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Confidential
AvacaPharmaInnovation for Better Health
Formulation Development II Analytical Development II Commercial Manufacturing
Cellix Bio Pharma Initiates Acquisition of Avaca Pharma
Vision To become a globally recognized pharmaceutical development organization by 2025.
Mission Innovate for better health.
Values Adhering to patient centricity.Valuing our stakeholders.Applying QbD principles.Caring our environment.Acting with integrity.
Our Goal
Formulation Development II Analytical Development II Commercial Manufacturing
AvacaPharma, a new-gen pharmaceutical development and commercialization organization
AvacaPharma Commercial Operations Center (COC) is located between Hyderabad and Vijayawada,
Andhra Pradesh, and will host commercial manufacturing, packaging, analytical, and warehousing facilities within the 15 acres
environmentally friendly campus. The facility will have a total built up cGMP space of 126,685 sq.ft.
meeting regulatory compliance standards.
Facilities
AvacaPharma Research and Development Center (RDC) at IDA Pashamylaram, Hyderabad, has a total cGMP space of 6000 Sq. ft. in a 1.2-acre location, of which
Formulation occupies 3000 sq. ft. and Analytical Operations 3000 sq. ft. with provisions for expansion.
Formulation Development II Analytical Development II Commercial Manufacturing
AvacaPharma Research and Development Center (RDC) and Commercial Operations Center (COC)
Formulation Development
Analytical Development
Support Services
R&D Business Verticals
Pre Formulation Studies- Proof of Concept- Solubility Profile
- Evaluation of RLD- Formulation Studies
- Drug-ExcipientInteraction Studies- Container/Closure
System Compatibility- Quality by Design
(QBD) Development- Scoring Evaluations
Method Development
Method Validation
Stability Studies
Method Transfer
CMO Management
CRO Management
Project Management
Quality Assurance
Regulatory Services
Formulation Development II Analytical Development II Commercial Manufacturing
An integrated R&D business model to support your product
Scalability & Commercial Opportunity
Scientific R/B
analysis
IP status & Strategic fit
Confidential
Portfolio Selection Criteria
Liquid Orals
Parenterals
Topicals
Immediate release tablets and capsules Powders for suspension, solutionSustained/Controlled/Extended releaseMulti-particulate systems (Pellets)Gastro-retentive systems
Solid OralsLiquid injectionsMicro emulsionsDepot formulationsPowders for constitutionPowder for injection
SuspensionsSolutions
CreamsGelsLotions
R&D Dosage Form Capability
Formulation Development II Analytical Development II Commercial Manufacturing
Formulation and process development
Confidential
Powder for Solutions
Powder for Suspensions
Liquid injectables
Parenteral Formulation Capability (SVP)
ANDA formulations
NCE formulations
505 (b) 2 formulations
Simple generics Complex generics
New formulation (IP)Novel process (IP)
Orphan Drugs Formulation strategy (IP)
Pre clinical tox formulationLate stage clinical formulation
Formulation Development II Analytical Development II Commercial Manufacturing
Your strategic fast to file product development partner for regulated markets
Supporting Submission Pathways
cGMP Formulation Facility
Formulation lab
▪ Rooms and areas:
Pre-formulation (solubility, flow, stability profile).
Granulation (horizontal high-shear granulator).
Fluid bed processing (top spray, bottom spray).
Compression suite (PLC with HMI controls, compression, ejection force monitoring, compaction force control)
In-process testing (weight variation, friability, hardness, thickness, disintegration).
Coating suite (Ganscoater 2kg).
Packaging (bottle and blister).
Formulation warehouse (temperature, RH monitored).
Formulation Development II Analytical Development II Commercial Manufacturing
Ample formulation development and warehouse space
R&D Processing Equipment
Fluid bed
▪ Prism high shear mixer granulator 2/5/10 L (Dry and WetPowder Mixing).
▪ Prism bin blender: 2/5/10 L (15° inclined position, rotates forwith 3 dimension action).
▪ Prism vibratory sifter (with base plate centrally attached togyratory motor).
▪ ACG GPCG1.1 fluid bed processor (top spray and bottom-sprayWurster configurations for drying, granulation and pelletcoating).
Formulation Development II Analytical Development II Commercial Manufacturing
Granulation technologies that fit
R&D Processing Equipment
Tablet press
▪ Kambert Compression machine 8 stations (turret with lowerpunch keyway for various depth of fill lower cam tracks,feeding system for MUPS)
▪ Gansons Coating machine 2 kg (coating drum withcountersunk perforation, baffle design block air, thus reducingdrying efficiency and increasing spray bounce-back).
▪ Labindia disintegration, hardness, friability, tap density tester
Formulation Development II Analytical Development II Commercial Manufacturing
QbD process development
R&D Processing Equipment
Blister packaging
▪ EzeeBlist blister packing machine (equipped with cammechanism, PVC- ALU, PVDC - ALU, PVC - ACLAR and ALU-ALU).
▪ Sigma Pro GMP induction cap sealer (semi-automatic, 20mm to120mm diameter).
▪ Electrolab USP leak test apparatus 300 mm.
▪ Compressed air machine 45 CFM.
▪ Diesel generator set 82.5 KVA.
