PHARMACEUTICAL & BIOTECHNOLOGY

INDUSTRY UPDATE

July 2020

 McIlvaine Company

 

TABLE OF CONTENTS

 

UNITED STATES

 

REST OF WORLD

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UNITED STATES

Alnylam’s Manufacturing Facility, Norton, Massachusetts

Alnylam Pharmaceuticals is constructing a new drug substance manufacturing and cGMP warehouse facility in Norton, Massachusetts, US. The company broke ground on the $200m facility in April 2016.

The project is part of Alnylam’s expansion plans aimed at increasing its manufacturing capacity. Fully-operational in 2018, the facility produces the company’s RNAi therapeutics and to be a commercial stage company.

Products manufactured at the Norton facility will be sold across the world. The facility will initially generate 150 new full time jobs at Norton, which is expected to increase to 300 in the future.

The cGMP manufacturing facility is expected to be commercially operational in the second half of 2020.

The three-story plant will house several production lines, GMP warehouse, as well as office space.

Alnylam’s new state-of-the-art Norton facility will occupy an area of approximately 200,000ft² (18,580.6m²) on a 12-acre site. It will be responsible for developing innovative therapeutics based on RNA interference.

RNAi therapeutics developed by Alnylam will target a number of illnesses including TTR, hemophilia, hepatic porphyrias, beta thalassemia, hypertension and liver infections.

Development of the facility involved various levels of discussions with the contractors to develop a building plan, which met Alnylam’s specifications. The company ensured that the plan appropriately included machines used in its manufacturing process.

Machinery used by Alnylam is similar to that used in the production of small molecules. RNA synthesis, which requires advanced purification techniques, will be used to produce drugs at the facility. An appropriate building plan was therefore required to meet this requirement.

The new facility will include a number of green initiatives including the use of recycled water to reduce its environmental footprint.

Alnylam surveyed a number of sites worldwide before deciding on the Norton location. The proximity of the facility to its headquarters in Cambridge will help the company to cut operational costs and also enable its management to monitor the production process.

Locating in Massachusetts also enables Alnylam to capitalize on the region’s innovative economic environment and skilled workforce. Further, the Norton town council is providing Alnylam with a $7m tax break over a period of 13 years for the project.

Alnylam has rented a small site in Cambridge to initially produce its lead drug, Patisiran, which is used for the treatment of a rare neurological disease. The company will also use third-party manufacturers for back-up production capacity.

Alnylam’s remaining drugs will be produced at the Norton facility. Having its own manufacturing facilities will enable the company to establish a strategic supply chain for its products.

Jacobs Engineering Group was awarded the engineering services and procurement contract for the project in August 2016.

Gilbane is serving as the construction manager for the project.

A/Z was contracted to serve as the Building Information Modeling (BIM) Coordinator during the construction of the facility.

Hereva is the project manager responsible for supervising the design and engineering and supporting the environmental permit process.

Albireo Energy won a contract to design and install a customized building management system for the biopharmaceutical manufacturing facility.

Marketing commentary on Alnylam Pharmaceuticals:

Alnylam Pharmaceuticals is a global leader in the development of novel therapeutics based on RNA interference and translation of RNAi as a new class of medicines. The company was founded in 2002 to focus on RNAi therapeutics for genetically defined targets to treat life-threatening diseases.

RNAi therapeutics, which is a new approach towards treating diseases, is a natural process of gene silencing that occurs in plants and mammals. RNAi therapeutics use this natural process and inhibit the creation of disease-causing proteins.

Alnylam has established investigational RNAi therapeutics in major strategic therapeutic areas namely genetic medicine for the treatment of rare diseases, cardiometabolic for liver expressed disease targets in dyslipidemia, hypertension and type 2 diabetes, and hepatic infection disease for infections such as hepatitis B and D virus infections.

The company aims to have ten such drugs in the pipeline in various stages of clinical programs. It also has set the goal of having at least three commercial products by 2020. It already has two drugs in phase III trials.

 

Bionova’s New GMP Manufacturing Centre

Bionova Scientific began the construction of the new biologics manufacturing plant at its existing site in Fremont, CA in July 2020.

Bionova Scientific is constructing its new state-of-the-art manufacturing facility in California, US, for the production of biologics.

The good manufacturing practices (GMP) compliant facility will improve the company’s service offerings to the biotherapeutics industry, while also supporting it to meet the increasing demand for industrial biomanufacturing capacity.

The ground-breaking ceremony of the GMP manufacturing center took place in July 2020. The company is anticipated to complete the construction of the facility within ten months, starting operations in the third quarter of 2021.

Bionova is currently in talks with customers for production slots starting from 2021. The company’s move to build the biologics manufacturing facility was in response to demand from clients to meet their GMP production needs.

The manufacturing center is located within Bionova Scientific’s 56,000ft² headquarters in Fremont, California, extending across an area of approximately 36,000ft².

The production facility will use single-use technology for all core unit activities. It will include two 2,000l mammalian cell culture trains (XDR bioreactor trains), which will manufacture clinical and commercial bulk drug substances.

It will add GMP manufacturing to Bionova’s existing portfolio of services including cell line development, process development, GLP material production, process characterization and analytics.

The plant will be equipped with Cytiva’s FlexFactory bioprocess platform, designed to produce monoclonal antibodies and other recombinant proteins.

The GMP center previously served as a cleanroom facility. The company is reconfiguring the facility and installing plug-and-play equipment and systems.

FlexFactory bioprocessing platform mainly uses single-use technology and includes distinct unit operations connected by single-use tubing sets. It provides the flexibility of installation in new or current workspaces and can include several automation schemes.

It can be used to manufacture biologics including monoclonal antibodies (mAbs) or vaccines. The technology also allows scalability of capacity from pilot stage to commercial production.

A FlexFactory platform may usually have bioreactor systems, AKTA chromatography systems for protein purification operations, and Xcellerex XDUO and XDM Quad Mixing Systems for automation of the mixing of buffers, media, and intermediates.

“The production facility will use single-use technology for all core unit activities.”

Expansion of the company’s operations is backed by a $22m equity commitment made by health care investment firm Great Point Partners (GPP) in June 2019.

GPP provided $13.3m as of June 2019 and intends to fund a further $9m by 2021.

The growth equity funding is intended to support the construction of the Fremont GMP facility.

Bionova collaborated with DGA for design and architect services and Dome Construction for engineering and construction.

Marketing commentary on Bionova Scientific

Bionova Scientific is a contract development and manufacturing organization (CDMO) that specializes in protein production, cell line development, process development and analytical science.

Founded in 2014, Bionova has experience in terminal stage and commercial launch projects.

The company worked with more than 200 customers in the biopharmaceutical industry to support them in their drug development efforts.

It assists in the management of different stages of development and manufacturing of biologics, including initial research material development, process development, and contract manufacturing.

In March 2020, Bionova announced that companies involved in the development of treatments for Covid-19 would be provided priority access to its lab capacity.

 

OncoGenerix & Alpha Capital to Build Injectables Factory in the U.S.

Novel and generics pharma producer OncoGenerix and Alpha Capital LLC have come to an agreement to build a new injectable pharmaceutical factory in the U.S. The production facility will serve as an affiliate factory, similar to the one that OncoGenerix already operates in China.

Alpha Capital LLC is considering a Georgia Opportunity Zone as the location for the new plant. The output capacity of the project is expected to reach 20 million vials of injectable oncology products and vaccines.

