The latest news from CDMOs, CMOs, and suppliers featuring news from Dipharma, Fujifilm Diosynth Biotechnologies, Univercells, and Aphena Pharma Solutions.

Chemicals/Chemical API Manufacturing

Dipharma Completes Construction of New cGMP Suite in US

Dipharma, a CDMO of active pharmaceutical ingredients, has completed a new cGMP quality control laboratory and cGMP kilolab at its site in Kalamazoo, Michigan.

The new cGMP manufacturing suite offers a range of services for molecules from preclinical to the commercial stage. With the construction of the new kilolab, Dipharma will implement cGMP capability at its US subsidiary, Kalexsyn. With an engineering batch already scheduled for production, Dipharma is currently assembling all documents required by the US Food and Drug Administration for drug-establishment registration.

Dipharma has commercial offices in Italy, the US and China. It has research and development centers, located in the US and in Italy, to develop chemical processes and crystalline forms for pharmaceutical companies worldwide.

Source: Dipharma

Biologics Manufacturing

Fujifilm Diosynth Expands its Manufacturing Facility in North Carolina

Fujifilm Diosynth Biotechnologies (FDB), a biologics CDMO, has broken ground on an expansion at its facility in Research Triangle Park, North Carolina.

The 31,778-square-foot addition includes the expansion of its cell-culture and microbial manufacturing trains through the addition of new recover and purification suites. The North Carolina site will increase its cell-culture manufacturing capacity by approximately 25% and microbial capacity by approximately 50%. A new receiving warehouse is also included in the expansion project.

Fujifilm expects the increased production capacity will be ready for cGMP manufacture by mid-2021.

FDB has locations in Teesside, UK; Research Triangle Park, North Carolina; College Station, Texas; and Hillerod, Denmark.

Source: Fujifilm Diosynth Biotechnologies

Univercells Secures $54 Million in Financing for Viral Product Bioprocessing

Univercells, a provider for biolog has received up to EUR 50 million ($54 million) in financing from Gamma Biosciences, a new investment platform supported by the investment firm, KKR, to fund new bioprocessing technologies for the production of advanced biologic therapies, including gene-and cell-based therapies.

The investment will be deployed in a newly created Univercells subsidiary focused on accelerating the industrialization and commercialization of Univercells’ manufacturing technologies, including its NevoLine biomanufacturing platform, a manufacturing platform for viral vaccines, gene therapies, and oncolytic viruses, and the scale-X bioreactor portfolio, for upstream processing of viral products that includes fixed-bed design chained with in-line product concentration.

With the new financing, Univercells will focus on scaling the NevoLine platform and the scale-X bioreactor portfolio. Specifically, the investment is intended to support continued expansion into the gene-therapy segment, including new developments in solutions for viral manufacturing.

The transaction is expected to close in the first half of 2020.

Source: Univercells

Packaging

Aphena Pharma Solutions Expands Bottling Capacity with New Bottling Line

Aphena Pharma Solutions, a provider of contract packaging and manufacturing, is expanding its bottling capacity with the purchase of a new solid-dose bottling line with an integrated cartoner. The line will be available for new business starting May 1,2020 at Aphena’s facility in Cookeville, Tennessee.

The new line will be dedicated to packaging solid-dose over-the-counter products, both in the branded and private-label categories. The new line will create additional capacity in the range of 15 million to 20 million bottles annually. Aphena currently has two sites in the US and handles solid dose, liquids, gels, creams, ointments, foams, suspensions and lotions.

Source: Aphena Pharma Solutions