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Integrated Drug Development Solutions

expediting your drug’s trek to reach acme w w w . a i z a n t . c o m

Your right partner with the right equipment


Service Focus Drug Discovery/ API

Formulation Development

Clinical Program

Analytical Development

Preformulation

Product Registration Support

Preclinical

IND

Phase I

Scale Up & Tech. Transfer

Stability

Phase II

Phase III

NDA

Integrated Drug Development Solutions

PAI


Company Profile

Improving health care and quality of life through science, innovation and built-in quality Aizant® is an integrated drug development solution provider. Aizant was established by experienced pharmaceutical professionals with global exposure. We are a rapidly growing Contract Research Organization (CRO) with a diverse portfolio of services catering to the top pharmaceutical companies globally. We offer comprehensive solutions for Preformulation, Formulation Development, Analytical Development, cGMP Scale-up, Stability, Bioavailability, Bioequivalence, Bioanalysis, Pharmacokinetics, Biostatistics and Clinical Diagnostics. We add exponential value to our clients R&D at every stage of drug development right from the discovery of the molecule to it's entry into the market. We are a vital link between the pharmaceutical companies and the healthcare industry.

The Facility

Infrastructure that meets and surpasses global regulatory standards Aizant is a green field project in Hyderabad, India; specifically designed to deliver a wide range of solutions from formulation development through clinical success. The campus is spread over 4 acres with 75,000+ sq. ft. facility for product development and clinical operations. We have room to expend to another 80,000 sq. ft., within the campus. About 30,000 sq. ft. of laboratory space is dedicated to product development with state-ofthe-art infrastructure. We have dedicated areas for R&D, GMP with additional facilities to handle potent molecules. About 42,000 sq. ft. of laboratory space is dedicated to conducting pharmacokinetic studies and bioanalysis. We have dedicated areas for volunteer registration & screening, biostatistics & clinical diagnostics.

“We provide a safe and environmentally friendly work place”


Quality

By design and not an after thought The foundation for AIZANT success has been the uncompromising quality of its services. Aizant will create value and confidence to its esteemed customers by providing services of the highest quality. We maintain, monitor and continually improve quality systems resulting in efficient processes. All our external comprehensive audits by top pharmaceutical companies worldwide have been completed successfully without a single critical observation. This commitment to quality is the primary reason for a robust product pipeline at Aizant!


Dosage form Development

Leaders in formal research with innovation as a differentiator Our formulation laboratories are fully equipped for development of any product from NCEs to generics including specialty products. We also specialize in reformulation and life cycle extension of existing molecules. We develop effective and efficient products within the committed timelines by utilizing process analytical technologies (PAT). We have a cGMP compliant manufacturing facility providing preformulation, formulation and analytical development that can expedite the drug development process.


Preformulation Our dedicated team of scientists have their core training in the area of preformulation and have expertise in complete pharmaceutical profiling of NCEs. The team is also extensively trained in safe handling of the NCEs. § Preformulation Services: Polymorph screening and selection § Salt form selection § Crystalline properties § pH solubility and stability § solid-state and solution-state stability § Photostability § pKa and partition coefficient determination § Hygroscopicity § Morphology assessment § Solubility studies § § Intrinsic dissolution Excipient compatibility § § Leachables and Extractables studies Flowability § § Particle size determination by laser lights Container – API interactions §

Capabilities: Thermal Analysis: DSC, TGA § Dynamic Vapor sorption/desorption § pXRD § NMR § FTIR § Capillary Electrophoresis § SEM and TEM § Potentiometer § Hot-stage Microscopy § Laser light diffraction Particle size analyzer § Intrinsic dissolution § Head Space GC analyzer §


Formulation Development Our formulation scientists have extensive experience in developing formulations for all phases of drug development. We are experienced in developing solutions for early-in-human formulations, phase II formulations, life cycle management products, IND formulations along with generic equivalents to currently marketed products. Our scientists use Quality-By-Design (QbD) tools at all stages of development of formulation development. Use of Design of Experiments (DoE) along with risk assessment strategies allows us to design our experimental plan. Our development approach allows us meet our delivery timelines and helps us in providing our client's with cost-effective drug delivery/formulation development solutions.

