The latest from CDMOs, CMOs, and suppliers featuring National Resilience, Alcami, Abzena, and Sai Life Sciences.  

Biologics Manufacturing 
* Resilience, Taiwan Bio-Manufacturing Corp. Form Biomanufacturing JV 
* Abzena Launches New Analytical Services Platform 
Formulation Development/Drug Product Manufacturing 
* Alcami Expands Sterile Fil–Finish Capacity 
General 
* Sai Life Sciences Expands DMPK Testing Labs 

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Biologics Manufacturing 

Resilience, Taiwan Bio-Manufacturing Corp. Form Biomanufacturing JV 
National Resilience, a CDMO of biologics and advanced therapies, and Taiwan Bio-Manufacturing Corporation (TBMC), a joint venture between the Taiwanese government and National Resilience, focused on digital intelligent mass production technology, have formed a joint venture (JV) focused on biomanufacturing.  

The JV combines the technological capabilities of Resilience with Taiwan’s expertise in automation, digital manufacturing, and life-sciences workforce management. As part of the collaboration, Resilience will license certain manufacturing technology platforms in all five of its therapeutic modalities (biologics, vaccines, nucleic acids, cell therapies, and gene therapies) to TBMC and will provide support in designing and constructing cGMP facilities and process development laboratories for the JV. In return, Resilience becomes an equity shareholder of TBMC.  

Source: National Resilience 

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Abzena Launches New Analytical Services Platform 
Abzena, a San Diego, California-based CDMO of biologics and antibody drug conjugates, has launched a new analytical platform, LabZient.  

The platform combines predictive in–silico evaluation with laboratory methods that de-risk the application of platform analytical procedures to measure antibody critical quality attributes  

The platform’s methods are fit for across a range of antibodies, including monoclonal antibodies, antibody fragments, and bispecifics. 

Source: Abzena 

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Formulation Development/Drug Product Manufacturing 

Alcami Expands Sterile Fill-Finish Capacity 
Alcami, a CDMO of drug products and analytical testing services, has announced the expansion of its sterile fill–finish manufacturing capacity with the addition of a new sterile fill–finish line with isolator and two lyophilizers at its existing site in Charleston, South Carolina. 

The new sterile filling line offers the flexibility to fill liquid and freeze-dried vials under isolator technology at clinical and commercial scale. 

Source: Alcami 

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General 

Sai Life Sciences Expands DMPK Testing Labs 
Sai Life Sciences, a Hyderabad, India-headquartered contract provider of drug-discovery, medicinal chemistry and testing services and a CDMO of intermediates and active pharmaceutical ingredients, has announced an expansion of its drug metabolism and pharmacokinetics (DMPK) capabilities. The expansion comprises the addition of 25,000 square feet of labs equipped with instrumentation enabling automation.  

The expansion includes: (1) a centralized lab design where assays are performed using automation; (2) expanded space for animal holding and procedure and surgical rooms for supporting rodent PK studies; (3) infrastructure for supporting bioanalysis of samples at higher sensitivity and faster turnaround time; (4) space expansion with dedicated necropsy rooms and safety hoods to perform non-GLP in vitro safety and in vivo toxicology studies supported by immunohistochemistry and toxicokineticanalyses; and (5) a dedicated lab for manual patch-clamp setup for supporting cardiotoxicity profiling and for ion-channel-based research. 

Source: Sai Life Sciences