Averica Discovery Services, an analytical development contract research organization (CRO), has acquired new equipment that it says significantly expands its capacity and capability. Averica offers analytical development services to pharmaceutical companies, supporting new drug profiling, early to mid-stage clinical development, and CMC.

The new instrument systems include a new preparative supercritical fluid chromatography (SFC) system, mass-directed preparative HPLC systems, and a charged aerosol detector (CAD). The additions enhance the company's ability to supply early drug development programs while shortening project timelines. Averica has also filled three new laboratory positions. "Averica is growing dramatically," said Jeffery Kiplinger, president, Averica. "Our analytical technologies and scientists are critical to the high quality services we provide. The added preparative chromatography capabilities will offer more capacity for our core services. The new detectors will enable support for new types of client projects, continuing Averica's growth trajectory."

Marlborough, MA

Brammer Bio Opens New Manufacturing Facility

The new 50,000 square foot facility in Lexington, MA will be dedicated to late phase development and commercial manufacturing for advanced cell and gene therapies.

The contract development and manufacturing organization (CDMO) announced the establishment of the new facility at BIO International, in San Francisco.

The new facility will include space for Phase III and commercial production of viral vector-based and cell-based advanced therapies and is expected to be qualified and operational by the second quarter of 2017.

The company recently merged with Flordia Biologix – adding capabilities in process development and phase I/II manufacturing.

“We are now entering the year of personalized medicine,” Brammer Bio President and CEO Mark Bamforth said at a press event at BIO International. “What has been an idea and a plan in people’s minds for several decades is now coming to fruition.”

Bamfroth added that the company will eventually employ up to 200 people in the new facility with a total of $50m invested, “to provide these therapies for our clients to they can bring them to patients around the world.”

Massachusetts’s Secretary of Economic Development, Jay Ash, also spoke at the event, thanking Brammer for its commitment to the state.

“A couple of years ago when Massachusetts was talking about being number one in life sciences, that meant research and development … but we’re now having conversation after conversation about manufacturing,” he said.

VGXI Plant Expansion to Support Inovio's Zika DNA Vaccine Development

DNA vaccines are safer and quicker to produce than egg or cell-based products, says VGXI which manufactured material for a recently approved first-in-man study of a Zika vaccine.

Inovio Pharmaceuticals announced it received approval to initiate a Phase I trial of its Zika DNA vaccine GLS-5700, which it said induced robust antibody and T cell responses in small and large animal models during preclinical tests.

The product is being co-developed by Korean firm GeneOne Life Science and made at its Houston, Texas-based subsidiary VGXI which specializes in clinical material for DNA vaccines – immunization using plasmid DNA genetically-modified to include DNA coding specific proteins from a pathogen.

“DNA vaccines are composed of purified, circular DNA molecules produced by bacterial fermentation,” Christy Franco, business development manager at VGXI told Biopharma-Reporter.com.

“Unlike traditional vaccines that contain dead or weakened virus, DNA vaccines do not contain any viral particles and are therefore much safer for patients. Since they do not require eggs or mammalian cells for production, DNA vaccines are also much safer and faster to manufacture.”

The contract manufacturing organization (CMO) has already provided the clinical material for the first-in-man study, but Franco said it is looking to continue to support the Zika clinical programme through a site expansion completed earlier this month.

The firm has opened a small scale cGMP manufacturing facility at its site in The Woodlands, near Houston, adding fermentation capacities from 10L to 40L and full scale purification of clinical-grade plasmid DNA.

“The motivation behind this expansion was the increasing clinical success of DNA Vaccines and gene therapies, which have led to an increasing demand for VGXI’s highly specialized plasmid production services and extensive experience in this area,” Franco told us.

“The expansion includes an additional, small scale GMP production plant to augment our current large scale facility. The second plant provides greater manufacturing capacity as well as flexibility for multiple client campaigns to run in parallel. It will be critical in allowing VGXI to continue to support clinical programs such as the one for the Zika vaccine.”

University of Minnesota Health, Clinics and Surgery Center, Minneapolis, Minn.

Budget: $165 Million

Size: 342,000 sq. ft.

Project team: CannonDesign (Architect), Studio Five Architects (Partner Architect) Affiliated Engineers (Engineering) and McGough Construction (CM)

Description: The University of Minnesota Health (M Health), Clinics and Surgery Center is a destination ambulatory care center designed to elevate an inter-professional care delivery model while providing an entirely new type of patient experience that introduces improved care delivery models, patient flows and turnaround of outpatient procedures.

The five-story, 342,000 sq. ft. outpatient center in Minneapolis, MN is uniquely designed with innovative ideas pulled from other consumer industries including retail and air travel to orchestrate a patient experience that promotes personalization, convenience and the elimination of touchpoints. The facility is also powerfully efficient—allowing M Health to accommodate twice as many patients as it could with its previous facility, with far fewer exam rooms.

Key examples of the Clinics and Surgery Center’s cross-market influences include:

Inspired by Retail Design and specifically Apple Stores, the Clinics and Surgery Center features no formal check-in or check-out areas. Instead, patients are greeted by a staff member with a mobile device capable of checking them in, filling out health forms, finding their exam room and scheduling future visits.

Modeled after the check-in procedures for airlines, M Health’s new facility offers patients’ technologically-advanced check-in solutions they can use from home to eliminate the need for a formal check-in process.

M Health also leveraged contemporary workplace strategies in the redesign. In lieu of space allocated to private offices that tend to be empty up to 90 percent of the time, the new facility features touchdown spaces and enclosed offices—all of which can be reserved for pieces of time, but are not designated for one individual. This allowed underutilized space to be reallocated toward collaborative and social staff areas which take advantage of abundant daylight and views of the campus.

Embedded within the Clinics and Surgery Center’s creative design are also highly flexible and adaptable clinical modules designed to accommodate changes in program development, best practices and innovations over the decades ahead. These modules further promote M Health’s inter-professional care model, which brings medical, research and education professionals together for collaboration and teaching.

Completion Date: Feb. 2016

GE Healthcare Opens Life Sciences North American Headquarters

GE Healthcare’s Life Sciences business, a global provider of technologies and expertise to the biopharmaceutical and life sciences industries, opened its new 210,000 square-foot North American headquarters in Marlborough, Massachusetts. At full capacity in 2017, it will employ more than 500 scientists and professionals in the Boston area focused on accelerating precision medicine across a portfolio including:

Manufacturing technologies for cell and immune therapies that are showing the potential to cure some of the world’s toughest diseases, such as cancer
Early stage research tools used to develop the next generation of precision medicines
Technologies and consumables for manufacturing vaccines, insulin and the rapidly growing new class of drugs known as biologics
Leading-edge contrast agents and nuclear medicine tracers that clinicians use to diagnose disease

The new facility at 100 Results Way will be home to 40,000 square feet of laboratories supporting cell and immune therapy research and development, early stage drug development, biomanufacturing, as well as scientific and medical affairs support.

The laboratories will house GE’s ninth global Fast Trak facility, which partners with and trains biotech innovators to discover new drugs, develop manufacturing workflows, and optimize their biomanufacturing processes. In 2017, the site will also include GE’s FlexFactory manufacturing platform, originally designed in Marlborough, MA, and which pioneered end-to-end, flexible, small batch biologic drug manufacturing.

"General Electric's ongoing investment in Massachusetts is just the latest proof that the Commonwealth is a global leader in life science innovation, from discovery to manufacturing and commercialization," said Governor Charlie Baker. "With a deep bench of talent and supportive economic environment, we are excited to have GE Healthcare be a part of Central Massachusetts' growing workforce and look forward to the advances that will benefit the health and wellbeing of our citizens."

GE Healthcare’s nearby Westborough, MA, facility will continue to produce single-use products and consumables for biopharmaceutical manufacturing and with GE’s corporate headquarters moving to Boston this summer, by the end of 2016, GE will have nearly 5,000 employees across Massachusetts.

“Two years ago, we began to move our east coast North American operations to the Boston area to better coordinate our focus on patients, clinicians and customers’ needs,” said Kieran Murphy, president and CEO of GE Healthcare’s Life Sciences business. “Having our North American headquarters in the heart of Massachusetts’ rich ecosystem of healthcare, pharma, and biotech brings us closer to key customers, outstanding talent and ground-breaking innovation and is already helping fuel further growth for our business.”

Alcami Enhances Laboratory Services at Wilmington, NC Headquarters

Alcami has announced an upgrade to its laboratory service capabilities at the company’s Wilmington, NC-based headquarters.

Approximately 5,000 square feet of the current Technology Center will be converted to newly reconstructed laboratory space for dissolution testing (Apparatus I, II, III, IV and intrinsic dissolution), Karl Fischer testing (humidity controlled room), microbiology, and formulations development.

According to the Alcami (the newly rebranded company combining AAI Pharma Services and Cambridge Major Labs), the new space adds 15% additional capacity for dissolution in addition to a new UV sampling automation capability.

The announcement is the latest in a series of equipment and personnel investments – since January 2015, Alcami has grown its development teams by 10% and has invested $1.6m in equipment.

New construction, which was announced in November 2015, will bring additional laboratory capacity. One of the additional five lab spaces has been completed with the remaining labs expected to be finished by the end of the year.

Additionally, as Outsourcing-Pharma.com reported in March, Alcami previously announced an $11m investment in its Cortex innovation center in St. Louis, Missouri.

Kite Opens Commercial CAR T-cell Plant

Kite Pharma has opened a T-cell manufacturing facility in California it says can overcome the logistical problems of autologous therapies and treat up to 5,000 patients per year.

The 43,500 sq. ft. plant in El Segundo, California officially opened its doors last week, ahead of the US approval and launch of Kite Pharma’s lead candidate, KTE-C19, anticipated by the firm next year.

The product is intended to treat chemorefractory diffuse large B-cell lymphoma (DLBCL) and is an autologous chimeric antigen receptor (CAR) T-cell therapy, meaning it is made using a patient’s own modified cells, as Kite’s EVP of technical operations Timothy Moore explained.

