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Supplier News: SK pharmteco, Ardena, Jabil & More 

Chemicals/Chemical API Manufacturing 
* SK pharmteco Opens HPAPI Lab  
* AGC Pharma Chemicals Expanding HPAPI Capabilities 
* TriLink, Avantor In Pact to Supply Nucleic Acid Products 
Formulation Development/Drug Product Manufacturing 
* Ardena Completes Acquisition of Catalent Drug Product Mfg Facility  
* Jabil Acquires CDMO Pii
* Recipharm Expands Aseptic Filling on Pilot and Clinical Scales

Chemicals/Chemical API Manufacturing 

SK pharmteco Opens HPAPI Lab  
SK pharmteco, a CDMO of small-molecule active pharmaceutical ingredients and cell and gene therapies, has announced the launch of an enhanced analytical testing laboratory dedicated to high-potency active pharmaceutical ingredients (HPAPIs).  

Located at SK pharmteco’s Rancho Cordova, California site, the cGMP laboratory is an addition to the site’s current HPAPIs’ laboratory operations. Designed for the safe handling of potent chemicals for cGMP testing and release, the lab is now fully operational and has already achieved the successful release of its first API. 

Source: SK pharmteco 

AGC Pharma Chemicals Expanding HPAPI Capabilities  
AGC Pharma Chemicals, a CDMO of small molecules, has announced an expansion of its high-potency active pharmaceutical ingredients (HPAPI) capabilities at is site in Barcelona, Spain. The expansion includes:  

  • A new R&D laboratory, operational from March 2025, featuring advanced containment systems with an occupational exposure band of 5 (OEB5); 
  • New IPC/QC laboratories, operational from March 2025, supporting all development phases;
  • Multi-purpose existing kilolab facilities equipped with OEB5 containment systems; and  
  • Advanced new manufacturing facility (operational in the second half of 2025) with an OEB5 HPAPI bay with reactors volumes of 1.5 cubic meters. 

Source: AGC Pharma Chemicals 

TriLink, Avantor In Pact to Supply Nucleic Acid Products 
TriLink BioTechnologies, a San Diego, California-based supplier of nucleic acids, has partnered with Avantor, a provider of products and services to the life-sciences and advanced technologies industries, to expand availability of nucleic acid products to customers across Europe, the Middle East, and Africa (EMEA). Through the agreement, TriLink’s products will now be more widely available in EMEA, including its CleanCap cap analogs (co-transcriptional mRNA caps), catalog mRNAs, over 150 modified and unmodified nucleotides, and high-performance IVT enzymes. 

Source: TriLink BioTechnologies 

Formulation Development/Drug Product Manufacturing 

Ardena Completes Acquisition of Catalent Drug Product Mfg Facility  
Ardena, a Ghent, Belgium-based CDMO of drug substances and drug products, has completed its acquisition of Catalent’s drug-product manufacturing facility in Somerset, New Jersey.The facility encompasses over 50,000 square feet of cGMP manufacturing space and is home to 200-plus scientists and technicians. It is a Center of Excellence for Advanced Oral Dosage Forms, specializing in modified-release formulations, hot-melt extrusion for enhanced bioavailability, and the handling of controlled substances. 

Additionally, Ardena has announced the expansion of its bioanalytical services in North America by opening a new bioanalytical lab at the Somerset facility. The initial investment will include a new 2,500-plus-square foot lab, expected to be operational by the third quarter of 2025 and will provide advanced analytical testing services for both small and large molecules. 

Source: Ardena 

Jabil Acquires CDMO Pii 
Jabil, a global manufacturing company across multiple industries, including pharmaceuticals, has completed its acquisition of Pharmaceutics International (Pii), a Hunt Valley, Maryland-based CDMO of drug products.  

Founded in 1994, Pii’s footprint has grown to over 360,000 square feet across four sites on a single campus in Hunt Valley, Maryland. Pii’s GMP facilities contain over 70 manufacturing rooms, including containment suites for handling high-potency compounds and hormones, dedicated manufacturing suites for oral products, an aseptic facility for injectables, a formulation development center, and analytical and microbiology laboratories.  

In the pharmaceutical space, Jabil focuses on parenteral drug delivery. The acquisition will enhance the company’s existing pharmaceutical service offerings, which includes the development and commercial production of auto-injectors, pen injectors, inhalers, and on-body pumps.  

Source: Jabil 

Recipharm Expands Aseptic Filling on Pilot and Clinical Scales 
Recipharm, a CDMO of drug substances and drug products, has announced that a new modular sterile filling system for process development and pilot-scale and clinical supply, is now fully operational at its facility in Wasserburg, Germany.  The advanced system performs aseptic filling within a Grade A isolator and operates in full compliance with GMP standards and features interchangeable modules that support various product types, such as syringes and vials. The line can deliver 500 to 50,000 units per batch, covering all the development phases of a product An additional pre-filled syringe module is being added to the installation.  

Source: Recipharm