Development and aseptic manufacturing of complex liquid/lyophilized parenteral products in small to medium batch sizes.
Development and manufacturing of complex oral dosage forms in small to medium batch sizes.
Development of custom synthesis and purification procedures for biopolymers and small molecules.
From Discovery to Phase III and Commercialisation
KABS’s integrated teams offer advanced support and solutions for drugs, biologics and generic products development. All aspects of drug product development are performed at reasonable cost with efficient timeline management.
New drugs and biologics
Preclinical Development
Project management
Projects are managed by Team leaders integrating analytical R&D, Product Development R&D, Manufacturing and Quality Assurance, all located at one site.
Regulatory affairs
Our regulatory affairs specialists provide both strategic and tactical support during early development phases leading to toxicology studies and IND filings.
Audits of suppliers
The synthesis of API is a global market that requires intensive regulatory and technical monitoring. Our QA department audits manufacturing sites worldwide.
API synthesis strategies, solid state chemistry, specification
We provide full support for selection of intermediates manufacturers, chirality aspects, characterization of amorphous states, evaluation of process impurities, crystallization strategies with respect to polymorphism, hygroscopy and stability, development of specification.
Development of bioprocesses
KABS bioprocess team prepares and purifies your secondary metabolites and proteins. Our services include cell culture condition improvement, optimization of growth and/or expression factors, scale-up, purification process development, and protein/metabolites modification.
Pre-Formulation
Physico-chemical characterization of initial batches of API
We perform thorough physico-chemical characterization and stability testing, keeping in mind strategic aspects involved in qualifying process impurities observed in initial batches of API to be used in toxicology studies.
Pre-formulation prototypes for human phase I
A sizable proportion of small molecules and biologics are not readily soluble and/or bioavailable. Solubility and bioavailability are modulated via specific crystalline forms, micronization, surfactants, pairing agents, and trans-membrane transport co-factors. KABS offers a range of solid dosage formulation predictive modeling tools involving partition studies, Pampa Plate Systems, Franz osmotic systems to predict solubility and bioavailability of experimental formulations.
Design of formulations for toxicological studies
Formulations for animal toxicology studies must be simple, stable and homogeneous. KABS pre-formulation teams are working with these objectives in mind.
Phases I, II and III
Engineering considerations in future scaling-up of manufacturing process
KABS formulation strategies include scaling-up criteria insuring that formulation that are successful in phases I and II will be scalable to mass production equipment for phase III and ulterior phases leading to commercialization.
Development of CMC dossiers for API and drugs product
Over the years KABS has developed expertise in the generation, interpretation and integration of cGMP compliant data into sound CMC dossiers
Manufacturing, labelling and distribution to clinical sites
Our cGMP compliant manufacturing plants and laboratories are located on the same site. In-process testing is performed rapidly, reducing costly delays in manufacturing. KABS offers cGMP and GCP compliant labelling/blinding protocols and distribution to your clinical sites.
Transfer of manufacturing process for mass production
Formulations and processes developed at KABS are designed for easy scale-up. We offer full support for transferring pilot manufacturing processes to mass production plants.
Generic products
Reverse engineering
Our analytical R&D group and formulators have developed solid expertise in reverse engineering of formulation and manufacturing methods.
Evaluation of generic API
Generic drug substances are often synthesized by alternate routes generating unusual impurities. Solid-state characteristics of generic substances may be different from the desired characteristics. KABS helps identify and solve these potential pitfalls before they become expensive problems.
cGMP compliance audit of drugs substances manufacturers
The synthesis of drugs substances is a global market that requires regulatory and technical monitoring. Our QA department audits manufacturing sites worldwide.
Small scale manufacturing/testing of generic prototypes
Bioequivalence is achieved using equivalent solid state characteristics, formulation and manufacturing processes. Close collaboration between our formulation/manufacturing and analytical groups insure rapid testing of generic prototypes manufactured under various microscale conditions.
Scaling up of manufacturing process for bioequivalence studies
Formulations and manufacturing processes developed at KABS are configured for direct scale-up to bioequivalence clinical batches.
Scaling up of manufacturing process for mass production
KABS provides full technical and regulatory support for process transfer to mass production facilities.
Biopolymers
Development of bioprocesses
KABS biopolymers team prepare and purify proteins and antibodies. Our services include process development in aqueous based synthesis, modification and purification/desalting via TFF.