Supplier News: CordenPharma, Porton, MilliporeSigma & MoreBy
The latest from CDMOs, CMOs, and suppliers featuring CordenPharma, Porton Pharma, MilliporeSigma, Seqens, Onyx Scientific, Aldeveron, Jubilant HollisterStier, Recipharm, Alcami, CMIC Holdings, ten23 health and Bionter.
Chemicals/Chemical API Manufacturing
* CordenPharma Adding Oligonucleotide API Mfg
* Seqens Investing $43 M for Mfg in China
* Onyx Scientific Opens Second CMC Site
* Porton Starts Construction of Antibody, ADC Facility
* MilliporeSigma, South Korea Gov’t Advance Partnering for Bioprocessing Mfg Center
* Arranta Bio, MIT in Pact for Continuous Mfg of mRNA Therapeutics
Formulation Development/Drug Product Manufacturing
* Aldeveron Expanding mRNA-Based Drug-Product Mfg
* Jubilant HollisterStier Names New President
* ten23 health, Bionter in Pact for Particulate Testing
* CMIC, DNP Form Strategic Alliance for Joint CDMO Services
* Alcami Completes Expansion of Biostorage Facility
Chemicals/Chemical API Manufacturing
CordenPharma Adding Oligonucleotide API Mfg
CordenPharma is adding synthetic oligonucleotide manufacturing, a new manufacturing area for the company, through a two-phase investment at its site in Colorado.
Phase One involves reconditioning existing laboratory space, purchase of development equipment, and hiring of a team to set up process and analytical development capabilities. Target completion is expected in the fourth quarter of 2023.
Phase Two, which is being initiated at the same time as Phase One, includes the redesign of existing manufacturing space to create a fully GMP-compliant manufacturing area housing synthesis, cleavage, downstream processing, and lyophilization at the 10–100 mmol scale. These manufacturing assets provide early- to mid-phase clinical trial supply. They can be integrated with company’s lipid nanoparticle formulation development services and sterile filling capacity at the company’s facility in Caponago, Italy, as well as with multiple CordenPharma sites for the supply of standard and custom lipid synthesis capabilities.
The company says that future expansions are being planned to increase capacity and scale capability.
Seqens Investing $43 M for Mfg in China
Seqens, a CDMO of active pharmaceutical ingredients, pharmaceutical intermediates, and specialty ingredients, has announced an investment of nearly CNY 300 million ($43 million) in three new production capacity projects in China. These three projects will complement Seqens’ industrial facilities and investments in Europe and support products for the healthcare and cosmetics markets.
Onyx Scientific Opens Second CMC Site
Onyx Scientific, a CDMO of small-molecule active pharmaceutical ingredients (APIs), has announced the opening of a second chemistry, manufacturing and controls (CMC) facility in Sunderland, UK.
The new site, close to Onyx’s UK headquarters, doubles the company’s current footprint and allows for expansion of all CMC services, including the introduction of additional GMP facilities that increases capacity for clinical and commercial API manufacturing by 50%.
The first phase of the multi-million British pound development is complete and operational with GMP certification and commercial API manufacturing approval from the Medicines and Healthcare products Regulatory Agency, the UK’s pharmaceutical regulatory authority.
The final two phases of this new development are expected to be completed by the end of 2022.
Source: Onyx Scientific
Porton Starts Construction of Antibody, ADC Facility
Shanghai Porton Nova Biologics, a wholly owned subsidiary of Porton Pharma Solutions, has launched the construction of its biologics R&D and manufacturing site in the Waigaoqiao Free Trade Zone of Pudong New Area, Shanghai, China.
The site will provide CDMO services for early clinical-stage process development and pilot-scale production of antibodies and antibody-drug conjugates (ADCs). The facility will have a total area of nearly 7,000 square meters.
The site will have capacity for process development and GMP production for antibodies and ADCs, with services from cell-line construction, upstream and downstream process development, conjugation process development, formulation process development, analytical method development, technology transfer to GMP drug-substance manufacturing, GMP fill–finish, release testing, stability studies, and regulatory filing support.
The process development platform and manufacturing facility at the site are expected to be operational in the third quarter/fourth quarter of 2023.
Source: Porton Pharma Solutions
MilliporeSigma, South Korea Gov’t Advance Partnering for Bioprocessing Mfg Center
MilliporeSigma, the life science business of Merck KGaA, has signed a non-binding memorandum of understanding with the South Korean Ministry of Trade, Industry and Energy (MOTIE), and Daejeon City for a new Asia-Pacific BioProcessing Center to support commercial manufacturing.
