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Let’s Make Drug Product

Vials

Lyophilization

Syringes

Fill & Finish

Althea offers a unique range of aseptic fill & finish to address production needs that span small scale early stage clinical products to larger scale commercial products. Althea’s equipment and expertise paired with our flexibility and responsiveness, provide you with the capacity to advance your projects through all stages of clinical and commercial development.

Our aseptic fill finish projects for clinical batches can be as small as 100 units all the way up to batch sizes reaching over 70,000 vial units. Vial volume sizes can range from 0.5 mL to 100 mL depending on the needs of your drug product program. Over 2,000 lots of finished cGMP product have been filled in our facility. We have 5 Formulation Suites and 5 Independent fill & finish Suites with 3 automated aseptic filling lines. Contact Althea today to learn more about our aseptic vial fill finish services.

Althea Facility Capacity

  • Vials from 0.5 mL to 100 mL
  • Line speeds up to 7,500 vials/Hour
  • Comprehensive range of media fill configurations
  • Limited line loss
  • ISO5 oversealing environment
  • Batch sizes up to 70,000 vials

Althea Fill Finish Technical Capabilities

  • Nitrogen overlay
  • High speed vial labeling
  • Continuous environmental monitoring
  • Peristaltic and rotary piston pumping
  • Integrated from vial washing through capping

Althea Dosage Forms

  • Parenteral products
  • Lyophilized products
  • Viscous products
  • Suspension products
  • Complex formulations of liposomes, adjuvants, crystallized proteins

Specification Table

Product TypesLarge molecule, small molecule, vaccines
Vial Sizes2 - 20 mL (ROTA 150)
2 - 100 mL (ROTA 50)
Aseptic Filling Speed75 - 125 vials per minute, depending on vial size
Annual Capacity15 million units
Maximum Lot Size75,000 (ROTA 150)
25,000 (ROTA 50)
Manufacturing ScaleCommercial and clinical

Lyophilization Services

The process of lyophilization or freeze drying can achieve superior product stability, and improved shelf-life. If your molecule requires the added stability of lyophilization, Althea offers cGMP lyophilization services in conjunction with our Fill Finish capabilities. If you have an existing lyophilization process, we will work with you to transfer and adapt your lyophilization cycles to our equipment.

Althea’s VIRTIS Ultra 35EL lyophilizer has a maximum lot size of 6,100 x 2 mL vials and can fill a range of vial volumes from 2 mL to 50 mL. The lyophilizer, with external condensers, has temperature control to as low as -65 °C and vacuum control between 50 and 1000 millitorr.

Prefilled Syringes

Prefilled syringes offer many advantages as a unit dose medication drug delivery system and are continually employed for clinical testing and commercial products. Althea offers comprehensive prefilled syringe contract manufacturing services including parenteral manufacturing on our high-speed prefilled syringe line. Our prefilled syringe production facilities utilize Restricted Access Barrier (RAB) technology to ensure the required sterility for fill finish.

Secondary packaging and visual inspection is conducted to finish the final product and prepare prefilled syringes for clinical or commercial distribution. In our clinical manufacturing facility, we fill batch sizes of up to 20,000 prefilled syringes. For commercial-scale fill finish  programs, we accommodate batch sizes of up to 100,000 units, supporting your progress through the clinic and into the commercial market.

Althea Prefilled Syringe Facility

  • Maximum lot size is 100,000 syringes
  • 5 Head peristaltic pump or rotary piston pump systems
  • Prefilled syringe sizes – 0.5 mL – 20 mL
  • Non-destructive fill checks
  • Restricted Access Barrier System (RABS)
  • INOVA H3-5V
  • Glass or polymer syringes
  • Automatic Tyvek® lid and liner removal
  • Line rated at 13,000 prefilled syringes/hour
  • Vacuum filling & vacuum stoppering
  • Non-Destructive weight checks
  • Compliant with cGMP standards and FDA guidelines

 

Althea Technical Capabilities and Testing for Prefilled Syringes

  • Break-Free, glide force and injection force testing
  • Syringe/container biocompatibility testing and analysis
  • Micro-Flow imaging for sub-visible particle analysis
  • Field Flow fractionation (FFF-MALS) for protein aggregation evaluation
  • Mass spectrometry
  • Evaluation of interactions with silicone oil and tungsten oxides
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