Pharmaceutical Technology Editors

MilliporeSigma, the US and Canada Life Science business of Merck KGaA, announced on Sept. 8, 2022, that it would be investing €130 million into its manufacturing plant in Molsheim, France. This investment is geared toward strengthening its manufacturing capabilities for single-use assemblies.

The expansion will increase capacity for the manufacturing of single-use assemblies belonging to MilliporeSigma’s Mobius portfolio.These additions include multiple 37,00 ft

 ISO7 clean rooms, an administrative building, and a new logistics warehouse, all of which are planned to be operational by the end of 2024 and at full production by 2028. The company estimates that this investment will create more than 800 jobs by the end of 2028.

“MilliporeSigma is determined to provide patients in Europe and worldwide with reliable access to vaccines and life-saving therapies,” said Belén Garijo, chair of the executive board and CEO, Merck KGaA, in a press release. “This investment in France is an integral component of our plans to expand our global manufacturing footprint and deliver superior customer value across the globe.”

“France is central to our strategy to drive long-term growth and expand our global leadership position in Life Science,” said Matthias Heinzel, member of the executive board of Merck KGaA, and CEO of Life Science. “In recent years, many biopharmaceutical manufacturers have turned to single-use technologies for their flexibility, cost savings, speed, and reduced contamination risk, leading to double-digit market growth for this segment. The Covid-19 pandemic has reinforced this trend. The investment will accelerate the delivery of critical products and technologies our customers need to bring breakthrough treatments to patients in need around the world.”

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MilliporeSigma’s €130 million (USD$132 million) investment is designed to increase manufacturing capacity of single-use assemblies.

MilliporeSigma to Invest €130 Million in French Manufacturing Facility

GSK announced on Sept. 6, 2022 that the World Health Organization (WHO) has awarded prequalification to Mosquirix, GSK’s malaria vaccine. This is the first prequalification for a malaria vaccine, according to a company press release. The WHO’s decision is an important step to beginning the process of distributing the vaccine in countries with moderate to high malaria transmission.

The WHO prequalification is a mandatory prerequisite for United Nations agencies, such as UNICEF, to gain vaccine partnership with Gavi, the Vaccine Alliance, and eligible countries. GSK was determined to meet standards of quality, safety, and efficacy with its vaccine before prequalification.

“WHO prequalification of Mosquirix is a key step in reaching children with [this] malaria vaccine,” said Thomas Breuer, chief global health officer, GSK, in a company press release. “Malaria remains a significant cause of illness and death for children in many parts of the world, and it is a significant driver of inequality. So far, [more than one] million children in Ghana, Kenya, and Malawi have had at least one dose of Mosquirix, donated by GSK, through the Malaria Vaccine Implementation [Program], and WHO’s prequalification paves the way for more children to benefit from the vaccine.”

WHO has awarded prequalification to GSK’s Mosquirix, an approved malaria vaccine.

WHO Grants Prequalification to GSK’s Malaria Vaccine

Syanffix, a provider of clinical-stage platform technology, and Emergence Therapeutics, a biopharmaceutical company researching targets through antibody-drug conjugates (ADCs), announced a licensing agreement worth up to $360 million on Sept. 6, 2022. The agreement grants Emergence target-specific access to Synaffix’s portfolio of ADC platform technologies; this includes GlyoConnect, HydraSpace, and SYNtecan E linker-payload.

According to a company press release, Emergence will be responsible for the research, development, manufacturing, and commercialization of the ADCs, while Synaffix will manufacture components that are specifically related to its proprietary technologies. Payment of the full $360 million is contingent on achievement of various development, regulatory, and commercial milestones. In addition to these payments, Synaffix is also eligible to receive royalties on commercial sales.

“This transaction demonstrates our commitment to the development of our pipeline of first-in-class and/or best-in-class ADCs,” said Jack Elands, CEO, Emergence Therapeutics, in the press release. “Beyond our lead program ETx-22, a next generation Nectin-4 ADC, we are actively advancing further programs to develop treatments for high unmet-need cancers. We are impressed with the Synaffix technology and are pleased to select it as a key component to accelerate our pipeline of ADCs.”

