Seqens, Ampac, WuXi Biologics and Catalent ExpandBy
The latest news from CDMOs, CMOs, and suppliers featuring news from Seqens, Ampac, WuXi, and Catalent.
Chemicals/Chemical API Manufacturing
Seqens to Open New Innovation and Development Center
Seqens, a contract development and manufacturing organization of pharmaceutical synthesis services and a provider of specialty ingredients, has opened a 34,000-square-meter lab that will serve as the company’s center of excellence at its site in Porcheville, France, near Paris.
Known as Seqens’ Lab, the new lab offers research and development (R&D) services from early research and development stages to production for clients in several markets, including pharmaceuticals and cosmetics as well as specialty ingredients.
The R&D center has employees with skills and expertise in organic chemistry development. The center includes two referring laboratories in physics and solid-state chemistry as well as in process safety. It has kinetic and thermodynamic simulation tools and capabilities for large batch manufacturing for preclinical and clinical studies as well as the means for developing future processes, particularly in flow chemistry.
The Seqens’ Lab is also available to customers of Seqens North America (formerly PCI Synthesis).
Ampac Reopens Virginia API Mfg Facility
Ampac Fine Chemicals (AFC), a Rancho Cordova, California-headquartered contract manufacturer of active pharmaceutical ingredients (APIs) and intermediates, has reopened manufacturing operations at its API manufacturing facility in Petersburg, Virginia.
The reopening follows upgrades to technology and infrastructure refurbishment in the plant. The plant is located on nearly 200 acres with 50,000 gallons of total capacity. The company expects the plant to generate more than 110 new jobs over the next few years for positions ranging from custodial care to chemical engineering.
AFC was recently acquired by SK Holdings, an investment holding company of SK Group, headquartered in Seoul, South Korea.
Source: Ampac Fine Chemicals
WuXi Biologics to Add Commercial Mfg to Biologics Conjugation Center in China
WuXi Biologics, a contract provider of biologics discovery, development and manufacturing services, has announced plans to expand its new biologics conjugation solution center in Wuxi, China to include commercial manufacturing.
In June 2018, the company began construction on a $20-million, 6,000-square-meter antibody-drug conjugate (ADC) service center in Wuxi, China for ADC drug substances and drug products. This center is expected to initiate GMP manufacturing later this year. The new 5.5-acre expansion, announced this month (June 2019), will enable cGMP commercial manufacturing for ADC drug substances and drug products.
WuXi Biologics has more than 20 ADCs under development and has advanced 11 ADC projects to investigational new drug (IND) filings.
Source: WuXi Biologics
Catalent to Acquire Novavax’ Development and Mfg Facilities
Novavax, a late-stage biotechnology company developing vaccines for infectious diseases, and Catalent Biologics’ Paragon Gene Therapy unit have announced an arrangement under which Paragon will assume the leases to two Novavax product development and manufacturing facilities.
The agreement reduces Novavax’ operating costs and provides a cash payment at closing of approximately $18 million, according to Novavax.
Under the agreement, Paragon will purchase from Novavax all of the related manufacturing equipment and facility assets and more than 100 of Novavax’ manufacturing and quality employees will transfer over to Paragon.
Most Novavax employees at the two sites will transfer to Paragon and will continue to provide process and analytical development and potentially manufacturing GMP materials for clinical trial supplies of two Novavax’ vaccine, NanoFlu and ResVax, among other new projects. hese employees will also provide continuity and support of Novavax’ biologics license applications and post-licensure activities. Over the longer term, Paragon will be available to manufacture commercial quantities of the vaccines for Novavax.
Additionally, Novavax says it will be entering into a long-term arrangement with Paragon to provide process development and manufacturing services for specified Novavax programs.
The transactions are expected to close in July 2019.