“[Our] therapies involve a process of extracting cells from a cancer patient and air shipping them to our El Segundo facility,” he told Biopharma-Reporter.com. “In a six to eight day process utilizing Kite’s proprietary genetic engineering technology, the cells are re-engineered to seek and selectively destroy cancer cells while leaving normal cells unharmed.”

The modified cells are then frozen and shipped back to the patient, Moore continued, where they are re-infused into the patient. “The entire vein-to-vein process takes about 14 days, one of the fastest in the industry.”

Time is critical for patients who receive CAR T therapies, and this was a factor in the location of the new facility.

“Our facility’s location, next to Los Angeles International Airport, one of the largest and busiest airports in North America, is ideal for expediting the shipment of CAR T therapies.”

As for the manufacturing process, Moore said the El Segundo site will have the capacity to produce up to 4,000-5,000 patient therapies per year using semi-automated equipment source from multiple suppliers.

“The facility is equipped with technology that separates, washes, expands and genetically modifies cells to meet the necessary potency and dose for patients.”

The site will also produce clinical trial material for Kite’s other CAR and T-cell receptor (TCR) candidates, complementing Kite’s existing clinical manufacturing facilities in Santa Monica. However, as the site is focused on commercial quantities, we asked how Moore how confident the firm was KTE-C19 would be approved next year.

“As reported, early results achieved with this therapy have been very encouraging. Approximately half of the treated patients achieve a complete response. Of all patients treated, the overall response rate is 70 to 80 percent. So we remain on track for FDA review in 2017.”

Brown University to Build Computational Biology Center

With the support of a five-year, $11.5 million grant from the National Institutes of Health, Brown University is establishing a new Center of Biomedical Research Excellence (COBRE) to advance computational biology research.

The Center for the Computational Biology of Human Disease will be designed to foster collaboration between empirical and computational biologists in analyzing large genomic data sets in order to accelerate translational medicine.

"Brown scientists and students from a number of departments around the university — from computer science and applied mathematics to biology, medicine, and public health — have been working collaboratively to understand and realize the benefits of advanced genomics," David Savitz, vice president for research at Brown, said in a statement. "This new COBRE will expand those programs to help move Brown to the forefront of this exciting, promising field of research."

The center will initially fund the work of five teams of early-career researchers working under established faculty mentors, and will include a biomedical big data core of scientists developing analysis tools to support the teams' projects.

These projects will focus on ethnic and gender genomic disparities in leukemia; tolerance of viral/bacterial co-infections in the lung; the gut microbiome in irritable bowel disease; drug targets for healthspan extension; and genomic variation in preeclampsia.

"There's data and then there's information," David Rand, director of the new center, noted. "Turning data into information you can use for something is what computational biology is all about."

PYRAMID Laboratories Expands Capabilities

PYRAMID Laboratories, Inc. a clinical and commercial contract aseptic drug product developer and manufacturer is proud to announce it is celebrating 28 years of providing cGMP services to the Pharmaceutical and Biotech industries during July 2016.

PYRAMID's President & CEO, Medhat Gorgy states "I am very proud of the high quality services we have provided the past 28 years and wish to thank our employees and Clients for making it possible. PYRAMID has grown tremendously since our modest beginnings in 1988 to having over 70,000 square feet of GMP facilities with state of the art equipment today."

PYRAMID announces that on Monday, May 16, 2016 through Wednesday, June 1, 2016, the FDA conducted a Pre-Approval and cGMP Inspection at PYRAMID's facilities. PYRAMID Laboratories, Inc. is pleased to announce that the FDA did not issue a Form 483.

PYRAMID was found to be in compliance with cGMP's and has a documentation program that allowed the investigators to easily track, review and assess all aspects of our quality systems. The inspection evaluated various regulatory submissions, operational processes and procedures regarding the utilities, manufacturing process, media fills, batch records, equipment validation, training records, material handling, data review, reporting and records management systems. The investigator also confirmed the compliances of our responses to observations from the previous inspection. All of PYRAMID's systems were found to be compliant and satisfactory with all cGMP requirements

PYRAMID also announces that it has expanded its portfolio of services with the addition of a new state-of-the-art Warehouse, Storage and Distribution Facility. The new facility includes cGMP labeling, approximately 27,600 cubic feet of monitored and alarmed validated controlled temperature storage, and distribution service capabilities for parenteral drug products.

PYRAMID's Warehouse, Storage and Distribution Center is located adjacent to PYRAMID's clinical and commercial manufacturing sites that include aseptic fill/finish for vials and syringes in addition to lyophilization services. PYRAMID also provides full service formulation and process development as well as analytical support for all phases of drug development and manufacturing.

Hovione Breaks Ground for its New Jersey Facility Expansion

Hovione recently held the official groundbreaking for the expansion of its New Jersey Facility in East Windsor, NJ.

The expansion will add an additional 30,600 ft² (2,843 m²) to the existing 24,000ft² (2,211m²) facility. It will introduce a new commercial spray dryer unit to complement the existing pilot unit and this installation will be specifically designed to handle potent drug substances (APIs). In addition the Hovione New Jersey facility will more than double its capacity to manufacture drug substance. The expansion is expected to add approximately 60 new jobs to the current workforce over the next three years.

“The start of the construction activities to expand our site in East Windsor is a very exciting moment for us and for our customers. This is an important step to strengthen our continued commitment to the pharmaceutical industry and to the patients by offering innovative technologies and services. The site will be unique in offering at a single location drug substance, spray drying, hot melt extrusion and drug product manufacturing services using innovative continuous manufacturing technology. The state and especially the local government have been extremely supportive and we are happy to strengthen our presence in East Windsor by creating highly qualified jobs in the local community” said Dr. Marco Gil, General Manager, Hovione New Jersey.

“This investment is part of the company’s strategy to increase its global development and commercial capacity which will meet the increasing demands of Hovione’s customers in the API and Spray drying services. It will also include the addition of a continuous drug product manufacturing capability to its offering through the partnership with Vertex Pharmaceuticals announced earlier this year” said Kristine Senft, Vice President Marketing and Sales.

The start-up of the operation is expected to take place in April 2017 for the drug substance and spray drying services while the continuous drug product manufacturing is planned for the end of 2017.

Pfizer Breaks Ground on New Biologics Clinical Manufacturing Facility

Pfizer broke ground on its new Andover, MA-based biologics clinical manufacturing facility this week, which will feature single-use and disposable technologies.

The company will invest more than $200m in development of the 175,000 sq. ft. facility, which is expected to be operational by January 2019.

According to Pfizer, the new clinical manufacturing facility was designed with five independent manufacturing suites.

The facility will feature single-use bioreactors and disposable process technologies and will be fully enabled to support next generation manufacturing.

The Andover campus currently includes seven buildings housing laboratories, clinical and commercial manufacturing suites, and other support areas.

The campus also features a multiproduct manufacturing facility.

As part of the new investment, Pfizer will hire approximately 75 new employees to support clinical manufacturing.

Novasep Opens Kilo Lab Extension

Novasep, a supplier of services and technologies for the life sciences industry, has finalized the set-up of its new synthesis laboratory and kilo lab at its US facility. Production of kilogram scale batches of synthetic molecules for biological testing and preclinical trials has begun according to schedule.

“Drug developers in the US are responding positively to our extended CMO services that support their early stage programs," said Andrew Brennan, general manager at Novasep’s US operations. “The opening day was held together with our customers and Novasep’s scientific board member Prof Alois Fürstner, who made an inspiring presentation on catalysis. This was a great way to kick-off the opening of our new lab.”

“This extension is part of our 'Back to Basics' strategic plan,” said Thierry Van Nieuwenhove, Synthesis BU president. “The proximity to our US experts will help to secure and speed up our customers’ projects. And beyond the technical expertise of our team, the trusted partnerships that Novasep is building with US companies will promote future development and commercial supply agreements to keep up with the fast growing US pharmaceutical market.”

The US facility in Boothwyn, PA, is equipped with jacketed reactors ranging from 100mL to 50L in size and with a 35L filter dryer for isolation of kilogram quantities of compound. The laboratory extension features all the necessary equipment for standard and cryogenic chemistry. In terms of purification services, it provides North American customers with the complete portfolio of Novasep preparative chromatography technologies, such as HPLC (Hipersep®) and SFC (Supersep®). In addition, it has all the required analytical tools for process research and development (HPLC, HPLC/MS, GC, GC Headspace, UPLC, UPLC/MS, etc.), including a calorimetric reactor for preliminary process safety testing.

FUJIFILM Opens New Laboratory in North Carolina

FUJIFILM Diosynth Biotechnologies completed construction on a new three-story, 62,000-square-foot facility in Research Triangle Park, NC. A ribbon cutting ceremony was held on May 9, 2016, the company said in a press announcement. The new building, called BioProcess Innovation Center, houses the company’s Process and Analytical Research and Development, Process Sciences, and Stability groups. These groups will concentrate on process invention, design and development, and process and product characterization. The new facility is located at 6051 George Watts Hill Drive. FUJIFILM Diosynth Biotechnologies also has facilities in Billingham UK, and College Station Texas.

Coastal Life Technologies Breaks Ground on New Headquarters

Coastal Life Technologies (CLT), a contract manufacturing outsource provider focused on delivering turn-key services for medical devices, is building a new 135,000 square foot headquarters in San Antonio, Texas. The company is breaking ground on the facility in January, and expects it to be completed within a year.

The new building nearly doubles the company’s footprint compared to its current facility, with an expansion of 70,000 square feet. This includes 16,000 square feet of office space and a 22,500 square foot manufacturing area with a 12,000 square foot ISO Class 8 clean room as well as space for soft goods production, electronic assembly, testing and staging. The new building will also include warehousing and distribution facilities.

“With our significant growth in recent years, we simply need more space to meet demand. This new building will enable us to streamline our services, from process engineering all the way to end user distribution, with maximum efficiency and room to grow,” said Coastal Life Technologies Chief Operating Officer David Huff.