Earlier this year, Alpha Capital launched an international capital raise to secure a substantial stake in OncoGenerix, which recently completed a pharmaceuticals factory in Mudanjiang Province, China. The offering is a digital investment opportunity - tokenized ownership of a pharmaceutical facility. Alpha Capital is offering up to 500 million ONGX Tokens at U.S. $0.12 per token and a U.S. onshore offering of shares in Alpha Capital's special purpose vehicle. The ONGX Tokens are built on the ERC20 blockchain protocol, serve as a SAFE (simple agreement for future equity), and will be exchangeable at the option of the investor for equity-token securities.

“Our joint work with OncoGenerix is helping to bring new pharma production capacity to U.S. soil. The planned facility will be able to alleviate substantial shortages, as well as increase injectable--liquids and vaccines--manufacturing capability. It has been hard in the past for independent investors to enter the pharmaceutical industry as building pharma production capacity takes substantial investments of financial capital and time. Individual investors typically were only able to access this vertical via publicly traded securities. The ONGX Token makes it possible for individual investors to step in earlier, while reducing the investment ticket size by orders of magnitude,” said Alpha Capital LLC’s co-founder and CEO Colin Breeze. “We are excited to extend our manufacturing capacity to the United States together with Alpha Capital and look forward to helping solve existing oncology drug shortages to support the U.S. market,” said Oleksandr Zabudkin, CEO of OncoGenerix.

OncoGenerix’s manufacturing services include technical transfer, process development, scale-up, equipment and process validation, formulation, filling, lyophilization, inspection, labeling, and packaging. OncoGenerix combines sterile drug manufacturing to deliver compliant and cost-effective drug production.

 

Catalent’s Harmans Site Approved to Manufacture AveXis’ Gene Therapy

Catalent was approved by the U.S. FDA to produce commercial drug substance intermediate for AveXis’ spinal muscular atrophy (SMA) gene therapy at its manufacturing facility in Harmans, MD.

The approval follows an FDA inspection of the Harmans commercial-scale gene therapy manufacturing center in June. Under Catalent’s partnership with AveXis, a Novartis company, a dedicated suite space has been prepared at the Harmans facility for the commercial manufacture of this adeno-associated virus (AAV) gene therapy.

“This is a significant milestone for Catalent and the gene therapy industry as a whole. Catalent is proud to be the first contract development and manufacturing organization to be approved for commercial gene therapy production,” commented Manja Boerman, Ph.D., President of Catalent Cell & Gene Therapy. “This approval allows us to leverage our now-licensed, state-of-the-art GMP commercial manufacturing facility, and our deep AAV expertise, to support AveXis as it delivers a life-changing treatment for patients.”

“Given the complexity and length of time required to make gene therapies, manufacturing is critically important,” said Dannielle Appelhans, Chief Technical Officer for AveXis. “This approval further complements our internal manufacturing capacity and, over time, will allow us to increase supply to meet growing patient needs.”

Catalent’s Harmans commercial manufacturing facility, located near BWI airport, is equipped with single-use technology, and houses over 200,000 sq.-ft. of late-stage clinical and commercial-stage gene therapy production. The facility is one of Catalent’s five gene therapy facilities in Maryland providing clinical through commercial scale services, and houses multiple CGMP manufacturing suites, including fill/finish, central services and testing labs, warehousing, and supply chain capabilities.

 

Pall Gets $4.9M DoD Contract to Build Ventilator Filter Mfg. Line

New line set to open in fall 2021.

Pall's ventilator filter production capacity will increase from 485,000 units per month to 650,000 units per month.

Pall Corporation, a global filtration, separation and purification company, was selected by the U.S. Department of Defense (DoD) to receive a $4.9 million contract to build a new breathing filter manufacturing line within an existing U.S.-based Pall manufacturing facility to increase ventilator filter production. When the new line opens in the fall 2021, Pall's ventilator filter production capacity will increase from 485,000 units per month to 650,000 units per month—allowing Pall to help meet the growing demand in the U.S. for ventilator filters driven by COVID-19.

The grant is the result of a partnership between the DoD and the Department of Health and Human Services (HHS) to determine how to increase domestic ventilator critical component suppliers' capacity.

"We are proud Pall was awarded this DoD contract, which allows us to increase the production of ventilator filters to help protect patients and give health care workers the equipment needed in a pandemic situation," said Jennifer Honeycutt, president of Pall Corporation and Danaher Group Executive.

In addition to Pall's efforts to produce additional breathing filters for ventilators, Pall solutions play a major role in global COVID-19 response efforts. The company's lab solutions are used in COVID-19 research and Pall's expertise in scaling up vaccine manufacturing processes is currently being applied by several drug makers. Notably, Pall is a core member of the consortium led by The University of Oxford, which is responsible for one of the front runners in the race to develop an effective COVID-19 vaccine. AstraZeneca joined forces with the consortium and committed to enabling global access to the vaccine, including low and middle-income countries.

"From the start of the COVID-19 crisis, Pall has drawn on the depth and breadth of our material science and engineering expertise across a wide range of industries to devise trusted solutions that support research, help patients heal and eliminate the spread of this disease,” said Honeycutt. “It's through our innovation that we will continue to apply our expertise in novel ways to protect people around the world.”

 

CoreRx Fully Operational in New Product Development Center

CoreRx, Inc., a global contract development and manufacturing services company opened its fourth new facility, on the ICOT campus in Clearwater, FL in April 2020. The new Product Development Center includes 9 R&D formulation development and R&D-scale manufacturing suites, nearly 5,000 sq. ft. of analytical laboratory space as well as capacity for an additional 35 employees to the Clearwater workforce over time.

The new 26,000 sq. ft. space expands the capacity of CoreRx’s oral and topical dosage form development group, increasing drug product volume through several formulation technologies that include: blending, roller compaction, wet granulation, fluid bed drying, spray drying, and extrusion spheronization. According to the company, the increased R&D development capacity is in response to higher demand for expert contract services. This expansion will assist its pharmaceutical chemists in the development of robust, reliable dosage form options made available to our clients.

This expansion gives CoreRx’s clients access to over 150,000 sq. ft. of space at the ICOT center campus.

The new facility is designed to streamline workflow and optimize product development efficiency, with analytical development, pre-formulation, and formulation development teams all collocated for optimal synergy.

“The establishment of our International Center of Excellence on our Clearwater campus is both an indicator of our continued growth and a commitment to our global and domestic customers,” said Bill Reid, chief operating officer, CoreRx. “Investing in new facilities, increasing development capacity, and expanding our capabilities help us to meet the growing demand for our services and is also an important way of creating jobs and supporting the communities where we operate.”

 

KBC Adding A Cleanroom Suite

Kentucky BioProcessing is getting some improvements.

AES Clean Technology picked up a building permit last week for an $857,000 renovation and the creation of a cleanroom suite.

 

Gemini Bio’s New Manufacturing Facility

Cell culture solutions provider Gemini Bioproducts (Gemini Bio) opened its new manufacturing facility in West Sacramento, California, US, in June 2020.

The facility will allow Gemini Bio to satisfy the demands of cell therapy and research markets while meeting the criteria of global regulatory compliance.

Gemini Bio’s cGMP-compliant manufacturing center will expand the company’s production capabilities, enabling it to serve the needs of its pharmaceutical partners.

The ground-breaking ceremony of the manufacturing facility was held in September 2019.

The new cGMP manufacturing facility is located in West Sacramento, California in the US, extending over an area of approximately 25,000ft².

Gemini Bio’s facility will support the production of cell culture media, sera, cytokines (humans, mouse or rat), growth factors, buffers and other supplement reagents with products for the cell therapy and gene therapy.

