PHARMACEUTICAL & BIOTECHNOLOGY

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UNITED STATES

PPD Expands Bioanalytical Lab

PPD is expanding its immunochemistry and biomarker space by 8,000 square feet, the addition of which will also support a dedicated team for one of the company’s global biopharmaceutical clients.

“The expansion of the lab’s immunochemistry, biomarker, and chromatography services builds on the ongoing investments we’ve made in our Richmond facilities over the years,” said Christopher Fikry, MD, executive vice president of PPD Laboratories.

The Richmond location provides various services such as small molecule, biologics, vaccines, and biomarker testing for all phases of drug development. Specific testing services include drug pharmacokinetics and pharmacodynamics (PK/PD), immunogenicity, and biomarker quantitation.

Approximately 200 new positions are expected to be added as a result of the expansion, which follows previous additions to the company’s vaccine sciences, biomarker, genomics, and automation services.

Said Fikry, “PPD’s laboratory operations – elements of which have been part of the Richmond community since 1985 – have grown significantly during the past three decades.”

The company today employs more than 1,000 people at the Richmond location which spans more than 250,000 square feet, making it “one of the largest bioanalytical labs in the world,” Fikry said.

PPD also this month is initiating the addition of 30,000 square feet dedicated to chromatography services. Additionally, work is on track to create a 4,500 square foot cell lab.

The company recently moved its administrative staff into 36,000 square feet at One Holland Place and earlier this year completed an 8,600-square-foot expansion to its sample management and biorepository offerings.

Albemarle Expands Pennsylvania Custom Manufacturing Facility

Albemarle Fine Chemistry Services (FCS) has announced the expansion of its operations at its Tyrone, Pennsylvania custom manufacturing facility with the construction of a new, state-of-the-art operations building.

The construction was begun 15 months ago, and Albemarle FCS projects that the new building will be fully operational within two weeks. The new, 8,900 sq. ft. facility will feature a new 400 sq. ft. control room and data center and a new 2000 sq. ft. quality control laboratory.

Albermarle is a US supplier of regulatory starting materials (RSMs), intermediates, and high-value active pharmaceutical ingredients (APIs).

The new laboratory will contain ample space for the integration of existing equipment, including inductively coupled plasma mass spectrometry (ICP-MS) for elemental metal impurity analysis, and will facilitate ongoing expansion of analytical capabilities at the site in support of the rapidly growing RSM business there.

Relocating control room and data center operations to the remote, hardened location will enhance the overall reliability and optimize the site from a safety and environmental standpoint. In addition, operations will be supported by a new 6,500 sq. ft. office complex.

Relocating the quality control operations to the newly constructed building will free up approximately 1,500 sq. ft. of space to allow expansion of the existing R&D laboratory. This will allow for ongoing upgrades to the overall infrastructure, as well as specific equipment and capabilities.

Critically, some of this open space will be allocated for the construction of a new kilo lab, which will facilitate the production of early-stage RSMs at scales intermediate between what is possible at the existing R&D laboratory and the pilot plant and will enhance on-site scale-up and development services.

"We continue to invest in our sites to provide innovative, state-of-the-art solutions to our customers," said Scott Martin, President of Albemarle Fine Chemistry Services. "The new building incorporates the latest safety features, as well as improved integration of our QC lab and operations staffs."

Particle Dynamics Completes New Innovation Center

Particle Dynamics announced the completion of a new, state-of-the-art Product and Process Innovation Center located within its US-based, St Louis facilities. Additionally, Particle Dynamics has received three FDA inspections in the past nine months with zero Form 483 observations.

The new, fully integrated innovation center includes development laboratories and pilot-scale processing rooms housing technologies in Spray Drying, Microencapsulation, Continuous

Granulation, and Solid Dosage Form Development. Designed for a fully integrated and seamless transition of new products to commercial scale, the new innovation center will streamline process development and enable more rapid commercialization of products into either of the Company's FDA inspected, GMP facilities in St Louis, MO and Seymour, IN. In addition to the facility and equipment investments, Particle Dynamics has developed a project management infrastructure, and hired leaders in Technical Operations, Innovation, and Sales to fuel the company's next level of growth; supporting customer success aligned with current market trends.

"This investment is fully aligned with our Vision to provide a fully integrated portfolio of products and services to the global Healthcare industry," said Nicolas Fortin, CEO at Particle Dynamics. "Having advanced technologies such as spray drying, microencapsulation, granulation, and advanced dosage form development under one roof will enable us to more rapidly respond with the right technical solutions to meet the needs of our customers."

"The completion of our Product and Process Innovation Center marks a major milestone in providing innovative solutions for our customers," said Chad Dykes, Vice President of Technical Operations. "This new center is the latest in our journey to create a more integrated and agile development process. By consolidating development and manufacturing operations under the same leadership, we will move faster through the development, scale-up and commercialization of solutions for our customers."

Foxx Life Sciences Expands to New Worldwide Headquarters

The laboratory equipment supplier's new 75,000 sq. ft. New Hampshire, US, facility will allow it to triple cleanroom space and sterile manufacturing capabilities

Foxx Life Sciences, the laboratory equipment supplier, is expanding into its fourth new building in 10 years to triple production. The new building is located next to the Manchester-Boston Regional Airport, just 46 miles (74 km) north of Boston and is almost 75,000 sq. ft., nearly double the New Hampshire-based company's current building in Salem, NH.

Some operations will move from its Salem facility, which will maintain its production cleanroom.

The company is investing $1 million in renovating the facility and constructing three new cleanrooms for sterile manufacturing. It also has lines of credit from the Small Business Administration to grow the company’s inventory, said the newspaper.

The old McKesson building at 12 North Wentworth Ave. is being fitted up with front office space, and about 5,000 sq. ft. of warehouse space will be converted into the three new cleanrooms for manufacturing products over the next six to nine months.

The facility will provide a prime second location, allowing space for expanded inventory and greater distribution capabilities as a result of increased cleanroom space and sterile manufacturing capabilities.

This expansion will allow the company to provide customers with more effective and efficient service, shipments and laboratory product innovations.

The state-of-the-art distribution center boasts 30 ft. extra high ceilings, new pallet racking, a bar code inventory control system, and 13 bays for efficient delivery, shipping, and inventory management. Neighboring the airport is also a bonus, as it saves extra time for expediting orders.

"With the new distribution center, we fully expect time of delivery to be reduced and product breadth to increase," the company said in its blog.

"We are excited to have Foxx Life Sciences as a new tenant in our Londonderry building. Our property's location, size and potential for expansion fits well with Foxx's continued growth and success.", said Ben Dulac, North River company.

"Based on our rapid growth rate, Foxx was forced to add additional space for our five main businesses: bioprocess single-use system (SUS) cleanrooms, biopharma filtration, fluid management, lab safety, and lab glassware inventory," said Thomas Taylor, President & CEO of Foxx.