Centrally located in San Antonio, Texas, CLT is a single-source solution for medical device manufacturers who want to increase productivity and decrease time to market in a cost-effective and quality-controlled environment. CLT specializes in the assembly, packaging and sterilization of single-use surgical devices, and offers streamlined solutions including process engineering, warehousing, order fulfillment, distribution and shipping. CLT is ISO 13485:2003 certified with ISO Class 8 cleanrooms.

REST OF WORLD

Xellia Working on Testing Lab in Hungary

Xellia Pharmaceuticals has started building a stability and release-testing unit at its API facility in Budapest, Hungary that is designed to support increased output.

The 34,432 sq. ft. (3,200 square meter) laboratory will house microbiological and chemical analysis capabilities and is intended to provide testing capabilities for active pharmaceutical ingredients (API) and finished formulations made at a neighboring facility.

Xellia said it will spend $10m on the new lab and said it would hire an additional 80 staff by the time the facility is fully operational next year.

CEO, Carl-Åke Carlsson, citied growing global demand for generic antibiotics as the main driver for the expansion.

“With anti-microbial resistance posing a very real international threat, our work in the production of generic anti-infectives is especially important. As a world-leading supplier we are committed to providing the highest level of quality and compliance in the manufacture of our APIs and FDFs.”

“The Centralized Laboratory Services building will ensure that, as our global production volumes continue to increase in response to customer demand, we have the expertise and the capacity to continue to deliver effective and quality assured anti-infective products.”

The Budapest facility produces five APIs, including vancomycin hydrochloride. The site employs 190 people.

The investment is the first Xellia has made since it bought a manufacturing site in the US that was previously owned by now defunct contract manufacturing organization (CMO) Ben Venue Laboratories.

Japanese Firms form Monoclonal Antibody Manufacturing JV

Mitsubishi Gas Chemical and Nippon Kayaku have said they will start making monoclonal antibody drugs at a site in Niigata, Japan within two years.

The firms formed Cultivecs - a biopharmaceutical joint venture - this month, explaining that the plan is to develop therapeutic antibody products and biosimilars and provide contract manufacturing services for such products.

Manufacturing operations will be based at Mitsubishi’s facility in Niigata using technology and knowhow gained from the firm’s 2014 collaboration with GlycoNex.

Nippon Kayaku entered the biologics space in 2010 when it teamed up with Korean firm Celltrion to develop an infliximab biosimilar. The product was approved in Japan in 2014.

A year later Nippon and Celltrion started development of a trastuzumab biosimilar.

Mitsubishi Gas Chemical and Nippon Kayaku – which share ownership of Cultivecs 55%/45% - cited Japan’s dependence on imported monoclonal antibodies as the main motivation for establishing local production capacity.

“The growth of biologics, particularly monoclonal antibodies, is very prominent in domestic and global pharmaceutical markets.

“Japan is highly dependent on import of biologics, which is estimated to exceed $5bn every year” they continued, adding that “Made-in-Japan biologics of high quality with stable supply security system are highly required.”

Cultivecs will also develop and manufacture biosimilars according to Mitsubishi Gas Chemical and Nippon Kayaku.

Juniper invests in Tablet Technology

Juniper Pharma Services has invested in a tablet press that can produce 42,000 pills an hour citing customers’ clinical trial supply needs as the driver.

Juniper completed the validation of the RoTab press at its facility in Nottingham, UK.

It said the technology is designed to manufacture drug batches in the 50g to 50kg range in a variety of single and bi-layer formats.

A company spokesman said, “The extended capability gives us the scale to meet clients’ demands in later phase clinical trials as opposed to commercial scale.”

The largest clinical trial in history – which began in the UK last year – is examining the effects of a single daily dose of aspirin on the long term health of 11,000 people who have been diagnosed with early stage cancer.

In theory, based on our calculations, Juniper’s new tablet press could make the 48,180,000 tablets needed for the full 12-yearlong study in around 143 days, assuming it was operated for eight hours a day.

The investment is one of a number Juniper has made in recent months.

Last November it bought a Xelodose powder micro-dosing system for the production of Phase I trial materials.

More recently Juniper acquired spray drying technology capable of producing 20kg batches and a Becomix homogenizer it will use to make topical and semi-solid production for Phase III trials.

Valeant Plans Canadian Manufacturing Investment

Valeant will transfer production tech and modernize a controlled-release finished formulation facility as part of a $27.5m (€24m) investment in its Canadian manufacturing network.

The investment will see the transfer of products between Valeant Pharmaceuticals International’s drugmaking facilities in Steinbach, Manitoba and Laval, Quebec and concentrate on upgrading the sites to ensure regulatory compliance.

“The investments will focus on modernizing the plants through upgrading of manufacturing technology to ensure the robust security of products through international distribution channels,” said a spokesperson from the firm.

The Steinbach site will benefit from $7m in upgrades to product manufacturing technology and $8m for the transfer of North American production of Valeant’s semisynthetic antibiotic Xifaxan (rifaximin) and anti-inflammatory drug Apriso (mesalamine).

“Steinbach focuses on the manufacturing of controlled-release products and it is engaged in the formulation, clinical testing, registration, manufacturing, sale and promotion of pharmaceutical products utilizing advanced drug-delivery technologies,” and currently produces and packages around 1.2 billion tablets.

“The investments will also focus on ensuring compliance with US regulatory requirements and maintaining the Steinbach plant's North American manufacturing mandates.”

At Laval, $10m will be used to upgrade product manufacturing technology, while a further $2.5m will be used to transfer production of the firm’s gum disease treatment Arestin (minocycline hydrochloride).

“The investment for Arestin supports enabling a precise production method, including the construction of specialized rooms fitted with electrical power conditioning and reinforced concrete to ensure a vibration-free zone,” the company said.

Historically, Valeant has been vocal in its use of contract manufacturing organizations (CMOs) but when asked why the firm was opting to invest in its own sites, the company said it is committed “to grow its operational presence and export capacity there and a desire to leverage the strong talent and innovation at these sites.”

Since 2012, Valeant has transferred 27 manufacturing technologies to Steinbach and numerous to Laval, including the production of antifungal medicine Jublia (efinaconazole) transferred earlier this year.

“It has been Valeant’s stated business strategy to grow its Canadian capacity and increase its export sales.”

Canada opens Innovative Lab for T Cell Therapy

Built with philanthropic funds, the Conconi Family Immunotherapy Lab forms the hub of custom immunotherapy treatment production for cancer patients across British Columbia.

With CA$5.5 million raised through the BC Cancer Foundation to launch immunotherapy clinical trials, the lab is a critical component, providing a facility to create promising new treatments. Scientists will now begin testing the facility and T cell therapy production to ready for clinical trials.

The new lab bears the Conconi name, honoring a $2 million gift the family made to the BC Cancer Foundation, which inspired more than 5,900 donors across the province to open their hearts and give.

The lab’s initial focus will be on Adoptive T Cell Therapy. This is a specific form of immunotherapy that amplifies the power of T cells—immune cells responsible for destroying viruses and tumors—extracted from an individual cancer patient. In a highly selective process, scientists identify the T cells already attempting to destroy the cancer and multiply them by the thousands in the lab. The end product is a supercharged batch of a patient’s own T cells that can be delivered through an IV infusion.

Porton Updating Facilities

Porton Biopharma has begun construction on a new bioprocess development and manufacturing facility in the UK equipped with fermentation and down-stream processing suites.

The Wiltshire, UK-based biomanufacturer has begun working on the 57,000 sq. ft. (530m2) building to replace older facilities and expects construction to be finished by November, with the equipment installed and the labs operational early next year.

Dr. Phil Luton, commercial and marketing manager at Porton, said more about the site:

What is this new suite of developmental labs set to be used for?

It will be primarily used to support our two existing products, Erwinase - used to treat Acute Lymphoblastic Leukaemia - and the UK’s anthrax vaccine, but will also be used for contract development of projects that we have in our pipeline or with our customers. Obviously the latter are under confidentiality so I can’t go into detail!

What about improving biomanufacturing processes?

The new facility will undertake work such as developing and accessing new and improved methods, and or processes that can be fed into the existing processes to improve yields, or replace older technology with more modern one.

A key part of that is to provide the data/evidence that we need to assure ourselves and the regulators, so that we can then apply for license variations for products.

The site will feature a fermentation suite with a range of bench-scale reactors and a down-stream processing suite for activities such as filtration and chromatography, but what sort of technologies are you equipping these with?

With regards to single use technology or stainless steel, we do have both but are using more single use disposable technology. For example the new suite will still have a range of fermenters so that we can look to optimize growth and expression parameters, but we are also using technologies like wave bags for growing certain organisms, and then a lot more plastic consumables for the downstream processing aspects.

What benefits do the disposable elements bring?

Some of the advantages of disposable technologies are that they are essentially ‘plug and play.’ You don’t need sanitization and sterilization runs between experiments, and a lot of the manufacturers now provide fully validated systems, so it is easier to model and then scale processes from the development labs to the production facilities.

How will the new plant fit in with your existing network?

The facility will support our existing network by allowing us to continue to provide our expertise and knowledge to our partners/customers who want assistance to enable them to get their products to market.

We feel that not only do we have the scientific credibility of having developed many products over many years for various customers, but also that by having our own licensed products at market that we can also provide our knowledge of engineering, quality and regulatory aspects to our partners.

And finally, as a UK-based company, I have to ask, will these plans be affected by Britain’s decision to leave the European Union (EU)?

I think it is too early to speculate on the effects of Brexit.

Pfizer and GE Team on Modular Biosimilars Plant in China

Pfizer has struck a strategic partnership with GE Healthcare to construct and equip a biomanufacturing center focused on producing biosimilars for China.

The $350m (€315m) investment is the latest spend by Pfizer in its biologics network, and comes just days after the firm broke ground on a $200m clinical biomanufacturing facility in Andover, Massachusetts.

The new facility in Hangzhou Economic Development Area (HEDA), China will make biosimilar products for the local market once production begins in 2018, said Pfizer spokesperson Loucineh Mardirossian.

“Not only will this Biotechnology Centre ensure the local production of high-quality, affordable biosimilar medicines that will benefit patients in China and across the world,” she said, but “it will also help contribute to the continued development of the biotechnology industry in China and support nation healthcare reforms.”

