Feliza Mirasol is the science editor for 

Feliza Mirasol

The Public Investment Fund (PIF), Saudi Arabia’s global investment organization, announced on June 18, 2023 that it has launched Lifera, a commercial-scale contract development and manufacturing organization (CDMO). The CDMO will enable growth of the local bio/pharmaceutical industry, strengthen national resilience, and support Saudi Arabia’s position as a global pharmaceutical manufacturing destination.

Lifera will focus on the manufacture of essential biopharmaceutical products, including insulins, vaccines, plasma therapeutics, monoclonal antibodies, cell and gene therapies, and innovative small molecules. The company will also create partnerships with leading local and international companies as well as attract targeted investments in a bid to grow local capacity and strengthen domestic manufacturing in this sector.

A part of Lifera’s goals is to drive formulation development, medicine development, and manufacturing. The company also intends to increase testing services for sterile bio/pharmaceutical products.

“PIF is investing to enable a leading health sector in Saudi Arabia, supporting the development of and access to advanced medicines and treatments. Biologics represents one of the most critical and fastest-growing pharmaceutical segments, both in Saudi Arabia and globally,” said Yazeed A. Al-Humied, deputy governor and head of Middle East and North Africa (MENA) Investments at PIF, in a company press release. “Lifera intends to partner with leading companies in the sector to localize manufacturing, attract investment, and enable the private sector to scale up, ensuring easier access for patients, whilst securing supply of life-saving medicines that can meet local, regional, and global demand.”

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PIF has established Lifera, a new manufacturing entity that will manufacture, stockpile, and supply bio/pharmaceuticals both locally and through partnerships.

Saudi Arabia’ PIF Launches Lifera, a New CDMO

Choose New Jersey, a nonprofit economic development organization for the state of New Jersey, announced on June 15, 2023 that Enzene Biosciences, a Pune, India-based biotech company will invest $50 million to open a new biopharmaceutical manufacturing plant on the Princeton West Innovation Campus in Hopewell, NJ. The facility is expected to start up in June 2024 and is the company’s first location outside of India, according to a press release issued by the nonprofit.

Enzene is a contract development and manufacturing organization and a subsidiary of Alkem Laboratories, an Indian pharmaceutical company. As part its expansion plans, Enzene will initially hire 50 employees and grow to 300 employees at the New Jersey facility.

The placement of the facility is intended to provide North American biopharmaceutical companies with streamlined supply chains, quick turnaround times, enhanced communication, and greater control over the manufacturing process, according to the press release. Enzene expects to support the development and production of a diverse range of biologics at the facility.

“The strong relationship between New Jersey and India has gained increasing momentum since we opened the New Jersey India Center to cultivate economic opportunities during our trip to the country in 2019,” said NJ Governor Phil Murphy, in the press release. “I am proud to welcome Enzene Biosciences and their expanding global presence to New Jersey’s flourishing life sciences industry. New Jersey’s favorable business environment, skilled workforce, strategic location, supportive ecosystem for growth, and deep cultural ties are why Indian companies thrive in our state.”

“Enzene Biosciences is thrilled to establish our manufacturing operations in New Jersey, as it allows us to extend our local manufacturing capabilities to our valued North American clients,” said Himanshu Gadgil, CEO of Enzene Biosciences, in the release. “We are excited to provide them with access to our cutting-edge continuous manufacturing platform, which enables streamlined and efficient production processes. New Jersey’s highly skilled workforce, state-of-the-art infrastructure, and renowned academic institutions make it an ideal location for Enzene, ensuring that we can deliver exceptional services and support to our clients in the [United States].”

India’s Enzene Biosciences is investing $50 Million into a new biopharma manufacturing plant in Hopewell, NJ.

Enzene Biosciences Invests $50 Million into New Jersey Biomanufacturing Facility

MilliporeSigma, the US and Canada Life Science business of Merck KGaA, Darmstadt, Germany, announced a €35 million (US$37 million) investment on May 31, 2023 made by its life science business sector into the company’s Glasgow and Stirling sites in Scotland. The investment is intended to increase biosafety testing for drug development and commercialization at those sites.

The investment includes a new 1200-m2 facility in Glasgow that will house molecular biology and sequencing services, and the company will add biosafety testing, analytical development, and viral clearance suites in its current buildings to expand testing capacity. In addition, the expansion will create nearly 500 new jobs, raising the company’s workforce to more than 1200 employees across the two sites.

“We remain committed to ensuring the safety of the world's medicines through our state-of-the-art testing solutions for our customers around the world that drive new treatments,” said Dirk Lange, head of Life Science Services, MilliporeSigma, in a company press release. “Since mid-2022, we have announced investments of more than €350 million [US$374 million] in our global testing network to meet the growing demand for these services.”

Under the €35 million (US$37 million) investment, MilliporeSigma will expand its sites in Glasgow and Stirling, Scotland, to increase biosafety testing for drug development and commercialization.

MilliporeSigma Invests €35 Million to Strengthen Biosafety Testing in Scotland

invoX Pharma, a UK-based wholly owned subsidiary of China-based Sino Biopharmaceutical, announced on June 1, 2023 the completion of a second tranche of investment in pHion Therapeutics, a UK-based vaccine development company. The investment is meant to further develop next-generation messenger RNA (mRNA) vaccines.

The investment will support growth of pHion’s proprietary RALA platform. One of the first priorities will be the advancement of PTX_V1, pHion’s lead project, into clinical trials in the first half of 2024. PTX_V1 is a first-in-class therapeutic vaccine in development for treating human papilloma virus-related cancers. pHion’s pipeline also includes differentiated therapeutic vaccines for the treatment of ovarian (PTX_V5) and prostate (PTX_V3) cancers.

