The latest news from CDMOs, CMOs, and suppliers featuring news from Vetter, Catalent, Cambrex,  Sharp and Biotechpharma. 

Chemicals/Chemical API Manufacturing

Cambrex Completes Construction for High-Potency API Facility and QC Lab for Generic APIs

Cambrex has completed the construction of a $24-million highly potent API (HPAPI) manufacturing facility at its site in Charles City, Iowa. The 6,000-square foot facility is currently undergoing validation and will be ready to commence customer projects in May 2019.

In a separate development, Cambrex has opened a new 120-square-meter quality control (QC) laboratory at its site in Paullo, Milan, Italy. The laboratory expands on the current QC facilities that analyze and test its portfolio of generic active pharmaceutical ingredients (APIs) of products during development and manufacturing. The QC laboratory is now fully operational, having been authorized by the Agenzia Italiana Del Farmaco (AIFA).

New instruments, including a polarimeter and infrared spectrometer, have been added, with the systems linked to secure, electronic data capturing software to allow full traceability in line with regulatory requirements.

Source: Cambrex (HPAPI facility) and Cambrex (QC Lab)

 Biologics Manufacturing

Biotechpharma Plans $56 Million Investment to Expand Fermentation Capacity and Process Development Lab

Biotechpharma UAB, a biopharmaceutical CDMO based in Vilnius, Lithuania, has announced further expansion of its fermentation capacity to 5,000 liters along with an additional process development laboratory for an investment of more than EUR 50 million ($56 million).

The new plant in Europe, located at the company’s site in Vilnius, Lithuania, will contain a new line of bioreactors for microbial fermentation at a 5,000-liter scale and the necessary equipment for downstream processing operations. Flexible facility design will also allow for increased mammalian cell culture production capacities in addition to the already existing two lines of 1,000 liters and 2,000 liters for mammalian cell production, both equipped with single-use bioreactors. Completion of the plant, which should be operational in the fourth quarter of 2020, will result in an increase in Biotechpharma’s volume capacity by nearly a factor of two.

Source: Biotechpharma

Formulation Development/Drug Product Manufacturing

Vetter Nears Completion of US Clinical Manufacturing Facility

Vetter, a CDMO of aseptically prefilled syringe systems, cartridges and vials, is nearing completion at its US clinical manufacturing facility located at the Illinois Science & Technology Park in suburban Chicago in Skokie, Illinois.

Since beginning full operations in late 2011, Vetter’s US early-stage development site has been expanding. As recently as 2016, the site expanded its storage capacity by 150% to 3,700 square feet. With the new additions, most of which are expected to be completed by April 2019, the site will increase its storage space by an additional 3,100 square feet. The new storage includes a 2,500-square-foot. freezer farm as well as a planned 600-square-foot walk-in refrigerator. In total, 6,800 square feet of storage space will result. A second extension, now in the final planning stage, will include an additional 1,500 square feet.of room temperature and freezer space. When completed, the facility will have more than double the overall storage space it currently has available.

New offices with 45 work stations, conference rooms and an archive room are also included. To support the increase in customer projects, a permanent second work shift will be added in visual inspection over the next months. A second shift in quality oversight is also planned.

Source: Vetter

Catalent To Expand Softgel Capacity and Capabilities

Catalent has announced that work is underway to expand integrated turnkey softgel capabilities at its facility in Eberbach, Germany.

The $14-million expansion, which is scheduled to be completed by mid-2020, includes two new softgel encapsulation lines dedicated to Catalent’s proprietary Vegicaps technology. This addition is driven by increased global demand for animal-free consumer health products, and these new lines will be completed by September 2019. The investment also includes new printing technology, a vision- inspection system, expansion of the facility’s softgel coating capabilities, and the addition of further packaging capacity.

In addition to these capital investments, the site is increasing its total production output by growing the workforce by more than 10% across operations, quality control, and related supporting functions.

Source: Catalent

Packaging

Sharp Plans $21-Million Investment in US Packaging Capacity and Capabilities

Sharp, a provider of contract packaging and clinical supply services, is investing $21 million to expand US packaging capacity and capabilities.

The latest expansion in the company’s campus in Allentown, Pennsylvania includes a co-investment with one of Sharp’s clients and represents the third phase of development of its Biotechnology Center of Excellence. New equipment installations will include vial labelers as well as a vaporized hydrogen peroxide (VHP) cold sterilization system.

Building Four in the Sharp Allentown Campus opened as the company’s Injectables Center of Excellence in April 2016. When the Allentown facility was built, it included an additional area of undeveloped space of approximately 21,500 square feet. Subsequent investment doubled pre-filled syringe, autoinjector and pen assembly and increased cold storage capacity at the site.

Other recent investments over the past several years include $11 million for its new Clinical Services Center of Excellence in Wales, an additional $11 million for enhancing its injectable and cold-chain capabilities in the US, Belgium, and the Netherlands, and $23 million on its recently refitted facility in Bethlehem, Pennsylvania.

Source: Sharp