to come.”

Intel’s operations in Arizona go back more than 40 years. With this new expansion, Intel will employ nearly 16,000 Arizonans and will have invested more than $50 billion in our state. Intel operates four other fabs in Arizona, including Fab 42, the company’s largest chipmaking factory in the United States and said to be the most advanced in the world. In addition to high-volume manufacturing, Arizona is also home to Intel’s Assembly Test Technology Development group and functions like marketing, finance, human resources, legal, supply chain and logistics, and more.

Intel’s contributions to Arizona extend beyond jobs and manufacturing to also include supporting local schools and students, promoting healthy forests and rivers, providing pandemic relief, and more. Since 2015, Intel and the Intel Foundation have given more than $35 million to support Arizona schools and nonprofits and employees have contributed more than 750,000 volunteer hours.

With a global shortage of semiconductor chips, Arizona is poised to continue growing its technology and advanced manufacturing footprint. Arizona is already a top-five state for semiconductor production, with multiple industry leaders choosing the state to start, expand or relocate operations.

 

More on Intel in Arizona

Patrick Gelsinger, the chief executive of Intel, vowed that Intel would become a major manufacturer of chips for other companies, in addition to producing its own.

Patrick Gelsinger, the chief executive of Intel, vowed that Intel would become a major manufacturer of chips for other companies, in addition to producing its own.

Intel’s new chief executive is doubling down on chip manufacturing in the United States and Europe, a surprise bet that could please government officials worried about component shortages and dependence on factories in Asia.

Patrick Gelsinger, who took the top job in February, said that he planned to spend $20 billion on two new factories near existing facilities in Arizona. He also vowed that Intel would become a major manufacturer of chips for other companies, in addition to producing the processors that it has long designed and sold.

Intel had stumbled in developing new production processes that improve chip performance by packing more tiny transistors on each piece of silicon. The lead in that costly miniaturization race had shifted to Taiwan Semiconductor Manufacturing Company, or TSMC, and Samsung Electronics, whose so-called foundry services make chips for companies that include Apple, Amazon, Nvidia and Advanced Micro Devices.

Some investors and analysts had pushed for Intel to spin off or discontinue manufacturing in favor of external foundries, an approach taken by most other chip companies to increase profits.

But a pandemic-fueled shortage of semiconductors for cars, appliances and other products has underscored the vital role of chip factories in supporting many sectors of the economy. And before the recent concerns, worries about the Asian foundries’ proximity to China had already prompted Congress and several branches of the Trump and Biden administrations to back plans to encourage more domestic chip manufacturing, though funding had not yet been appropriated.

Officials in Europe have also floated proposals for new factories to reduce reliance on foreign-made chips.

The Intel strategy recognizes “that the world no longer wants to be dependent on the ring of fire that is right there next to China,” said G. Dan Hutcheson, an industry analyst at VLSI Research. “It’s very forward-looking.”

TSMC previously announced plans for a new factory in Arizona, a project that it valued at $12 billion and that is expected to receive federal subsidies. Samsung is seeking government incentives for a $17 billion expansion of its facilities in Austin, Texas.

Mr. Gelsinger, who first joined Intel at 18, left in 2009 after 30 years. He served eight years as chief executive of the software maker VMware before Intel’s board persuaded him to replace Robert Swan, who was ousted in January.

Intel said its new global foundry service would operate from the United States and Europe, with further factory additions expected to be announced in the next year. It already runs plants in Ireland and Israel.

“The industry needs more geographically balanced manufacturing capacity,” Mr. Gelsinger said.

While it is committing $20 billion up front, Intel hopes to negotiate with the Biden administration and other governments to get incentives for its manufacturing expansion, said Donald Parker, an Intel vice president.

Though it makes most products in house, Intel has long used external foundries for some less advanced chips. Mr. Gelsinger said the company would expand that strategy to include some flagship microprocessors, the calculating engines used in most computers. That will include some chips for PCs and data centers in 2023, he said, and give Intel more flexibility in meeting customer needs.

