From Discovery to Phase III
KABS's integrated teams offer advanced support and solutions for drugs, biologics, generic products and veterinary vaccines development. All aspects of drug product development are produced at reasonable cost with efficient timeline management.
New drugs and biologics
Projects are managed by Team leaders integrating analytical R&D, Product Development R&D, Manufacturing and Quality Assurance, all located at one site.
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
KABS provides 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.
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.
Design of formulations for animal toxicological studies
Formulations for animal toxicology studies must be simple, stable and homogeneous. KABS pre-formulation teams are working with these objectives in mind.
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.
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.
Our analytical R&D group and formulators have developed solid expertise in reverse engineering of formulation and manufacturing methods.
Evaluation of generic API
Generic API are often synthesized by alternate routes generating unusual impurities. Solid-state characteristics of generic API may be different from the desired characteristics. KABS helps identify and solve these potential pitfalls before they become expensive problems.
cGMP compliance audit of API manufacturers
The synthesis of API 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 API 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.
Development and scaling of bioprocess
KABS bioprocess team produces and purifies your vaccines. Our services include cell culture condition improvement, optimization of growth and/or expression factors, purification process development, protein/metabolites modification, and scale-up. All development work is performed keeping in mind the scale-up to mass production.
Selection of adjuvants
Selection of the appropriate adjuvant is as important as the production of quality biomass. This selection requires a high level of collaborative development work. For this purpose KABS bioprocess specialists maintain close collaborations with adjuvant manufacturers and in-vivo vaccine testing organizations.
Projects are managed by experienced team leaders at KABS’s multi-functional facility.
All aspects of drug product development are produced at reasonable cost with efficient timeline management.
From concept to production
At KABS, we offer full support and service for transferring pilot manufacturing processes to mass production plants.