The latest from CDMOs, CMOs, and suppliers featuring Simtra BioPharma Solutions, Kindeva Drug Delivery and MilliporeSigma.  

Formulation Development/Drug Product Manufacturing 
* Simtra BioPharma Investing $14 M In ADC Conjugation & Purification Clinical Suite 
* Kindeva Completes Registration Batch at New Injectable Fill-Finish Facility 
General 
* MilliporeSigma Opens $318-M Biosafety Facility 

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Formulation Development/Drug Product Manufacturing 

Simtra BioPharma Investing $14 M In ADC Conjugation & Purification Clinical Suite 
Simtra BioPharma Solutions, a CDMO of injectables, has announced a $14-million investment to expand its clinical-scale conjugation and purification capabilities for antibody-drug conjugates (ADCs) at its site in Halle/Westfalen, Germany. 

Set to be operational by late 2025, this expansion is part of Simtra’s strategy to build an end-to-end service offering, from development to clinical and commercial fill–finish. The new clinical suite at its Halle/Westfalen, Germany site will support ADC development by providing key capabilities, including conjugation mixing, single-use tangential flow filtration, and diafiltration and buffer exchange.  

Source: Simtra BioPharma Solutions 

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Kindeva Completes Registration Batch at New Injectable Fill-Finish Facility 
Kindeva Drug Delivery, a CDMO for sterile injectable, pulmonary, nasal, transdermal, and intradermal finished dosage products, reports that it has successfully completed its first registration batch at is new aseptic injectable fill-finish facility in Bridgeton, Missouri, on its Groninger high-volume vial line. 

This is the first of four lines planned to be installed in the next 18 months. The first Optima line is expected to arrive in November 2024, with qualification slated for completion in the first quarter of 2025. By the end of 2025, Kindeva anticipates both Optima lines will be fully qualified to enable production capacity exceeding 100 million units annually across vials, cartridges, and syringes. 

In addition, the company reported that it successfully completed the factory acceptance testing on the first of two Optima syringe/cartridge filling lines planned for the new facility. 

Source: Kindeva Drug Delivery 

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General 

MilliporeSigma Opens $318-M Biosafety Facility 
MilliporeSigma, the life science business of Merck KGaA, has opened a new EUR 290 million ($318 million) biosafety testing facility in Rockville, Maryland. 

The 23,000-square-meter facility will house biosafety testing, analytical development, and cell-banking manufacturing services. It consolidates labs currently spread across four buildings into a single facility. The new site will feature advanced testing capabilities, including a rapid methods package, designed to accelerate virus testing of bulk harvest material.   

Millipore has made investments over the last five years to expand its biosafety testing capabilities. The company’s global biosafety testing network includes sites in the following: Shanghai, China; Singapore; Stirling and Glasgow, UK; and Rockville, Maryland. 

Source: MilliporeSigma