Problem: Client process yielding only 15 mg/L after final purification.
Solution: PD performed media and feed development to establish a high cell density fermentation process that yielded 1800 mg/L after final purification, a 120-fold improvement in yield.
Althea Technologies offers the highest quality biologics manufacturing services available. From the establishment of the Master Cell Bank to the final fill and release of your product, Althea will apply our extensive experience to achieve product success. Althea is focused on offering highly responsive customer service, flexible scheduling, and rapid turnaround times to meet the requirements of both early stage clinical programs and commercial programs alike.
Althea's expert process development team understands that every project is unique and utilizes DOE and Quality by Design methodology. Utilizing a modular approach, our clients can also leverage our expertise to develop individual steps in their process, whether it be upstream or downstream.
UPSTREAM DEVELOPMENT
Fermentation
+ Media Optimization for Bacterial & Yeast Cell Cultures
+ High Cell Density Process for Increased Titers
+ Batch, Fed-batch or Continuous Processing
+ High Cell Density Process for Increased Titers
+ Batch, Fed-batch or Continuous Processing
Cell Harvest/Product Recovery
+ Cell Breakage (Intracellular Product Recovery)
+ Separation / Clarification and Concentration Steps
+ Centrifugation, TFF, Depth Filtration
+ Solubilization and Refolding for Inclusion Body Products
+ Separation / Clarification and Concentration Steps
+ Centrifugation, TFF, Depth Filtration
+ Solubilization and Refolding for Inclusion Body Products
DOWNSTREAM DEVELOPMENT
Chromatography
+ Ion Exchange
+ Hydrophobic Interaction Chromatography (HIC)
+ Affinity
+ Size Exclusion (SEC)
+ Mixed Matrix
+ Hydrophobic Interaction Chromatography (HIC)
+ Affinity
+ Size Exclusion (SEC)
+ Mixed Matrix
Compound Formulation
+ UF/DF
+ Complex Aseptic Processing
+ Rotary Evaporation and Homogenization
+ Complex Aseptic Processing
+ Rotary Evaporation and Homogenization
biotech and pharmaceutical companies from pre-clinical development through commercial supply.
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