Production capacity is set to be 25 million vials per year, in the first phase, she added.

The site itself will use multiple 2,000L single-use bioreactors with associated downstream systems implemented through a strategic partnership with life sciences technology firm GE Healthcare, which is managing the facility set-up from conception to completion on behalf of Pfizer.

“GE Healthcare is providing a complete turnkey approach to Pfizer, including proof of concept, transportation and construction of the KUBio [GE’s modular facility platform], manufacturing process optimization, validation of the facility and training of Pfizer’s manufacturing professionals in China,” said GE’s Saara Nordenström.

She added the approach was similar to GE’s partnership with JHL, which saw the opening of the world’s largest modular cGMP biomanufacturing facility in Wuhan last month.

GE boasts its KuBio modular platform can significantly reduce a facility’s build time of 18 months, compared to the approximate three years for a traditional plant. “This rapid deployment translates to reduced risk and faster time to market,” Nordenström said.

But, she continued, the platform is customable, and thus Pfizer’s KUBio design differs from JHL’s and includes the additional feature of a fill/finish unit for packaging of the final product, constructed in the same off-the-shelf modular approach as the main KUBio.

Like the Andover investment, this latest news shows further support from Pfizer for single-use technologies within its own biologics network.

Mardirossian said the facility will be equipped with disposable technologies, and while it is not 100% single-use, "this Global Biotechnology Center in Hangzhou represents the most significant investment in single use technology within Pfizer to date."

She continued: "Pfizer is currently investing in GE technologies for the manufacture of biopharmaceuticals for our innovative development lab in Andover, Massachusetts. Combined with Hangzhou, and another new investment in GE technologies that we are making at our Global biotechnology site in Grange Castle, Ireland, Pfizer will have a fully integrated and standardized biotechnology development and manufacturing capability in one platform."

Pfizer Plans First-ever Asian Biotech Hub

Despite the problems in China, Pfizer ($PFE) is betting big on its first biotech space in the region, stumping up £$350 million for a new biotech center that it hopes will help tap into the $185 billion China healthcare market and the promise of greater market penetration in Asia.

The U.S. Big Pharma’s new China and Asia biotech base--its first in the region--will focus on biosimilar drugs as well as bio-manufacturing, dovetailing with Pfizer's Hospira biosims unit.

Housed in the Hangzhou Economic Development Area, the center is set to be completed by 2018 and will be Pfizer’s third biotech center globally and the first on the Asian continent.

The building of the Pfizer Global Biotechnology Center (GBC) also represents further investment in R&D and clinical research across China, according to a statement from the company.

This GBC will include an advanced modular facility by GE Healthcare ($GE), based on single-use bio-manufacturing tech.

“We believe that the Pfizer Global Biotechnology Center in Hangzhou will help support China’s aim to increase the complexity and value of its manufacturing sector by 2025, and contribute to building a truly innovative and vibrant biopharmaceutical industry,” said John Young, group president, Pfizer essential health.

“We are encouraged by a series of important reforms introduced by Chinese government that will further stimulate the industry to meet emerging health challenges, such as the rising incidence of non-communicable diseases and an aging population; as well as attract both domestic and foreign investment in healthcare and R&D.”

China is in a strange place, at once punishing Big Pharma firms for high drug prices but equally attempting to speed up its drug regulatory process, which has been so slow that many of the newest drugs--especially in hep C--have failed to reach the country for years.

The country wants to nurture homegrown drugmakers and biotechs, but will also need to help established foreign companies set up shop in the region to gain access to the latest innovations. The country is undergoing reform to help speed up access to these meds.

At the same time, however, China just last month launched an investigation into all aspects of drug and medical device sales and prices among domestic and foreign firms in a step that could lead to enforcement action.

Unfazed, Pfizer said that its center aims to “support China’s healthcare reforms, assist the Chinese government in its continuing efforts to update the local industry in this sector, and provide world-class biological medicines for patients in China and the world.”

This comes after Novartis ($NVS) announced the opening of a $1 billion research center in China, with a focus on lung, liver and gastric cancers.

Nod for a High-Biotechnology Park I Vietnam

The Dong Nai high-biotechnology park in Cam My District will carry out research, incubation, application and transfer of biotechnology. It will also develop human resources, support hi-tech startups, manufacture and sell hi-tech products, and provide hi-biotech services.

The government of Dong Nai is told to collaborate with the Ministry of Science and Technology to prepare operation regulations for the park for submission to the Government for approval, and introduce policies to attract investors.

Dong Nai is in charge of assessing and approving the master zoning plan for the high-biotechnology park, supervising construction work and managing the project when it is put into use. The province is also responsible for establishing a management board and appointing a board leader for the hi-biotech park.

In June last year, the Prime Minister approved a master zoning plan for hi-tech parks in the country by 2020 with a vision to 2030. Accordingly, provinces and cities will develop a number of hi-tech parks using their budgets and other resources.

The plan aims at attracting investments in hi-tech projects and bolstering the sector’s development.

Dong Nai’s hi-biotechnology park is among the hi-tech projects approved by the Government. A hi-biotechnology park in Hanoi and the Ascendas-Protrade hi-tech park in the southern province of Binh Duong Province have got approval.

Celltrion to Expand Biosimilar Capacity

Celltrion will invest $275m at its biosimilar production site in Korea to ramp up capacity from 140,000L to 310,000L by 2021.

The Korean drugmaker currently has two mammalian cell culture facilities at its site in Incheon, South Korea, boasting total capacity of 140,000L. In a decision passed through the company’s board this week an extra 170,000L will be added over the next few years.

Plant 1, consisting of four 12,500L production lines, has a capacity of 50,000L, and is set to double in size by 2018, with commercial production expected by the following year 2019. Meanwhile a third plant - which had initially been planned to add 90,000L of capacity - will now be built to house 120,000L, with commercial production expected by 2021.

The 325bn won ($275m) investment will support Celltrion’s marketed biosimilars and future mAb pipeline, spokesperson InSun Joo related.

Remsima and Inflectra are both manufactured by Celltrion and have already been launched in a number of regions including Western Europe, with markets already seeing a major market impact on its reference product, Janssen’s Remicade (infliximab).

And last month the mAb was granted approval in the US.

Celltrion’s sole customer is Celltrion Healthcare – a “related party” which sells the products to global distribution partners, including Celltrion’s own sales and distribution subsidiary Celltrion Pharm and – in the US - Pfizer.

Therefore while the extra capacity will support increased demand for Inflectra/Remsima globally, “Pfizer is in charge of marketing and distribution of Inflectra in the US, and the sales schedule is in discussion,” said Joo.

However, he confirmed once constructed Celltrion’s “plants will have sufficient production capacity to cover the whole infliximab market,” and “protocols have been set up to ensure minimal risk in the stockpiling of infliximab.”

But, Joo added, the firm is also “building new facilities due to production preparation of subsequent products, Truxima & Herzuma.”

Herzuma – a version of Roche’s Herceptin (trastuzumab) - has been approved in Korea, while Truxima is a copycat of Biogen/Roche’s Mabthera (rituximab) currently awaiting approval.

The news comes six months after fellow South Korean biosimilars maker Samsung Biologics announced plans to build a third facility at its site in Songdo, effectively doubling mammalian cell culture capacity to 360,000L by 2018.

When it comes online, it will be the largest biologics site in the world, surpassing such mega-sites as Genentech’s Vacaville, California site (set to have a capacity of 240,000L) and Celltrion’s the planned 310,000L.

PerkinElmer Expands in Taiwan

PerkinElmer has officially opened its Taipei Customer Knowledge Center (CKC) in Neihu District, Taipei City.

The Taipei CKC is a relocation and expansion of PerkinElmer’s presence in the country, where it has been for more than 25 years.

It contains detection and analytical instruments for providing instrument demonstrations, sample analysis, application testing, method development, education and training in food safety, environmental testing, and industrial applications.

In 1991, PerkinElmer established a service location in Taiwan. Its head office is located in Taipei, with an office in Kaohsiung, and employees in north, central and south Taiwan.

Nam-Hoon Kim, VP and general manager of global sales and service, said it was looking forward to sharing products, services and expertise in the region.

“Opening this new Taipei CKC in an area where many of Taiwan’s technology industry is situated is a strategic investment that enables us to further connect with our customers and partners.”

PerkinElmer’s customers in Taiwan include academic institutions, government agencies, foundations and large corporations.

The firm reported revenue of $2.3bn in 2015 and has about 8,000 employees serving customers in more than 150 countries.

Updates at BMI Mount Alvernia Hospital in Guildford, Surrey

Medical Air Technology (MAT) has recently completed work at BMI Mount Alvernia Hospital in Guildford, Surrey, UK, installing an energy efficient ultraclean ventilation (UCV) canopy from its healthcare award-nominated ECO-flow range.

The hospital wanted to increase the number of orthopedic operations it was able to offer, so decided to upgrade an existing theatre to include a UCV canopy. MAT already has a relationship with BMI Healthcare, having worked at its hospitals in the past, so both MAT and BMI Mount Alvernia Hospital knew they would be partnering with market-leading organizations and could anticipate a highly successful outcome.

The hospital wanted the new theatre to be completed during the relatively quiet Easter period. As the work would include not only installation of a UCV canopy, but also considerable preparatory work to prepare the space, and full refurbishment including a new ceiling and complete redecoration, carefully scheduling to ensure minimum disruption to staff and patients was essential.

The only access to the new theatre was through the clean corridor – the hospital anticipated this could be an issue, as noise and dust are an inevitable byproduct of major building works. However, thanks to close liaison between the teams from MAT and the hospital, and a high level of professionalism and commitment to client needs throughout, the anticipated issue failed to cause problems, and the project was handed over on time and within budget.

'From a hospital perspective, MAT were an absolute pleasure to work with and we hardly knew they were in the building. It is fair to say that when you are faced with the prospect of losing one of your main theatres for a few weeks but still have to continue operating in the other two, it causes a fair amount of stress. However, we should not have worried - MAT were a delight to work with from their meticulous planning right through to the actual work and final completion. The team at BMI Mount Alvernia cannot praise them enough,' said Nick Fox, Executive Director, BMI Mount Alvernia Hospital.