Our extensive formulation development services and capabilities include Formulation development for early safety § studies Prototype formulations for clinical trials § Prototype formulation screening studies § Formulation / process optimization § Preliminary process identification § Commercial formulation development § Process development optimization § Scale up / technology transfer §

At Aizant, we are constantly enhancing our capabilities to suit the needs of our diverse client base. We are currently expanding our offering in enabling formulations with nanotechnology based products, hot-melt extrusion, parenteral drug delivery. We are also expanding our capabilities in handling potent compounds with appropriate engineering controls and personnel protective equipment.

Dosage forms: § Tablets: immediate-release, sustained-release,

delayed-release, film-coated

Equipment and process capabilities: Direct tablet compression §

§ Capsules: powder, granule filling

Fluid bed processing (granulation, drying, §

§ Pellets: into tablets or capsule filled

coating) High shear wet granulation § Dry granulation (roller compaction, § slugging) Extrusion spheronization § Perforated pan tablet coating § Automated capsule filling (powder, § granules, pellets) Spray drying § Microencapsulation § Low humidity / moisture requirements § Taste-masking § High potency compound handling §

§ Powders: powder in a bottle § Liquids: solutions, suspensions, emulsions § Semi-solids: Creams, ointments, gels, lotions


Analytical Research and Development Analytical research and development (AR&D) offers standalone services and supports our formulation development activities. The AR&D teams are integrated with preformulation, product development and quality assurance teams to ensure effective and accelerated product development. Our experience in developing methods for highly complex and unstable drug products complements our formulation capabilities.

Equipment and Capabilities: HPLCs with photodiode array detectors § Head space GC analyzer § FT-IR § NMR § pXRD § Thermal Analysis: DSC, TGA § Dynamic Vapor sorption/desorption § Capillary Electrophoresis § SEM and TEM § Potentiometer § Laser light diffraction Particle size analyzer § Intrinsic dissolution §

Our extensive analytical development services and capabilities include API Characterization § Method development, validation and § transfer Stability studies § Photo stability studies § Analytical methods for cleaning § verification and validation Dissolution and drug release profiling § Forced degradation studies and stability § indicating method development Specifications development § Leachables and Extractables studies § Regulatory support §

Stability Testing

Microbiology

Aizant offers GMP compliant ICH stability testing services. We have dedicated stability chambers for informal (R&D) and registration (cGMP) stability. All our walk-in stability chambers are continuously monitored. We use 21 CFR Part 11 compliant software. An alert system, back up chamber and electricity backup infrastructure guarantees sample retrieval. Following climatic zones are available:

We offer a wide range of compendial and non-compendial testing services. Our microbiology laboratories are designed to facilitate in-house studies as well standalone testing services for our clients. § Our core strengths include: § Microbial Limit test § Antimicrobial Efficacy test

§ 5°C

§ Environmental Monitoring

§ 25°C/60% RH

§ Water chemical and Microbial analysis

§ 30°C/65% RH

§ Bacterial Endotoxin test

§ 30°C/35% RH

§ Antibiotics and Vitamins assays

§ 40°C/75% RH

§ Raw materials/excipients analysis as

§ Photo stability chamber

per BAM § Disinfectants analysis

Customer specific conditions §


Manufacturing

We know the right balance of costs, quality and expediency Aizant provides cGMP manufacturing services for clinical trial materials (CTM) for non sterile dosage forms. Our facility offers flexibility and variety in batch sizes as well as processing requirements. The pilot facility is located in the same facility as our product development. We have additional facilities to handle development and manufacturing of potent compounds. We also undertake low volume commercial production of solid oral dosage forms.