"Most importantly, the new facility offered the opportunity to triple our cleanroom space and sterile manufacturing capabilities," Taylor added.

Director of Bioprocess Sales Alice Molteni said the diversity of products — single-use pharmaceutical lab equipment, biopharma filtration, fluid management products, lab safety equipment and laboratory glassware — ensures Foxx has a diversity of customers, including big and small manufacturers, research and development firms, and universities.

Taylor said he’s received a lot of support from the state and SBA, and he said the goal is not to sell the company but to keep growing.

“We’ve been offered a lot of money for the company, but we’re kind of old-school stubborn,” Taylor said.

Cannabis Testing Lab Cannalysis Gets Cash Injection to Expand

Cannalysis Lab, an ISO/IEC 17025-accredited and state-licensed cannabis testing laboratory in the US, has raised $22 million in funding and committed growth capital from CanLab, a cannabis, hemp and CBD testing laboratory network.

Headquartered in Santa Ana, California, Cannalysis said the cash injection will allow the company to double the size of its operation and expand its footprint into additional states.

Cannalysis provides testing services that meet or exceed state-level compliance standards through the combination of robotics and validated scientific methods. The company said due to proprietary technology it has been successful at increasing the precision and accuracy of results while dramatically reducing variability and errors.

“Our purpose-built laboratory features some of the most advanced technologies for testing cannabis and hemp products," said Brian Lannon, CEO of Cannalysis. "By streamlining the process through automating sample preparation, to pushing test data directly to other platforms, including consumer-facing marketplaces, we offer value beyond compliance,” he explained.

Lannon said the use of robotics and data-automation has allowed Cannalysis to reduce human error while providing customers with sample tracking to follow the test's progress in real-time. "Together with CanLab, we hope to introduce a new gold-standard for the cannabis testing industry," he said.

All cannabis, hemp and CBD products must go through scientific testing at licensed labs before becoming available for legal purchase.

Currently, these labs are regulated independently of each other by local state governments, creating inconsistencies in results. CanLab proposes a universalized ecosystem that instills transparency and trust in the process.

“Cannabis and hemp testing are still in its nascent stages, and there’s an enormous market opportunity as legalization becomes more widespread and the utility of CBD products become more prevalent," explains Gary Hopkinson, executive chairman of CanLab. "Cannalysis has set a new precedent for what the standards for cannabis testing should be with its focus on technology and automation. We look forward to joining forces to help cannabis brands and businesses navigate and pass strict compliance regulations,” he added.

Most consumers are unaware of the risks associated with unregulated or poorly tested cannabinoids.

Beyond potency testing, labs also test for several substances that can be harmful to consumers, such as; pesticides, heavy metals and microbial (like E. coli).

Through the Cannalysis online platform, cultivators and manufacturers can monitor testing progress and access Cannalysis’ APIs to automate the flow of data between third-party platforms, like Weedmaps, and integrate directly with internal ERP systems.

Cannalysis also provides customers with value-add tools and services like state-compliant labelling and PhD consultations that help identify and advise on process change and testing parameters to improve processes.

Sterling Pharma Solutions Invests $1.5 Million in US Facility Expansion

Sterling Pharma Solutions is investing $1.5 million into a phased expansion of its US facility in North Carolina.

The investment follows the acquisition of the former US CiVentiChem site earlier this year. Over the next three years, the company plans to expand the cGMP production suites, add a non-GMP scale-up production facility, expand its QC laboratory and increase the site’s R&D capacity.

“The North American market now makes up 70% of our customer portfolio. And, having expanded our US presence earlier this year with the acquisition of our facility in North Carolina, we have continued to experience strong growth,” Mat Minardi, President US Operations said. “This investment will allow us to continue to meet customer expectations and take on new projects, as well as bolster Sterling’s chemistry development capabilities. The specialist capabilities provided by Sterling, particularly our ability to handle challenging chemistries, are in high demand as a result of the increasing complexity of products entering the drug pipeline and the need for more efficient and cost-effective production of APIs. We’re confident this investment will be of huge benefit to our customers.”

The investment plan will also allow Sterling to expand its quality assurance (QA) team to provide more support for cGMP projects, increase its team of chemists and put measures in place to help it secure its US Drug Enforcement Administration (DEA) Schedule I manufacturing approval. This recruitment drive, along with the initial facility expansion, forms the first part of the phased investment.

As part of its expansion plans Sterling is also recruiting for its US BD and sales team.

PTC Therapeutics’ Biologics Facility

PTC Therapeutics’ biologics facility will be located within the Bristol-Myers Squibb (BMS) campus in Hopewell, New Jersey, US.

PTC entered a long-term lease agreement with BMS, gaining access to approximately 185,000 square feet (ft2) of space within the campus. The company will pay approximately $88m for the initial rental term of 15 years, starting from July 2020. The rental period of the PTC Therapeutics’ biologics facility can be extended twice for ten years each.

The company will make use of the existing state-of-the-art biologics production facility and associated research and operations buildings available within the space, as part of the lease agreement. The biologics facility is expected to support PTC’s gene therapy production.

The Bristol-Myers Squibb’s Hopewell campus spans over one million ft2, which is proposed to be converted to a multi-tenant research and development campus.

The campus features a state-of-the-art biologics manufacturing facility, as well as associated buildings for research and other administrative operations.

The company proposes to shift its research operations to a newly renovated building on the same campus. The relocation of research operations, following the start of gene therapy production, is also planned for 2020.

The acquisition will add Bristol Myer’s Squibb’s technology and qualified biologics operation professionals to PTC’s portfolio.

The cGMP suites of the facility will be renovated to produce materials for various pre-clinical and clinical programs. It will be an addition to the company’s existing pre-clinical trials material production capacity in Bridgewater, New Jersey. The company may also request to construct a separate approximately 75000 ft2 building within the campus area.

Access to best-in-class technology and highly qualified biologics operation specialists will enable PTC to meet its goal of becoming a leader in gene therapy.

PTC’s advance gene therapy products such as Emflaza (deflazacort), Translarna (ataluren), and Tegsedi (inotersen) will be developed and commercialized in the facility. The FDA-approved Emflaza (deflazacort) is indicated for the treatment of Duchenne muscular dystrophy (DMD) in patients two years or older. PTC is awaiting approval over a supplemental new drug application (sNDA) submitted for the drug in July 2019.

Translarna (ataluren) received approval from the Brazilian health regulatory authority (ANVISA) in the first quarter of 2019, expanding PTC’s footprint in Brazil. The drug is also approved in the European Union (EU) for the treatment of DMD.

Tegsedi (inotersen), indicated for the treatment of the polyneuropathy of hereditary transthyretin-mediated amyloidosis (hATTR) in adults, is approved in the US, Canada and EU. The drug received priority review from ANVISA and is anticipated to be approved by the end of 2019.

