Supplier News: Lonza, Cytiva, Alcami, Curia & MoreBy
The latest from CDMOs, CMOs, and suppliers featuring Lonza, Cytiva, Vibalogics, Alcami, Curia, Formosa Laboratories, HCmed Innovations, Evonik, and INCOG BioPharma Services.
Chemicals/Chemical API Manufacturing
Lonza Expands API Labs in China
Lonza has completed a laboratory expansion at its active pharmaceutical ingredients (APIs) manufacturing site in Nansha, China.
The expansion focused on extending development laboratories and kilogram-scale manufacturing laboratories for clinical supply of highly-potent APIs. The expansion increased the laboratory footprint to 250 m2 and is equipped with analytical and manufacturing equipment. The new laboratories will begin operations in March 2022.
Cytiva Opening Unit in New Single-Use Mfg Facility
Cytiva is opening a new 11 000-m² manufacturing facility for single-use bioprocessing components in Cardiff, Wales. The facility is part of a two-year, $1.5-billion global expansion plan by both Cytiva and Pall, both companies of the Danaher Corporation. The facility is part of a £300 million ($394 million) investment in the UK by the companies.
The site has begun to make mixer bags, flow kits and tubing assemblies, used in the development and production of biopharmaceuticals. By the end of 2022, Cytiva says there will be six ISO 7 class cleanrooms in Cardiff. The first cleanroom has been installed.
The company reports thousands of units of product are expected to be shipped globally from Cardiff in 2022. Construction on five more cleanrooms will be completed later this year (2022). When complete, Cytiva says the new site will help increase its global manufacturing capacity for single-use products by 20%. Hiring is ongoing to fill 250 new jobs to staff the facility.
Vibalogics Expands Viral-Vector Mfg Facility
Vibalogics, a CDMO of oncolytic viruses, viral vector vaccines, and viral vectors, has completed an expansion at its facility in Cuxhaven, Germany to provide added capacity and scalable clinical services for virotherapy manufacturing.
The new building features Biosafety Level 2 Grade B/C cleanrooms supporting host-cell expansion suites, upstream processing capacity at 500-L single-use-bioreactor production, and separate downstream purification suites.
With the first construction milestone complete, Vibalogics says it will now progress manufacturing campaigns for multiple clients currently contracted to the new building.
The project is a part of an overall $50-million investment into the 100,000-ft2 facility to support construction of additional cleanrooms, process development and quality control testing laboratories, and raw materials warehousing.
Formulation Development/Drug-Product Manufacturing
Alcami Adds Formulation Development Lab
Alcami, a CDMO of drug products and provider of analytical testing services, has added a formulation-development laboratory to support small- and large-molecule programs.
The dedicated 3,800-ft² formulation development space is co-located within the same facility as Alcami’s parenteral manufacturing operation, which has four isolator filling lines for liquid and lyophilized products.
Alcami’s formulation development laboratory is outfitted with a high potency suite, lyophilization cycle development center, stability chambers to facilitate lead candidate selection, and the equipment to support a variety of research and early-phase development activities, including bench-scale manufacturing of drug product to support preclinical studies.
Curia, US Government in Pact To Expand Sterile Fill-Finish Capacity
Curia (formerly AMRI) has entered into a cooperative agreement with the US government to expand domestic production of injectable medicines.
This agreement with the Biomedical Advanced Research and Development Authority (BARDA), part of the US Department of Health and Human Services, includes funding to add a new advanced isolated high-speed fill–finish vial line, which includes Biosafety Level 2 containment, at Curia’s existing facility in Albuquerque, New Mexico. Curia is also self-funding two lyophilizers for the high-speed fill–finish line and an isolated flexible filling line for vials, syringes and cartridges to support smaller batch advanced therapies.
The 65,000-square-feet expansion will include two 430-square-feet lyophilizers, automated visual inspection technology, automated packaging capacity, ultra-cold storage capability, and security features. Curia will add the isolated flexible filling line to its filling facility.
Formosa, HCmed Innovations Form CDMO for Inhalation Drugs
Formosa Laboratories, a Taoyuan City, Taiwan-based producer of active pharmaceutical ingredients and UV filters, Formosa Pharmaceuticals, a Taipei, Taiwan-based late-preclinical and early clinical-stage bio/pharmaceutical company, and HCmed Innovations, a Taipei, Taiwan-based company specializing in drug-nebulizer combination development, have signed a memorandum of understanding to form a CDMO for inhalation drugs.
The new CDMO business will integrate HCmed’s vibrating mesh nebulizers, Formosa Laboratories’ drug development and manufacturing capabilities, and Formosa Pharmaceuticals’ nanotechnology platform.
Source: HCmed Innovations
Evonik Invests in Laxxon Medical for 3D Printed Pills
Evonik, a specialty and fine chemicals producer, has invested in Laxxon Medical, a Carson City, Nevada-based company that has developed 3D screen printing technology for the manufacture of structured tablets.
The inner structure of 3D printed pills can have alternative layers of active ingredient and inert layers, which allows for several doses of the drug to be released over time. In another design, multiple drugs can be layered on top of each other, combining several pills into one. The size, geometry, inner structure, and materials used all combine to allow kinetics for the release of the active ingredients.
Evonik’s products will be used in Laxxon’s printing pastes. In addition, Evonik and Laxxon have signed a joint product development and cooperation agreement. Based on this agreement, Evonik intends to manufacture tablets for Laxxon.
INCOG BioPharma Completes QC Testing Suite
INCOG BioPharma Services, a recently formed CDMO of sterile injectables, has completed its quality control (QC) testing laboratories and a technology transfer and scale-up suite at its headquarters in Fishers, Indiana. In late December 2021, the company began installing and qualifying equipment in the 6,000-square-foot laboratories at its fill–finish facility.
INCOG says it will provide end-to-end QC chemistry and microbiology services, process development, and process optimization as part of its parenteral form-fill–finish offering. The newly designed analytical chemistry and microbiology laboratories will provide biological and chemical testing to support sterile injectable drug products, including sterility testing.
INCOG is investing over $100 million to bring the facility on line while bringing together a team of individuals in the injectable drug product space. INCOG says its next major milestone is the arrival, installation, and qualification of an OPTIMA multi-use filling line.
Source: INCOG BioPharma Services