But manufacturing will remain the core of Intel’s strategy, Mr. Gelsinger said, despite its recent technical problems.

He said significant improvements were being made in its next production process, which was delayed last summer. Intel also will engage with IBM in a new partnership to develop new chip-making technology, he added.

Mr. Gelsinger’s plans are bound to meet skepticism. Besides recent problems with manufacturing technology, Intel has tried in the past to operate as a foundry for other companies with little success.

But Intel has modified those plans in several ways. For one thing, it will for the first time be willing to license its technical crown jewels — the so-called x86 designs used in most of the world’s computers — so customers can incorporate that computing capability in chips they design for Intel to make, the company said.

 

Intel Expansion of Several Campuses

Intel has announced a massive expansion of its semiconductor manufacturing operations in Chandler. The company plans to add two new facilities to its existing Ocotillo Campus.

The expansion will add more than 3,000 high-tech, high-paying jobs. It will also support an additional 15,000 jobs indirectly. The company says 3,000 construction jobs will be created while the new facilities are being built. Construction is slated to begin later this year.

"Intel's continued expansion of its largest, most advanced manufacturing site in the world exemplifies the presence of innovation in Chandler," said Chandler Mayor Kevin Hartke. "A talented workforce, excellent quality of life, proactive planning, and decades of infrastructure investments enable global innovators like Intel to excel in our community."

Intel's opened its first production facility in Chandler and has grown to become the city's largest employer.

Gov. Doug Ducey attended today's announcement ceremony. In a tweet, he thanked Intel for "choosing Arizona to grow your business."

The news comes amid a worldwide chip shortage that is snarling industries from automobiles to electronics and worries the U.S. is falling behind in semiconductor manufacturing.

The announcement signals that Intel will continue to focus on manufacturing.

A semiconductor wafer during an Intel event ahead of a IFA International Consumer Electronics Show.

A semiconductor wafer during an Intel event ahead of a IFA International Consumer Electronics Show.

Intel announced that it will spend $20 billion to build two new chip factories, called fabs, in Chandler, Arizona.

Intel stock rose as much as 5% on the news.

The announcement, coinciding with new CEO Pat Gelsinger’s first public remarks since taking over the job, signals that Intel will continue to focus on manufacturing during industry shifts that have led competitors to increasingly separate chip design and chip fabrication.

The news comes during a global chip shortage that is snarling industries from automobiles to electronics and worries the U.S. is falling behind in semiconductor manufacturing.

“Intel is and will remain a leading developer of process technology, a major manufacturer of semiconductors, and the leading provider of silicon globally,” Gelsinger said.

Intel also said that it will act as a “foundry,” or a manufacturing partner, for other chip companies that focus on semiconductor design but need a company to actually make the chips. Intel said its foundry division will be called Intel Foundry Services and will be led by Randhir Thakur, a current Intel senior vice president.

Gelsinger said the foundry business will compete in a market potentially worth $100 billion by 2025 and will manufacture a range of chips, including chips based on ARM technology, which are used in mobile devices, and has historically competed with Intel’s favored x86 technology.

A slide displayed by Intel suggested that companies including Amazon, Google, Microsoft and Qualcomm could be customers for the business. Microsoft CEO Satya Nadella appeared at Gelsinger’s talk in a show of support for Intel’s move.

Why Intel is opening new factories,

Intel’s commitment to manufacturing has national security implications. Intel said it is entering into a partnership with IBM to improve chip logic and packaging technologies, which will “enhance the competitiveness of the U.S. semiconductor industry and support key U.S. government initiatives.”

Intel currently operates four factories, called “wafer fabs,” in the United States. In addition to its site in Arizona, which is being expanded, it also has fabs in Massachusetts, New Mexico and Oregon. It also makes chips in Ireland, Israel and has a single fab in China.

Intel’s foundry will offer a U.S. and Europe-based alternative to Asian chip factories.