Equipment and process capabilities: Direct tablet compression § Fluid bed processing (granulation, § drying, coating) High shear wet granulation § Dry granulation (roller compaction, § slugging) Perforated pan tablet coating § Automated capsule filling (powder, § granules, pellets) Microencapsulation § Low humidity / moisture requirements §


Clinical Research

Ethical, efficient and compliant clinical research Bioavailability and Bioequivalence We handle all types of bioavailability (BA)/ bioequivalence (BE) studies in healthy human male and female volunteers in accordance with International Conference on Harmonization (ICH)-Good Clinical Practice (GCP) guidelines. Two clinics of 40 beds each are spread in 14,000 square feet area. Both the clinics seamlessly combine into a single 80 bed clinic for larger studies. With an extremely large female volunteer database of about 500 we currently conduct a large number of female studies. Our large female volunteer database with our unique facility design enables us to conduct mixed gender studies complying with global ethical standards. Our volunteer registration software is equipped with biometrics and is 21 CFR Part 11 compliant.

We conduct these studies for pharmaceutical companies across the globe on various dosage forms: Relative bioavailability § Absolute bioavailability § Multiple dose/Steady state studies § Dose escalating studies § Food & Drug interaction studies § Pharmacokinetic studies § Dispensing/Compounding pharmacy § Our dedicated group of Quality Assurance (QA) team provides absolute confidence to our customers through their systems resulting in ethical, efficient and compliant clinical research.

Clinical Laboratory Services

“Our on-site qualified pharmacists, formulation scientists and supporting QA staff from our product development with the know-how, cGMP materials & qualified equipment are uniquely qualified in compounding your tough formulations right before the clinical study”

Hematology § Biochemistry § Immunology / Serology § Urine analysis § Clinical pathology § § Radiology


Bioanalysis

We can navigate the process in time and in compliance Our GLP certified bioanalytical laboratory* is equipped with state-of-the art Liquid Chromatography and Tandem Mass Spectrometry (LC-MS/MS) instruments with a sample processing capacity of 4000 samples per week. Our highly qualified team of scientists with in-depth knowledge in instrumentation and application of LC-MS/MS technology enables us to provide you with rapid method development. We validate our analytical methods as per global regulatory requirements. * National GLP compliance monitoring authority

With a proven track record in developing methods for highly complex (hormones) and unstable molecules we are your right partner for all of your bioanalytical needs. Our scientists have derived a process flow that generates results with quality withstanding any regulatory scrutiny while meeting your timelines. We currently perform bioanalysis on the following LC-MS/MS: § Shimadzu UFLC – API 4000 Sciex § Waters Alliance – Quattro premier XE § Agilent Infinity UHPLC – Agilent 6460


Biostatistics

Project Management

We do it all. Your integrated drug development partner

People, who speak your language, understand your course and move you ahead

Our dedicated pharmacokinetics & biostatistics team provides statistical support using WinNonlin and SAS with focus on your timelines and quality control. Capabilities include: § Writing and documenting validated SAS programs for data analysis and reporting § Selection of appropriate statistical methods § Generation of randomization schedules § Defining analysis populations § Sample size rationale § Description of statistical methodology § Identifying outliers

At Aizant, Project management is all about delivering to plan, in time, within the budget and with right sized communication. Our project managers are experienced in managing complex projects, working with geographically distributed resources, suppliers, vendors and contractors with a pulse on execution. Aizant has the right resources available to deal with each project and its uncertainties. Our key differentiators are: § Experienced project managers with knowledge of Six Sigma processes § Metrics based project planning and execution § Nimble change control process § Single point of contact for accountability § Supported by a multifunctional team


Integrated Drug Development Solutions

Aizant Drug Research Solutions Pvt Ltd. Sy No. 172 & 173, Apparel Park Road, Dulapally, Hyderabad - 500014 A.P. India. T : +91 40 23792190 / 91 / 92 F : +91 40 23792223 E : info@aizant.com

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