Curia Acquires LakePharma; Thermo Fisher, Cytiva Expand Single-Use Mfg Sites

The latest from CDMOs, CMOs, and suppliers featuring Curia, Thermo Fisher Scientific, Cytiva, Jubilant Biosys, Olon, Cevec Pharmaceuticals, Ardena, and Formulated Solutions.

Chemical/Chemical API Manufacturing

Jubilant Biosys Appoints New CEO
Jubilant Biosys, a CDMO of medicinal chemistry and synthetic chemistry services, has appointed Giuliano Perfetti as its new Chief Executive Officer (CEO).

Mr. Perfetti has more than 20 years of experience with expertise in strategy, sales, marketing and business development, including with Accenture, a management consulting company, and AstraZeneca. Prior to joining Jubilant Biosys, Mr. Perfetti was Chief Commercial Officer with Fabbrica Italiana Sintetici (F.I.S.), a Montecchio Maggiore, Italy-based supplier of pharmaceutical ingredients.

Source: Jubilant Biosys

Biologics Manufacturing

Curia Completes Acquisition of LakePharma
Curia (formerly AMRI) has completed its acquisition of LakePharma, a San Carlos, California-based biologics contract research, development and manufacturing organization (CRDMO) with operations in California, Massachusetts, and Texas.

With the addition of LakePharma, Curia offers expertise in both large and small molecules from drug discovery through drug-substance manufacturing, sterile injectable formulation, and fill-finish production.

LakePharma will operate as part of Curia’s Research and Development Division, led by Christopher Conway, President, R&D. Hua Tu, Ph.D., LakePharma’s founder and Chief Executive Officer, also will serve on Curia’s executive team as Chief Technology Officer.

Last month (August 2021), Curia also completed its acquisition of Integrity Bio, a Thousand Oaks, California-based CDMO of drug-product formulation development cand fill-finish services

Source: Curia (LakePharma) and Curia (Integrity Bio)

Thermo Fisher To Add Single-Use Mfg Site in Tennessee; Other Updates
Thermo Fisher Scientific has announced plans to establish a manufacturing facility in Nashville, Tennessee for the production of single-use technologies (SUT) products.

The facility new facility will more than double the company’s SUT manufacturing capacity. The first phase of construction is scheduled to be operational by the second quarter of 2022.

The Nashville site is part of Thermo Fisher’s now more than $650-million capital investment to expand its bioprocessing production capabilities across 11 manufacturing sites in North America, Europe, and Asia. Additional capacity is being planned to be added in 2021 with the completion of expansion projects in Logan, Utah; Suzhou, China; and a new SUT manufacturing site in Singapore.

The $650-million investment program also includes capacity expansions at several sites (Grand Island, New York; Miami, Florida; and Inchinnan, Scotland) to increase production capacity for Gibco cell culture media, supplements, and process liquids as well as the manufacturing of customer-owned proprietary media formulations.

Source: Thermo Fisher Scientific

Cytiva Expanding Single-Use Consumable Capacity in China
Cytiva is expanding its manufacturing capacity for bioprocessing single-use consumables at an existing facility in China. The planned expansion will consist of eight additional new manufacturing lines, two of which are expected to launch by the end of 2021 and with the other six lines scheduled in to be launched in the third quarter of 2022. It adds 1,300 square meters to the manufacturing area of the ISO Class 7 cleanroom and also includes a 1,200-square-meter warehouse. These expansion, which triples the company’s single-use consumable capacity in China, is part of the recently announced $1.5 billion-dollar investment by Cytiva and Pall Corporation, both which are part of Danaher Corporation.

Source: Cytiva

Olon To Expand Fermentation Mfg Capacity
Olon, a CDMO of active pharmaceutical ingredients (APIs), has announced plans to expand microbial fermentation manufacturing capacity at its site in Settimo Torinese, Italy. The site is a center of excellence for biotechnological manufacturing.

Source: Olon

UCB, Cevec in Gene-Therapy Mfg Technology Licensing Pact
Cevec Pharmaceuticals, a Köln, Germany-based provider of cell technology for biomanufacturing, has signed an agreement with UCB on the evaluation and use of Cevec’s gene-therapy manufacturing technology, Elevecta, for the research, development, and manufacturing of adeno-associated virus (AAV) vectors for gene-therapy applications.

Under the agreement, Cevec will grant UCB non-exclusive rights for research and development using Elevecta producer cell lines for specific transgenes selected by UCB. The agreement also grants UCB options to obtain licenses for use of the Elevecta producer cell lines in commercial manufacturing of potential AAV gene-therapy products and for the internal use of the Elevecta technology at UCB to generate new producer cell lines. Under the terms of the license, Cevec is eligible for license fees, clinical and regulatory milestone payments, as well as royalties on potential future net sales.

Source: Cevec Pharmaceuticals

Formulation Development/Drug-Product Manufacturing

CDMO Ardena Acquires CDMO Idifarma
Ardena, a Ghent, Belgium-based CDMO, has acquired Idifarma, a Pamplona, Spain-based CDMO of oral solid dosage forms, from Suanfarma, a company specializing in the development, production and commercialization of ingredients for the pharmaceutical, veterinary, and nutritional sectors.

Idifarma provides formulation development, analytical, and manufacturing services for highly potent drugs.

The acquisition brings the total number of Ardena facilities in Europe to seven, including its headquarters in Ghent, three sites in the Netherlands, and two sites in Northern Europe (Sweden and Latvia).

Source: Ardena and Idifarma

CDMO Formulated Solutions Completes Expansion
Formulated Solutions, a Largo, Florida-based CDMO, has completed an infrastructure expansion project to increase capacity in manufacturing, warehousing, process flow, blending and employee space. Highlights of the investments include: (1) the addition of 30,000 square feet of new employee and onsite warehousing space; (2) increases in blending capacity supported by custom-built blending vessels; (3) installation of aerosol filling upgrades; (4) qualification of an automated high- airless filling and assembly production line; and (5) installation of expanded capacity in pre-weighing of raw materials and incoming raw material inspection.

Additionally, Formulated Solutions has also designed and installed a fully dedicated “plant within a plant” for new nasal spray products, including pre-weigh, blending and filling.

Source: Formulated Solutions