In February, President Joe Biden said domestic semiconductor manufacturing is a priority for his administration. His administration hopes to fix going chip shortages and address lawmaker concerns that outsourcing chipmaking had made the U.S. more vulnerable to supply chain disruptions.

In an executive action, Biden started began a 100-day review that could boost American chip companies with additional government support and new policies.

“Today’s Executive Order, combined with full funding for the CHIPS Act, can help level the playing field in the global competition for semiconductor manufacturing leadership, enabling American companies to compete on equal footing with foreign companies heavily subsidized by their governments,” Intel said at the time in response to the executive order.

Gelsinger took over Intel on Feb. 15 from former CEO Bob Swan. Although he was most recently the CEO of VMWare, he started his career at Intel and his appointment has been regarded as a homecoming.

He took over a company facing a variety of challenges. Intel had lost its semiconductor manufacturing edge to Asia-based rivals, most notably TSMC. Intel’s most advanced chips use a 14-nanometer or a 10-nanometer process. Intel both designs the chips, then makes them in its own factories, called fabs.

But competitors, including Intel customers like Apple and rivals like AMD, just design the processor, then have it manufactured by an outside chip factory. These chip factories, like TSMC and Samsung, use a more advanced 5-nanometer process, which is superior because more transistors can fit in the same sized chip, boosting power and efficiency.

“We will pursue customers like Apple” for Intel’s foundry business, Gelsinger said.

Gelsinger said that its 7-nanometer chips are on track to hit a milestone in the second quarter and that it plans to manufacture the majority of its products itself. Still, Intel will increase its use of third-party foundries, including TSMC, Samsung, and GlobalFoundries, he said.

Intel also announced full-year guidance. The company said it expects $4.55 in adjusted earnings per share on $72 billion, below Refinitiv estimates of $4.77 in adjusted earnings per share and $72.94 billion in revenue in revenue. Intel said it expects $19 billion to $20 billion in capital expenditures for the year. Analysts polled by FactSet had expected $14.59 billion.

 

 

 

Electronics and Nanotechnology

 

Microfactories, Not Gigafactories, Will Build It Back Better

A British EV company offers up a radical departure from conventional manufacturing.

If you buy Elon Musk’s vision of reinventing manufacturing in America, that means the bigger the better. His multiple gigafactories are squarely in the tradition of Henry Ford’s 16-million square foot, vertically integrated Rouge River plant. But that was nearly 100 years ago.

For some of us, the way to achieve the Biden Administration’s “Build Back Better” challenge is a radical shift, to smaller, ultra-efficient, easily built plants nearer the point of sale and use: microfactories.

The final nail in the coffin of conventional large-scale global manufacturing was the horrific sight of the gargantuan Evergreen Given container ship stuck in the Suez Canal.

That came after the COVID crisis disrupted manufacturing and shipping from China for months, and corporate leaders declared that global warming must be dealt with through drastic changes. “A bold 2030 target is needed to catalyze a zero-emissions future, spur a robust economic recovery, create millions of well-paying jobs and allow the U.S. to ‘build back better’ from the pandemic,'' more than 300 U.S. businesses and investors stated in a letter to President Joe Biden. “New investment in clean energy, energy efficiency and clean transportation can build a strong, more equitable and more inclusive American economy,'' they wrote.

The solution to all of these problems—scale, efficiency, and location—may be in the approach of a British startup, Arrival, which is moving with astonishing speed toward opening its first three plants, in England; Rock Hill, South Carolina; and Charlotte, North Carolina.

When operational, the plants will manufacture electric delivery vans and transit buses challenging conventional assumptions about vehicle design and production—and underscoring exactly how much the Industrial Internet of Things (IIoT) allows a radical departure from conventional manufacturing. The resulting benefits will include higher operating efficiency, reduced supply chains, and lower environmental impact.