MilliporeSigma also plans to work with the Daejeon government to support biotech companies based in the Daedeok Research Complex located in Daejeon, as well as expand bio-research cooperation with Korean universities.
Arranta Bio, MIT in Pact for Continuous Mfg of mRNA Therapeutics
Arranta Bio, a Watertown, Massachusetts-based CDMO of live biotherapeutics and part of Recipharm, a CDMO of small-molecule active pharmaceutical ingredients, biologics, and drug products, has signed a contract with the Massachusetts Institute of Technology (MIT) to develop continuous manufacturing technology for mRNA therapeutics. The contract is part of the US Food and Drug Administration’s (FDA) initiative to have a fully integrated, continuous manufacturing production line for mRNA vaccines. The three-year project will accelerate the deployment not only of mRNA vaccines for rapid response against future pandemics but also of mRNA therapeutics.
Formulation Development/Drug Product Manufacturing
Aldeveron Expanding mRNA-Based Drug-Product Mfg
Aldevron, a Fargo, North Dakota-based CDMO of drug products, is expanding its mRNA production capabilities to include lipid nanoparticle (LNP) encapsulation and aseptic fill–finish capabilities. This new capability will support the production of clinical and commercial mRNA therapies for cancers and genetic diseases, and clinical-stage vaccines for infectious diseases.
Aldevron, a Danaher Corporation operating company, is partnering with fellow Danaher operating companies Precision Nanosystems (PNI), a Vancouver, British Columbia, Canada-based CDMO of LNP and mRNA, and Cytiva. When fully operational, the services will leverage PNI’s LNP formulation expertise, and feature Cytiva’s SA25 aseptic filling workcell.
The expansion is anticipated to be fully online in the second half of 2023.
Jubilant HollisterStier Names New President
Jubilant HollisterStier, a CDMO of sterile fill–finish injectables, ampules, ophthalmics, and sterile liquid products, has appointed Chris Preti, most recently President of HollisterStier Allergy, as President.
Preti has 25 years of varied pharmaceutical experience in research and development, marketing and sales, and operations, including positions of increasing responsibility at GlaxoSmithKline and HollisterStier Allergy, where he was most recently President.
Source: Jubilant HollisterStier
ten23 health, Bionter in Pact for Particulate Testing
ten23 health, a Basel, Switzerland-based CDMO, and Bionter, a Basel, Switzerland-based provider of analytical testing technology, have entered a collaboration to advance testing methods of particulate matter.
Bionter has launched EVE, an automated particle-testing system, to assess sub-visible particulate contamination for parenteral drug applications based on light obscuration, ten23 health has been running customer samples on an EVE system and is also acting as an application center for Bionter.
Source: ten23 health
CMIC, DNP Form Strategic Alliance for Joint CDMO Services
CMIC Holdings (CHD), the parent company of CMIC CMO, a CDMO of drug products, has formed a strategic alliance with Dai Nippon Printing (DNP), a Tokyo-based printing company, including products/services to the healthcare industry, to provide integrated CDMO services in the following project areas:
- Development of value-added pharmaceuticals by combining the packaging technology of the DNP Group with the-drug formulation technology of the CMIC Group;
- Establishment of an integrated system from the API process development and manufacturing of the DNP Group to the CMIC Group’s formulation development and manufacturing;
- Collaboration in the CMIC Group’s clinical development and clinical trial site support business areas using DNP Group technology and know-how; and
- Business alliance targeting the building of a healthcare ecosystem.
As part of the new alliance, DNP will jointly operate CMIC CMO with CHD through the acquisition of 50.1% of CMIC CMO’s shares. CMIC CMO will become a consolidated subsidiary of DNP. In addition, CHD will continue to hold 49.9% of the shares, and CMIC CMO will be a joint venture between the two companies.
Alcami Completes Expansion of Biostorage Facility
Alcami, a Wilmington, North Carolina-based CDMO of storage, has completed the expansion of its cGMP biostorage facility in Amherst, New Hampshire. With the completion of the expansion, a total of 160,000 square feet of ambient cGMP biostorage capacity with 21,000 pallet locations is now operational to support a variety of cGMP storage.
In addition to the expansion in Amherst, Alcami has added nearly 10,000 cubic feet of -20 ˚C cold-storage capacity and over 12,000 cubic feet of ICH stability storage in Massachusetts.