It is equipped with cleanroom suites, cold storage facilities, warehouses and administrative area. The additional production will deliver a fourfold increase in the company’s production capacity.

The facility will allow for rapid growth and development while improving the quality level of Gemini Bio’s products.

Gemini Bio intends to be a center of excellence supporting the requirements of customers in the cell and gene therapy market.

It is relocating to the new facility from its existing 12,000ft² location in West Sacramento.

MarketOne Builders, a design-build contractor, and architecture firm DGA worked on the design and construction of the new manufacturing facility in West Sacramento.

In June 2020, Gemini Bioproducts received a contract worth $3.6m from the US government to deliver essential products to boost Covid-19 testing efforts. The award is a part of the broader commitment of Gemini Bio to support Covid-19 containment.

“CGMP-compliant manufacturing center will expand the company’s production capabilities, enabling it to serve the needs of its pharmaceutical partners.”

Gemini Bio will provide reagents in the Phosphate Buffered Saline (PBS), Saline Solution and Viral Transport Media (VTM) areas and will utilize its facility to support the initiative.

Development of media solutions is a primary focus area of the firm. VTM is important to the coronavirus testing process and the company will support measures to increase testing.

The company is mainly targeting the delivery of its products and solutions in the areas of cell culture, viral harvesting and transport, analytical instruments and research tools. Gemini Bio is complying with the recommendations of the Centers for Disease Control and Prevention (CDC) throughout its manufacturing processes.

Marketing commentary on Gemini Bioproducts:

Gemini Bioproducts provides cell culture technologies to scientific organizations involved in cell and gene therapy, biotechnology, biopharma and academic research.

The company also provides contract manufacturing services and regulatory consultancy services to its clients. It aims to offer holistic solutions for cell culture to facilitate the discovery and manufacturing of therapies. The state-of-the-art facility will provide services such as fill and finish, and the development of custom media.

BelHealth Investment Partners, a healthcare-focused private equity company, invested in Gemini Bio in September 2018.

Founded in 1985, Gemini Bio is headquartered in West Sacramento, California. Gemini has a global distribution network that services cell culture laboratories across the world.

It purchased life sciences instrumentation firm ORFLO Technologies in November 2019. The acquisition added Moxi Go and Moxi Z products to Gemini Bio’s portfolio. The company also formed an exclusive partnership with FroggaBio, under which the latter has the rights to distribute the media and sera products of Gemini Bio across Canada.

 

Skender Completes Compounding Pharmacy for Major Chicago Hospital

Skender, serving as general contractor, recently completed interior construction of a 7,500-square-foot compounding pharmacy at a large Chicago hospital. The project consolidates three existing oncology pharmacies while expanding capacity to support projected growth.

The new sterile pharmacy allows for the safe preparation, mixing and packaging of drugs to meet individual patient needs. It features six compounding spaces that were constructed using cleanroom design to keep airborne particles within specified limits. The project also includes 17 mixing hoods, refrigerated and non-refrigerated drug storage and an interlocked anteroom with cleanroom doors that allow the opening of only one door at a time.

To comply with cleanroom specifications, material selection included solid surface wall protection, Terra Universal cleanroom doors, lab casework and extensive mechanical equipment to support cleanroom functionality and standards. Skender worked with Kahler Slater and ESD to successfully complete the new pharmacy.

The project took place within an active hospital, requiring special logistics and safety measures, such as precise-sized materials to fit elevators, extensive noise and vibration controls and electrical and plumbing shutdown coordination. With space and access constraints, a knockdown air handling unit was delivered in panelized sections, assembled and installed on site over four weeks.

 

SCA to Expand Operations in Little Rock

SCA Pharma to renovate an existing 42,000-square-foot facility at the Clinton National Airport and construct an additional 20,000-square-foot facility.

SCA Pharma, an FDA-registered outsourcing facility, is expanding its operations in Little Rock. SCA will be investing more than $10 million and will create the opportunity to double its current Little Rock workforce of 180 people.

Additionally, the investment will allow SCA Pharma to renovate an existing 42,000-square-foot facility at the Clinton National Airport and construct an additional 20,000-square-foot facility adjacent to the existing facility. SCA also plans a 40 percent expansion of its Windsor, Conn. facility.

Construction at Windsor will allow company to add second cleanroom.

SCA Pharma, an FDA-registered outsourcing facility, plans to expand its sterile pharmaceutical manufacturing facility in Windsor, CT, by 40 percent. It currently operates two sterile pharmaceutical manufacturing facilities located in Windsor and Little Rock, AK. The planned expansion would increase the size of the Windsor facility to approximately 150,000 square feet with the ability to add state-of-the-art automation, compounding capability, and technical employees to manufacture critical medicines. 

“Ensuring that hospitals have all of the readily available sterile injectable pharmaceuticals they need to properly treat and care for patients is more critical today than ever before,” said Milton Boyer, chief executive officer, SCA Pharma. “The demand for SCA products continues to increase, and we are committed to meeting that need safely, efficiently and reliably. Our new construction will position us to expand our capacity and make products even more accessible to hospitals.”

Boyer said construction would take approximately nine months to complete.

“We are very pleased that as we continue our geographical expansions in both Arkansas and Connecticut, we can partner with the Arkansas Economic Development Commission (AEDC) and the Little Rock Municipal Airport Commission to solidify and expand the operations of our legacy operations,” said Milton Boyer, CEO of SCA Pharma. “Little Rock has been the foundation that has allowed for our other expansion projects, and this project will bolster that foundation for years to come.”

SCA says it has experienced significant growth over the past five years and believes that creating an additional clean room capacity will provide another avenue to increase supply.

“Arkansas is committed to nurturing its homegrown companies from seed stage upward,” Gov. Asa Hutchinson said. “We are proud to see the success that SCA Pharma is experiencing and look forward to the products and services being developed here in central Arkansas that will positively impact the lives of people around the country.”

The expansion of both locations will also create the need for technical and highly skilled jobs for both areas.

“Even in these trying and turbulent times of a global pandemic and its uncertainty, Little Rock is continuing to see companies invest and create new jobs for our citizens,” said Mayor Frank Scott Jr. “We are thrilled and grateful SCA Pharma is joining Little Rock’s momentum and creating high-paying jobs that will have a lasting impact on our economy.”

 

Novavax, FUJIFILM Initiate Large Scale Mfg. of COVID-19 Vax Candidate

FUJIFILM to manufacture bulk drug substance for NVX-CoV2373 from its site in Morrisville, NC for Phase III trial.

Novavax, Inc. and FUJIFILM Diosynth Biotechnologies (FDB), a contract development and manufacturing organization for biologics, viral vaccines and gene therapies, entered an agreement to manufacture bulk drug substance for NVX-CoV2373, Novavax' COVID-19 vaccine candidate. FDB's site in Morrisville, NC has begun production of the first batch of NVX-CoV2373.

This agreement falls under Novavax' recent $1.6 billion award by the federal government as part of the Operation Warp Speed (OWS) that aims to deliver millions of doses of a vaccine for COVID-19 to the U.S. population. The OWS funding is being used by Novavax to complete late-stage clinical development, including a Phase 3 clinical trial; establish large-scale manufacturing; and deliver 100 million doses of NVX–CoV2373 beginning as early as late 2020.

NVX-CoV2373 consists of a stable, prefusion protein made using Novavax' nanoparticle technology and includes Novavax' Matrix–M adjuvant.  The batches produced at the FDB site in North Carolina will be utilized in a future Phase 3 trial of up to 30,000 subjects, which is expected to begin in the fall of 2020.

