Supplier News: Evonik, Jubilant, Lonza, Cambrex & More
The latest from CDMOs, CMOs, and suppliers featuring Evonik, Jubilant HollisterStier, Lonza, Cambrex, Croda, DFE Pharma, Euroapi, Societal CDMO, Evotec, and Hanmi Fine Chemical. Highlights below.
Chemicals/Chemical API Manufacturing
* Hanmi Fine Chemical Launches Additional CDMO Biz
Biologics Manufacturing
* Evotec To Acquire Rigenerand To Add Cell-Therapy Mfg
Formulation Development/Drug Product Manufacturing
* Evonik, US Gov’t Partner on New $220-M Lipid Mfg Facility
* Jubilant HollisterStier, US Gov’t Partner in $193-M Injectables Mfg Expansion
* Lonza Adds Early-Phase Clinical Mfg Facility
* DFE Pharma Launches Center of Excellence in India
* Croda Launches Croda Pharma
* Euroapi To Develop Lipid Nanoparticle for Sanofi
* Societal CDMO in $1-M Contract for Alzheimer’s Drug
General
* Cambrex Acquires Q1 Scientific
Chemicals/Chemical API Manufacturing
Hanmi Fine Chemical Launches Additional CDMO Biz
Hanmi Fine Chemical, a CDMO of active pharmaceutical ingredients, is launching an additional CDMO business to include services for raw materials, such as those used in mRNA vaccines, including lipid nanoparticles, nucleotides, capping materials, polyethylene glycol (PEG) derivatives, and peptides.
The company will invest approximately KRW 10 billion ($8 million) to build facilities. In 2021, Hanmi Fine Chemical was selected to conduct the Korean government’s project for expanding production facilities for COVID-19 vaccines and raw materials and received KRW 1.6 billion ($1.2 million) to support the expansions efforts. In addition, the company plans to further upgrade these facilities with KRW 8 billion ($6.4 million) of its own funds.
Source: Hanmi Fine Chemical
Biologics Manufacturing
Evotec To Acquire Rigenerand To Add Cell-Therapy Mfg
Evotec, a Hamburg, Germany-based drug-discovery and development company, has agreed to acquire Rigenerand Srl, a Medolla, Italy-based cell-therapy technology company, for EUR 23 million ($24 million). Rigenerand operates a cGMP cell-therapy manufacturing facility with 1,200 square meters of manufacturing space and quality control and development labs.
Source: Evotec and Rigenerand
Formulation Development/Drug Product Manufacturing
Evonik, US Gov’t Partner on New $220-M Lipid Mfg Facility
Evonik, a specialty and fine chemicals producer, including of excipients, is partnering with the US government for a new $220-million global-scale production facility for pharmaceutical lipids at Evonik’s site in Lafayette, Indiana.
Construction at the new plant, located at Evonik’s Tippecanoe site in Lafayette, Indiana, will begin in early 2023, and the plant is scheduled to go on stream in 2025.
The US government is funding the facility with up to $150 million of the $220-million project through the Biomedical Advanced Research and Development Authority, a component of the Office of the Assistant Secretary for Preparedness and Response in the US Department of Health and Human Services.
The new multi-purpose facility will allow for the production of a variety of lipids to support future applications of mRNA technology in infectious disease control, cancer immunotherapy, protein replacement, and gene therapy as well as ensure lipid supply for future pandemics.
Source: Evonik
Jubilant HollisterStier, US Gov’t Partner in $193-M Injectables Mfg Expansion
Jubilant HollisterStier, a CDMO of sterile fill–finish services, has partnered with the US government in a $193-million project to double the company’s injectable filling production capacity at its facility in Spokane, Washington. This expansion is slated to be completed by 2025.
The total cost of the expansion is $193 million with the US contributing $149.6-million through a contract with the company and the Army Contracting Command, in coordination with the Joint Program Executive Office for Chemical, Biological, Radiological, and Nuclear Defense on behalf of the Biomedical Advanced Research and Development within the US Department of Health and Human Services.
