Delivering on the Promise of Purity

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Delivering on the Promise of PurityTM

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Pfanstiehl Vaccine & Biologic Stabilization Solutions

Proteins in biologics & vaccine formulations are sensitive molecules that can undergo denaturation, aggregation, or degradation under various conditions, such as temperature, pH changes, or mechanical stress. Stabilizing proteins is essential for maintaining their therapeutic efficacy, especially in the development of protein-based drugs and biopharmaceuticals.

Therapeutic proteins that are not correctly stabilized can have the following challenges:

Loss of Biological Activity:

One of the most critical effects of protein degradation is the potential loss of biological activity. Proteins rely on a specific three-dimensional structure to carry out their functions, and degradation may disrupt this structure, rendering the protein ineffective or significantly reducing its activity.

Altered Pharmacokinetics:

Protein degradation can lead to changes in the pharmacokinetics of the drug, affecting factors such as absorption, distribution, metabolism, and excretion. This can result in unpredictable drug behavior in the body and may impact the desired therapeutic outcomes.

Immunogenicity:

Degradation can expose hidden epitopes or induce structural changes that make the protein more immunogenic. This may trigger an immune response in the patient, leading to the formation of antibodies against the therapeutic protein. Immune reactions can reduce the protein’s efficacy and, in some cases, cause adverse effects.

Increased Toxicity:

Visible aggregates are often viewed negatively from a marketing perspective. Patients and clinicians typically expect injectable products to be transparent and free from visible particles. The presence of aggregates can raise concerns about the product’s safety and efficacy.

Reduced Stability in Formulations:

Degradation can compromise the stability of the protein in the pharmaceutical formulation. This instability may result in physical changes, such as aggregation or precipitation, which can further reduce the efficacy of the drug.

Inconsistent Dosing:

Degradation may lead to variations in the concentration of the active protein in the pharmaceutical product. Inconsistent dosing can impact the therapeutic response and may lead to under- or overdosing in patients.

Loss of Specificity:

Protein degradation can result in the loss of specificity for the target molecule or receptor. This loss of specificity may reduce the therapeutic selectivity, potentially affecting the intended therapeutic outcome.

Failure to Achieve Therapeutic Goals:

Ultimately, the cumulative effects of protein degradation can lead to the failure of the pharmaceutical product to achieve its intended therapeutic goals. This is a significant concern, especially in the context of protein-based drugs where precision and specificity are often critical

How Can Pfanstiehl Help?

Pfanstiehl’s Technical Sales Scientists can discuss with you to understand your challenges and provide guidance based on experience and literature reviews to stabilize the structure and biologic activity of the therapeutics. Controlling and minimizing degradation is crucial for maintaining the safety, efficacy, and quality of these medications. 

 

Lets us help put together some ideas for:

Formulation optimization:
  • Adjusting the pH: Maintaining proteins at their optimal pH can prevent denaturation.
  • Buffering: Using suitable buffers to maintain a stable pH range.
  • Adding stabilizing agents: Including excipients like sugars, polyols, and amino acids can help stabilize proteins.

Stabilizers

Pfanstiehl HPLE-LMTM Sucrose
Pfanstiehl HPLE-LMTM Trehalose
Pfanstiehl HPLE-LMTM Maltose
Pfanstiehl HPLE-LMTM Mannitol

Buffer Components

Pfanstiehl HPLE-LMTM TRIS Base
Pfanstiehl HPLE-LMTM Tris HCL
Pfanstiehl HPLE-LMTM Sodium Succinate

Lyoprotectant Cryoprotectants

Pfanstiehl HPLE-LMTM Sucrose
Pfanstiehl HPLE-LMTM Trehalose

For over 100 years, Pfanstiehl has made cGMP Injectable grade excipients, stabilizers, and buffer components that are guaranteed high purity and low endotoxin.  Our components are used in the majority of the world’s top utilized pharmaceuticals and we continue to grow every year. 

 

Our customers know the combination of Pfanstiehl’s award winning technical support and high purity low endotoxin cGMP components will help ensure better consistency from batch to batch for your therapeutic and reduce the risk of manufacturing batch failure.

 

If you have a protein biologic or vaccine that needs stabilization excipient technologies to stabilize your protein, please contact us and we will be happy to discuss how we can work together to make your product as high quality as possible.

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