Novavax expects preliminary immunogenicity and safety results from a Phase 1/2 trial of NVX-CoV2373 in 130 healthy participants 18 to 59 years of age during the first week of August. The Phase 2 portion to assess immunity, safety, and COVID-19 disease reduction is expected to begin shortly thereafter. The Phase 1/2 clinical trial is being supported by an up-to $388 million funding arrangement with the Coalition for Epidemic Preparedness Innovations (CEPI).

 

MedPharm Expands U.S. Footprint

UK topical and transdermal firm invests in $4 million expansion of laboratory facility in Durham, NC.

MedPharm, a UK-based developer of topical and transdermal products, recently unveiled a substantial expansion at its Center of Excellence in Durham, NC. Supporting clients from discovery lead optimization to GMP clinical batch supply, MedPharm has facilities in Guildford, UK, in addition to the Durham site. The company’s expertise covers products to be applied to and/or through the skin, nail, eye, airway or mucosal membranes. Contract Pharma spoke with Jeremy Drummond, senior vice president of business development, about the expansion and MedPharm’s plans for future growth on both sides of the Atlantic.

Contract Pharma (CP): Could you please tell me about the features of the Durham facility?

Jeremy Drummond (JD): MedPharm’s facility in Durham, NC has recently been expanded to 25,000 square feet, tripling the area of the existing footprint. The $4 million investment will predominantly provide additional laboratory space and equipment.

Medpharm's Jeremy Drummond

In addition to the performance testing using our proprietary in vitro models based on human tissue, MedPharm now can offer pre-formulation/formulation development, histology and microbiology services out of North Carolina. Importantly the facility will also encompass a dedicated innovation laboratory to help solve unique problems presented by clients and ensure that MedPharm stays at the forefront of technology.

This new facility will be able to accommodate 100 new highly skilled scientific personnel.

CP: Why was the expansion necessary—were you looking to add capabilities in certain areas, capacity or both?

JD: The expansion has become necessary because of the increased demand for MedPharm’s services across all sectors of the pharmaceutical industry. There is increased demand, from biotech start-ups to Big Pharma, to develop topical and transdermal products based on new chemical entities. These companies recognize the inherent risks in topical formulation development and increasingly appreciate how MedPharm’s specialist skills coupled with its in-depth experience can de-risk their development plans and help them to attract investors when they seek funding.

The increased demand is fueled by the growing interest in developing new and repurposed drugs currently registered for oral or IV delivery for indications which require delivery through the skin, direct to the eye or into an airway. Another contributing factor has been MedPharm’s pioneering expertise in the use of in vitro models based on human tissue to meet the recently published FDA and EMEA guidance on demonstrating generic equivalence for topical medicines.

MedPharm is now also attracting projects from OTC companies who are keen to use its in vitro models to help educate their key opinion leaders about their products and broaden the marketing claims of their products with regulatory authorities.

This investment is just a first step in MedPharm’s vision to expand its services in the future, particularly around contract manufacturing.

CP: Could you tell me a little more about the dedicated innovation laboratory—its features and capabilities?

JD: MedPharm’s Innovation Laboratory has a wide-ranging remit to help customers resolve key questions to de-risk or simplify their product development.

By example, recently the team has developed a new model for assessing penetration through human nasal epithelia based on air liquid interface tissue culture of primary human cells in the laboratory. This allows clients to assess the performance of their products before they commit to clinical trial decisions.

In a further step, MedPharm has expanded these models based to support pharmaceutical development programs targeting Coronavirus treatments. These models allow clients to assess therapeutic effectiveness in nasal, airway (bronchial), and deep lung (alveolar) epithelia against members of the Coronaviridae family. The work will help to de-risk development programs and screen drugs for therapeutic effectiveness to accelerate development prior to clinical trials.

Studies have shown that human tissue can vary significantly from that of animals used in in vivo models and so this approach provides the most realistic read out of how a topical drug product is going to behave in the clinical environment.

In a similar way the innovation laboratory has refined MedPharm’s whole eye model for monitoring penetration to encompass the activity of formulations on key biochemical pathways and is extending the viability of fresh skin kept in the laboratory from weeks to months to open the opportunity for novel assays for monitoring wound healing and acne amongst others.

 

REST OF WORLD

CMIC Group Establishes Biopharma CDMO in Japan

CMIC Holdings has established CMIC Bio, a fully-owned subsidiary that offers CDMO services for biopharmaceutical drug substance.

CMIC Bio has a single-use facility in Shizuoka, Japan for process development and GMP manufacturing of antibody drug using mammalian cell line. The facility will be in full-scale operation from October 2020.

In recent years, the biopharmaceutical-related market has continued to expand, and companies from other industries other than pharmaceutical companies have entered the market. Each company emphasizes the speed to acquire POC in order to quickly identify the development compound, and at the same time, the need for multi-product, small-volume production is rising.

Given this situation, it is difficult to produce all of the development products in-house, and an increasing number of cases utilize outsourcing.

From April 2014 to September 2019, CMIC JSR Biologics participated in the Japan Science and Technology Agency's Program (NexTEP) (Project name: design and manufacturing technology of multispecific antibodies). Research has been conducted in the fields of manufacturing and quality control of biotechnology-derived pharmaceuticals, with a focus on the manufacturing process development of bispecific antibodies.

"Based on these experiences, we establish CMIC Bio and start the biopharmaceutical drug substances CDMO business. At CMIC Bio, we have personnel with abundant experience at pharmaceutical companies and have strengths in GMP API manufacturing bases in Japan to assist in accelerating the development speed of biopharmaceuticals," said Hiroshi Kosaku, President of CMIC Pharmaceutical Sciences.

"CMIC Group will provide end to end solutions from non-clinical testing, running clinical trial, GMP manufacturing of biopharmaceuticals to the commercialization and post market," Kosaku added.

 

Sandoz Partners with Austria to Boost Antibiotics Production

Swiss pharmaceutical company Novartis unit Sandoz has partnered with the Austrian Government to boost integrated antibiotics production in Europe.

Sandoz plans to invest more than €150m over the next five years to improve the long-term competitiveness of its antibiotic manufacturing activities at Kundl.

The company will develop manufacturing technology for active pharmaceutical ingredients (APIs) and finished dosage forms (FDFs).

As part of the joint plan, the Austrian government would provide or coordinate public funding worth about €50m towards the total investment.

The government expects this initiative to enhance the European-based manufacturing of essential medicines.

Novartis added that the joint plan is subject to formal approvals by both parties, which expect a formal closing of the agreement by the end of this year.

Sandoz CEO Richard Saynor said: “Antibiotics are the backbone of modern medicine and our Kundl facility in Austria is the hub and center of the last remaining integrated production chain for antibiotics in the western world. This joint investment will help to keep it that way.”

 

Sorrel Medical’s New Manufacturing Facility, Netanya, Israel

Wearable drug delivery devices manufacturer Sorrel Medical opened a new manufacturing facility in Israel in July 2020.

The facility will develop and manufacture a range of wearable drug delivery devices to boost clinical and commercial supply capabilities. The company is looking to ramp up production of the wearable devices as it prepares for upcoming clinical trials.

The manufacturing plant can assist Sorrel’s partners in the pharmaceutical and biotechnology industry to bring advanced drug delivery solutions to the market.

Increased production scale-up capability is expected to support the needs of patients suffering from severe, high-burden illnesses.

The new facility for the manufacturing and commercialization of wearable drug delivery devices is located in the city of Netanya in Israel. It includes an advanced production cleanroom to enable the production of scalability of wearable drug delivery devices.

