Ajinomoto Bio-Pharma, Cambrex, MilliporeSigma, Almac ExpandBy
The latest from CDMOs, CMOs, and suppliers featuring Ajinomoto Bio-Pharma, Cambrex, MilliporeSigma, Almac, Archimica, Argonaut, and others.
Chemical/Chemical API Manufacturing
Cambrex Upgrades Kilo Lab in Estonia
Cambrex has completed an investment project at its facility in Tallinn, Estonia to upgrade its kilogram-scale laboratory for GMP manufacturing pharmaceutical intermediates.
The project includes the installation of a new 160-liter reactor train in the laboratory, which will expand the site’s capabilities to manufacture material for clinical trials and allow early-phase projects to be developed further at the site prior to tech transfer and scale-up. Building work and installation of the new reactor and supporting equipment is now complete, and preparation for GMP qualification is underway.
The facility also houses 150-liter glass and stainless-steel reactors, which will continue to offer kilogram-scale manufacturing of materials for preclinical toxicological study applications.
The site in Tallinn provides custom organic synthesis and contract research, analytical and development services for process development and scale-up synthesis to kilogram quantities.
Archimica Invests $1.5 M To Expand Development Labs
Archimica, a Lodi, Italy-based CDMO of active pharmaceutical ingredients (APIs) and intermediates, has started the operation of its expanded development laboratories at its site in Lodi.
The company invested EUR 1.3 million ($1.5 million) to expand its process development and manufacturing capabilities for projects for API and building-block custom process development and manufacturing. The investment comprises chemical and analytical capabilities.
Almac Group Invests $450,000 in New Continuous Mfg Equipment
Almac Group, a Craigavon, UK-based CDMO, has invested £325,000 ($450,000) in continuous flow chemistry equipment,
Additional flow equipment within the facility includes: microreactors, photocatalysis flow rig, continuous stirred-tank reactors (CSTR’s), vapourtec E series flow rig, in-house built cryogenic rigs, microbubble and pressure technology, as well as, spray drying, UF/DF and liquid-liquid separation technology.
The equipment will be part of dedicated lab as part of the company’s recent £5-million ($7-million) expansion for a new R&D center for flow chemistry, biocatalysis and peptide technologies.
Formulation Development/Drug-Product Manufacturing
Ajinomoto Bio-Pharma To Expand Fill-Finish Capacity
Ajinomoto Bio-Pharma Services, a CDMO of active pharmaceutical ingredients (APIs) and drug products, plans to open a new multi-purpose fill–finish line at its commercial manufacturing facility in San Diego, California.
The new fill line will accommodate a range of configurations, including prefilled syringes, cartridges, and vials. The fill suite also houses two formulation suites, one of which is capable of handling flammable (Class H) compounds.
The line can accommodate a high-speed process rated to move 22,000 syringes per hour with a batch capacity of over 200 thousand syringes. The line will become fully operational in the summer 2021.
Source: Ajinomoto Bio-Pharma Services
MilliporeSigma Accelerates Scale-Up of Lipids
MilliporeSigma is accelerating the scale-up for lipids with the launch of a new high-purity synthetic cholesterol product.
MilliporeSigma is collaborating with more than 50 companies to support their efforts in the development and production of COVID-19 vaccines and treatments, providing custom lipids, as well as other critical raw materials, processing equipment, and services used in mRNA drugs and vaccines manufacturing. Beginning in February 2021, the company announced the extension of its strategic partnership with BioNTech to accelerate the supply of lipids and increase the quantities to be delivered toward the end of 2021. The lipids will be used for the production of the Pfizer–BioNTech COVID-19 vaccine.
This neutral lipid, used in commercially marketed products, offers high batch-to-batch consistency and is scalable under commercial GMP. MilliporeSigma manufactures lipids at its facilities in Schaffhausen, Switzerland; Darmstadt, Germany; and St. Louis, Missouri.
The launch of this new product follows the company’s acquisition of AmpTec, a Hamburg, Germany, based mRNA contract development and manufacturing organization.
Argonaut Plans New Mfg Facility, Lyophilization Center
Argonaut Manufacturing Services, a CDMO, is expanding with a new GMP facility in Carlsbad, California. The new facility will be equipped with upgrades in additional automation to Argonaut’s existing formulation and fill–finish infrastructure and be home to its new National Lyophilization Center.
Argonaut expects the additional facility space to be fully operational in 2021. This expansion will bring Argonaut’s manufacturing space to over 90,000 square feet.
Source: Argonaut Manufacturing Services
Evonik Launches Enteric, Ready-to-Fill Capsules
Evonik, a specialty and fine chemicals producer, has launched its Eudracap platform of capsules.
Eudracap Enteric, an enteric coated pre-locked capsule, is the first product of the platform to become commercially available.
The capsule is designed to optimize gastric resistance, boost intestinal absorption and enhance bioavailability. The new Eudracap platform uses Evonik’s Eudragit functional coatings to optimize the release profile of oral drug products. The coated hydroxypropyl methyl cellulose capsules are suited to protect sensitive active pharmaceutical ingredients from moisture and gastric acid.
Tergus Pharma Opens New HQ, Commercial Mfg Facility
Tergus Pharma, a Durham, North Carolina-based topical CDMO, has opened a new,100,000-square-foot headquarters and commercial manufacturing facility.
In addition to corporate and administrative offices, the new facility houses research and development laboratories, in addition to six commercial GMP manufacturing suites, six filling and packaging suites, along with two dedicated suites for high-potent and hormonal products
Source: Tergus Pharma
PPD Opens Clinical Research Laboratory in China
PPD, a contract research organization, has opened a new multipurpose laboratory in Suzhou, China, to support Western and China-based pharmaceutical and biotech companies managing China research studies for small molecules, biologics, and cell and gene therapies.
The 67,000-square-foot facility in the Suzhou New District, Jiangsu Province, offers bioanalytical, biomarker, and vaccine laboratory services to support trials across all phases of pharmaceutical development. The company anticipates adding approximately 300 professionals over the next three years (as reported on May 24, 2021) as a result of the expansion. This new lab supplements the company’s existing Shanghai central lab, established in 2015.
In addition, PPD plans to add central lab services in Suzhou in 2022 to augment the current capabilities in Shanghai and Singapore.
UPS Healthcare Launches Cold-Chain Capabilities
UPS Healthcare is expanding its specialty pharmaceutical offerings by establishing UPS Cold Chain Solutions, a suite of cold-chain technologies, capabilities, and new and expanded global facilities for end-to-end temperature-controlled logistics.
UPS Healthcare is expanding and augmenting its cold chain storage capacities, roughly 390,000 square feet of coolers and freezers installed at UPS facilities, to support the storage of biologics ranging from two degrees Celsius to as low as minus-80 degrees Celsius.
The company is also providing packaging customization, including recommendations for specific temperature-controlled packaging options. It is also expanding its European cold-chain ground network by adding more ground transportation fleets.
The company is also updating its transportation efficiencies with four temperature-regulated service options via air or ocean freight that can be configured for pharmaceutical packaging, as well as monitoring protocols to provide visibility into covered pallets, boxes, trailers and packages.
The company is also providing facility updates, including construction of two new distribution facilities in Italy and Australia, as well expansions and cold-chain retrofit projects to facilities in the Netherlands, Czechia, Poland, Hungary and the US.