Waylivra™ (volanesorsen), indicated for the treatment of familial chylomicronemia syndrome (FCS), secured a positive CHMP opinion from the European medical authorities in the first quarter of 2019. The company plans to start early access programs in Latin America in 2019, following ratification by the European Commission.

The facility will also support the company’s gene therapy pipeline for central nervous system disorders, which includes Friedreich ataxia program and Aromatic L-amino acid decarboxylase (AADC) deficiency gene therapy program. Gene therapy development for the treatment of Angelman syndrome and other cognitive disorders are in the early stage of development.

Marketing commentary on PTC Therapeutics:

“The relocation of research operations, following the start of gene therapy production, is also planned for 2020.”

PTC Therapeutics, a biopharmaceutical company in the US, focuses on research and development of orally administered drugs used in post-transcriptional control processes. The discovery programs direct the targets in multiple therapeutic areas, while the company’s main focus is on developing and commercializing treatments for orphan and ultra-orphan disorders.

The company acquired Agilis Biotherapeutics and is currently collaborating with Akcea Therapeutics, Odylia Therapeutics, Roche and Aldevron for advancing its gene therapy platform.

PTC Therapeutics does not own any manufacturing or distribution facilities for their gene therapy product candidates and relies only on third-parties for all the manufacturing, packaging, labelling and distribution of the commercial and clinical products. The company currently employs more than 700 people worldwide.

The company is backed by the New Jersey Economic Development Authority’s (NJEDA) net operating loss (NOL) program, which enables potential technologies and life sciences companies to sustain competition before it starts making a profit.

REST OF WORLD

Jubilant Biosys Begins Two Drug Discovery Facility Expansions in India

The CRO has invested in expansion of the Greater Noida and Bengalaru facilities

Indian Jubilant Biosys has commenced two expansion projects in Greater Noida and Bengaluru. The company said growing customer demand for its range of functional and integrated drug discovery services is the drive behind the scale up.

The Indian CRO has started design and construction of brand new chemistry services laboratories on the existing Jubilant Greater Noida site. The chemistry FTE capacity will be doubled and operations are expected to commence in 2020. The new site can accommodate up to 500 Chemistry FTE's. The site will be designed for the highest global compliance standards and deliver superior speed and quality in the entire drug discovery process.

In Bengaluru, Jubilant Biosys has obtained a 10-acre plot in the Devanahalli Industrial Park. A completely new drug discovery services site will be constructed in phases for further expansions.

In addition, the company has formed a new digital business unit comprising of Bio-Informatics, Data-curation for AI/ML, TrialStat EDC software as well as discovery focused AI/ML capabilities. This business unit will also further expand on the new Bengalaru site and deliver increased benefits to our customers.

Marcel Velterop, President of Jubilant Biosys, said: " We will soon be able to offer our customers much-improved capacity and services as well as ability to deliver an integrated IND package along with superior functional discovery services."

NGS Cleanroom Solutions Finishes Grade D Probiotic Cleanroom in England

NGS Cleanroom Solutions has finished construction of a GMP Grade D (ISO Class 8 equivalent) cleanroom for Probiotics International in England. The contractor provides a full range of cleanroom solutions, from concept to completion.

When it came to the need for a GMP Grade D Cleanroom, Probiotics International turned to Cleanroom-Solutions to design and install a cleanroom using an FM approved Puracore Cleanroom System.

The 13,450 sq. ft. (1250 sq. meter) cleanroom in Somerset is made up of 28 internal processing rooms. Each processing room is fitted with rapid speed gates to facilitate easy entry and exit while maintaining the air environment in the room.

In addition to the cleanroom construction, an important requirement for this cleanroom is the air management. The powder blending and tableting operations require a relative humidity level of 10% RH with tolerances of +/-2% RH.

Furthermore, an integrated cold store and a total of 300 kW of system cooling capacity was included in the cleanroom construction.

Cell Therapies Gains First T-Cell GMP Manufacturing License in Australia

The Therapeutic Goods Administration (TGA) of Australia has granted Cell Therapies of Melbourne, a product class (T-Cells) GMP manufacturing license for commercial supply of these cells. The company is the first to gain a license for this purpose in the country.

This new license, specifically for Cell Therapies and its clients, allows for the collection, manufacturing, testing, storage and release for the supply of any commercial T-cell product, including the novel cancer treatment, CAR-T cell therapy.

A CDMO, Cell Therapies provides apheresis management, clinical trial support, and consulting and advisory services.

“This license affords everyone involved a huge benefit, it’s also an acknowledgement of confidence in us from the TGA”, commented A/Prof Dominic Wall, CSO of Cell Therapies.

With this new manufacturing license, Cell Therapies is becoming the Australian “local manufacturing hub” for commercially approved products.

“By now being able to provide direct access to the market, we’re able to speed up the production of new and exciting cell therapy treatments,” Wall said. “Our clients can use our services to treat patients faster. It will also help us to accelerate the uptake of new treatments in this new and exciting field of research, and that makes me extremely proud of my team at Cell Therapies”.

With a regulator pre-approved Technical Transfer process, Cell Therapies can significantly de-risk their client’s product registration with a clear path to rapid local manufacturing approval.

Gerry McKiernan, Quality Manager of Cell Therapies, added: “This is the first license of its type issued in Australia and one of only a few globally. This will greatly assist in bringing these types of therapies to the Australian public. It also demonstrates that we have the requisite systems in place to obtain additional regulatory licenses to supply other countries should our clients require this.”

By bringing manufacturing to Australia, Cell Therapies will improve patient care with reduced risk of delays for these cells, which usually require their complex manufacturing to occur in distant sites in Europe or North America.

Source Bioscience Invests in Irish Microbiology and Sterility Testing Lab

Source Bioscience has invested €585,000 (US$650,000) in microbiology and sterility testing labs at its stability storage facility in Tramore, Co Waterford, Ireland. The investment expands the lab service and product provider's current service offering at the site with the aim of reducing turnaround times to allow more rapid feedback to customers and to minimize risk when storing samples.

Accessible, high-quality microbiology and sterility testing services are increasingly becoming a key requirement within the pharmaceutical, cosmetic and food industries in the UK and Ireland. The company's new labs boast equipment served by highly-trained personnel combined with a robust compliance ethos. Tests offered include sample pick up, quick turnaround times and full reporting to meet customer's requirements.

The investment supports the further expansion of this offering in the Irish and European markets.

Russell Wheatcroft, Commercial Director of Source Bioscience said: "The funding is part of a two-stage process and we now look to expand our footprint in Ireland further by increasing the capacity of our Tramore facility by 40%. The Irish market is a key element to our expected growth in Europe and this investment will be critical in driving the company through the next phase of its development."

Source BioScience has been providing outsourced stability storage services for more than 40 years and has served the Irish market since 2007. Recently rebranded as Source Stability Storage Solutions, the company offers a portfolio of stability storage options, delivering 24/7 outsourced controlled environment storage for stability trials at all World Climatic ICH conditions, as well as bespoke conditions.

Schilling Delivers Cleanroom to German Cancer Research Centre

New 1,076 sq. ft. (100 sq. meter) GMP Grade B laboratory at IOZK center in Cologne has been planned for the restricted space

The Immun-Onkologisches Zentrum Köln (IOZK) in Cologne, Germany, works on researching and developing new methods of cancer treatment. The center needed a 1,076 sq. ft. (100 sqm) GMP cleanroom laboratory for the sterile production of the vaccines.

Since 1985, the IOZK has been employing physicians and natural scientists to research the role of the immune system in cancer. The immunotherapies developed aim to support the body’s immune system in destroying cancer cells.

Tobias Geef, Head of Purchasing and Technology at IOZK, explained the complex processes of the therapy in simple terms: “We use the biological foundations of immunology in our research and develop vaccines that activate the immune cells of the body for fighting cancer.

“Through our vaccine, the immune system is targeted specifically at the tumor antigens of the tumor to attack it. The therapy should put the immune system in a position to become active itself and fight the disease on its own. In the ideal case, the tumor is thus completely and sustainably removed by the body’s defenses without side effects.”

The combination of oncolytic viruses that can specifically attack cancer cells creates a groundbreaking approach to fighting cancer that drastically reduces the side effects of the treatment.

The IOZK has received the authorization to develop combination agents mixed with certain viruses: the vaccines invade and alter the tumor cells. This form of therapy is still not a treatment standard but is already being made available as an individual treatment method for private patients.

In the laboratory, human cells are made to grow in special nutrient fluids and at body temperature. Foreign particles as interfering factors and any bioburden must be excluded in the process.

The production of the patient’s individual vaccines takes place in a sterile CleanSteriCell-branded cleanroom laboratory that meets the requirements for GMP cleanroom class B.

Commenting on the necessity of the new investment, Geef said: “The IOZK has several laboratories for research, diagnostics and production. For the production of the patient’s individual vaccines, we have to meet the requirements for pharmaceutical production and the requirements of the Medicinal Products Act.

“We have now invested in a brand new production laboratory with cleanroom technology. The cleanroom system corresponds to GMP cleanroom class B, is energy-efficient and is state-of-the-art; that was important to us.”

The cleanroom laboratory was planned and built by Schilling Engineering. A special challenge resulted from the limited space conditions and the low ceiling height in the existing building.

The 1,076 sq. ft. space of the cleanroom was tailored to the classified environment, and the corresponding ducting was planned for the air- conditioning technology. The cleanroom laboratory was planned especially for the restricted space.

The supply of ultra-pure air to the clean areas and workstations was achieved with more than 120 air changes per hour, according to the principle of low-turbulence displacement ventilation.

Filtering takes place via laminar flow units equipped with ULPA 15 high-performance filters integrated into the ceiling.

Schilling Engineering said the system is operated with a unique energy-efficient air recirculation process to reduce the high energy costs associated with the operation of a cleanroom.

A large portion of the air discharged from the cleanroom is circulated within the walls and introduced back into the circuit via the filter units.

“Because this air is already cooled and has a reduced particle count, the high costs of air conditioning are omitted,” the company explained. Also, the filter units take longer to become clogged and thus have a considerably longer service life.

Workstations for up to ten employees were set up in the new GMP laboratory. Three personnel and three material airlocks operated with different air pressure stages and air changes guarantee the purity of the laboratory system to GMP class B.

A special feature of the cleanroom laboratory is the integrated GMP-compliant monitoring. Particle count, temperature, relative humidity and air pressure are continuously monitored and recorded for the required supervision.

Serving as a control system for the cleanroom and the air-conditioning technology is the user-friendly CR Control unit, in which all setpoints, including the air-conditioning technology, are regulated and monitored. The CT Control unit is operated via a central touch screen or a mobile device.

The CleanSteriCell cleanroom system has a modular design and can be flexibly extended and converted thanks to a patented silicone-free GMP sealing clip system.

GMP-compliant LED light strips provide for pleasant and energy-saving lighting and long life span.

The cleanroom laboratory was qualified according to GMP regulations and handed over in turnkey condition by Schilling Engineering.

“The qualification of the GMP cleanroom went smoothly,” Geef said. “There are very many regulations that have to be adhered to here, but our cleanroom supplier prepared or took over everything well for us. We just went into production and are very satisfied with the way things are running,” he concluded.

Covance Announces New R&D Center in Shanghai

LabCorp® announced its Covance Drug Development business announces the opening of its new R&D Center in Shanghai, China, which is now its largest facility in the Asia Pacific region. The opening ceremony was attended by Chao Yang, vice chairman of the Shanghai Municipal Commission of Commerce; Feng Huang, chairman of the Shanghai Association of Foreign Investment; John Ratliff, CEO, Covance; and Honggang Bi, Ph.D., corporate vice president of Covance and general manager, China, as well as biopharmaceutical and biotech industry leaders, clinical research key opinion leaders, research partners and local dignitaries.

“We entered China in 1998 and have grown our breadth of services, scientific capabilities and therapeutic expertise progressively, building our operations to meet global standards and requirements,” said Ratliff. “Today we are the only provider to offer comprehensive R&D services from early development through commercial solutions in China, as well as globally. Our Shanghai R&D Center continues our investment in China, bringing professionals and teams together to serve both the burgeoning Chinese pharmaceutical and biotech industry, as well as global biopharmaceutical clients working in the region. I’m proud to dedicate this new facility on behalf of all our colleagues in China, who apply their talents and passion to develop solutions for our customers and for the patients who benefit from our mission to improve health and improve lives.”

The R&D Center occupies 129,120 sq. ft. (12,000 square meters) in the Zhangjiang Hi-Tech Park of Shanghai's Pudong District. It doubles Covance’s capacity to serve customers with clinical development and commercialization solutions, bioanalytical services and central laboratory services. Covance’s Early Development services, including safety assessment, metabolism and lead optimization, will remain at Covance’s facility on Kangxin Road in the Shanghai International Medical Zone in close proximity to the R&D center.

“It’s an exciting time to be at the heart of pharmaceutical R&D in China,” said Bi. “The government has identified pharmaceutical innovation as a national strategy, with a program of reforms and regulations that has ignited innovation and accelerated development at both a national and global level. The inauguration of our R&D Center in Shanghai signals our long-term commitment to this exciting and growing industry.”

Merz Completes Construction of New Plant and New Filling Line

Merz announces that it has completed the construction of a new plant for its botulinum neurotoxin product and unveils a ‘robot-controlled’ filling line.

Both developments took place in Dessau, Germany, where Merz has held a manufacturing footprint since 2002.

Merz’s subsidiary, Oncotec is based in the same location and announced that it had completed the installation of a ‘robot-controlled’ filling line, which includes technology for the automated visual inspection of syringes and represents a total investment of €35m ($38m).

Oncotec, as a contract manufacturing organization (CMO), produces sterile cytostatics at the site that are used to treat cancer and autoimmune diseases.

The CMO employs 306 people at the location and the company’s managing director, Maron Michel, said that the investment would allow the company to meet ‘future, global demand and developments’ in drug manufacturing.

In addition to its investment in Oncotec’s capabilities, Merz announced the completion of a €15m investment for a new plant.

The production plant, which covers129,120 sq. ft. ( 12,000-square-meters), will be responsible for producing Belotero (botulinum neurotoxin).

Belotero is part of Merz’s medical aesthetics portfolio and is used as a dermal filler.

Philip Burchard, CEO of Merz, said, “The new production plant is of strategic importance to our business, as it enables us to meet the increasing demand for our dermal fillers. We are proud that our location in Dessau plays such a crucial role in securing the international supply of our medical aesthetics products.”

As well as being used for medical aesthetic purposes, the treatment is also used to address neurologically-induced movement disorders.

Histoindex Expands AI-Based Digital Pathology Platform

The Singapore-based company recently expanded its AI-based digital pathology platform to support preclinical discovery and drug development programs.

HistoIndex’s Second Harmonic Generation (SHG) technology is a stain-free method quantifies more than 450 parameters associated with nonalcoholic steatohepatitis (NASH), including fibrosis, inflammation, ballooning, and steatosis, according to the company.

"While there are no US Food and Drug Administration (FDA) approved drugs today, there are currently multiple clinical trials to find a treatment for NASH,” said Dr. Gideon Ho, chief commercial officer, HistoIndex.

“Therefore, there is an urgent need to monitor therapeutic responses for positive outcomes in drug discovery, one of which is quantifying changes in NASH characteristics such as fibrosis, steatosis, lobular inflammation, and hepatocyte ballooning,” he said.

“Here is where innovative technologies like HistoIndex's AI-based digital pathology platform can support pharmas and biotechs in their preclinical discovery as well as drug development program for NASH."

HistoIndex partners with pharma and biotech, contract research organizations (CROs), academia, and other research institutes, and is currently involved in multiple preclinical studies in addition to several ongoing NASH trials.

The company recently inked a collaboration with the A*STAR's Genome Institute of Singapore (GIS) to validate in vivo and in vitro NASH models. It also is providing R&D services and smart imaging analysis to the CRO, WuXi Apptec.

The European Investment Bank Loans Polish Biotech $33m for Growth

Blood cancer-focused Mabion will use the financing for its R&D program, conducting clinical trials, as well as expanding its manufacturing capacities.

The European Investment Bank (EIB) has agreed to lend €30 million (US$33 million) to Mabion, a Polish biotech company, to finance its growth plans. Mabion will use the financing for a wide-ranging R&D program, conducting clinical trials, as well as expanding its manufacturing capacities with state-of-the-art equipment.

The company expects to employ 96 additional staff as a result of this financial injection.

The EIB loan is backed by the European Fund for Strategic Investments (EFSI), the financial pillar of the Investment Plan for Europe, the Juncker Plan. The project is the first in Poland to benefit from the EFSI-backed European Growth Finance Facility, which specializes in venture debt.

Mabion is a Polish pre-commercial-stage biotech company focused on the development and manufacturing of medicine to treat certain types of blood cancer, such as lymphoma, and rheumatoid arthritis.

Jean-Christophe Laloux, EIB Director General, Head of Lending Operations, said: "This loan represents a milestone in the EIB support for Poland: it makes innovative financing available for an innovative company that invests heavily in R&D and develops much needed treatment for oncologic diseases. By joining forces with the European Commission, the EU bank can support the long-term plans of Mabion and thus contribute to the growth of the biotech sector in Poland".

Vytenis Andriukaitis, European Commissioner for Health and Food Safety, said: "I am delighted that yet again the EU is investing in a project dedicated to healthcare. It is particularly encouraging to see that those who suffer from cancer and autoimmune diseases will greatly benefit from this investment. It is also another sign that this sector is creating jobs and providing incomes to families. It is a clear demonstration that the EU is a strong supporter of innovative, grass-roots companies in Poland and throughout Europe."

Grzegorz Grabowicz, Member of the Board and Financial Director at Mabion, concluded: "After obtaining the consent of EMA to introduce our medicine for sale in the European Union, we will need funds for infrastructure development and to cover the costs of further research. [The] EIB loan addresses a large proportion of our investment and development needs".

The loan amount will cover around 30% of the estimated costs ($1bn) of the company's growth plans. It will cover R&D costs related to both early and late-stage development programs including "biosimilars" and innovative drugs, as well as capital expenditures for the scale-up of manufacturing. This includes furnishing existing premises with manufacturing equipment and furnishing an extension of the plant with manufacturing equipment, R&D and quality control laboratories. The transaction will be divided into three milestone-based disbursement tranches.

Thanks to EFSI support, the EIB can take more risk and provide stable long-term financing with a flexible repayment and interest structure, which limits cash outflow from Mabion in the short to medium term and thereby enables the company to focus on investing in innovation and growth.

After completion of clinical trials for its most advanced program – a biosimilar of rituximab for the treatment of certain types of blood cancer - Mabion is expecting to obtain an opinion of the Committee for Medicinal Products for Human Use (CHMP) by the end of 2019. A positive opinion of the CHMP, a body of the European Medicines Agency (EMA), is the basis for the European Commission to grant marketing authorization for a medicine. Mabion could become the first EU-based company to introduce a biosimilar of rituximab into the EU market.

The project has a potentially positive impact on employment: it is estimated that it would generate around 96 additional new permanent positions, including for highly skilled people focused on R&D.

Univercells Ups Process Development Capacity with Modular Labs

The portable structures for viral production process development were designed, prefabricated offsite, delivered, and assembled into a full laboratory environment in less than a year.

Univercells has completed a 4,300 sq. ft. (400 sqm) extension to its Nivelles, Belgium site to support viral development. Modular Biosafety Level 2 (BSL-2) and 3 (BSL-3) laboratories were installed in an unusually quick timeframe.

These laboratories are dedicated to process development for client and internal projects developing polio, measles and rubella vaccines at an affordable price.

As a counterpart, Univercells engineering workshop hosts the development of proprietary manufacturing technologies, the scale-X bioreactor portfolio and NevoLine biomanufacturing platform, and are run by mechanical, software and electromechanics engineers.

The deployment of the modular laboratory additions was done with half the amount of time and resources that conventional facility construction usually takes. In less than a year, the portable structures were designed, prefabricated offsite, delivered, and assembled into a full laboratory environment.