“This marks an important milestone for Synaffix as this is the 10th ADC developer who has licensed our innovative ADC technology to develop proprietary ADCs for their own pipeline,” said Peter van de Sande, CEO, Synaffix, in the press release. “By consolidating all essential technologies within Synaffix, we have repeatedly enabled the development of best-in-class and first-in-class ADCs under a single technology license agreement. We are thrilled that Emergence has selected Synaffix as its long-term ADC technology partner and look forward to working closely with Emergence as they build out their portfolio of ADC candidates.”

Emergence Therapeutics will work with Synaffix’s ADC technology platform to develop multiple ADCs against undisclosed targets.

Emergence Therapeutics to License Synaffix ADC Technology Platform in Deal Worth Up to $360 Million

Salipro Biotech, a Swedish biotech company focused on the stabilization of membrane proteins for drug development, announced on Sept. 7, 2022 that its patent entitled “Saposin Lipoprotein Particles and Libraries from Crude Membranes” has been issued by both the US Patent and Trademark Office and by the China National Intellectual Property Administration.

The patents cover the company’s novel method of direct extraction of membrane proteins from cells or crude membranes to enable drug development for challenging drug targets. The patents also protect the generation of Salipro libraries representing the membrane proteome, the particles themselves, and their use in drug discovery and membrane protein research, amongst others.

According to a company press release, the Salipro technology enables the development of novel therapeutics against targets that previously could not be investigated.

“We are excited to announce the granting of these patents in the [United States] and in China. This news represents an important corporate achievement that fosters our position to accelerate drug discovery programs with pharma companies on challenging drug targets,” said Jens Frauenfeld, CEO of Salipro, in the press release.

Salipro has been granted patents in the United States and China for its proprietary technology to enable the development of therapeutics against challenging drug targets.

Salipro Biotech Obtains Patents in US and China for Direct Extraction of Membrane Proteins and Library Generation

Charles River Laboratories and Cure AP-4, a non-profit foundation dedicated to raising funds and awareness about adapter-protein 4 hereditary spastic paraplegia (AP-4 HSP), announced on Sept. 6, 2022 a manufacturing collaboration.

Patients afflicted with any of the AP-4 HSP genetic disorders may present symptoms including, global developmental delay, microcephaly, seizures, brain malformation, and hypotonia. According to a company press release, out of the 249 currently confirmed global AP-4 HSP cases, most patients experience low mobility in some or all extremities as the disorder progresses and are severely intellectually challenged.

Under the collaboration, Charles River will provide high quality (HQ) plasmid DNA for Cure AP-4’s Phase I/II gene therapy trials against AP-4 HSP. DNA plasmids are a critical starting material for many cell and gene therapy therapeutics, and demand continues to exceed supply. To address these supply shortages and support the growing needs of the cell and gene therapy field, Charles River has opened its new HQ plasmid DNA Center located in Cheshire, United Kingdom.

Charles River Laboratories and Cure AP-4 will collaborate on gene therapy manufacturing for AP-4 hereditary spastic paraplegia.

Charles River and Cure AP-4 Announce Manufacturing Collaboration

Avance Clinical, an Australia-based contract research organization (CRO) for biotechs, announced on Sept. 6, 2022 that it has expanded its services into North America with the acquisition of C3 Research Associates, a US-based CRO partner company. The acquisition will enable Avance to offer biotech clients an easier transition from early phase to later phase studies.

With the acquisition, Avance will have the capability to progress early phase studies in Australia and New Zealand into the United States, allowing biotech clients to continue their clinical development programs while retaining the same CRO services. This efficiency would reduce time and cost and allow for biotech companies to deliver quality data that will be acceptable to FDA.

The company intends to make significant investments in its US operations, including growing its team to more than 120 people and leveraging deep industry experience across a broad range of therapeutic areas, specifically oncology, according to a company press release.

“Avance Clinical has been working with C3 Research Associates in recent years, and they share a similar culture and focus on customer service and clinical excellence. This strong relationship made C3 Research Associates a natural acquisition choice for Avance Clinical’s expansion plans into North America. The due diligence process has taken more than [six] months, and we are excited to now welcome our US team and offer the GlobalReady model for our clients,” said

Yvonne Lungershausen, CEO of Avance Clinical, in the press release.

Avance Clinical’s acquisition of C3 Research Associates expands its CRO services to North America.