The new UCV canopy at the heart of BMI Mount Alvernia Hospital’s new theatre, the ECO-flow 2800, is designed to significantly reduce energy usage and cost, without any reduction in the level of efficacy. Energy efficiency is achieved through innovative internal design and the introduction of infinitely variable-speed DC motors, while highly efficient centrifugal fans reduce the energy drain required for cooling.

LED cruciform lighting has also been added to the ECO-flow canopies, which use up to 60% less power than other similar canopies, even in full ultraclean mode.

MAT developed the ECO-flow range to support hospitals as they work to improve efficiency and reduce their carbon footprint, and continues to invest in new technology and the development of skills and expertise to ensure this initiative develops even further.

Biocon Expands Indian Biomanufacturing Site

Indian drugmaker Biocon has been given the go-ahead to expand a biopharmaceutical manufacturing facility in Bangalore.

The biopharma firm was given clearance by Bangalore’s high-level committee on industrial investments to begin construction on a new facility at its site in Bangalore, India.

According to spokesperson Rumman Ahmed, an investment of 10.6bn rupees ($158m) has been planned across the site, which includes the construction of a solid oral dosage manufacturing unit for small molecule generics that has already begun.

But the company is also looking at expanding its biologics capabilities at the site, Ahmed told Biopharma-Reporter.com, in order to support its growing monoclonal antibody portfolio.

Biocon has already launched two proprietary monoclonal antibodies, Alzumab (itolizumab) for psoriasis and Biomab (Nimotuzumab) for glioma, while its biosimilar version of Roche’s mAb Herceptin (trastuzumab), Canmab - co-developed with Mylan – was approved in India in December 2013.

The Bangalore site already has 200,000 sq. ft. of biologics capacity used to manufacture Alzumab and Canmab, and also houses a training academy the firm has set up in order to address the shortage of biotech workers in the country.

Despite the approval from local government, further details were not divulged but according to Ahmed the investment was first proposed in January.

Biocon has been investing across its network over the past few years, buying a Vizag, Andhra Pradesh potent API facility from its supplier Acacia Lifesciences in October last year, several months after laying down plans to build a commercial API and intermediates site in Mangalore, on the West Coast of India.

In 2010, the firm invested $161m to set up an insulin manufacturing plant in Malaysia.

CMC Biologics Expands GMP Manufacturing Capacity in Denmark

CMC Biologics as upped its production capacity at its Copenhagen facility with plans to have equivalent capacity on both sides of the Atlantic in 2017.

The company announced today that it has completed the first stage of the expansion for its Copenhagen, Denmark- based manufacturing facility with the addition of a single-use Bioreactor 3PACK facility, currently ready for production runs.

The 3PACK contains three 2,000L single-use production bioreactors and associated seed train for scale up. According to the company, the facility allows for flexible production with scales from 2,000L to 6,000L in a single production suite. Additionally, the bioreactors can be run singly, simultaneously, sequentially, or in staggered mode.

"With this additional cGMP production capacity, we are continuing our long-term strategy to provide innovative solutions to our customers, from early-stage development to large-scale commercial production," said Patricio Massera, General Manager at the Copenhagen Site.

The company plans to add three additional 2,000L single-use production bioreactors in 2017 to establish a Bioreactor 6PACK line identical to the services in its US and European manufacturing facilities.

"Establishing this unique facility design in both our US and European manufacturing facilities enables us to significantly optimize process transfer and synergies between the sites," said Gustavo Mahler, PhD, President and CEO of CMC Biologics. "We are changing the way CMOs operate and we continue to generate innovative solutions for our clients."

The company received regulatory approval for the upgrades in October 2013. The facility is approved for GMP production by the EMA and is also fully US Food and Drug Administration (FDA) compliant.

Novartis $1 Billion Research Center Opens

Novartis AG employees in Shanghai have a new $1 billion home.

The seven-building campus on the outskirts of Shanghai is accented by bamboo staircases and tree-lined courtyards. The company said the 1,300-person facility will be its third major research center, after Basel, Switzerland, and Cambridge, Massachusetts.

Foreign drugmakers are investing in China because of surging demand for medicines as the incidence of chronic conditions like cancer, heart disease and diabetes rise. The government has provided incentives to encourage more investment in innovation, while Chinese consumers are spending more on health care as their incomes rise.

“The commitment that Novartis is making in China is bigger than anybody else in the industry,” Chief Executive Officer Joe Jimenez said in an interview. “We expect Shanghai to ramp up relatively quickly” in terms of drug discovery.

The Novartis research center will further focus on diseases more prevalent in China, such as lung, liver and gastric cancer. Having new medicines in those areas in coming years will help the Basel-based company to secure a toehold in the world’s second-largest pharmaceutical market after the U.S.

Speaking more broadly about Novartis’s growth, Jimenez sees potential in acquisitions around the globe -- anywhere between $1 billion to $5 billion -- for its four business units: pharmaceuticals, oncology, eye care and generics. Such opportunities may arise amid the flurry of deal activity in the industry, as companies are forced to sell off assets to appease antitrust regulators, he said.

“If there were biosimilars, we could potentially acquire those to complement the pipeline in Sandoz,” Jimenez added, saying that while he hasn’t seen biosimilar assets in China to acquire there “definitely are in other parts of Asia.”

Novartis would consider bigger deals in situations where the rationale was “immediately evident to our shareholders,” he said.

Jimenez said the biggest advantage of the new Shanghai campus -- which was announced in 2009 and includes a fitness center and on-site restaurants -- will be for recruiting. He declined to comment on how many employees the company would add in the world’s most populous country, saying it was correlated to the growth of its China business, which was increasing “nicely.”

Using the heart failure drug Entresto as an example, Jimenez commented on the squeezing of drug prices in the U.S. and China, saying that “as long as you’re innovative and not making me-too drugs, you’re going to be fine because those drugs will always be reimbursed.” That forms the central strategy of Novartis in China, he added, since it would be making innovative drugs that specifically address Chinese patients.

In March, Novartis said it agreed to pay $25 million to settle a U.S. Securities and Exchange Commission case that claimed it paid bribes to health professionals in China to increase sales from 2009 to 2013.

Novartis’s SEC settlement came at a time when China’s own crackdown on corruption has ensnared the health-care industry, with GlaxoSmithKline Plc’s sales in the country falling 17 percent last year after a government probe crippled its growth since 2013. A state-led campaign to slash drug prices has triggered a further slowdown in China sales growth for global drugmakers.

Jimenez said the company had reduced the amount of pay that is variable and increased the amount of fixed pay, which “better balances the incentives for the field sales representatives.” It has done this in a number of countries but China in particular, he added.

“We’re here for the long term,” Jimenez said. “We’re committed because we’re doing great science here in Shanghai, no matter what buildings we’re in.”

Novartis' Shanghai R&D facility, a $1 billion research center that has been in the works since 2009, officially opened its doors this week. Novartis also has two other R&D centers, which are located in Cambridge, Mass., and Basel, Switzerland.

Ten years ago, many companies were drawn to China on account of lower salaries among their scientists. Today, however, companies are tasked with a challenge in the Chinese pharmaceutical market: government pressure on drug prices.

According to an article in the Asset magazine, "In China, prescriptions drugs drive around 40% of total healthcare spending compared to 15% in the U.S., so the government has preferred generics to cut costs."

Keep in mind that this is in addition to scandals, such as GSK's bribery case, and regulatory hurdles, like slow registration processes for new drugs.

Despite these apparent challenges, Novartis CEO, Joe Jimenez, "is keen to look past recent troubles for the industry in the region, saying that there has 'been an explosion of talent in China,'” according to a report in Fierce Biotech. This declaration comes soon after monumental changes within the company, as Novartis recently split its drug division in two: Novartis Oncology and Novartis Pharmaceuticals.

“The Chinese historically have not been proven innovators in certain areas [drug discovery],” Jimenez told Fortune. “If you look at what’s happening now, it’s changing. I think partly because of the flood of new technologies that are emerging, and companies like Novartis that are training Chinese scientists in the way that we discover drugs."

According to an interview Jimenez had with Fortune, the company is currently spending about $200 billion each year on research and development, which is second only to the U.S.

"Single-digit growth is going to be the new normal in China," Jimenez said. "We had consistently seen 11% or 12% growth five or six years ago. The economic slowdown has led to a slowing because a lot of pharmaceuticals in China are still paid out-of-pocket. But we’re saying look, when you compare to U.S.’s 1% to 2% growth or Europe’s 1%, it’s pretty good."

Synexus Opens Dedicated Clinical Research Site in Frankfurt, Germany

Synexus, a Site Management Organization (SMO), dedicated to the recruitment of patients’ and hands-on conduct of clinical trials on behalf of pharmaceutical, biotech and CRO clients, has opened a new Dedicated Clinical Research Site in Frankfurt. The state-of-the-art expansion into new facilities in Frankfurt supports the global Synexus mission to be the patient’s choice for clinical research and to offer customers efficiency in the clinical trial process by recruiting more engaged patients from more capable sites.

At the formal opening of the new Synexus Frankfurt Clinical Research Site, Dr Christophe Berthoux, CEO of Synexus, was joined by Christoph Dietrich, the Managing Director of Synexus Germany and by Nicole Freibott, Head of the Synexus Frankfurt Clinical Research Site. Representatives of pharma, CRO, partner GPs and specialists were present to celebrate this important occasion and to reiterate the company’s long term plans to build service capability in this country where pharmaceutical and biotech companies are continuing to conduct a large number of clinical trials.

The opening, attended by clients, network doctors and business partners, was performed by Christophe Berthoux, CEO of Synexus, who commented “Germany is one of our leading locations for running clinical trials with its excellent medical expertise, a history of running high quality clinical trials and good access to patients. Europe continues to be a favored region for our clients in the running of their global clinical trials and we are planning to further develop our business in Germany.”

