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Services we offer

All services provided by K.A.B.S. may be performed either independently or in close interaction with your staff, according to your specifications.
Reports are presented either as self supported files including all the provisions of the GLP guidelines (certificates of validation, calibration, training, etc) or in simpler form with the supporting quality assurance documents available in our files.

1. Development and Validation of analytical methods for:

Raw Materials
- Raw drugs, excipients and additives (assay, impurities, OVI, forced degradation studies).

Processes
- Cleaning validation (traces of active ingredients, residual detergents).
- In-process analysis (dissolution profiling, content uniformity, hardness, thickness, etc.).

Finished Products
- Tablets, capsules, syrups, gels, creams, aerosols etc. (assay, impurities, OVI, dissolution, long-term and accelerated stability studies).

2. Transfer of methods and techniques to your lab
- Training (courses on instruments, method development, validation, regulations etc.).
- Troubleshooting in your laboratory.
- Interlaboratory validation.

3. Quality control analyses
- USP, BP, EP, JP, FCC methods.
- In-house validated methods or your  methods.
- Containers permeability testing.
- Gases (i.e. residual oxygen in sealed ampoules, containers etc.)

4. General consulting services
- Solution of physico-chemical problems in your experimental formulations.
- Isolation and identification of unknown impurities.
- Scientific advice for your communication with regulatory agencies.
- Solution of process inconsistencies and process validation.

Services for Biotech developers and Manufacturers

K.A.B.S. is offering characterization services for glycoproteins, proteins and DNA to bio-pharmaceutical developers and manufacturers. These services are performed under the cGMP regulations insuring the conformity of your characterization and quality control data. We also propose a regulatory consultation service specifically designed to support your biotech development team in developing specific, rapid and validated quality control tools for your products and formulations.

The Routine Quality Control Tests include:
- Determination of Molecular Weight (Ferguson Plot Method)
- Determination of Isoelectric point
- Quantitative Profiling by SDS-Capillary Gel Electrophoresis
- Quantitative Profiling by Capillary Isoelectric Focussing
- Quantitative Profiling of Glycoforms by Capillary Electrophoresis
- Quantitative Profiling of Oligosaccharides and Saccharides (Microheterogeneity)

Mapping and Submapping Related services:
- Development, Validation, Troubleshooting of GC, HPLC and CE Methods
- Courses and Training in all Aspects of Regulated Analytical Chemistry
- Quantitative Profiling of Monoclonal Antibodies
- Chiral Chromatography
- Biotechnological Process Validation

At your convenience, we welcome in-depth audits of its operating procedures and laboratories.

 

© 2000 KABS Laboratories Inc.
Pharmaceutical analysis laboratories providing analytical services for the pharmaceutical industry.