Perhaps most startling is the factories' size, or lack thereof.  Instead of a massive plant taking years to design, permit and construct, the Arrival microfactories are so modular, small, and automated that they only require 200,000 square feet, and can actually be assembled in existing, vacant industrial warehouses, rather than requiring a new building. Unlike conventional plants that may take 2 years to be operational, they are slated to be up, running, and revenue producing in as little as six months.

Inside, robotic, modular workstations replace the conveyor belt. My bet is that, once fully functional, the IoT-based automated production system will even beat Siemens’ “factory of the future” record, 99.99885%

The microfactories’ efficiency is also due to totally rethinking vehicle design. The first thing you notice about both the Arrival delivery vans and buses is the totally flat floor, which sits on a “skateboard” undercarriage of axles, battery, and motors. The frame itself is made of lightweight extruded aluminum, not stamped metal.  The body is a picture of efficiency: instead of massive presses needed to stamp metallic body parts, their bodies are made of woven composite with colors mixed in, so no paint stations are needed (and scratches are hidden because the color is not just superficial).   Instead of scrap that contributes to environmental impact, inefficiency, and costs, any left-over pieces of the vehicles’ bodies can be ground up and used again right in the factory.

The robotic machinery can be easily reprogrammed for design changes, and even for mass customization that will increase customer satisfaction and revenues.

The only negative factor in this new approach is that their small size and efficiency means Arrival plants only employ 200 or so people, as compared to thousands at conventional vehicle factories.  However, as a World Economic Forum article on the micro factory concept pointed out, the potential for proliferation of small micro factories  worldwide can more than compensate:

“Ultimately, job growth driven by local manufacturing is an important offset against globalization,” the article stated. “There’s been much pontificating on the idea that Industry 4.0 will eliminate manufacturing jobs, but a ‘think global, build local’ approach bucks this trend. While globally, job loss from automation will outpace job creation from automation, locally automation is a creator—not a destroyer.”          

There have been micro factories before, but they have concentrated more on niches than on replacing conventional mass-produced items. Five years ago, IW wrote about Local Motors, a U.S.-based vehicle maker that must have been an inspiration for Arrival but has focused more on one-off and custom designs capitalizing on microfactories’ ease of retooling.

In the environmental field, there are clever microfactories in Australia created by materials scientist Veena Sahajwalla of the University of New South Wales.  Her facilities, some as small as 500 square feet, break down and recover materials from old smart phones and other electronics.  Thermal technology recovers and turns the wastes into usable new materials. Sahajwalla’s vision is that “the small scale of the machines will make it easier for them to one day operate on renewable energy, unlike most large manufacturing plants. The approach will also allow cities to recycle waste into new products on location, avoiding the long, often international, high-emission treks between recycling processors and manufacturing plants.”

The most exciting thing about Arrival’s microfactories is that they are no mere proof-of-concept. UPS was impressed enough by the vehicles and their production that they bought a minority interest in Arrival, and their engineers played a full role in design of the vans for ease of commercial use. The company made an initial commitment to buy up to 10,00o0, and has options to buy 10,000 more.  According to Luke Wake, UPS’s international director of automotive engineering and advanced technology, “There are a lot of startups with EV ideas. Unfortunately, we have not seen a lot of that materialize in terms of products that come to the market. What helps set Arrival apart is the way that they were well-funded to actually turn some of these ideas and visions into a reality.”

The last year has seen a disastrous convergence for manufacturing as usual: supply chain disruption, a recognition by business that it must play a leading role in fighting global warming and a continuing decline in manufacturing. To this observer the way is clear: gigafactories just perpetuate business as usual, while microfactories harness the IIoT, modern materials science, robotics and other innovations to point the way to a future that will bring production closer to the point of use, reduce supply chain size and inefficiency, and, in the long run, create more manufacturing jobs throughout the world than they will displace.

W. David Stephenson, principal of Stephenson Strategies (Millis, Massachusetts), is an IoT consultant and thought leader. His The Future Is Smart (HarperCollins Leadership), was one of the first books on IoT strategy.