Biotherapeutics and Custom Antibodies

Biotherapeutics

Biotherapeutic Development Support

At Peak Proteins we have many years of experience in supporting the early-stage development of protein based biotherapeutic molecules. Our team has supported biotherapeutic projects involving antibodies, antibody derivatives, chemokines and other protein classes.

Whilst we are not a GLP or GMP facility, we follow Quality by Design principles in taking upstream and downstream laboratory scale processes and modifying them so that they are amenable for manufacture. These are underpinned by Design of Experiments, using JMP software, where appropriate. The ultimate aim is to generate a process that is robust, reproducible, has steps that are scaleable and considers both COSHH and the overall environmental impact. Furthermore, we take into account the cost of goods when designing the process.

During our development experiments we employ mass spectrometry and other analytical techniques with the aim of establishing an early definition of critical quality attributes for your molecule.

In addition, we have a strong track record in providing customers with antigens for their biotherapeutics (including membrane protein targets) along with offering various biophysical techniques to evaluate the antigen / biotherapeutic interaction.

This approach aims to give you the highest chance of delivering a successful biotherapeutic candidate and production process to a CDMO.

Summary of what we provide

If what you need is not listed below then please contact us, as it is likely that one of our team has experience with the technique you require.

Target Engagement

  • Antigen construct design for assay optimisation
  • Dedicated Membrane Protein team
  • Antigen/antibody complex analysis
  • Structural Biology (X-Ray crystallography/ NMR/ Cryo-EM) antibody structural resolution, antigen antibody engagement
  • Epitope Binding and Binning.
  • Bispecific ternary complex assessment
Upstream and Downstream Process Development

Upstream and Downstream Process Development

  • USP and DSP amenable for full scale manufacture.
  • Following quality by design principles.
  • Parallel expression of multiple constructs
  • Up to 25 L scale expression
  • DoE and cell line optimisation
  • Low endotoxin working
Design and Format

Design and Format

  • Format assessment mAb, antibody fragments, multi-specifics, fusions
  • Introduction of conjugatable handles
  • Small molecule conjugation capabilities.
  • In-depth Biophysical and QC analysis. Methods including SPR, ITC, MST, MS, SEC-MALS and FIDA
Lead Optimisation

Lead Optimisation

  • Post translational characterisation.
  • Sequence liability determination.
  • Optimisation of conjugation.
  • Fc Effector function assessment.
  • PK characterisation

Custom Antibodies and Antibody Derivatives

We have experience producing and characterising custom antibodies and derivative forms.

CUSTOM ANTIBODIES

Custom Antibodies and Antibody Derivatives

  • Conventional antibody isotypes and subtypes (IgG, IgD, IgA, IgM, IgE)
  • Chimeric and humanised antibodies
  • Antibody fragments (ScFv, Fab, Fc, VHH, Nanobody, VNARs) and Fc fusions
  • Bispecifics and Trispecifics
  • Scaffold and format switching

Biotherapeutics and Custom Antibodies Resources

TitleContentCategoriesResources Typeshf:categorieshf:tax:resource_type
Developing a robust biopharmaceutical production processCase StudyMOREcase-study
Use of mass spectrometry to elucidate critical quality attributes of a biopharmaceuticalCase StudyMOREcase-study
The Role of Structural Biology in the Development of Biotherapeutics, , , , BlogMOREantibodies biotherapeutics cryo-em blog x-rayblog
Contributing to the Development of New Anti-Thrombotic Biotherapeutics, , Company NewsMOREantibodies biotherapeutics peak-protein-newscompany-news
Enhancing Biotherapeutic Protein yield through CHO Expression OptimisationCase StudyMOREcase-study
Using Design of Experiments to Increase Protein Yield in HEK293 6E cellsCase StudyMOREcase-study
More Papain, More ProblemsCase StudyMOREcase-study
Sherlock Holmes and the Case of the Three Missing Amino AcidsCase StudyMOREcase-study
DoE: THE experimental method that every scientist should be aware of, , BlogMOREbiotherapeutics design-of-experiments blogblog
Chinese Hamster Ovary Cells – A Biologics Powerhouse (past, present & future?), BlogMOREbiotherapeutics blogblog
Sherlock Holmes and the Case of the Missing Cysteines.Case StudyMOREcase-study
A Quick and Cost-effective Test for COVID-19 Antibodies for Frontline Healthcare WorkersFrontline and healthcare workers are at high risk of developing COVID-19 in the current pandemic. Using swab tests to detect …Company NewsMOREantibodiescompany-news
Time critical purification of multiple Fab constructs for assayCase StudyMOREcase-study