The 860 sq. ft. (80m²) cleanroom conforms to the ISO class 7 environment standard, designed to minimize particulate pollution in accordance with the standards of ISO 14664-1:2015 and EU GMP Annex 1 and regulate other environmental variables including pressure, temperature and humidity.

The company will leverage the Netanya site to switch from initial design and development, with low-volume production, to scalable high-quality production.

Sorrel Medical’s new manufacturing facility will allow the firm to increase its production capacity to hundreds of thousands of units a year. It also features an IQC laboratory and spaces to meet gowning, washing, and warehousing requirements.

Sorrel’s pre-filled and pre-loaded wearable drug delivery systems are used for self-administration of drugs with high viscosities.

Flexible and fully connected on-body injectors improve the patient experience and help pharmaceutical firms to provide combination products for patients.

The devices feature a primary container-agnostic configuration to handle a range of drug packages, UV LED disinfection and smart sensing capabilities. The presence of multiple sensors also allows for detection of cartridge placement and needle position, as well as performing internal system checks.

The company’s devices incorporate electromechanical pumping mechanism, while the flow rate is up to 3ml per minute. Devices are equipped with Bluetooth low energy and near field communication (NFC) enabled connectivity.

Wearable drug delivery devices, or wearable injectors, are intended for the self-administration of injectable drugs. They provide a solution for the drug administration of large volumes and high viscosities into the subcutaneous tissue in a user-friendly drug delivery system.

Drug delivery devices offered by Sorrel Medical are available in multiple configurations including 2ml, 3ml and 10ml. The features of the devices enable optimized usability and enhanced patient safety.

Sorrel Medical is focused on the development and commercial production of platform-based, pre-filled, and pre-assembled wearable injectors.

The medical device firm was formed as a spin-off from Israel-based company Q Core Medical and operates as a subsidiary of Eitan Group.

Eitan Group is engaged in advanced infusion therapy solutions and provides patient-centric connected, software-based solutions to meet evolving drug delivery needs. In addition to wearable solutions, the company offers systems for hospital care and ambulatory settings.

Sorrel leverages technology to simplify processes for end-users and pharma companies. It aims to develop innovative technology solutions to meet challenges in the drug delivery market.

The company supports its partners with its expertise in technological flexibility, production scale-up, regulatory compliance and marketing to reduce time and risk.

 

Sharp Acquires Stake in Berkshire Sterile Manufacturing

Agreement will allow Sharp’s Clinical division, via BSM, to offer sterile fill/finish services.

Sharp, part of UDG Healthcare plc, has purchased a minority 25% ownership in Berkshire Sterile Manufacturing (BSM), extending the existing preferred partner agreement that has been in place between the two businesses since 2018.

BSM offers specialized isolator-based sterile filling of vials, syringes, cartridges and containers, as well as Lyophilization and terminal sterilization to small, medium and virtual pharma and biotech companies.

The agreement will allow Sharp’s Clinical division, via BSM, to offer sterile fill/finish and extend these services to Sharp Packaging’s existing rare and orphan therapy biotech customers where market demand is growing significantly.

“Starting in 2018, our partnership with BSM has been incredibly successful for both parties, bringing a significant number of new business leads to Sharp Clinical and enabling BSM to realize additional sales,” commented Frank Lis, president of Sharp Clinical Services. “Strengthening our relationship with a minority stake will be a great benefit to our respective clients as BSM’s capabilities are a natural extension of the existing services that Sharp offers.”

As part of the agreement Frank Lis and Kevin Orfan, president of Sharp will join the BSM board.

“Having Frank and Kevin join the BSM board as part of this deal will be greatly beneficial as the collaboration between our companies grows in the years to come,” added Shawn Kinney, CEO of Berkshire Sterile Manufacturing. “The agreement will also allow further collaboration in Quality, Project Management, IT, Logistics, Storage and Distribution and will enhance our respective integrated service offerings, reducing timelines and ultimately optimizing the client experience.”

The deal follows BSM’s announcement of a $20 million investment into expanding its filling capacity and capabilities. This expansion will double the company’s cleanroom and warehouse space, and bring an isolator-based robotic flexible sterile filling line. With this new line, BSM will be able to fill larger quantities of vials (RTU and bulk), cartridges, syringes and custom containers.

 

Colorcon Opens New Facility

The new center is in the award-winning Caribbean Business Park in Australia.

Colorcon has opened a new technical center in Melbourne, Australia. The facility provides customers in Australasia access to pharmaceutical class development services such as tablet formulation and coating as the region seeks to shorten supply chains and increase the capacity of its pharmaceutical sector.

“Opening this facility demonstrates Colorcon’s continued commitment to supporting the growing pharmaceutical and nutritional markets in Australia, reducing our customer’s time to market during product development. The investment reflects Colorcon’s dedication to providing best-in-class products and services,” commented David Wei, general manager, Colorcon South East Asia.

Tim Horwood, business development manager in Australia, explained, “The new technical service center will provide both large and small customers the opportunity to work directly with Colorcon and for the first time in Australia to conduct laboratory-scale compression and coating trials, using automated coating equipment, saving valuable development time and cost.”

“The facility will also provide the opportunity to extend the educational events offered through the Colorcon Academy to our customers, with resources to conduct training programs to expand their knowledge in formulation and coating; benefiting both companies and individuals,” added Glenn Russell, technical director. “Colorcon’s continuous investment in customer support is unmatched in the industry; this additional facility brings the total number of Technical Service Laboratories around the world to twenty-two and is the seventh within Southeast Asia.”

 

Sekisui Invests in Biopharma CDMO Business

Sekisui has invested £14.4 million ($18.93 million) in its biopharma CDMO business aimed at cGMP microbial capacity expansion at the existing site in Maidstone, Kent to be completed by the second half of 2022.

This investment follows the investment of $1.9 million in its new Bioprocess Innovation Center, completed in October 2019, and is part of a long-term investment strategy to grow its share of the microbial biopharma CDMO market.

Previously part of Genzyme Corporation, Sekisui Diagnostics' Enzyme business launched its microbial biopharma CDMO service offering, BioProduction by Sekisui, in 2017. The facility expansion and cGMP upgrades will enable Sekisui to take on drug substance contract manufacturing for programs entering the clinical trial phase. The new cGMP certified microbial fermentation and purification suites will accommodate production scales up to 1,000L, complementing its existing capabilities which range from 20L to 5,000L fermentation scale.

Sekisui has wide experience with projects from pre-clinical to commercialization, including but not limited to recombinant systems such as E. coli and Pichia pastoris, and 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.

"This investment represents our commitment to serve our Biopharma customers with much needed cGMP microbial CDMO production capacity." said Robert Schruender, president & CEO of Sekisui Diagnostics and Sekisui Medical board member. "Over many years we have built both a technical and operational competency and expertise in enzyme production and microbial fermentation. As the Biopharma CDMO market grows, we aim to further leverage this capability to grow our share in this market."

 

Lonza Expands Facility in Switzerland

Lonza is expanding its microbial manufacturing facility in Visp, Switzerland. The new facility will provide mid-scale commercial manufacturing to multiple customers and in particular, serve the growing needs of Servier, an independent international pharmaceutical company and long-term Lonza partner.

Servier and Lonza have recently signed a long-term extension to the manufacturing agreement for L-asparaginase, produced at Lonza since 2009. The extension and expansion of the collaboration will provide Servier with the additional capacity required to provide treatment to many more patients with acute lymphoblastic leukemia (ALL), a cancer of the white blood cells. Servier intends to expand access to asparaginase-based multi-agent chemotherapeutic regimens.

