NewLab BioQuality offers a wide range of analytical services used to determine the identity, purity, integrity and stability of biopharmaceutical products. The methods fulfill all requirements set by international regulatory authorities.

Product characterization

NewLab BioQuality assists in compiling a comprehensive set of testing methods for your individual product.  These are dependent upon the regulatory guidelines and the stage of product development. Our assays are validated according to the current ICH guidelines prior to use for client samples.  Sample-specific validation is also performed when required. The following analytical methods are available:

• 1-D and 2-D SDS-PAGE, reducing and non-reducing conditions, silver or Coomassie stained, including scanning densitometry
• Western blot
• Isoelectric focusing
• Peptide mapping using reverse phase HPLC
• Reverse phase, size exclusion and ion exchange HPLC
• Carbohydrate analysis using the HPAEC-PAD method
• Capillary electrophoresis
• Bradford assay, BCA
• Spectrophotometric analysis
• Determination of pH, appearance, color
• ELISA / ILA assay development
• N-terminal sequencing, mass spectrometry and amino acid analysis are also available through subcontractors

In vitro potency assays

NewLab BioQuality has validated, viral-based bioassays for determining the potency of interferon a2b and interferon ß as described in the European Pharmacopoeia.  In addition, an in vitro-based bioassay for EPO is available. The statistical evaluation of the bioassays are performed using the parallel line model.
Utilizing its experience with bioassays, NewLab has also developed client-specific bioassays.  These include bioassays to determine the potencies of other antiviral agents and for growth factors.  A bioassay should be developed early in the research phase of product development to set the standards for the future product.  In addition, assays which have been developed for use in the research laboratory can be transferred to NewLab, validated and then used to perform GMP-compliant testing as required by the regulatory authorities.

Stability testing

NewLab BioQuality has environmental chambers which have been qualified and validated under strict GMP requirements to be used for stability studies. The storage conditions are specified in the ICH guidelines for long-term and accelerated stability studies. All chambers have computerized temperature control and humidity monitoring systems as well as back-up systems and alarms.
A broad set of analytical services are available for the stability testing of biopharmaceutical proteins as well as plasmids used in gene therapies. NewLab BioQuality can assist you in designing ICH-compliant stability testing programs and identifying the suitable methods to show product stability. All methods are validated prior to use and the instruments have been qualified by a well-trained technical staff. Documentation related to the study is maintained throughout all phases.
A Project Manager will be assigned to your project and will assist you during the study, from the design stage throughout to finalization of the study. This provides you with a one-point contact ensuring that all timelines are met and that you are routinely updated on the progress of your study.

Protein contaminants

Host cell proteins

Generic host cell protein assays are available for E. coli and CHO-derived products.  These assays have been developed by NewLab and have been validated on a generic sample matrix.  These assays may be useful in the early stages of process development for a general investigation into HCP burden.
A specific host cell protein assay is normally required for later phases of product development.  NewLab BioQuality  has developed several specific assays to quantify HCP using either the ILA or the ELISA methods.  Assay development starts with testing for a suitable, specific antigen which has been produced by our client.  This antigen will be used to immunize the animals from which the antisera will be obtained.  A specific detection system is developed and optimized for the specific matrix. 

According to the regulatory authorities, the assay should be validated prior to use in the quality control of a biopharmaceutical.  The development and validation of a client-specific HCP assay normally requires between six and twelve months. Therefore, development of the assay should begin as soon as the downstream process development has been finalized.

Protein contaminants

NewLab BioQuality offers highly sensitive, validated methods for the quantitation of specific, potentially contaminating proteins.  Generic methods include common protein additives as seen in the following table.  We are also able to develop client-specific immunoassays for their specific potential contaminant.  Examples of assays we have developed for protein contaminants include: