Pharma Prospects

March 4, 2021


·         Biogen to spend $200M on gene therapy plant in North Carolina

·         Dover pumps in chromatography and sterile filtration

·         GEA pump for vaccines and cell cultures

·         Oxular Limited 

·         Forbion

·         Allied Cleanrooms supplies So Young  with 750 ft2 of ISO 7 3750 ft2 of ISO 8

·         Asgard  supplies G-Con pods with 3 month delivery time

·         Asgard provides Regeneron with bulk biologics facility

·         Other Asgard Cleanroom Projects

·         WHP builds large CGMP facility with 122 modules in 2020

·         WHP  building cleanrooms for VMIC

·         WHP  supplied  cleanrooms for ADC.

·         WHP supplied cleanrooms to Oxford BioMedica

·         Wiskind supplying  modular cleanroom for Russian COVID  Vaccine

·         Wiskind provided modular cleanroom for the largest Chinese vaccination plant

·         Chinese plants with 100 million dose capability

·         Inova vaccine phase III trials in Brazil in only  3 months with Wiskind Cleanroom

·         Connect 2 Cleanrooms builds temporary unit for NHS Wales COVID response

·         Thermo Fisher announces major expansion plans

·         FDA gets in on the stimulus action from new relief bill

·         Flowserve supplying pumps, valves for Pfizer vaccine production

·         Little-known drug manufacturer, Phlow gets big contract for COVID-19 response

·         SteriValves, Valves and Accessories for the Pharmaceutical Industry

·         Merck Announces € 59 Million Antibody-Drug Conjugate Manufacturing Expansion 



Biogen to spend $200M on gene therapy plant in North Carolina

Permission granted by Biogen

Kristin Jensen

March 4, 2021


Dive Brief:

·         Biogen plans to spend $200 million to build a gene therapy manufacturing facility at its Research Triangle Park campus in North Carolina as the company invests further in the fast-growing field of genetic medicine.

·         The 175,000-square-foot plant should be operational by 2023 and employ about 90 people, Biogen said Thursday. The company said it chose the location because it's found the area attracts diverse and "highly qualified and passionate employees."

·         Biogen didn't detail the types of therapies that would be produced at the facility but said it will have "differentiated, sustainable and advanced manufacturing capabilities." The company has primarily focused on gene therapies for eye diseases, most notably through a roughly $800 million buyout of Nightstar Therapeutics. 


Dover pumps in chromatography and sterile filtration

The QF2500 Quaternary Diaphragm Pump from Quattroflow, part of PSG, a Dover company, extends the company’s range of pumps. The pump has a maximum flow rate of 2500 lph (660 gph) to meet the needs of chromatography, tangential flow filtration, virus filtration, sterile filtration, and depth filtration applications.


GEA pump for vaccines and cell cultures 

The GEA Hilge Novatwin hygienic, stainless-steel twin-screw pump, part of the GEA Varipump line, is now available in six sizes. GEA says the pump can be used for pharmaceutical products including nutraceuticals, blood products, vaccines, enzymes, and cell cultures. 

Oxular Limited ("Oxular"), a leading retinal therapeutics development company, today announced that it has completed a $37 million (£27 million) financing led by Forbion. Proceeds will fund planned further clinical development of its lead asset, OXU-001, for the treatment of diabetic macular edema (DME), as well as accelerating development of its early-product pipeline.

Forbion is a dedicated European life sciences venture capital firm that manages over €1.7 billion of investments and works closely with entrepreneurs to build life sciences companies that will change the future of medicine. In the financing, Forbion were joined by existing investors IP Group, NeoMed, and V-Bio Ventures. Dr. Dmitrij Hristodorov, Principal at Forbion, will join the Oxular Board. Prior to joining Forbion in March 2020, Dr. Hristodorov was Senior Director of Global Business Development & Licensing at Bayer Pharma where he was responsible for the Ophthalmology and Cardiovascular Franchises.

The investment will fund Phase 2 human clinical studies, commencing later this year, to evaluate OXU-001 for the treatment of DME, a serious retinal disease that affects 24 million people globally and is the leading cause of blindness in young adults in developed countries. A key challenge facing patients with DME is the need for frequent clinic visits for repeated treatment injections. To address this, OXU-001, an innovative, sustained-release formulation of dexamethasone, provides up to 12 months' treatment effects following a single administration. Dexamethasone is a well-known, safe and effective treatment for inflammatory retinal diseases, including DME.