Synexus German Managing Director Christoph Dietrich commented: “This is a further step in our plan to update and expand our very successful network of clinics across Germany by providing modern clinics which benefit both our patients and our clients. Our success in bringing clinical trials to Germany is dependent on our ability to deliver engaged patients and high quality data. We have put in place a proven patient engagement program which improves the patient experience and it is these added-value extras which really pay dividends in terms of client success.”

The new clinic, which will be managed by Nicole Freibott, is placed ideally for easy patient access as it is located in the inner city, close to the popular shopping street Zeil with immediate access to public transport and parking facilities.

PBL’s Pharmaceutical Fermentation Facility, United Kingdom

Porton Biopharma Limited (PBL) started construction of a new pharmaceutical fermentation facility at the Porton Down Science Park located near Salisbury, Wiltshire, UK, in May 2016. The facility is expected to be ready for operation by 2018.

It will be PBL's second major investment after opening of a multimillion pound new freeze drying facility in November 2015. The new facility will help PBL to develop and produce a range of life-saving products.

The new fermentation facility will spread over 225,960 sq. ft. (21,000m²) area and will be used for manufacturing medical products in a modern environment, which will be constructed fully in compliance with the latest pharmaceutical regulations. It will be equipped with a fermenter, process train and associated utilities to develop a range of life-saving products.

The new facility will include a viewing gallery that will allow visitors to see the high-tech process without having to go through the gowning-up process that is obligatory for entering clean room pharmaceutical manufacturing facilities.

PBL is currently continuing to manufacture in its existing plant, but addition of the new plant will bring the new capacity on stream to meet the increasing global demand for its product.

The groundbreaking ceremony for the construction of the pharmaceutical fermentation facility was held in May 2016, which was attended by John Glen, MP of Salisbury.

The new facility's construction will be followed by demolition of older facilities and construction of a new workshop and a water plant room to support the facility. The equipment installation and pharmaceutical validation will be implemented at the newly constructed facility in a phased program.

The new facility will be equipped with technical capabilities to translate research methodologies into production processes. It will include capabilities from 2L benchtop fermenters to 100L production vessels, cell processing, prokaryotic and yeast fermentation. It will also include a range of production platforms, including Wave™, roller bottles and multi-layer disposable vessels.

"It will be PBL's second major investment after opening of a multimillion pound new freeze drying facility in November 2015."

The plant will also include product purification technology with sophisticated analytical methods including LC-mass spectrometry, HPLC, UPLC, electrophoresis, ELISA and dynamic light scattering. It will use in process and final product analysis including forced degradation studies and stress testing.

PBL is the sole manufacturer of the UK-licensed anthrax vaccine, which is manufactured for, and on behalf of, the UK Government and supplied for occupational health purposes and to protect service personnel from the use of anthrax as a biological weapon.

PBL is working together with US Company NanoBio to develop next-generation anthrax vaccine at the new facility in Wiltshire.

PBL also produces Erwinase®, which is used for the treatment of acute lymphioblastic leukemia (ALL) in children. The drug was approved by the US FDA in November 2011. It is also registered in 20 countries and commercialized in more than 75 countries world-wide. Erwinase is distributed and commercialized by Jazz Pharmaceuticals worldwide.

Based at Porton Down in Wiltshire, UK, PBL was established in April 2015 to commercialize the pharmaceutical development and manufacturing capabilities that were previously within Public Health England.

The company offers expertise in development and production of biologicals, including product characterization, process and analytical validation and scalability for market. It also develops new vaccines, therapeutic proteins and enzyme products and also undertakes contract manufacturing at all stages of the product development/commercialization lifecycle.

Fermion API Manufacturing Facility Expansion, Hanko, Finland

Global pharmaceutical substance manufacturer Fermion is expanding its active pharmaceutical ingredients (API) manufacturing plant in Finland to further develop its manufacturing and commercial production capabilities.

The construction on the facility is expected to begin in 2016 and is scheduled for completion in 2018. The expansion will replace the oldest factory production and is expected to take Fermion to a new level in global API and highly potent API (HPAPI) manufacturing to meet the increasing demand.

"The $34m investment in the Hanko facility is the biggest investment made by the company since 1970."

The $34m investment in the Hanko facility is the biggest investment made by the company since 1970 and also adds up a new achievement in the history of the Finnish pharmaceutical industry.

The company aims to build a new facility, which can comply with all the regulatory requirements and support both its current and new business.

The expansion includes the construction of a new state-of-the-art facility that will add 64,583 sq. ft. (6,000m²) of manufacturing space for increasing the production capacity by 50% of the current 300t.

The new facility will not only produce standard but also potent APIs ensuring high quality and delivery reliability of the products. It is expected to produce 100t of HPAPI a year, which will increase the total production of the Hanko facility to more than 400t of API a year.

The investment will ensure that Fermion will be able to supply pharmaceutical ingredients for Orion's current proprietary drugs and also its pipeline products.

The new API manufacturing facility will contain 76m³ of reactor space installed with highly automated systems, controlled material flow, isolators and smart infrastructure.

A reactor space of approximately 25m³ will be dedicated to OEB5 compounds requiring a contaminant level of 0.1µg/m³, while the remaining space will be equipped for the compounds requiring a contaminant level of 1-10µg/m³.

The fully equipped existing facility consists of three production units with total reactor capacities of 240m³, reactors ranging from 1,000l to 6,300l in capacity, fully automated active pharmaceutical ingredients production, a separate micronization area, dedicated areas for the large-scale manufacture of class IV narcotics and immuno-suppressants and buss loop reactor of 500l for hydrogenations up to 80bar. It also contains on-site incinerators of volatile organix compound (VOC) gases and a biological waste water treatment facility.

The facility is complaint with environment, health and safety (EHS) regulations, with features such as solvent recycling capacity of approximately 8,000t, and frequent monitoring of emissions and effluents in co-operation with local and national authorities.

Fermion is a wholly owned subsidiary of Orion Corporation, providing APIs for generic, specialty and branded pharmaceutical companies. It also offers fully integrated contract development and manufacturing services from phase one stage to commercial-scale production.

It is a leading global pharmaceutical substance manufacturer, with headquarters, R&D facility and two manufacturing sites located in Finland.

The company is known for its dynamic capabilities to prioritize and satisfy customer needs and adherence to the current industry regulations to provide a competitive service.

Famar to Buy Spain Formulation Plant from Roche

Famar will buy a Roche solid dose manufacturing facility in Spain in an agreement that will also see it make drugs for the Swiss pharmaceutical giant.

The facility in in Leganés, Spain produces solid dose pharmaceutical products and has capacity to handle high potency active pharmaceutical ingredients (APIs). It is licensed to various markets including the US, which Famar cited as the major motivation for the deal.

Swiss drug manufacturer Roche announced its intention to sell the Leganés facility, along with API plants in Clarecastle, Ireland and Florence, South Carolina, US, and a formulation site in Segrate, Italy, in November last year.

At the time spokeswoman Claudia Schmitt told us “The four sites support our mature portfolio of small molecules,” adding that “this commercial portfolio is at the end of its lifecycle, resulting in a declining demand overall.”

She predicted the divestitures would cost Roche CHF 1.6bn ($1.6bn) and said that products made at the four sites will be transferred to third-party manufacturers.

This was confirmed by Famar, which said it has signed a “long term manufacturing agreement that will allow Famar Leganés to supply Roche in the future from this facility with the current portfolio of products produced at the site.”

A Roche spokeswoman told us "The Leganés site is modern and advanced in terms of infrastructure, process equipment and is approved for worldwide supply.

"It provides Famar with capacities and expertise in solid high potent production, which represents new technology for the company and completes its technology portfolio in solids dosage formulations" she continued, adding that the facility "is just a few kilometers from an existing Famar site in the Madrid area."

The transaction is expected to complete on July 1.

The acquisition comes a few months after Famar said it will buy manufacturing facility in Quebec, Canada from German conglomerate Bayer.

The Pointe-Claire facility is approved by the US FDA to make liquids, creams, ointments and solids. As with the Roche deal, Bayer has also contracted Famar to make products on its behalf.

The Swiss drug manufacturer's efforts to sell its other plants have been less successful.

The spokeswoman told us "Despite discussions with a global pharma service company on the potential sale of the sites in Clarecastle, Florence, and Segrate, negotiations ended without an agreement.

She added that: "Roche will continue divestment discussions for Segrate while operations in Florence and Clarecastle will be ceased in a phased approach."

SGS Introduces New Comprehensive Testing at Expanded Shanghai Facility

SGS has introduced comprehensive drug compatibility study testing at its Shanghai laboratory in China. This new service, for the analysis of potential extractable and leachable contamination within pharmaceutical products, harmonizes services offered in this field across SGS’s global network of laboratories.

China’s Center for Drug Evaluation (CDE) made drug compatibility studies mandatory for all New Drug Applications (NDAs) and Abbreviated New Drug Applications (ANDAs) in 2014. SGS’s investment in these services comes after a multi-stage expansion of its laboratory in Shanghai, which was completed in 2015. It includes the installation and validation of new quadrupole time-of-flight (Q-TOF), liquid chromatography-diode array-mass spectrometry (LC-DAD-MS) and gas chromatography–mass spectrometry (GC-MS) instruments.

“We have seen an increased demand for these services since the regulations have been tightened, and we have been working with regulatory bodies and industry associations to help define and establish definitive testing guidelines in this area going forward,” commented Andy Yi, General Manager, SGS Life Sciences, Shanghai. “With this investment, SGS has been able to build on its strong reputation to attract new customers, as well as increase business with pharmaceutical R&D teams looking to engage with experts earlier in the process to ensure compliance.”

SGS has been providing extractable and leachable testing services from its Shanghai facility to local clients, and international clients with a presence in China since the facility opened in 2006. Expansion of the facility commenced in 2014 and initially included increased capabilities in cGMP chemistry and biotechnology testing laboratories. The microbiology laboratory was expanded subsequently, increasing the total floor space to 34,432 sq. ft. (3,200 square meters).

Valeant Plans Canadian Manufacturing Investment

Valeant will transfer production tech and modernize a controlled-release finished formulation facility as part of a $27.5m (€24m) investment in its Canadian manufacturing network.

