Analytical Services

KEMP PROTEINS: ANALYTICAL CAPABILITIES

As a partner in your product development, Kemp Proteins offers a suite of analytical capabilities to establish In Process Controls (IPC) and Release Assays. We are dedicated to establishing assays for your process that are functional and valid across labs to provide the relevant information throughout you program cycle.

Development of applicable Analytical Testing for your Therapeutic Biologic, Vaccine, or Protein/ Antibody Diagnostic can be based on client provided assays, Kemp Proteins’ internal validated Quality Control assays, or de novo method development depending on the client needs. Our highly qualified team will collaborate with you to establish method feasibility, development, qualification, and validation processes that result in a comprehensive documentation dossier to ensure an efficient method transference to your preferred GMP partner.

IPC are paramount in ensuring Process Discovery/ Development efforts maintain the Critical Quality Attributes (CQA) for your molecule of interest. In conjunction, IPC and CQA help derive the Critical Process Parameters (CPP) that assist in defining the finalized Upstream and Downstream Processes. Kemp Proteins believes in Quality by Design and are flexible in deriving appropriate assays to address the criticality of every step in the process. We are here to help you navigate the process, from conception to reproducibility.

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REFERENCE MATERIAL AND MOLECULAR TOOLS

Assay development, qualification and validation relies heavily on access to suitable reference material that is representative of the final, preferred molecule of interest. In some cases, we receive programs that are in the initial conception or early discovery phase that need suitable representative material and/ or molecular tools. If suitable reference material is unavailable, Kemp Proteins has a long history of protein expression and purification and can produce these materials for your program needs. In other cases, Kemp Proteins receives methods from clients that need optimization, or rely on externally provided reagents. We recommend getting control of your IPC and Release Assays through the internal generation of protein-based reagents. From conjugated molecular probes to Anti-IDs Kemp Proteins is here to help your program succeed.

Kemp Proteins team and equipment enable the following protein characterization:

Chromatography Based Characterization

Size-Exclusion with Multiangle Light Scattering
Analytical Size Exclusion
Reverse Phase HPLC
Analytical HPLC

1. Ion Exchange
2. Hydrophobic Interaction
3. Hydrophilic Interaction Liquid Chromatography

Dynamic Light Scattering

ELISA/ BLI Based Characterization

Affinity Characterization
Residual Host Cell Protein
Residual Host Cell DNA
Residual Protein A
Glycan Screening

Other Standard Characterization

SDS-PAGE and Western Blotting
Enzymatic Activity Assays
Protein Quantitation
Nucleic Acid Quantitation
Osmolality
Microbial Enumeration following USP <61>
Sterility following USP <71>

Stability Studies

Stress (accelerated) Stability Studies at X^oC and XRH%
Real Time Stability Studies at X^oC and XRH%

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Kemp Proteins’ Project Management Process

Client communication: Initial discussions and an ongoing collaborative communication process is vital to us maximizing the potential for your successful project outcome. Our initial discussions are information gathering to enable us to generate a statement of work, a “project plan”, that is shared with you. Together we refine the plan until the plan captures your project specifications and deliverables and nuances that may be particular to your protein of interest and its intended use. We will supply regular updates through conference calls or information download through electronic means such as “Box” or your preferred alternative.