Allied Cleanrooms supplies So Young  with 750 ft2 of ISO 7 3750 ft2 of ISO 8

California-based bioscience firm So Young America, Inc. was experiencing growth of its own. As an FDA-registered, GMP-ready/cGMP manufacturing facility for food, beverages and supplements, the organization looked to build out within its existing warehouse to accommodate its need for cleanroom space. The additions would provide much-needed room for R&D work, an organic chemistry lab and other labs devoted specifically to food production, according to Robert Tsai, President of So Young America.  

The project also would include additional warehouse storage as well as partitioning within So Young’s front office entryway. The project included a 750 sq. ft., class 10,000, ISO 7 standalone cleanroom on the main floor of the warehouse with a second level mezzanine devoted to storage. Allied Cleanrooms also installed a 3,750 sq. ft., Class 100,000, ISO 8 modular cleanroom structure on the second floor of the facility on top of an existing wood mezzanine. Modular walls installed within the structure provided So Young with six separate work-spaces that varied in size. The project included all necessary flooring, electrical, HEPA filters and fire suppression and HVAC systems to maintain the ISO requirements for these structures.

The result was two high-quality structures that not only met specific cleanroom standards, but also provided functional work and storage space and an impressive, pristine aesthetic.

Allied Cleanrooms also installed a modular wall and door with keypad lock in the lobby to separate the entry from the hallway leading to the work area. “We wanted that extra wall and door so there wasn’t access to walk directly into the work area,” Tsai explained, noting that the new look is not only functional and flexible but also attractive.


Asgard  supplies G-Con pods with 3 month delivery time

G-CON Manufacturing, Inc.’s prefabricated, turnkey cleanroom systems represent a significant transition to forward thinking in pharmaceutical and biopharmaceutical processing. G-CON Manufacturing, the innovator of autonomous cleanroom PODs, turned the challenges experienced by the biopharmaceutical industry into readily deployable, flexible, mobile and scalable cleanroom solutions. PODs are ideal for multi-product sites, rigorous containment needs, and on demand scaling of production and laboratory space.

Asgard Cleanroom Solutions are manufacturing PODs in their new off-site manufacturing facility in Castlecomer, Co. Kilkenny, Ireland pursuant to G-CON’s quality system for their EMEA customers.

G-CON now has a wide array of cleanroom PODs to accommodate the increased demand from the pharmaceutical, biopharmaceutical and cell therapeutic industries. Moreover, G-CON’s patent portfolio continues to grow which will effectively preclude imitators from copying G-CON’s initial and more recent innovations. G-CON will continue to evolve and grow with the industry to provide a comprehensive cleanroom solution that truly is flexible, scalable and fast, all for a fair and known price from the time the contract is signed. G-CON has simplified the purchase pf cleanrooms with their Standard Cleanroom PODs, ready for delivery  in 3 months. 


Asgard provides Regeneron with bulk biologics facility


Bulk Biologics –Limerick

Bulk Biologics Facility Limerick,  Ireland

Completed In 2016

11,000 M2 of AES Ceilings

Engineer- Jacobs Engineering

Main contractor  PM Group

AES Fully Flush Panel system

Asgard provides Pfizer with 1300 m2 cleanroom in Dublin


Project DSMPC

Grange Castle Dublin,  Ireland

Project Duration- 9 months

Size 1300 M2

Engineer- Jacobs Engineering

Main contractor  Sisk Group

Project value 2.85 million pounds

1000 m2 fully flush panel system

1300 m2 of walk on ceilings

1300 m2 of Mc Dur Trowel Flooring


Other Asgard Cleanroom Projects





Eirgen Pharma,


1400 m2


Bristol Myers Squibb

15,000 m2

Amgen Project Hawk


5,000 m2

MSD Project Lion


1,700 m2

MSD Ballydine


4,000 m2

Gilead Project Rex


5,500 m2

Servier Packing Hall

4,500 m2

Abbot Diagnostics


1,800 m2



2,500 m2



1150 m2



22,000 m2


WHP builds large CGMP facility with 122 modules in 2020

WHP was awarded its first contract to design and build a fully modularised containment facility. The project comprised the design and manufacture of 122 cGMP modules, making it one of the largest modular cGMP facilities in Europe.

WHP has completed the fully modelled design which included structural, M&E, architectural and also the external envelope which included staircases and security features. A bespoke effluent discharge system was also designed by the skilled in-house Engineering Team for this project.

The modules were manufactured in WHP's dedicated modular build facility in Tyne and Wear. They were then packaged and shipped to site in Europe where they are currently being installed, with commissioning and validation to follow through 2021.

Despite the impact of COVID-19, the WHP team pulled together to expedite the delivery of 122 modules before the end of the year. This resulted in a 300% increase in WHP's export sales from prior year, equating to 50% of the company's 2020 annual turnover.

Conal Bovaird, Head of Modular Build Projects, said: "This has been a fantastic achievement in what has been extremely challenging times for all of us. Full credit goes to the entire team for their relentless efforts to ensure the manufacturing phase has been completed safely and successfully while meeting the client's expectations. In addition, the team have achieved 536 days without a lost time injury. I look forward to successfully completing the site installation and commissioning works in 2021."


WHP building cleanrooms for VMIC

WHP has been awarded a design contract for the Vaccines Manufacturing Innovation Centre (VMIC), which is set for construction in Oxford. The contract will see WHP design an advanced array of laboratory and production facilities within a ‘cleanroom wrap’ environment. 

The contract was awarded to WHP as part of plans for the specification of versatile new cGMP suites and filling rooms for the VMIC.

These units will have the capacity to meet the Department of Health and Social Care requirements concerning the provision of vaccines in an infectious disease emergency.

The centre, which has secured £66m of funding from UK Research and Innovation, is being developed through the UK Government’s Industrial Strategy Challenge Fund (ISCF) Medicines Manufacturing Challenge and is scheduled to open in 2022.

WHP, which has already completed RIBA Plan of Work 2 covering conceptual design, is utilising 3D BIM modelling to finalise the cleanroom architecture, M&E components and process and critical utility systems for a facility that is set to become a national Centre of Excellence. 

The project also features complex zoned HVAC systems to maintain segregation, cleanliness, air pressures and other environmental controls, the new laboratory and production facilities will be developed in compliance with MHRA regulation


WHP supplied cleanrooms for ADC 

Production of new anti-cancer drugs at ADC Bio’s North Wales manufacturing plant has been boosted following completion of a new cleanroom facility. The project has been designed and built by WHP.

The new GMP cleanroom is part of ADC Bio’s construction of a bioconjugation facility at its site in Deeside, North Wales (UK) for the commercial production of antibody-drug conjugates in response to global customer demand.

“We are building a best-in-class facility to the highest possible global standards," said Charlie Johnson, CEO at ADC Bio. "We awarded the contract to WHP on the back of its relevant industry experience and reputation for delivering cost-effective, single-source cleanroom design and build packages," he added.

Project specs

Antibody-drug conjugates are a class of emerging biotherapeutics that require a bespoke infrastructure to ensure strict compliance with the highest global regulatory standards. 

The biotech company awarded the £5 million contract to WHP in December 2017. The new facility sees drug manufacturing in a stringently controlled environment. The site is operated under cGMP regulations, and also comprises support areas for washing, depyrogenation, thawing and buffer preparation.

WHP’s scope of work covered the design and build, including test and validation of a state-of-the-art containment manufacturing cleanroom within the existing 6,500 sqm hi-tech facility, along with new quality control and process development laboratories.

The infrastructure includes a Grade C cleanroom on a 110 sqm area and a Grade D cleanroom on a 390 sqm area. The site also features four complex zone HVAC system.


WHP supplied cleanrooms to Oxford BioMedica 

WHP Engineering  secured the design, construction and project management contract of a new viral vector manufacturing centre for Oxford BioMedica. New cleanroom facilities will enable the gene and cell therapy company to expand its bioprocessing operations and manufacturing capabilities. 

The new facility is being established in a former Royal Mail sorting office in Oxford, UK. Phases one and two of the expansion comprise the specialist conversion of the building into GMP cleanroom suites, fill and finish of the production areas, as well as completion of offices, warehousing and quality control laboratories.

