
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.
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