The new facility will be the sixth to be housed in Lonza’s new biopark in Visp, Switzerland, currently under construction. Lonza launched Ibex Solutions in 2018 to offer custom-tailored manufacturing solutions across a broad range of technologies while minimizing time to market with pre-built shells and infrastructure. The new mid-scale (3,000L) microbial facility will tap into existing central utilities and labs and will complement the existing small-scale (1,000L) and large-scale (15,000L) assets in Visp.

The facility is expected to be operational in the second half of 2022 and Lonza expects to add 100 new staff to the existing, highly-experienced microbial team.

 

Catalent’s Covid-19 Vaccine Manufacturing Facility, Anagni, Italy

Catalent Biologics’ manufacturing facility in Anagni, Italy will serve as the launch facility for the large-scale production and supply of the University of Oxford’s Covid-19 vaccine candidate, AZD1222.

The company signed an agreement with AstraZeneca, which is working with Oxford University on the development and production of AZD1222, in June 2020. The agreement will support the scale-up of capacity for the manufacturing of AZD1222.

The facility will provide vial filling and packaging capabilities to AstraZeneca. It will be ready for production by August 2020 and the company aims to deliver hundreds of millions of doses of the potential vaccine. The production of the adenovirus vector-based vaccine will continue until March 2022, subject to the approval by regulatory authorities.

It will also accelerate the launches of customers’ biologics and oral drug products and broaden Catalent’s network in Europe. Catalent plans to invest further in the facility for its growth.

The 301,280 sq. ft. (28,000m²) facility is a state-of-the-art pharmaceutical manufacturing facility located in an industrial area approximately 100km south-east of Rome. With a floor space of 207,668 sq. ft. (19,300m²), the facility lies on a 34ha site.

Biologics fill-finish and oral solid dose product manufacturing and packaging center was acquired from Bristol-Myers Squibb in January 2020.

Bristol-Myers Squibb used the facility for technology transfers and accelerated launch of its various flagship products including Opdivo® (nivolumab), Yervoy® (ipilimumab), Sprycel® (dasatinib) and Reyataz® (atazanavir). The facility continues to manufacture Bristol-Myers Squibb’s products.

The manufacturing facility specializes in filling aseptic liquid, and powder of biologics and sterile products in different vial sizes, as well as primary and secondary commercial packaging solutions with blister and bottling capabilities for product launches.

Other capabilities of the facility include automated warehousing, serialization and a service that provides shipping of packaging solution within 48 hours after order placement.

The facility is approved by several agencies including the US Food and Drug Administration (FDA), the Italian Medicines Agency (AIFA), Brazil National Health Surveillance Agency (ANVISA), and Ministry of Health, Labour and Welfare of Japan.

Developed by the Jenner Institute at the University of Oxford and the Oxford Vaccine Group, the recombinant adenovirus vaccine technology-based AZD1222 is backed by the US government.

AZD1222 utilizes a replication-deficient chimpanzee viral vector derived from a weakened version of a common cold adenovirus that infects chimpanzees. The vaccine contains SARS-CoV2 spike protein genetic material.

Vaccination will produce the surface spike protein and prepare the immune system of the patient to attack coronavirus if the body gets infected by it later. It will be a single dose vaccine to create a strong immune response in individuals. Vaccinated individuals will not suffer from ongoing infection as it does not replicate.

The drug is currently in clinical studies. It entered Phase I / II clinical trial to evaluate the safety, immunogenicity, and efficacy of the drug in more than 1,000 healthy individuals aged between 18 and 55 years in southern England in April 2020.

US Biomedical Advanced Research and Development Authority (BARDA) is supporting the vaccine development and production project with an investment of over $1bn.

The US Department of Health and Human Services (HHS) formed a partnership with AstraZeneca, under Operation Warp Speed, to deliver at least 300 million doses of Covid-19 vaccine AZD1222 by January 2021. First doses of the vaccine are expected to be available from October 2020. Phase 3 clinical studies of AZD1222 in Summer 2020 involve 30,000 volunteers in the US.

Marketing commentary on Catalent:

Catalent Biologics is a business division of Catalent, a pharmaceutical company based in New Jersey, US, focused on providing advanced delivery technologies and development solutions for biologics, drugs, and gene and cell therapies. The company operates a network of facilities in Europe including Brussels, Belgium, and Limoges, France, as well as other facilities in the US.

Catalent has more than 13,000 employees, including 2,400 scientists and technicians. In May 2020, it signed an agreement with Arcturus Therapeutics to manufacture the LUNAR-COV19 vaccine candidate at its biomanufacturing facility in Madison, Wisconsin, US.

 

Sanofi’s Evolutive Vaccine Facility (EVF), Neuville-sur-Saône, France

Sanofi is planning to build a new Evolutive vaccine facility (EVF) for the manufacturing of vaccines in Neuville-sur-Saône in the eastern part of France.

EVF facility will allow Sanofi Pasteur, Sanofi’s global vaccine company, to supply vaccines in case of new pandemics.

The investment will boost the company’s capability to further research and mass production of new innovative vaccines.

The project will involve an investment of €490m ($552.4m) over five years and create 200 new job opportunities.

Sanofi’s Evolutive vaccine manufacturing facility will be located in the Neuville-sur-Saône commune of France.

The Neuville-sur-Saône site is located close to the company’s facility in Marcy-l’Etoile, and Sanofi Pasteur’s global headquarters, as well as the Genzyme production site of Sanofi, situated in the center of the Sanofi Biotechnology Hub in the city of Lyon.

The company’s existing operations at the facility in Neuville-sur-Saône primarily include biotechnological manufacturing of vaccines. The Neuville-sur-Saône site represents the first dengue vaccine production center in the world.

In addition, the site includes a research and development (R&D) laboratory devoted to analytical sciences. The plant has high-tech facilities and an innovative structure that enables new vaccines to be developed in collaboration with R&D.

The state-of-the-art manufacturing facility will incorporate the latest advanced technologies for the manufacturing of vaccines.

EVF is a facility built around a central unit that includes completely digital production modules. The modern factory will be able to produce three to four vaccines at the same time, compared to only one in the existing sites.

Customization and modular design will enable the development of a specific vaccine on priority and in a more reasonable time frame depending on public health concerns.

Sanofi will work with the European Union (EU) and the French Government to create an additional vaccine or monoclonal antibody (installation of cell culture tanks and start-up projects) manufacturing capabilities for the EU and pharmaceutical firms in case of any healthcare emergency.

Marketing commentary on Sanofi:

Sanofi is a major healthcare company delivering solutions and services in more than 170 countries around the world. It plays an instrumental part in meeting customers’ healthcare demands and improving health services.

Through its global vaccines’ division Sanofi Pasteur, Sanofi is involved in the development and manufacturing of vaccines. The multinational company’s vaccine portfolio includes products to treat patients from infectious diseases, influenza and endemic diseases.

Sanofi Pasteur employs 16,000 personnel and operates 12 vaccine manufacturing sites, including three in France.

It supplies over 200 vaccines, medicines and healthcare-related drug products in France. It has 33 sites in France including 22 industrial sites.

The company has around 5,000 scientists and researchers engaged in therapy areas, with a focus on immuno-oncology, vaccine development, oncology and rare diseases. It is also planning to spend €120m ($135.3m) to set up a new research and development facility in France at Sanofi Pasteur’s Marcy-l’Etoile site to produce possible future vaccines.