The multi-disciplinary engineering company is responsible for both design and build, including testing and validation, which encompasses WHP’s integrated services. The design includes a full 3D building information model, including cleanroom architecture, HVAC, monitoring and evaluation systems, and process and critical utilities systems.

The specialist areas have been designed in full compliance with the Medicines and Healthcare products Regulatory Agency and conform to ISO cleanroom standards. 

This includes the use of zoned HVAC systems to maintain segregation, cleanliness, air pressures and other environmental controls. CT understands the cleanrooms will meet ISO 7 and 8 classification. The WHP team have finalised the detailed design and is commencing construction 

 Oxford BioMedica awarded WHP the contract for the design and installation of the original pilot plant for the LentiVector delivery platform at its Yarnton premises in 2015. As a result of the successful delivery and operation of this initial project, WHP was then appointed for this current, larger and more complex project.


Wiskind supplying  modular cleanroom for Russian COVID  Vaccine

Wiskiind is building a modular cleanroom in Moscow for  R-Pharm. Wiskind provided more than 40,000 square meters of rock wool cleanroom panels, cleanroom doors and other cleanroom enclosure products for the project.

The production base will produce the flagship home vaccine "Sputnik V" developed by the Epidemiology and Microbiology Centre. According to this project, when the factory reaches full capacity, it will produce up to 20 million doses of vaccine every month. The total investment in the project amounts to 8.6 billion rubles. 

The R-Pharm enterprise started operations at the end of December 2020, and the first batch of Sputnik V vaccines was  produced in Moscow Technopolis in January 2021. The construction of the complex located on the territory of the special economic zone "Technopolis "Moscow" took place in record time, which is necessary for the implementation of national and urban vaccination programs. The area of the new factory exceeds 20,000 sqm.


Wiskind provided modular cleanroom for the largest Chinese vaccination plant

CNBG China built the world's largest new COVID  vaccine production plant with a mass production annual capacity of 100 million vaccines, to meet the scale-up production requirements of emergency and routine vaccinations. Wiskind provided the cleanroom.

The new  vaccine production plant had stringent systems and tight schedules to meet, which created difficulties in the project. 

To successfully complete construction on time, the team organised several rush meetings to orderly schedule the procedures during the construction process, which is particularly critical in terms of material procurement and construction plans. 

Wiskind quickly provided all the materials needed to build a cleanroom and was able to provide a one-stop service.

For projects with tight turnarounds, Wiskind can provide modular cleanrooms that are fast assembly and standardised production.

By increasing the efficiency of cleanroom material production and construction, Wiskind was able to shorten the construction period by 20% to 40%, all the while improving the quality of construction.

This enables the producer  to start using its new facilities as soon as possible, thereby greatly reducing work delays and promoting the industry's profitability. 

Modular cleanroom includes cleanroom doors,  windows and wall panels.


Chinese plants with 100 million dose capability 

China National Biotec Group (CNBG) in July  completed construction of a new plant for coronavirus vaccines, doubling its capacity to more than 200 million doses a year, as it prepares late-stage trials of its potential COVID-19 shots.

CNBG, a unit of the state-owned China National Pharmaceutical Group (Sinopharm), has two COVID-19 vaccine candidates in human trials and plans a large-scale Phase 3 human testing in the United Arab Emirates. 

Its newly built plant in Wuhan, the epicentre of China’s coronavirus outbreak that started last year, has annual capacity of more than 100 million doses, and adds to its Beijing-based facility whose construction was completed in April.

Another Chinese vaccine developer Sinovac started around end-March to build a coronavirus vaccine plant with a 2020 completion target and capable of making up to 100 million shots a year.


Inova vaccine phase III trials in Brazil in only  3 months with Wiskind Cleanroom 

Sinovac Life Sciences Co., Ltd., (or “Sinovac LS”), previously known as Sinovac Research & Development Co., Ltd., is a research-based company incorporated in 2009 that conducts human vaccine research, development, manufacturing, and sales.  