“The investments will also focus on ensuring compliance with US regulatory requirements and maintaining the Steinbach plant's North American manufacturing mandates.”

“It has been Valeant’s stated business strategy to grow its Canadian capacity and increase its export sales.”

Merck & Co. and Fujifilm Share Capabilities at New Microbial Plant

A new $60m facility at a MSD site in Ireland will offer Fujifilm Diosynth customers 20,000L of microbial biologics capacity in a collaboration between the two firms.

MSD – known as Merck & Co. in North America – is investing $60m (€53m) at its site in Brinny, County Cork to build a large-scale microbial-based biologics facility.

The plant will manufacture biologic APIs to service clients of Fujifilm Diosynth Biotechnologies as part of a long-term collaboration between the two firms.

“MSD will be operating the facility [while] Fujifilm Diosynth will manage the commercial and programme management aspects,” said spokesperson Liza Rivera at this year’s BIO convention in San Francisco.

“Fujifilm brings its experience in process development and scale-up experience, MSD brings the large scale track record.”

Such a partnership between a Big Biopharma firm and a contract development and manufacturing organization (CDMO) is not common in the industry, Rivera continued, but harks back to Fujifilm's acquisition of certain MSD biomanufacturing assets back in 2011 .

But such a “new direction” between the two firms can maximize capabilities between the two sectors, Rivera said.

“Fujifilm Diosynth is always open to new and innovative ways to expand its offerings to the market place so we will of course keep our options open.”

The new facility – set to be operational in early 2018 - will house a 20,000L fermenter with high intensity fermentation and utilize stainless steel/single-use hybrid in the downstream.

The joint venture complements Fujifilm’s biologics network, which includes sites in in Billingham, UK and Research Triangle Park, North Carolina. The firm offers microbial fermentation bioreactors of between 100L and 5,000L and on the mammalian cell culture side, the firm has recently installed 2,000L single-use bioreactors at both sites.

MSD, meanwhile, has continued to invest in its Irish large molecule network, with this latest spend coming a year after the firm pledged €11.5m at its Keytruda (anti-PD1 mAb) facility in Carlow, and months after announcing it was adding an extra 200 production jobs in the country.

Carbogen Amcis to Buy GEA Plant for API Production

Carbogen Amcis plans to buy a GEA Pharma Systems facility in Bubendorf, Switzerland to support its API and ADC businesses.

The facility – ownership of which will transfer to Carbogen in January – will make active pharmaceutical ingredients (APIs) under good manufacturing practices (GMP) compliant condition according to the Swiss firm, which expects production to begin in 2017.

The GEA plant is 300 meters from an existing production facility at which Carbogen provides process optimization services and makes drug actives for late-phase clinical trials, commercial supply.

Spokeswoman Lucie Framinet said the acquisition was prompted by increasing demand from customers.

“This acquisition has been mainly made to support our business growth and company expansion as well as to face significant and continuous increase in customers’ demand for additional capacity.

The GEA facility will also “support our ADC capacity from early phase up to commercial scale” according to Framinet

Carbogen has made a number of investments in its antibody drug conjugate (ADC) production offering in the past few years.

In 2013 it partnered with St Asaph, Wales based specialist ADC Biotechnology and set up dedicated clean room capacity at the Bubendorf site and another facility in Riom, France.

More recently Carbogen signed a long-term lease agreement with chemicals and biotechnology firm Bachem to take over a high-containment unit it owns in Vionnaz, Switzerland.

Although the project conducted with ADC Biotechnology is now completed the "Vionnaz is growing and is currently undergoing several expansion projects" Framinet said.

Cristália to Make Burns Treatment at New Plant

Brazil’s ANVISA has cleared Cristália Laboratory to make an API for an over-the-counter (OTC) burns treatment at a recently established $40m biomanufacturing facility in Itapira, Sao Paulo.

The treatment – called Kollagenase – is a mixture of collagenase enzymes encoded by two genes - colG and colH – found in a strain of bacteria Clostridium histolyticum that Cristália scientists isolated from soil samples taken from a farm in Espirito Santo do Pinhal.

Collagen is widely used in Brazilian hospitals to remove dead tissue - a process known as enzymatic debridement – in patients who have suffered burns or other traumatic wounds. At present the country is supplied by laboratories overseas.

Cristália’s cGMP BSL3 facility in Itapira is the first in Brazil approved to manufacture collagenase according to company biotechnology director, Marcos Alegria, who told us all aspects of production and processing will be carried out on site.

“Cristália’s Clostridium histolyticum strain is cultured in stainless 1,500L steel bioreactor where collagenase is secreted into the supernatant. All culture media used in the process are free of animal components.

“The supernatant is filtered, purified and concentrated using tangential flow filtration (TFF) systems. Collagenase concentrated solution is stabilized and lyophilized, milled and packed to obtain the API bulk, preserving high enzymatic activity and purity.”

Cristália claims it supplies 60% of the collagen used in Brazil, which it imports from foreign production sites. According to Alegria, ANVISA approval to produce it in Itapira will further strengthen the firm’s position in the market.

Alegria said: “The company is expanding the boundaries of this special product to other territories such as US, Europe, LATAM and Asia” adding that “we are designing new trials aiming the approval of FDA and EMA.”

“The goal is to design targeted regulatory and marketing strategies in each territory in order to take an important share of these markets” he continued, adding that “new formulations, associations and dosage forms are also under development.”

Thermo Fisher Scientific Partners with Chinese Hospital to Develop Personalized Medicine Platform

Thermo Fisher Scientific announced today that it is partnering with West China Hospital of Sichuan University to jointly develop a platform to research precision medicine.

Under the terms of the agreement, the partners will build centers to train people as pathologic diagnosticians and to implement standardized pathology quality control. They will also develop advanced laboratories. West China Hospital said in a statement that it is aiming to become a national center for biomedical research.

Financial terms of the deal were not disclosed.

The deal is the latest personalized medicine-related partnership for Thermo Fisher. Earlier this month, the firm announced it would provide sequencing technology for tumor sequencing firm Strata Oncology. And over the last year, Thermo Fisher has signed companion diagnostic partnerships with Novartis and Pfizer, as well as a technology partnership with Pfizer for that firm's Chilean Center of Excellence in Precision in Medicine.

Orgenesis forms Israeli Cell Therapy JV

Orgenesis and Atvio have formed a cell therapy contract manufacturing joint venture and are looking to procure a GMP facility in Israel.

Orgenesis is a Maryland-based biotech which is using its Autologous Insulin Producing (AIP) cell transplantation technology to develop a cell therapy for diabetes.

According to an SEC filing, the firm has entered into a 50-50 joint venture with newly formed Israeli company Atvio Biotech in order to form a contract development and manufacturing organization (CDMO) for cell and virus therapy products in the field of regenerative medicine within Israel.

While Orgenesis did not respond to Biopharma-Reporter.com for more information, the filing says the firm has paid Atvio has been charged with setting up and maintaining a GMP facility in Israel, and has received $1m from Orgenesis to cover the costs.

“[Orgenesis] will share with Atvio the Company’s know-how in the field of cell therapy manufacturing, which know-how will not include the intellectual property included in the license from the Tel Hashomer Hospital in Israel to Orgenesis Ltd., the Company’s subsidiary,” the filing added.

The company’s initial product takes a liver biopsy from the patient, sends it to a central laboratory where the manufacturing platform is used to produce a sufficient amount of AIP cells which are then transplanted back into a patient’s liver.

In March 2015, the firm acquired contract manufacturer Masthercell SA to help progress the treatment into the clinic, adding a GMP production facility in Gosselies, Belgium.

If proven clinically successful, the firm claims the regeneration of functional insulin-producing cells could transform the diabetes treatment space.

Eurofins Lancaster Labs Announces Major Expansion Plans

Eurofins Lancaster Laboratories, part of Eurofins Scientific has announced strategic plans for the expansion of its Dungarvan, Ireland campus, including development of a new building as well as expansion of its current facility. Further, as a major employer in the South East of Ireland, Eurofins Lancaster Laboratories is set to increase its workforce to over 500 staff by 2021 with this investment by its parent company, Eurofins Scientific. Over 175 new jobs have been created in the past 24 months.

The launch of this major building expansion programme combines the expansion of the existing 29,000 sq. ft. (2,700m2) laboratory with an additional 47,344 sq. ft. (4,400m2) extension, as well as the development of a 19368 sq. ft. (1,800m2) second site on the campus located in the IDA Business Park, Dungarvan. This means that the project will bring the Group’s capacity to almost 96,840 sq. ft. (9,000m2) of state-of–the-art laboratory surface to serve the biopharmaceutical industry in Ireland and the UK. The project is in the planning submission phase and building works are planned to commence in Q4 2016. The project is another example of the commitment of Eurofins Scientific to continued growth and investment in its laboratory operations in the region.

“This expansion is the result of successfully growing strategic partnerships with our clients and the value we bring to them and their target markets. And it reinforces Eurofins’ absolute commitment to aggressively funding growth to enhance the way we serve our customers as well as build the best and widest-reaching testing network in the biopharmaceutical market,” said Timothy S. Oostdyk, Ph.D., Chairman, Eurofins Lancaster Laboratories, and Group Senior Vice President, Eurofins BioPharma Product Testing.

Carmel Fitzpatrick, Managing Director, Eurofins Lancaster Laboratories in Ireland, said, “We currently serve 18 of the top 20 global pharmaceutical companies and our success is attributable mostly to the excellent commitment and technical capability of our people. Our broad base of clients means we work on a diverse range of products and development projects which offers an excellent scope for continuous learning and development of technical depth that is unparalleled. We invest heavily in our internal training programs, and we are grateful to be supported by the IDA and the Skillnets to deliver technical competency in our team that is world class. We also pride ourselves on a service offering that meets the complex and varying needs of our clients, many of whom avail of all our service tiers, whether in-house or at the client facility. Our in-house testing services are complemented by our innovative and award-winning Professional Scientific Services (PSS) programme that places full-time analysts, technicians, scientists and technical support personnel managed by us directly at the client facility to provide long term staffing needs while maintaining the same services, expertise and cGMP compliance available at our facility in Dungarvan. We have PSS teams based at a variety of client locations in Ireland and UK.”