The proposed advanced digital facility in Marcy-l’Etoile will be equipped with specialized laboratories for vaccine development against emerging diseases and pandemic hazards.

Sanofi aims to transform its French operations into a center of excellence in the areas of vaccine research and manufacturing.

The company is also supporting global efforts to combat the Covid-19 pandemic disease. It joined forces with GSK to explore the use of recombinant DNA technology to produce a potential Covid-19 vaccine. Its research efforts, in partnership with TranslateBio, are focused on developing a vaccine using messenger RNA technology.

 

Marken Expands Global Footprint

Marken, the clinical supply chain subsidiary of UPS Healthcare, is adding a GMP-compliant depot in Los Angeles, CA, and a new GMP-compliant depot in Kiev, Ukraine. In addition, two GDP-compliant logistics branches will be added in Dublin, Ireland and Amsterdam, the Netherlands. These newest additions to Marken's global network add increased capacity and enables Marken to continue to offer superior supply chain services to its clients, their investigator sites and patients.

The Amsterdam facility will include a cryogenic filling station to meet the growing need of Marken's cell and gene therapy clients. An additional LN2 service station has been added to Marken's network in Geneva, Switzerland.

"The infrastructure investments we have made in all of our facilities globally serve a single purpose," said Ariette van Strien, president, Marken. "Since 2011, we have made investments which meet client demands where they need us. Marken will always strive to offer the very best service, reliability and security for our clients."

By early Q4, Marken will have 12 fully operational GMP-compliant depot locations, complemented by more than 10 million square feet of GMP-validated commercial warehouse space in 56 UPS Healthcare distribution centers. This extensive global network provides an exceptional degree of flexibility and efficiency, whether it involves coordinating supplies from a central or regional location based on trial enrollment activity or implementing innovative strategies that are built for future demand.

Wes Wheeler, president, UPS Healthcare, said, "Marken continues to lead as our clinical trial logistics subsidiary with unique new services and a very broad reach. We will continue to invest in Marken as the industry moves into new regions of the world, becomes more virtual, and demands a greater degree of control and visibility. We are also using their unique knowledge in clinical trials to influence our strategic investments in healthcare."

 

Also, Marken Doubles Capacity of Frankfurt Cold-Chain Facility

The company has expanded the footprint of the location to accommodate an anticipated increase in the need for COVID-19 vaccine and storage needs.

By increasing the size of its Frankfurt, Germany, facility (slated to go online in October) to more than 40,000 square feet, Marken is increasing its frozen-room storage capabilities and accommodating more clients looking to transport and store cell and gene therapy solutions. Outsourcing-Pharma (OSP) recently spoke with Marken president Ariette van Strien (AVS) about the GMP-certified facility, the industry’s evolving cold-storage demands and how COVID-19 is impacting the business.

OSP: Could you please share the history of the Marken GMP network – when was it launched, storage/logistics capabilities there, how it’s evolved over the years, etc.​

AVS: Marken has built and operated a fully GMP compliant owned network of 10 depots for the last decade, and these are also supplemented by select partner depots in other key locations around the world.  This network continues to grow with plans to open Los Angeles (USA) and Kiev (Ukraine) in the coming months.

Each depot is built after an extensive analysis of client demands as well as geographical needs, allowing clinical trials to be conducted in a cost efficient and optimized manner. These central depots allow us to serve our clients with comprehensive and efficient global distribution services for their clinical drug products and ancillary services; they are built to pharmaceutical manufacturing standards and are fully GMP compliant.

Depots are usually co-located with our logistics hubs in order to take advantage of well-established customer service, operations import /export and administrative support. Each of Marken’s depots are connected through the Solo platform, a global state-of-the-art, 21 CFR part 11 validated, cloud-based inventory management system which can interface with IRT for improved inventory reconciliation.

OSP: Could you please talk about the market conditions and client needs that helped drive Marken’s decision to expand its frozen-room storage capabilities there? Was the company eyeing this opportunity before COVID-19 hit?​

AVS: The expansion of cryogenic (liquid nitrogen) service locations facilitates global cell and gene therapy trials.  The combination of our expanded locations and packaging assets allows Marken to meet client demands in a rapidly growing industry.

Ultra-low temperature transportation has become an increasingly important supply chain requirement for cell, gene or immunotherapy-based medicines and those plans were in place well before the pandemic. We continue to see an increase in the demand for cell and gene therapy trial shipments.

We are committed to building the largest cryogenic service network in the clinical logistics industry to safely connect patients in all corners of the world with their required therapy.

OSP: In the announcement about the Frankfurt facility, you talk about cell and gene therapies being a particular focus for Marken—could you provide a little more detail about how industry work on/interest in this area has evolved in recent years, and how Marken is working to fulfill these associated needs?​

Ariette Van Strien, president, Marken

AVS: Advances in cell, gene and immunotherapy therapies continue to grow at a rapid rate and the clinical trial supply chain is evolving to provide personalized solutions for these life-changing therapies.

One of the more recent changes has been the development and issue of a new ISO standard that covers the transportation of cells for therapeutic use. Based on ISO9001, a panel of experts from the industry and ISO standards body worked together to develop ISO21973, which was released at the end of June.

This new standard points to the important considerations for those involved in this sensitive and essential work. Marken subject matter experts provided expertise early in the development of the new standard, with the ultimate goal to minimize variation, improve reporting and communications, and to achieve better quality of services for clients and patients.

Marken’s expanded cryogenic network of liquid nitrogen service locations and specialized fleet of packaging, allows our clients to recruit and treat patients from a greater number of countries around the world. Six Marken branches became Cell and Gene Centers of Excellence in 2019; in addition, a full-time, global team was appointed to develop and support the products and services required to handle cell, gene and immunotherapy materials and products.

The products and services have been designed to assure quality, chain of identity, data privacy and include a combination of best in class technology, facilities, processes and measurements. A central control center is now established at our headquarters in North Carolina; this team includes project management specialists, technology SMEs and logistics operations staff who are dedicated to cell and gene services on a full-time basis.

As an important part of many cell, gene and immunotherapies, cryogenic transportation at -150 degrees C are supported by Marken’s liquid nitrogen shipping fleet, which are serviced at 14 geographically distributed locations. Marken has been chosen as a key provider for global cell and gene trials and commercial supply shipments around the world.

OSP: Could you talk about how the COVID-19 pandemic has impacted Marken’s offerings in the clinical trial supply chain service realm? Please feel free to talk about offerings in general, as well as this facility in specific. I love this straight-forward quote: “Fewer handoffs mean fewer variables, less risk and an unbroken chain of custody.” Could you please elaborate on why shortening the chain (so to speak) is desirable for your clients, and ways in which your company helps make that happen?​

AVS: COVID-19 has impacted Marken in many ways including how we onboard clients, expansion of the number of countries in which we were able to provide direct-to-patient (DTP) services, greater deployment of single use packaging, and a myriad of other evolutions in our day to day business.

For instance, working closely with our clients, we have onboarded DTP trials in as little as a few days, as opposed to a more typical timeline of several weeks. Our teams have worked together to quickly procure and coordinate the appropriate temperature-controlled packaging solutions and temperature monitors into all countries.

We shifted our forecasting to add in more single use packaging rather than reusable because of quarantining policies in many areas and to help ensure the safety of our team members and clients.  We procured PPE equipment for our branches globally and ensured adequate supplies for all of our drivers and workers.  We adjusted our Standard Operating Procedures (SOPs) including DTP driver No Touch protocols and processes to safeguard everyone involved to meet the high demand to deliver treatments to thousands of patients in need.