Sinovac LS is a wholly-owned subsidiary of Sinovac Biotech (Hong Kong) Limited. It develops several human vaccines, including vaccines against pneumonia, DTaP, Hib, hepatitis B vaccines, and combo vaccines containing DTaP and Hib. Sinovac LS was granted 12 patents in vaccine technologies in China. Sinovac Life Sciences is the developer of CoronaVac, an inactivated COVID-19 vaccine candidate, and will be the marketing authorization holder of CoronaVac in China with a vaccine production license from China National Medical Products Administration (NMPA).The cleanroom system of this project is provided by Wiskind. In May, Wiskind finished all the cleanroom panels, doors, and windows, which were then shipped to the site.


Connect 2 Cleanrooms builds temporary unit for NHS Wales COVID response

09-Mar-2021 By Jenni Spinner 

The temporary medicines unit built for the agency's Central Intravenous Additive Service can produce up to 2,600 syringes weekly to meet growing demand. 

Connect 2 Cleanrooms (C2C), a company that specializes in the expedited design and build of temporary life sciences facilities, constructed a temporary medicines unit on behalf of the National Health Services of Wales (NHS Wales). The facility, constructed for the agency’s Central Intravenous Additive Service (CIVAS), is able to produce up to 2,600 syringes per week to meet the growing demand for COVID-10 solutions.


Thermo Fisher announces major expansion plans

Mar 10, 2021 

Bolstered by coronavirus-related contracts, Thermo Fisher Scientific has announced expansion plans that will more than double its manufacturing capacity. 

This week, the company said it plans to pump $600 million into capital investments through 2022. The expansion plans, created to support both short-term COVID-19 demands and long-term development goals, will add more than 1,500 jobs across 11 manufacturing sites around the world.  

In particular, the company plans to grow its prowess in three core areas: 

Single-use technologies: Thermo will expand its SUT capabilities at facilities in Utah, Pennsylvania, California, Singapore, Cramlington, UK and Suzhou, China.

Purification: The company will boost its resins manufacturing at a site in Massachusetts and reinforce its capabilities of process-scale chromatography for vaccines, gene therapies and other applications.  

Cell culture media and process liquid: Sites in New York, Florida and Scotland will increase their production of Gibco cell culture media, supplements and process liquids. 

Thermo, which specializes in lab equipment and diagnostics supplies, has experienced a major sales boom during the pandemic. This year, the company raked in an extra $2 billion in coronavirus-related revenue from July to September alone. And in its fourth quarter earnings statement for 2020, the company reported $10.5 billion in revenue — a 54 percent increase year over year.


FDA gets in on the stimulus action from new relief bill

Mar 09, 2021

President Biden’s $1.9 trillion COVID-19 relief bill is set to be signed into law this week and will dole out a host of benefits to the FDA and pharma industry.

Weeks ago, The House Energy and Commerce Committee added a nifty $500 million boost in funding for the FDA to the bill, which has dealt with a major increase its workload due to coronavirus-related activities. Thus, the fresh funds will be earmarked to support the development and post-market surveillance of COVID-19 vaccines and therapeutics. But the agency is also being asked to tackle other long-standing goals with the money, such as drug shortages and supporting the development of continuous manufacturing. 

And because the agency was forced to delay and halt many inspections due to the pandemic, the FDA will also be tasked with using the funds to help clear its backlog of inspections.  

The stimulus package will also set the stage for big R&D investments in pharma with a whopping $20 billion being pegged for federal research on vaccines and manufacturing for therapeutics, along with another $3 billion allocated to increase the national stockpile of vaccines.  

In addition, states will receive $8.75 billion to aid vaccine rollout.  

The one downside for the pharma industry in the bill will be the removal of a cap states can collect in rebates for certain drugs for Medicaid. The new provision, aimed at lowering drug prices, will go into effect in 2023 and impact Humira, some insulins and more.


Flowserve supplying pumps, valves for Pfizer vaccine production

March 1 (Reuters) - Flowserve Corp, an American supplier of industrial machinery, said on Monday it was providing pumps, valves and seals to Pfizer Inc to support the production of its COVID-19 vaccine. 

The company said it helped the drugmaker replace a mechanical mixer seal on its vaccine production line at a plant in Kalamazoo, Michigan.

The vaccine is one of the three authorized for emergency use in the United States along with Moderna and Johnson & Johnson.

A Flowserve's facility in Tennessee will supply Pfizer with more than 200 ball valves that can handle the cold temperature requirements needed to support the mass production of the vaccine, the company said.