The expansion is in addition to the $92-million filling-line expansion that the company announced in November 2021. That expansion will be commercially available by the end of 2024.
Source: Jubilant HollisterStier
Lonza Adds Early-Phase Clinical Mfg Facility
Lonza has added a dedicated early-phase clinical manufacturing facility for drug product intermediates and drug products at its site in Bend, Oregon.
The facility features eleven suites in total, seven of which are GMP processing suites, to provide for the development and clinical manufacture of drug product intermediates and drug products, including spray-dried dispersion powders for oral delivery and dry granulation for immediate-release dosage forms Toward the end of 2022, Lonza says it anticipates adding a second spray dryer specifically designed for the manufacturing of engineered particles for inhalation as well as encapsulation equipment for encapsulated drug products.
Source: Lonza
DFE Pharma Launches Center of Excellence in India
DFE Pharma, a Goch, Germany-based excipient manufacturer, has launched a new center of excellence in Hyderabad, India, for fast-track formulation services.
The services offered by the new facility are mainly focused on oral solid dosage forms, comprising all types of pre-registration work, including development, scale-up, and technology transfer. Formulation support includes specialized dosage forms such as orally disintegrating, effervescent, chewable, and sublingual tablets, and minitablets. The facility also supports efficiency projects such as conversion from wet granulation to direct compression. The center’s equipment covers an instrumented tablet press, an automated capsule-filling machine, a tablet coater, a blister packaging machine, stability chambers, and analytical equipment.
Source: DFE Pharma
Croda Launches Croda Pharma
Croda International, a producer of oleochemicals, excipients, and other ingredients, has announced that its Health Care division will become Croda Pharma.
The move brings Croda’s core specialty excipient portfolio with its lipid delivery systems of Avanti Polar Lipids and the company’s adjuvant systems arm all under one business. In 2021, the company acquired Avanti Polar Lipids, an Alabaster, Alabama-based lipids manufacturer.
Source: Croda International
Euroapi To Supply Lipid Nanoparticle for Sanofi
Euroapi, a CDMO of small-molecule APIs spun off from Sanofi, has expanded its collaboration with Sanofi to develop lipid nanoparticles for Sanofi’s mRNA vaccine platform.
As part of the collaboration, Euroapi will develop and optimize chemical synthesis routes and GMP manufacture batches for several cationic lipids. Euroapi will focus on lipids that are currently being tested as part of Phase I/II clinical trials for Sanofi’s mRNA vaccines, including flu vaccines.
Source: Euroapi
Societal CDMO in $1-M Contract for Alzheimer’s Drug
Societal CDMO (formerly, Recro Pharma), a Gainesville, Georgia-based CDMO of drug products, has been awarded a $1-million contract by AmyriAD Pharma, a Los Angeles, California-based bio/pharmaceutical company, to provide CDMO services for AmyriAD’s AD101, drug currently in clinical development for treating Alzheimer’s disease.
AmyriAD has successfully completed Phase II clinical trials of AD101 and is planning to initiate two Phase III studies. Under the contract, Societal will execute a range of clinical trial services to support the initiation of Phase III and Phase IV clinical studies of AD101. These activities will include packaging, carding, kitting and labeling, and matching placebo and an active comparator compound. Additionally, Societal will be responsible for storing the prepared materials and distributing them to clinical trial sites globally. These activities will be conducted in collaboration at Societal’s CDMO facilities in Georgia and California.
Source: Societal CDMO
General
Cambrex Acquires Q1 Scientific
Cambrex has acquired Q1 Scientific, a Waterford, Ireland-based provider of cGMP stability storage services. Q1 Scientific’s 20,000-square-foot facility in Waterford has nearly 40 walk-in stability storage chambers, reach-in freezers and stability units, and ultra-low temperature freezers. The company also provides sample management and transport services.
Source: Cambrex