"Modular labs and cleanrooms are easily transportable and offer cost-effective, low-footprint facilities, an ideal solution to rapidly accommodate Univercells', and other customers', growth," said Hugues Bultot, CEO and co-founder of Univercells.

"We are excited to show how this technology can be implemented internally, and we believe it will be particularly suited to indicate how we can deliver our NevoLine biomanufacturing solutions globally, and how manufacturers can enable this solution to rapidly implement sustainable production units locally," Bultot added.

With the NevoLine biomanufacturing platform, new viral production capacity can be established in existing or new infrastructure with great time, cost and resource savings.

In January 2019, the first NevoLine platform was built in the Nivelles facility to be later transported and installed at partner company, Batavia Biosciences for validation and scale-up (part of a Bill & Melinda Gates Foundation grant extension).

The team continues to work to refine the approach for the installation of modular and traditional facilities, to enable companies to update existing space or build out new facilities in a safe, fast and cost-effective manner.

Univercells aims to deliver products that help make biologics available and affordable to all by overcoming traditional bioprocess challenges. On the technology front, the team has developed a new process design with a low footprint to drastically reduce the investment needed and foster the emergence of new cost-effective facilities. And on the product front, the team continues to align with various partners on the development of polio, measles, rubella and rabies vaccines and other biologics.

WuXi STA’s Jinshan Facility Passes EMA Inspection

STA Pharmaceutical, a subsidiary of WuXi AppTec, announced its Jinshan manufacturing facility in Shanghai, China has successfully passed an inspection by the European Medicines Agency (EMA) with no critical and no major findings.

“It’s the first time that our Jinshan facility is audited by the EMA, with five auditors conducting a five-day inspection, spanning 11 products approved by the EMA in recent years. We continue to keep up a state of perpetual readiness across all our sites and actively welcome global regulators or client audits at any time. This is a direct testament to our organization’s culture of quality first, and real-time GMP monitoring.” said Mei Hao, Vice President of Quality at WuXi STA.

In March, the company’s new drug product manufacturing facility in Shanghai Waigaoqiao passed its GMP inspection by the European Medical Products Agency (MPA), and in June, its Jinshan manufacturing facility passed a Pre-Approval Inspection (PAI) by Japan’s Pharmaceutical and Medical Device Agency (PMDA) for an innovative drug. Further, in July, WuXi STA’s Analytical Service Unit (ASU) in Shanghai and active pharmaceutical ingredient (API) process R&D and manufacturing facility in Changzhou passed two inspections by the U.S. Food and Drug Administration (FDA) within the same week, with no Form 483s issued.

“The successful EMA inspection at Jinshan is yet further proof of WuXi STA's commitment to enforcing the highest global quality systems. We will continue to pursue a ‘quality first’ commitment, constantly enhancing our platform with new services to enable our customers to bring better medicines to patients faster,” said Dr. Minzhang Chen, CEO of WuXi STA.

WuXi STA has been engaged in new drug development and manufacturing for more than a decade, offering global partners efficient, flexible and high-quality solutions from preclinical to commercial uses with the integrated CMC (Chemical, Manufacturing, and Control) platform. More recently, WuXi STA expanded its platform to support oligonucleotides and peptides. The company has started construction of a new API process R&D center next to the current Jinshan site, adding 30,000 square meters of laboratories and more than 800 scientists. After completion, the Jinshan facility will become the second integrated site after Changzhou to support process R&D and manufacturing of innovative APIs for global partners. This year WuXi STA also initiated the third phase construction of a Changzhou API process development and manufacturing facility, which covers an additional 35 acres.

Swiss CDMO to Invest $3.5m in GMP Facility Expansion

The spray drying and capsule filling service provider Micro-Sphere will add a spray drying line to its facility in Switzerland to serve the US, Europe, New Zealand and Asia

Swiss Spray drying specialist and capsule filling service provider Micro-Sphere is investing 3.5 million CHF (US$3.5 million) into expanding its GMP manufacturing capabilities and processes.

Micro-Sphere will add an additional spray drying line to its facility in Switzerland in response to increased market demand for spray drying and capsule filling for dry powder inhalers.

The new production line, expected to be operational by Q1 2021, is Micro-Sphere's fifth and will allow the CDMO to handle larger quantities of pharmaceutical powders and commercial volumes of finished dosage forms.

Commenting on the investment, Michael Grassberger, Managing Director at Micro-Sphere said: "Our decision to invest has been fueled by greater demand for spray drying services and we expect it will generate significant benefits for our clients. Our flexibility is key to our success and this investment allows us to maintain that competitive advantage."

The Swiss facility, already home to spray drying and capsule filling technologies, will also benefit from the introduction of a new enterprise resource planning (ERP) system and "Chromeleon" a Chromatografy Data System (CDS) software to support the QC Lab workflow.

Both software systems will bring significant cost and time savings to the business and streamline process efficiency.

Grassberger added: "This year we have focused on making the necessary investments to prepare Micro-Sphere for growth in 2019 and beyond. As well as investing in new machinery to increase our capabilities and expertise, we have also made significant investment into the latest technology. This includes investing in software platforms to ensure the most efficient and robust quality and documentation management systems are in place."

From its GMP, SwissMedic, FDA and PMDA approved facility near Lugano, Micro-Sphere's the Micro-Sphere team supports customers in the US, Europe, New Zealand and Asia with spray drying capabilities for the development and manufacture of both potent and non-potent pharmaceutical products, with a focus on inhalable dosage forms.

GE Healthcare Sets Up UK Biotech R&D Lab

The newly-established facility is located inside the Mereside campus of Alderley Park in Cheshire, UK, which is the largest single-site life sciences campus in the country, according to GE Healthcare.

A spokesperson for the company said that there are 28 companies already interested in using the lab space, in order to advance their organization’s science and R&D.

The company stated that the facility aims to help small- and medium-sized enterprises at early R&D stages to boost their science through ‘advanced technologies, services and training’ that will be provided.

More specifically, the lab will be equipped with GE Healthcare’s process development and analytical technologies, including the Äkta chromatography systems for protein purification, the Biacore 8K equipment, enabling optimization and quality control of small molecules and biotherapeutics, and the IN Cell Analyzer 6500HS, for cellular imaging.

Through the establishment of the new facility, GE Healthcare aims to highlight the current market needs regarding R&D services, as well as the challenges that developers face, as well as promoting networking and partnering to address these needs.

According to GE Healthcare's spokesperson, the UK currently is "the second largest biotechnology cluster in the world, with a 65% growth rate since 2016 and more than £2 billion in investments in 2018."

"Northern England is one of the top five locations in the UK for R&D investment and has seen a 42% increase in biotechnology companies since 2016," the spokesperson noted, and added that "given the regional growth of the industry, Alderley Park is the best and most strategic location for this lab."

The Alderley Park spans over one million-square-feet, and includes life-science R&D laboratories, housing over 60 established and 150 pre-start up healthcare companies. Kath Mackay, managing director of the Alderley Park, commented that the launch of the facility by GE Healthcare is expected to complement the existing oncology, analytical and open access services.

CGT Catapult Manufacturing Facility Expansion

The CGT Catapult manufacturing facility, a cell and gene therapy manufacturing facility, in Stevenage in Hertfordshire, UK was expanded in September 2019.

The manufacturing facility expansion, referred to as phase two, was announced in May 2019 and completed in September. It doubled the company’s manufacturing capabilities and bolstered collaboration opportunities for up to six new companies.

Starting from 2020, the collaborator companies can make use of the space to manufacture their therapies at scale, under the Good Manufacturing Practice (GMP) standards.

CGT Catapult’s manufacturing facility is part of the GSK Bioscience Campus in Stevenage, which has acted as a world-class hub for cell and gene therapies development in Europe since 2012.

Stevenage has international air links at Heathrow Airport, Luton Airport and Stansted Airport, as well as well connected by road and rail line.

The six modules of the expansion project comprise grade C cleanrooms, each with 13,988 sq. ft. (130m²) production footprint, located on the second floor of the facility, which encompasses an already constructed area.

Each module is flexibly designed to hold 20 autologous cell processes in parallel or single bioreactor process ranging up to 1,000L bioreactors capacity for manufacturing viral vector or allogeneic cell.

The CGT Catapult manufacturing facility was opened in April 2018, securing Medicines and Healthcare Products Regulatory Agency (MHRA) licensing in August 2018. Spanning 98,992 sq. ft. (9,200m²), the GMP-compliant facility features six cleanroom modules in ‘hotel concept’, which enables the collaborators to design, develop and establish their production facilities.

The center received a commercial license from MHRA for the production of medicines for use in patients, in September 2018. The initial collaborators are Cell Medica, Adaptimmune, Autolus, Freeline Therapeutics, and TCR2 Therapeutics.

The center provides the required capabilities for the manufacture of new cell and gene therapies, starting with the availability of raw materials supply, quality control (QC) testing, storage, logistics and integration into the supply chain.

The Fisher BioServices’ CryoHub solution, used at the center, provides the collaborator companies with efficient cryogenic storage, distribution, as well as transportation of the products.

In addition to the production modules, the facility features a warehouse, waste handling zones, QC laboratories, and administrative space.

The CGT Catapult facility has so far received funding of more than £75m ($92.5m) from Industrial Strategy Challenge Fund of UK Government, Innovate UK, Department of Business Energy and Industrial Strategy and European Regional Development Fund (ERDF).

“Starting from 2020, the collaborator companies can make use of the space to manufacture their therapies at scale, under GMP standards.”

ERDF provided £3.36m ($4.1m) funding for the expansion project as part of its European Structural and Investment Funds Growth Program 2014-2020. The project also received £12m ($14.8m) from the Medicines Manufacturing Industrial Strategy Challenge Fund.

Hertfordshire Local Enterprise Partnership invested £2.9m ($3.7m) in the expansion, from its Local Growth Fund. The investment helped implement analytical technologies at the facility for the quality control of the cell and gene therapies.

Portfolio, Program and Project Managers (3PM) conducted project management services for the expansion project, while Fairhursts Design Group also participated in the facility development.

Kite Pharma’s Biopharmaceutical Manufacturing Facility

Kite Pharma, a subsidiary of Gilead Sciences, announced about the construction of its biopharmaceutical manufacturing facility in Hoofddorp, the Netherlands in May 2018.

The plant will be used for the engineering and production of cancer cell therapies, including chimeric antigen receptor T-cell (CAR T) therapies, not only improving the company’s manufacturing capabilities but also bolstering the delivery of cell therapies to cancer patients in Europe.

The manufacturing facility will be an addition to Kite Pharma’s manufacturing network in the US, which includes the California and Maryland sites.

The plant is expected to be fully operational by 2020, employing more than 300 people.

The manufacturing facility is located at the SEGRO Park Amsterdam Airport at Tufsteen 1 in Hoofddorp, North Holland province, Netherlands.

SEGRO Park is a 4,304,000 sq. ft. (400,000m²) flexible site developed by SEGRO, a real estate investment trust based in the UK, which can be divided into multi or single-tenant spaces for the accommodation of various types of industries including pharmaceutical, manufacturing, logistics and food and beverage.

The proximity of the facility to Amsterdam Schiphol Airport and the Amsterdam metropole provides an opportunity for business growth in the future. The site is also well connected by road via A4 to The Hague and Rotterdam, as well as the extended A5, which connects to the port.

Kite Pharma leased 117,000ft² of space in SEGRO Park from SEGRO for the development of the manufacturing plant. The facility features Grade A sustainable design and complies with the Building Research Establishment Environmental Assessment Method (BREEAM) Excellent standard, which helps in reducing the carbon footprint for the company.

The facility is equipped with solar panels and a thermal energy storage system capable of storing heat or cold underground through an aquifer, working in the same manner for heating or cooling the warehouse, whenever needed.

The facility also features an early suppression, fast response (ESFR) sprinkler system, and sound insulation. The big-box logistics facilities at the site will offer flexibility in transporting products to the European markets.

Kite Pharma will manufacture its cancer immunotherapy products in the facility, including the US Food and Drug Administration (FDA)-approved Yescarta® (axicabtagene ciloleucel).

The drug received marketing approval in the European Union in August 2018, indicated for the treatment of relapsed or refractory diffuse large B-cell lymphoma (DLBCL) and primary mediastinal large B-cell lymphoma (PMBCL) in adult patients.

The drug is also being studied for the treatment of indolent non-Hodgkin’s lymphoma (NHL) and first-line DLBCL.

The facility will increase the manufacturing and delivery capacity of Yescarta in the European market.

Marketing commentary on Kite Pharma:

Based in California, US, Kite Pharma is a biopharmaceutical company, which focuses on the development of innovative immunotherapies in oncology.

The company was acquired by Gilead Sciences in August 2017, which resulted in the addition of the former’s CAR T and T-cell receptors (TCR) cellular therapy platforms, as well as more than 700 employees to the Gilead’s portfolio.

Kite Pharma has two research and development (R&D) centers at the Amsterdam Science Park’s Matrix Innovation Centers and has also established a distribution center in the Netherlands.

Janssen Sciences Builds Irish Biomanufacturing Facility

Janssen Sciences Ireland UC, part of the Johnson & Johnson family of companies, has officially opened its new manufacturing building in Ringaskiddy, Co. Cork. The company expanded operations on its 40-hectare biopharmaceutical supply chain site in Ringaskiddy, which it has run since 2005.