The Irving, Texas-based company said it was also providing pumps to Pfizer for both their North American and European vaccine production.


Little-known drug manufacturer gets big contract for COVID-19 response 

May 19, 2020

Dive Brief:

·         Phlow, a Richmond, Virginia-based corporation that describes itself as a public benefit drug manufacturer, announced Tuesday the federal government will pay it hundreds of millions of dollars to make essential medicines that are at risk of shortage, including medicines used to respond to the coronavirus pandemic.

·         The money comes from BARDA, or the Biomedical Advanced Research and Development Authority, which is part of the U.S. Department of Health and Human Services. The contract starts with a four-year award of $354 million, which can be extended to a 10-year award worth $812 million total.

·         Phlow said BARDA's money has already allowed it to manufacture 1.6 million doses of five essential generic medicines used to treat COVID-19 patients. The medicines, which include a sedative, a pain management drug, and an antibiotic, were delivered to the U.S. Strategic National Stockpile, Phlow said. The corporation is working in partnership with Civica Rx, AMPAC Fine Chemicals and Virginia Commonwealth University's Medicines for All Institute.

SteriValves, Valves and Accessories for the Pharmaceutical Industry

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Our core business is provided by interception butterfly valves and flow regulation rotary valves while remaining highly committed to developing innovative solutions and designing products such as SteriSplit, now at the point of reference for safe powder handling.

Containment is a critical issue throughout the pharmaceutical industry; it is crucial to preserve the safety of the operator, as well as the quality of the product. For this, Sterisplit is the solution.


Merck Announces € 59 Million Antibody-Drug Conjugate Manufacturing Expansion  

-  Creates one of the largest single-digit nanogram containment manufacturing facilities for high-potent active pharmaceutical ingredient (HPAPI) production

-  Allows continuous flow manufacturing for antibody-drug conjugates (ADCs)

-  Approximately 50 full-time jobs to be added 

Sept. 9, 2020 /PRNewswire/ -- Merck, a leading science and technology company, today announced a € 59 million expansion of its HPAPI and ADC manufacturing capabilities and capacity at its facility near Madison, Wisconsin, USA. This investment will allow large-scale manufacturing of increasingly potent compounds for therapies that have the potential to treat cancer. Completion is expected by mid-2022 and should add approximately 50 full-time jobs starting in 2021.

Merck is expanding its ADC manufacturing capabilities. ADCs are an emerging class of medicines designed for high-specificity targeting and destruction of cancer cells, while preserving healthy ones.

"ADCs have posted incredible growth over the last decade, and regulatory agencies' approval in recent years demonstrate their promise as a targeted therapy," said Andrew Bulpin, head of Process Solutions, Life Science, at Merck. "With more than 35 years of experience in this space, we have been a frontrunner in the development and manufacturing of biologics, conjugation processes and small molecules. This investment underscores our commitment to working with innovators to bring new treatments to patients quickly and more efficiently."

Merck's new 6,500-square-meter commercial building will be one of the largest dedicated HPAPI manufacturing facilities specifically designed to handle single-digit nanogram occupational exposure limit materials. The project is an addition to the company's Madison campus, which was the first commercial ADC facility in North America designed to handle highly active materials. The new building will join Merck's established campus in St. Louis, Missouri, USA, which specializes in ADC bio-conjugation, active pharmaceutical ingredients, excipient and adjuvants manufacturing.

ADCs are an emerging class of medicines designed for high-specificity targeting and destruction of cancer cells, while preserving healthy cells. There are now only nine ADCs approved globally. However, the ADC industry is delivering strong growth and is expected to reach € 13 billion by 20301.

While ADCs can provide many benefits compared with other therapeutic options, they also present a unique set of challenges. Their development is complex, necessitating stringent containment infrastructure, and their structural exceptionality requires expertise in a number of different technologies for small and large molecules, as well as analytical capabilities. Due to these challenges, more than 70 percent of ADC projects are outsourced to contract development and manufacturing organizations2.

With more than 35 years of experience in the development and manufacturing of small molecules, biologics and ADC technologies, Merck offers extensive experience in both clinical and commercial manufacturing. The company's comprehensive service portfolio combines the steps of drug development and production — from pre-clinical to commercial — from a single source. This consolidation helps reduce risk and streamlines the process of getting therapies to patients faster.