Make Real-time Decisions On Your Process With Real-time Data.

Every unit operation in downstream bioprocessing requires an immense amount of critical data, most of which is hard to get. Atlas brings the core lab directly to your sample, providing critical data across all unit operations with the accuracy and sensitivity of HPLC analysis without the complexity.

Buffer Prep

The buffer prep step in downstream bioprocessing is crucial for ensuring the purity, stability, and efficacy of the final product, yet buffers aren’t verified consistently throughout the process. Atlas provides accurate buffer data in 1 minute so you can be proactive about your bioprocess, not reactive.


  • Buffer Composition: Now you can measure buffer composition for confident decision making.
  • Mixing: Atlas can measure the mixing process of your buffer in real time.
  • Validation For Regulatory Compliance: You can use Atlas to help validate your buffer prep processes

Chromatography

Chromatography is vital for achieving the purity and quality required for biotherapeutic development. Buffer composition must be optimized for each chromatography step to achieve the best separation and binding conditions. Atlas enables process control and monitoring to efficiently get you to optimal, repeatable chromatography operation.


  • Buffer Composition: How do you optimize if you aren’t completely sure what’s in it? Atlas can measure your chromatography buffer composition.
  • Process Control: You can use Atlas for process control to measure column loading and elution

Buffer Exchange and Concentration

Ultrafiltration/Diafiltration (UF/DF) is an essential step in downstream bioprocessing due to its role in concentrating the product, buffer exchange, and impurity removal. Atlas provides first-of-kind, real-time direct product and excipient concentration measurements so you don’t have to guess if your process is done or not. You’ll know.  


  • Membrane Flushing/Cleaning: Is your membrane truly clean of storage solution? Atlas can measure the real-time cleaning of a microfiltration cassette
  • Real-time Buffer Exchange: Want to know exactly what’s happening to each excipient and your drug substance?  Atlas can measure buffer exchange in real-time
  • Reagent Volumes: Need to conserve expensive buffers and reagents? With Atlas you can improve cost efficiency in UFDF
  • Real-time Concentration: There are so many complex physical and chemical phenomena that can alter your excipient concentrations during an ultrafiltration/concentration process. Those changes can have some very adverse downstream efficacy and stability effects, so why not measure them?  With Atlas you can measure excipients and drug substance in real-time during ultra-filtration, monitor the release of protein bound to a membrane after concentration, and characterize your membrane more efficiently.

Formulation

Formulation of biotherapeutics involves development and preparation of the final product that will be administered to patients. This stage ensures that the therapeutics are stable, effective, and safe for use.  Here’s how Atlas can help:


  • Selection of Excipients: It’s critical to you know the concentration of your excipients, including the tricky ones.   Atlas quantitates surfactants in stock solutions and complex formulations, and measure excipient concentrations in your formulation
  • pH and Ionic Strength Optimization: See what you’ve never seen before and get some real granularity into the chemistry of your formulation. Atlas can be used to observe the common ion effect in buffers and formulations, and amino acid concentrations with specificity at the species-level

Sterile Filtration

The sterile filtration process is crucial for safety, regulatory compliance and product integrity. With process-compatible form factors (autoclavable in-situ probes and sterilizable flow cells), Atlas can provide you with critical data to ensure consistent sterile filtration operations while maintaining integrity of sterility.


Filter Compatibility: Since filtration materials can negatively interact with your drug substance and/or excipients and affect efficacy and stability, how nice would it be to measure them in real time?  With Atlas you can do that.

Fill/Finish

The fill/finish process is essential for ensuring a safe, effective and high-quality product. With Atlas, you don’t have to wait on results from traditional end-product testing for dosage and identification for real-time release.


  • Dosage Concentration Accuracy: This is a critical statistic, but waiting for HPLC results can take, well, a really long time. Atlas provides the data you need to be confident in your final product
  • Product Identification:  Atlas can provide unique product signatures to ensure traceability across sites worldwide

Why is Buffer Validation So Important?


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Protein Stability

Buffers protect mAbs from variations in pH, which can lead to denaturation, aggregation, and fragmentation of the proteins. A well-buffered solution maintains its pH despite changes in processing conditions, containers, and raw materials, thereby preserving protein integrity.


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Process Efficiency

High-quality buffers enhance the recovery and yield of target proteins, reducing the need to discard or adjust out-of-specification buffers. This increases processing efficiency.


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Consistency & Quality

Ensuring that buffers meet consistency and quality requirements is essential. Impurities in buffers can negatively impact downstream processes like filtration and chromatography. Guaranteeing consistency and quality through GMP systems is vital to mitigate these risks.

Downstream bioprocessing is a vital step in biomanufacturing because it ensures the final drug product is safe, effective and high-quality.


BioPharm International

Have Any Questions?

We’d love to talk with you about your needs in upstream process monitoring! Feel free to reach out to us and our helpful team will get back to you.


Atlas Reveals Blind Spots Throughout the Bioprocess

Atlas provides confident quantitative results for excipients and antibody titer concentrations 5000X faster; with 100X less sample and 10X cheaper than current techniques.


info@nirrin.tech

(781) 285-5450

44 Manning Road
Billerica, MA 01821

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