The expansion of the biomanufacturing site increases the company's production capacity by an additional 205,516 sq. ft. (19,100 sqm) and creates 200 new full-time jobs. Approximately 450 people were employed on-site during the two-year construction project.

The official opening ceremony for the facility was attended by Simon Coveney TD, An Tánaiste and Minister for Foreign Affairs & Trade, Kathy Wengel, Executive VP and Chief Global Supply Chain Officer at Johnson & Johnson, and Martin Shanahan, CEO of IDA Ireland.

Speaking at the event, Coveney explained that in 2018 alone, 33% of Ireland's total exports were pharmaceutical and medical products, with Johnson & Johnson featuring as one of our single largest exporters.

Johnson & Johnson's Wengel, said: "Our Ringaskiddy facility is an important part of our global manufacturing network and expanding our capabilities here will allow us to pursue innovative solutions that advance how medicines are manufactured so that we can be at the forefront of treating, preventing, intercepting and curing some of the world's most devastating and complex diseases."

Edwards Expands Operations in Costa Rica

The company expects to have 1,100 employees by the end of 2020 in its facility at La Lima Industrial Park in Cartago.

Edwards Lifesciences Corporation, a developer of innovations for structural heart disease and critical care monitoring aimed at patients, expanded its presence in Costa Rica with a $100 million investment and the addition of 500 new jobs by the end of 2020.

The brand new facility is located in La Lima Industrial Park in Cartago and has an extension of 274,000 square feet.

The announcement was made in an official grand opening with the participation of the President of Costa Rica, Carlos Alvarado Quesada; Dyalá Jiménez, Foreign Trade Minister; André Garnier, Private Sector Linkage Minister; Jorge Sequeira, Managing Director of CINDE; Mike Mussallem, Chairman and CEO of Edwards Lifesciences; and Josué Campos, Plant Manager of Edwards Lifesciences in Costa Rica.

This new building joins the existing one within the same industrial park to collectively expand the capability to produce finished products, in addition to the processes that has been on operation since 2017.

"We work to strengthen the country's competitiveness, our human capital, and the conditions for companies that decide to grow in Costa Rica. More and more Costa Ricans are seen as highly skilled people in the life sciences sector, one of the most important for the country today, and I am proud that Edwards sees that potential," said President Alvarado.

The company will continue to focus in Cardiac Implantable products, used for patient treatment at medical facilities around the world. The company established operations in Costa Rica in 2016, as an additional facility in its network that includes locations in the United States and Singapore.

"The completion of this state-of-the-art plant in Costa Rica is an important milestone for Edwards as we expand our global heart valve network to serve patients around the world. Working in partnership with colleagues worldwide, our talented team in Costa Rica is building the capabilities to support our long-term growth aspirations and to meet the high-quality standards for Edwards' sophisticated heart valve technologies. The success in scaling our current operations in the country gave us confidence to expand further. We are proud of our employees and the passion they have shown for our patient-centered work at Edwards, and we are also happy to be partnering with the local community through a number of special charitable projects. " said Mike Mussallem, Edwards' chairman and CEO.

The Minister of Foreign Trade, Dyalá Jiménez, commented: "The announcement of the new plant of the company fills me with enthusiasm and shows that our stability, human talent, and legal security are key components for companies of high-quality standards to bet for us, generating opportunities for hundreds of families. In the life sciences sector, there is a lot of potential for our value proposition, and we must continue to grow".

Josué Campos, Plant General Manager of Edwards Lifesciences in Costa Rica, said they plan significant growth in the upcoming months. "We came to Costa Rica to grow hand in hand with the community. Not only have we already opened employment opportunities for more than 600 people, but we also expect to continue growing to achieve 1,100 jobs by the end of 2020. We are providing quality jobs to the people of Cartago and its surroundings, excellent development programs to our employees, the opportunity to support the health and treatment of patients worldwide, while continuing to contribute to the community through numerous social projects," he added.

There are job positions in operational, technical, and administrative roles. Available positions include business units such as facility management, engineering, human resources, finance, technical training, supply chain and logistics, quality, purchasing, microbiology, and chemistry. For operational positions, the requirements are having finished ninth grade, good motor and manual skills and ease of following and complying with instructions. Interested candidates should send an email to reclutamientocr@edwards.com with their resume or visit edwards.com/careers.

CINDE's Managing Director, Jorge Sequeira, added: "We are very proud to have Edwards Lifesciences in Costa Rica. Edwards is an example of how companies in the medical technology sector leverage Costa Rica's ecosystem, throughout the linkage of talent needs for the production chain, along with the local academy. They are working with the National Institute for Learning (INA, for its acronym in Spanish) to train operational, technical, and specialized workers, which contribute to its growth and employability. This is how the sector has become one of the most dynamic in our economy, where medical technologies contributed $ 3,308 million in 2018, as Costa Rica's main export product. The sector already generates about 30,000 quality jobs, formal, well-trained, and well-paid, where 55% are women, many of them single mothers and heads of household."

The new facility was designed to be a high-standard workplace. It offers modern spaces to its collaborators, cafeteria, wellness center, and medical services. "Its modern infrastructure and cutting-edge technology in critical systems are combined with green initiatives that allow water reuse, natural lighting and high-efficiency equipment that save energy and take care of the environment," said Josué Campos.

Sekisui Invests in New Bioprocess Innovation Centre

Headquartered in Burlington, MA, US, Sekisui is planning future investment in expanding cGMP manufacturing capabilities

Sekisui Diagnostics' Enzyme business will complete a new BioProcess Innovation Centre at its site in Maidstone, Kent by the end of 2019, following a US$1.9 million investment. This investment is part of a long-term investment strategy to grow its share of the microbial biopharma CDMO market, with future investment expected to focus on expanding cGMP manufacturing capabilities.

Previously part of Genzyme Diagnostics, and now part of Sekisui Chemical Co, Sekisui Diagnostics' Enzyme business launched its microbial biopharma CDMO service offering, BioProduction by Sekisui, in 2017.

The new BioProcess Innovation Centre will more than double its development laboratory space to facilitate process transfer and development. Specialized in expression and purification from microbial fermentation, the group has wide experience, including but not limited to recombinant systems such as E. coli and Pichia pastoris, with associated purification and analytical technologies. Its main expertise lies in the production of enzymes, however its capabilities are also suitable for plasmids, antibody fragments, and other protein production.

With production capabilities from 20 L to 5,000 L, Sekisui handles projects from pre-clinical through to commercialization.

"Over many years we have built both a technical and operational competency and expertise in enzyme production and microbial fermentation," said Robert Schruender, President & CEO of Sekisui Diagnostics and Sekisui Medical Board Member. "As the Biopharma CDMO market grows, we aim to further leverage this capability to grow our share in this market. This investment represents our commitment to serve our customers with innovative process development solutions."

McIlvaine Company

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