Welcoming the announcement Minister for Jobs, Enterprise and Innovation, Mary Mitchell O'Connor said: "It’s great to see an established successful company like Eurofins expanding its operations further in Waterford with the addition of over 160 staff over the next five years. That’s on top of the 175 jobs created in the past two years. A key priority for me as Minister is encouraging more companies to set up in our regions. Companies setting up and creating jobs in our regions ensures that there are opportunities for positive knock-on effects in the surrounding areas. Only a strong economy supporting people at work can pay for the services needed to create a fair society. Already a major employer in this key regional location, this further expansion and substantial number of new jobs will benefit the entire South East Region. It demonstrates great commitment by Eurofins’ parent company, Eurofins Scientific. I congratulate the company and their workforce and wish them continued success.”

CEO of IDA Ireland, Martin Shanahan said “This investment demonstrates Eurofins Lancaster Laboratories’ commitment to Dungarvan, and the large cluster of biopharma companies based in Ireland. Achieving increased levels of investment in regional locations is an important focus of IDA’s strategy ‘Winning – FDI 2015-2019’ and today’s announcement is an important step in that direction. I wish Eurofins every success as they continue to grow their operations in the South East Region.”

Biopharma CRO round-up: Eurofins, Charles River and More

An expansion in Ireland for Eurofins, new cell screening tech for Cyprotex, and an mRNA development deal for Charles River. Welcome to Biopharma-Reporter’s bio-service round-up.

Among the findings from the Jefferies 2016 Global Healthcare Conference last week, the growth in biologic approval numbers and unabated biotech funding have continued to drive investments and agreements among service firms. So here are a selection from the past week:

Eurofins

Eurofins Lancaster Laboratories has announced plans to add 4,400m2 of lab space to its bioanalytical facility in Dungarvan, Ireland, and has committed to a 1,800m2 second site nearby.

The firm – a subsidiary of Eurofins Scientific – is investing on the back of growth among its strategic biopharma partners, adding capacity for method development, microbiology, process validation and quality control.

Company chairman Timothy Oostdyk said the expansions “reinforces Eurofins' absolute commitment to aggressively funding growth to enhance the way we serve our customers as well as build the best and widest-reaching testing network in the biopharmaceutical market.”

The news was welcomed by Ireland’s Industrial Development Authority (IDA) which said the growth in support services would help cater for “the large cluster of biopharma companies based in Ireland.”

In recent months the country has seen biomanufacturing facility investments from the likes of Merck & Co., Merck KGaA, Shire and Biomarin.

Cyprotex

Next up is preclinical contract research organization (CRO) Cyprotex which has bought an IntelliCyt iQue screener in order to expand its cell-based services.

The tech uses flow cytometry to analyze fluorescently labelled cells in a fluid as they flow past a detector and can help discover immune-oncology antibodies by assessing multiple cellular parameters faster using lower amounts of reagents, or so the sales blurb at IntelliCyt goes.

But according to Cyprotex’s CEO Anthony Baxter, the purchase will help his CRO expand into the field of biologics which is seen as “a critical step in the continued growth of Cyprotex. Flow cytometry not only allows us to address this market but enables us to target immune-based phenotypic screening and safety assessment of small molecules.”

Charles River

To another preclinical CRO now and Charles River Laboratories (CRL) has inked a strategic deal with Moderna Therapeutics for nonclinical discovery and development efforts across the biotech’s messenger RNA (mRNA) pipeline.

The Massachusetts-based biotech firm has ten protein and antibody programs in development based on its proprietary modified mRNA technology and, according to Moderna’s CEO Stéphane Bancel, the CRL deal will help “enable the scale, efficiency and speed” of these.

“In particular, this collaboration will allow us to accelerate GLP toxicology study timelines, which will be instrumental as we continue to progress our development candidates into the clinic,” he continued. “Charles River’s expertise across discovery and nonclinical development activities, combined with their familiarity with our novel platform, make them an excellent partner for Moderna.”

Famar to Buy Spain Formulation Plant from Roche

Famar will buy a Roche solid dose manufacturing facility in Spain in an agreement that will also see it make drugs for the Swiss pharmaceutical giant.

She predicted the divestitures would cost Roche CHF 1.6bn ($1.6bn) and said that products made at the four sites will be transferred to third-party manufacturers.

A Roche spokeswoman said "The Leganés site is modern and advanced in terms of infrastructure, process equipment and is approved for worldwide supply.

The transaction is expected to complete on July 1.

The acquisition comes a few months after Famar said it will buy manufacturing facility in Quebec, Canada from German conglomerate Bayer.

The Pointe-Claire facility is approved by the US FDA to make liquids, creams, ointments and solids. As with the Roche deal, Bayer has also contracted Famar to make products on its behalf.

Roche plans

The Swiss drug manufacturer's efforts to sell its other plants have been less successful.

The spokeswoman said "Despite discussions with a global pharma service company on the potential sale of the sites in Clarecastle, Florence, and Segrate, negotiations ended without an agreement.

She added that: "Roche will continue divestment discussions for Segrate while operations in Florence and Clarecastle will be ceased in a phased approach."

CMC Biologics to Manufacture Behring’s Afstyla

CMC Biologics has entered an agreement to supply bulk drug intermediate for CSL Behring's recently FDA-approved product, AFSTYLA [Antihemophilic Factor (Recombinant), Single Chain], its long-lasting recombinant factor VIII single-chain therapy for adults and children with hemophilia A.

CMC Biologics' facility in Copenhagen, Denmark was inspected by the FDA as part of the approval for the commercial manufacture of AFSTYLA.

"Working together with CSL Behring to achieve this important commercial milestone has been a major focus for our entire team in Copenhagen," said Patricio Massera, Ph.D., site head and general manager of CMC Biologics' Copenhagen facility. "We are proud to have played an important role on the clinical development and manufacturing of the recombinant factor VIII single-chain of AFSTYLA."

Fujifilm, Merck Partner on $60M Microbial Biologics Facility

Fujifilm Diosynth Biotechnologies, a global biologics contract development and manufacturing organization (CDMO), said that it is in the process of establishing a long-term collaboration with Merck to invest in and operate a new 20,000 liter large-scale microbial-biologics facility for supply of active pharmaceutical ingredient (API) to its customers.

This collaboration involves a $60 million investment by Merck at its Brinny manufacturing plant in Innishannon, County Cork, Ireland. Merck in Brinny has been in operation for more than 30 years and is an integrated site for the development, testing and manufacturing of biologics.

It is intended that the large-scale biologics operations at Merck in Brinny will be operational in early 2018 for biotech and pharma customers of Fujifilm Diosynth. The deal addresses a market need for large-scale microbial biologics manufacturing and complements Fujifilm Diosynth’s existing microbial capacity that ranges from 100L up to 5000L both in the U.S. and UK.

According to the company, microbial fermentation remains vital technology for the process of manufacturing biologics, and this investment, drawing on the latest production advances, will enable Fujifilm Diosynth’s existing and future customers to have a clear and secure line-of-sight to higher product volumes along with lower cost-of-goods. The latter is particularly important as products enter late clinical phase and commercialization.

Sun Pharma Divests Two U.S. Manufacturing Sites to New CDMO

Frontida BioPharm, an affiliate of contract research organization (CRO) Frontage Laboratories, has acquired Sun Pharma’s oral solid dosage manufacturing facilities in Philadelphia, PA, and Aurora, IL, and 15 related pharmaceutical products.

Frontida has been founded to provide contract manufacturing and co-development services for Frontage’s large base of pharmaceutical industry clients and partners, and will utilize the facilities as its primary base of operations.

In connection with the transaction, Frontida has agreed to continue manufacturing certain products of Sun Pharma at these facilities on a contract basis and offer employment to all production, quality and administrative personnel at the sites. Additionally, Frontida will develop and manufacture the acquired products for distribution by commercial partners.

Frontida is offering co-development and commercialization services to pharmaceutical partners in collaboration with Frontage Laboratories’ research facilities in Exton, PA, and its affiliate’s research and development centers in Suzhou and Shanghai, China.

"We are pleased to complete this transaction with Sun and partner with them in manufacturing some of their key products,” said Song Li, chief executive officer of Frontida BioPharm and Frontage Laboratories. “The sites have experienced staff and state-of-the-art facilities and equipment that will serve as a foundation to Frontida’s launch of contract development and manufacturing (CDMO) services. Frontida’s CDMO services will complement the high quality development services offered by Frontage Laboratories and provide our long-term clients a trusted partner for product manufacturing and commercial support.”

Baylor, Chinese University of Hong Kong to Form Asian Center for Genetics Research

Baylor College of Medicine announced that it has signed a memorandum of understanding with the Chinese University of Hong Kong to create a center to advance genetics research and training in Asia.

The planned Chinese University of Hong Kong-Baylor College of Medicine Joint Center for Medical Genetics in Hong Kong aims to design, establish, and conduct training in clinical genetics and genetic counseling tailored to the Hong Kong, mainland China, and Asia region.

It will also establish a referral center in Asia for the prenatal and postnatal diagnosis and treatment of genetic disorders; conduct interdisciplinary basic and translational research in genetic disorder screening, diagnosis, and treatment; uncover the underlying mechanisms of genetic diseases; and host a series of pan-Asian symposia on clinical genetics care and research.

"This partnership will bring Baylor genetics activities onto the international stage, and together with the Chinese University of Hong Kong, we hope to be the leaders in genetics care, education, and research in Asia," Brendan Lee, chair of the department of molecular and human genetics at Baylor, said in a statement.

"Through the integration of clinical expertise and advances in genetic and genomic technology, the goal of the center is to bring breakthroughs in medical genetics, of which the scope is not confined to prenatal diagnosis but also extends to personalized medicine," Tak Yeung Leung, head of maternal and fetal medicine at the Chinese University of Hong Kong, added.

Lee and Leung will act as co-directors of the new center.

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