Operating with its RALA platform, pHion can deliver anionic molecules such as mRNA and self-amplifying RNA in a stealth-like way. This behavior evades detection and allows for the generation of a potent antigen-specific CD8+ T-cell response. The benefit of the RALA peptide-based drug delivery system lays in its 30-amino-acid sequence, which condenses anionic cargo—irrespective of size—into nanoparticles that are highly efficient at cellular entry and are able to outperform currently available technologies, according to a company press release. Compared with traditional mRNA vaccine delivery platforms, the RALA platform’s advantage includes ease of scalability and logistics, including stability at room temperature.

“At pHion Therapeutics, it is our mission to pioneer next-generation, first-in-class vaccines for infectious disease and oncology through stealth-like delivery of mRNA. With the additional support from invoX, we are set to accelerate our lead candidate, PTX_V1, to be ready for the clinic in 2024 and further develop our exciting preclinical pipeline of therapeutic and prophylactic mRNA vaccines. mRNA vaccines have the potential to truly transform healthcare interventions globally, and pHion will be at the forefront of this transformation, enabled by the RALA platform delivery technology,” said Helen McCarthy, CEO and founder of pHion, in the press release.

“We are delighted to have completed this additional investment in pHion,” said Ben Toogood, CEO of invoX, in the release. “invoX’s resources, global reach, and innovative R&D platform can help the company reach its potential and deliver treatments for patients around the world suffering from cancer and infectious diseases. We look forward to seeing PTX_V1 reach the clinic and supporting this program into the next stages of its development.”

invoX Pharma has made a second tranche of investment in pHion Therapeutics to support further development of next-generation mRNA vaccines.

invoX Pharma Invests in pHion Therapeutics to Develop Next-Generation mRNA Vaccines

On June 1, 2023, Lonza announced that it acquired Synaffix, a Netherlands-based biotechnology company with an antibody drug conjugate (ADC) technology platform. Under the deal, Lonza will initially pay €100 million (US$107 million) in cash and up to €60 million (US$64 million) in additional performance-based consideration. While it is now a Lonza company, Synaffix will continue to operate under the Synaffix name and will further expand its operations in Oss, The Netherlands, to prepare for further innovation and growth.

Synaffix’s ADC technology platform includes payload and site-specific linker technologies that will enhance and extend Lonza’s integrated ADC services, including Lonza’s early-phase offering. The ADC technology platform comprises proprietary GlycoConnect, HydraSpace, and toxSYN technologies, which can significantly enhance the efficacy and tolerability of ADCs, according to a company press release.

Through the acquisition, Lonza will combine its development and manufacturing capabilities with Synaffix’s ADC technology platform, which the companies expect will provide a comprehensive service to rapidly discover, develop, scale up, and commercialize novel and differentiated ADCs. The combination is also expected to streamline the path from discovery to clinic and commercialization.

“The acquisition of Synaffix underlines the strategic position of bioconjugates within Lonza’s portfolio, expands our offering in this fast-growing market and enhances our value proposition for clinical customers. With Synaffix, our combined … knowledge and capabilities have the capacity to support both clinical and commercial needs,” said Ulrich Osswald, vice-president, Licensing, Lonza, in the press release.

“On our mission to bring Synaffix’s ADC technologies to patients, we are excited to become part of Lonza, and, thus, through strong and immediate synergies, ensure a robust technology and manufacturing platform for our licensees as they progress into the late-stage clinical and commercial development phase. We can now also leverage the potential offered by Lonza to fast-track technology innovations in bioconjugates beyond cytotoxic ADCs,” said Peter van de Sande, CEO, Synaffix, in the release.

Lonza will gain access to R&D capabilities, including payload and site-specific linker technology, through its acquisition of ADC company, Synaffix.

Lonza Acquires Synaffix in ADC Deal

On June 1, 2023, contract research, development, and manufacturing organization WuXi Biologics (WuXi Bio) announced that it will increase its manufacturing capacity at two of its sites in Germany. The expansion will include drug substance and drug product manufacturing capacity.

At Chempark Leverkusen, Germany, the company’s sterile filling and freeze-drying plant for drug products, WuXi Bio will add a second variable filling line. The Leverkusen site currently has an annual capacity of approximately 10 million doses. At Wuppertal, Germany, the company’s drug substance facility, WuXi Bio intends to double total capacity from 12,000 L to 24,000 L on 30,000 m

The two site expansions will enhance WuXi Bio’s clinical and commercial manufacturing capacities in Europe and will strengthen its global dual-sourcing network strategy. Doing so will ensure that materials can be sourced and products manufactured at multiple sites within the company’s network, according to a company press release.

"The investment in our facilities in Germany will add new capacity and enhance our existing manufacturing services, which will strengthen our team’s ability to deliver timely support to our global clients to advance their biologics towards commercialization," said Chris Chen, CEO of WuXi Biologics, in the press release.

"WuXi Biologics’ increased capacity in Germany is intended to meet the growing needs of our global customers, especially those in Europe, thereby aligning us with the company's global strategy to work in close proximity to our clients. Germany is a leading biotech and pharma hub. The expansion of the two facilities is a clear commitment to Germany and Europe as high-tech locations and WuXi Biologics’ long-term growth strategy," said Benjamin Minow, managing director of WuXi Biologics Germany, in the release.

WuXi Biologics is expanding its manufacturing capacity for drug substance and drug product at its sites in Leverkusen and Wuppertal, Germany.