Risk mitigation is a multi-step process and requires planning, foresight, technology, and experience.  Reducing the number of handoffs eliminates potential weak points in the supply chain, which benefits clients because it means that their critical and high value shipments of medicine or treatment reach the patient.

Through decades of experience, Marken's team of experts can critically assess any shipping lane and immediately identify points of potential risk.  Mitigation steps can be taken early on to avoid as many potential pitfalls as possible. Communication is critical, amongst our teams and to our clients, to ensure success.

When clinical sites and hospitals needed to refocus on COVID-related treatments and testing, Marken was ready with services that allowed patients to continue with their trials through home visits. Direct to/from Patient (DTP/DFP) and home healthcare (HHC) services provide solutions to keep clinical trials going, while maintaining patient safety, by shipping treatments directly to participant’s homes.

Through DFP services, biological samples can be retrieved from a patient’s home and sent to laboratories for testing. Combining DTP services with HHC services allows patients to respect the confinement guidelines of their location while continuing to participate in their clinical trial.

Prior to the pandemic, Marken was operating DTP in 57 countries. Now, that service has been provided in over 80 countries.

After sponsors secure permission to include DTP services into their protocols, Marken successfully coordinates logistics and delivery of thousands of clinical drug products directly to patients participating in trials throughout Asia, Europe, the US and Latin America. All Marken staff and selected partners are trained to provide DTP services after the personnel perform careful risk assessments to ensure time and temperature control will be maintained for each shipment.

Further, Marken is adding cold storage space across our GMP network for vaccine storage. We have already procured an additional supply of -80C freezers with the option to double the volume as needed.

Early on, we assessed our availability for +2C to +8C and -20C storage needs in order to be ready for vaccine storage and are also in the feasibility stage of adding further capacity within Marken and the UPS fully owned GMP network. We are also closely working with our sister company, Polar Speed, a UPS subsidiary, to build out a large cold chain storage hub in the UK.

OSP: I understand you have additional facilities planned in various parts of the world—can you share any additional detail about that?​

AVS: In addition to the GMP-compliant facilities being added in Los Angeles, California and a new GMP-compliant depot in Kiev, Ukraine, two GDP-compliant logistics branches will be added in Dublin, Ireland and Amsterdam, the Netherlands. These newest additions to Marken’s global network add increased capacity and enables Marken to continue to offer superior supply chain services to its clients, their investigator sites and patients.

The Amsterdam facility will include a cryogenic filling station to meet the growing need of Marken’s cell and gene therapy clients. An additional LN2 service station has been added to Marken’s network in Geneva, Switzerland.

 

UK Invests to Scale Up Covid-19 Vaccine Manufacturing

The Government of UK has announced an investment of £100m ($127m) to scale up manufacturing of Covid-19 vaccine and gene therapy in the country.

The investment will support the new Cell and Gene Therapy Catapult Manufacturing Innovation Centre for expediting the mass production of a successful Covid-19 vaccine.

Schedule to open in December next year, the Centre will have the capacity to manufacture millions of doses per month.

In Braintree, Essex, England, the investment will help upgrade an existing facility into a fully-licensed manufacturing center. This is intended to boost the country’s capability to respond to diseases such as Covid-19, as well as any other future pandemics.

This will also create new jobs to support economic recovery.

The new center will support the Vaccines Manufacturing and Innovation Centre (VMIC), which is being built in Oxfordshire with a £93m government investment.

Following its completion next year, the facility will be equipped to generate enough vaccine doses to cater to the UK population at scale.

 

Eurofins CDMO Expands Drug Product Facilities

Eurofins CDMO announces the strategic expansion of its existing Drug Product operation capabilities with the completion of new Drug Product development and cGMP manufacturing facility located in Mississauga, Canada.

The expansion of Eurofins’ Drug Product operations spans 14,500 sq. ft. The assets include fully equipped state-of-the-art pre-formulation and formulation development laboratories, a development suite, multiple GMP manufacturing suites, clinical packaging, and warehousing. With the expansion, Eurofins CDMO can support development and clinical manufacturing of oral solid dosage forms, including Highly Potent API’s. The integration of Drug Product operations compliments Eurofins CDMO existing API development and manufacturing services by providing an enhanced Quick-to-Clinic drug product strategy designed to meet clients’ needs for phase I and II products.

“Our complement of services offers science-driven strategies which enhance the Drug Product performance of API’s, from IND enabling through to late stage programs.” notes Kevin Rosenthal, Business Head of Drug Product Operations at Eurofins CDMO Canada.

The new drug product facility allows Eurofins CDMO to offer all drug development services under one roof, achieving enhanced science faster.

 

Samsung Biologics Expands Manufacturing Facility in Incheon

Samsung Biologics will expand its Drug Product (DP) capability in line with increasing market demand and to ensure flexible production capabilities for new and existing clients.

Samsung Biologics has been providing aseptic filling and lyophilization services since 2013 and has 25 product approvals from global regulatory bodies, including the FDA and EMA. In response to the forecasted increase in demand for aseptic filling, the company is making a strategic investment on its global capacity by building a flexible filling line and two additional lyophilizer units with 41.2 m2 chambers.

The flexible filling line is expected to commence GMP operations in the second half of 2021, and the expanded lyophilization line will become operational in the first half of 2022. Through this expansion, Samsung Biologics will add small-scale cartridge and syringe filling to its DP product offerings, and increase the total lyophilization capacity by 246% of the current capacity. The company expects to demonstrate its ongoing commitment to reliability and quality-oriented services for its clients and strengthen existing partnerships in addition to procuring new orders.

"We are committed to meeting every market demand from our clients, especially during this global climate," said Dr. Tae Han Kim, CEO of Samsung Biologics. "Samsung Biologics continues to work rigorously to accommodate our clients with world-class services, and through this investment, we hope to offer more flexibility and demonstrate our extensive manufacturing capabilities with the largest production capacity in the industry."

 

GenScript Expands CDMO Capabilities

The inaugural GenScript Cell and Gene Therapy Industry Development & Cooperation Forum concluded in Shanghai on July 17, at which more than 700 researchers and corporate leaders shared insights on the future growth of the cell and gene industry.

At the event, GenScript unveiled the integration and upgrading of the original CDMO platform and the release of its latest brand, GenScript ProBio. The new brand is dedicated to providing end-to-end service from discovery to commercialization.

For the past 16 years, since 2004, GenScript has gradually expanded its reach in the antibody drug discovery segment and established its capabilities in process development, helping many customers with their IND approvals during the period.

In 2019, GenScript opened the Biologics Development Business Unit (BDBU), the predecessor of GenScript ProBio, and appointed Brian Min, senior vice president at Samsung Bioepis, to join as chief executive officer and form a management team. The core members of the team each have more than 15 years working experience at recognized international firms across the sector, including Roche, Pfizer, Henlius and Innovent, among others.

"The GenScript CDMO platform has established strong antibody capabilities within just 18 months since launch and has accumulated considerable experience in cell and gene therapy," said Dr. Min at the launch of the brand. "GenScript ProBio's one-stop antibody drug development solutions will proactively provide clients with end to end service from target to commercialization. Looking beyond China and the Asia Pacific region, many large multinational companies in the U.S. and Europe have also established productive partnerships with us. Operating under the principle of 'Innovation through Collaboration', we fully expect to drive the development and progress of the whole industry together with our customers."

 

McIlvaine Company

Northfield, IL 60093-2743

Tel:  847-784-0012; Fax:  847-784-0061

E-mail:  editor@mcilvainecompany.com

Web site:  www.mcilvainecompany.com