Catalent Plans $50-M Expansion; Seqens Inaugurates New HPAPI Mfg UnitBy
The latest from CDMOs, CMOs, and suppliers featuring Seqens, Catalent, Siemens, LSNE, Lunia Bio, Nutribrand, Jones Healthcare, and DWK Life Sciences.
Chemicals/Chemical API Manufacturing
Seqens Inaugurates HPAPI Unit at French Site
Seqens has inaugurated a high-potency active pharmaceutical ingredient (HPAPI) manufacturing unit at its site in Villeneuve-La-Garenne, France with an investment of EUR 30 million ($35 million).
This project, called UPP30, has been carried out in partnership with Mithra Pharmaceuticals, a Liège, Belgium headquartered pharmaceutical company focused on women’s health, for the production of a fifth-generation contraceptive molecule with a high level of biodegradability.
Luina Bio Plans Biomanufacturing and Development Facility Expansions
Luina Bio, a Brisbane, Australia-based biologics CDMO, plans to expand bacterial and yeast development and manufacturing capacity for microbiome and recombinant protein projects.
The company plans to open an additional small-scale (30 L) manufacturing suite in late 2020. This facility will be available to customers in the third quarter of 2020.
This expansion will be followed by the opening of four additional development laboratories in late 2020 to allow projects from early development to a volume of 500 L for microbiome and recombinant protein projects.
Luina also plans to commission a new 10,000-m2 late-phase clinical and commercial production facility in late 2021. The new facility will have up to five production lines in parallel to allow for multiple-strain live biotherapeutics projects. Luina’s largest reactor (2,000 L) will allow it to deliver live biotherapeutics volumes compatible with the commercial needs of those companies that have single-strain projects.
Source: Luina Bio
Formulation Development/Drug-Product Manufacturing
Catalent Plans $50-M Investment for New Filling Line at Indiana Facility
Catalent plans to invest $50 million to install an additional high-speed vial filling line at its facility in Bloomington, Indiana.
The new line is expected to be operational by April 2021 and will add capacity to support the growing pipeline of clinical programs and commercial launches at the site. It will provide sufficient capacity to produce up to 80 million vials annually under barrier isolator technology and a peristaltic pump filling mechanism under GMP.
This marks the third major investment in the last two years at the Bloomington site. By the end of 2021, the site will have high-speed filling capacity across three vial lines, two syringe lines, and a flexible line capable of filling vials, syringes, or cartridges. The facility has expertise in sterile formulation, with drug substance-development and manufacturing and drug-product fill-finish capacity, including primary and secondary packaging.
CPI Partners with Siemens, Perceptive Engineering in Continuous Mfg
The Center for Process Innovation (CPI), the process manufacturing arm of the UK government’s network of Catapult centers that are designed to encourage innovation in specific areas, has signed partnership agreements with Siemens, a process automation company, Perceptive Engineering, a provider of advanced process-control software platform, and Process Systems Enterprise (PSE), a supplier of advanced process modelling software, to add the companies as participants in the Medicines Manufacturing Innovation Centre, a collaboration between the CPI, GlaxoSmithKline, AstraZeneca and the University of Strathclyde in the UK for continuous manufacturing of oral solid dosage products.
The partnership agreements will help the Medicines Manufacturing Innovation Centre achieve its flagship Grand Challenge projects. As announced in June 2019, the Grand Challenge 1 involves development of a digitally twinned continuous direct compression (CDC) platform and workflow. The first stage of the project is to create a flexible plug-and-play development platform. This will involve adapting and improving existing CDC models and integrating process analytical technology.
The contribution by Siemens will also support the Grand Challenge 2, which is focused on adaptive clinical trial material supply through the development of just-in-time manufacturing and supply-chain capabilities. The project involves integration of a real-time release platform. At the time of a June 2019 announcement, it was expected that the automated platform and data integration would be delivered in the second quarter of 2021, along with completion of the Medicines Manufacturing Innovation Centre building in Glasgow, UK.
Source: Center for Process Innovation, Perceptive Engineering, and Process Systems Enterprise
LSNE Gets OK from Spanish Regulatory Authorities for FillFinish Facility
LSNE Contract Manufacturing, a CDMO of fill–finish and lyophilization services, has received approval from the Spanish Agency of Medicines and Medical Devices (AEMPS) for the manufacturing of clinical-stage biologic-based therapeutic products at its aseptic fill– finish facility in León, Spain.
LSNE has six GMP facilities: four located in New Hampshire, one in Wisconsin, and one located in León, Spain.
Source: LSNE Contract Manufacturing
Nutriband Acquires Transdermal Mfg Business for $7.5 M
Nutriband, an Orlando, Florida-based pharmaceutical company developing transdermal products, has completed the acquisition of the transdermal and health product manufacturing business of Pocono Coated Product, a Phillipsburg, New Jersey-based company specializing in the manufacturing of various products such as tapes, topical patches, and health products with a specific focus on coated products, for $7.5 million.
The acquisition builds on Nutriband’s 2018 acquisition of 4P Therapeutics, a drug-delivery and pharmaceutical company. Nutriband says it plans to consolidate the capabilities of both acquisitions including for the advancement of Nutriband’s abuse-deterrent technology for opioid-based transdermal medications.
The acquisition also includes the simultaneous acquisition by Pocono of Active Intelligence, a manufacturer of Active Intelligence kinesiology tape, a product that provides muscle support combined with soothing ingredients for aches or muscle pain. The product is designed to mimic the skin’s elasticity, so the user still has a full range of motion during its use.
Jones Healthcare Acquires New Label Printing And Converting Press
Jones Healthcare Group, a provider of advanced packaging and medication-dispensing product and services, has announced the installation of a new label-printing and converting press, to expand the company’s capacity to produce customized laser pharmacy labels.
The new label printing and converting press, named the Aquaflex LX 2350, features double-wide printing at 500 feet per minute through a series of five high-precision flexo print stations, allowing for a range of color options and double-sided print capabilities using water-based inks. With three die stations, the press can produce multiple label configurations with dual web construction, including paper and self-adhesive paper. The press also includes a matrix extraction system to allow for continuous production runs
The press has been installed and is now operational at the company’s facility in London, Ontario, Canada.
Source: Jones Healthcare Group
DWK Life Sciences Increases Glass Vial Production Capacity
DWK Life Sciences, a manufacturer of laboratory glassware and pharmaceutical packaging materials, has expanded its glass-vial production facility in Rockwood, Tennessee to meet demand for borosilicate glass vials for vaccines, diagnostics, and therapeutics.
The company combined new equipment installations with improvements to existing equipment to more than double production capacity. The company now operates fully automated production lines and a centralized Class 8-certified cleanroom.
Source: DWK Life Sciences