Formulation Development II Analytical Development II Commercial Manufacturing
Packaging development
R&D Analytical Development
Method Development
Stability Studies
Method Validation
Other Studies
Solubility studiesDissolution studies
Protocol based studiesMethod transfer
Method scoutingMethod development
Developmental stabilityICH stability
Formulation Development II Analytical Development II Commercial Manufacturing
Robust AQbD based analytical development program
R&D Analytical Facility
Wet lab
▪ Rooms and areas:
Instrumentation (HPLC, IR, KF, columns).
GC (GC, automatic liquid sampler).
Balance (ant-vibration frequency table of 10 Hz).
Dissolution testing (USP).
Analytical office (monitoring, documentation).
Wet lab (titration, standards, glassware).
Stability (monitoring system, power backup).
DC licenced storage (reagents, samples).
Fume hood, cleaning (glassware, volatile reagents).
Formulation Development II Analytical Development II Commercial Manufacturing
Ample analytical development space
R&D Analytical Instruments
Dissolution
▪ Advanced microcontroller dissolution test apparatus.
▪ Waters High performance liquid chromatography (HPLC): PDA.
▪ Waters High performance liquid chromatography (HPLC): UV.
▪ Perkin Elmer Perking UV-Vis spectrophotometer.
▪ Perkin Elmer Fourier Transform-Infrared spectroscopy (FTIR)
▪ Metrohm Karl fisher titrator.
▪ Milli-Q water system: Type 1 and 2 water.
Formulation Development II Analytical Development II Commercial Manufacturing
Excipient, API, formulation, cleaning, stability testing
R&D Analytical Controls
HPLC systems
▪ Biometric access controls (facility, lab, instrumentation room).
▪ Dry hot air oven (80 liters).
▪ Standalone system controls (printer, access, logbook).
▪ Secure data servers (empower, documentation)
▪ Mettler pH meters, conductivity meter.
▪ Muffle furnace (under fume hood).
▪ Software: empower 3, eLNB.
Formulation Development II Analytical Development II Commercial Manufacturing
Method development and validation
ICH Stability Chambers
▪ Zone I, II, III, IV, IVb
▪ 25 ±2°C / 60 ±5%RH- Long term
▪ 35 ±2°C / 65 ±5%RH- Intermediate
▪ 40 ±2°C / 75 ±5%RH- Accelerated
▪ Stand By for all above conditions
▪ Qualified Newtronic stability chambers
▪ Real-time monitoring software
Stability chambers
Formulation Development II Analytical Development II Commercial Manufacturing
Stability studies to support product development
Quality Oversight
Quality Culture
Quality Metrics
Quality Risk Management
R&D Quality
Work ethics and data integrity
Monitoring and reporting
ICH Q9 principles
Adherence to ICH Q8 and cGMPs
Knowledge
Science
Formulation Development II Analytical Development II Commercial Manufacturing
Committed to a higher level of control
R&D Process Focus
▪ Understanding customer requirements.
▪ New technology adoption and capability development.
▪ Project cost containment.
▪ Assured IP protection process.
▪ Transparent communication and responsiveness.
▪ Ensuring integrity through controls.
▪ Meeting project deliverable through PM.
Formulation Development II Analytical Development II Commercial Manufacturing
Customer focused
CM Technology Strategy
Why Continuous Manufacturing?
▪ Reduces costs by 50% = low COGS. Eliminates scaling,optimization and hold time studies. Lower energy, utility andminimal changeovers, segregation potential.
▪ Enhanced regulatory acceptance with product quality andintegrity in build.
▪ Smaller integrated equipment footprint with predicableoperational outcomes (RTD based process modeling).
▪ With minimal process variability CM is the preferred technologyfor brand product pipeline (small molecules).
Formulation Development II Analytical Development II Commercial Manufacturing
Strategic technology investment
R&D New Technologies
AvacaPharma is developing novel formulation and process technologies:
▪ Continuous manufacturing technology for solid dose products.
▪ Solubility enhancing formulation platform technology forbioavailability.
▪ Mini tablet formulation with consistent uniformity.
▪ Pellet formulation and process technology.
Formulation Development II Analytical Development II Commercial Manufacturing
An innovative R&D organization
R&D ANDA Product Pipeline
T
N
O
A
R
S
M
Ramelteon IR Tablets 8mg (Rozerem)
Oseltamivir Powder for Oral Suspension 6mg/mL (Tamiflu)
Aminocaproic Acid IR Tablets 500, 1000mg, Syrup 0.25gm/mL (Amicar)
Nebivolol IR Tablets 2.5, 5, 10, 20mg (Bystolic)
Tadalafil IR Tablets 2.5, 5, 10, 20mg (Cialis)
Mycophenolate Mofetil Suspension 200mg/mL (Cellcept)
Solifenacin Succinate IR Tablets 5, 10mg (Vesicare)
Formulation Development II Analytical Development II Commercial Manufacturing
An enhanced product portfolio selection process
R&D Services Summary
FRD
Formulation R&D
Analytical R&D
Support ServicesDrug-excipient compatibility studyDry blendingHigh sheer granulationFluid bed granulation (Top spray)Palletization (Wurster coating)Roller compactionEncapsulationScale up and technology transferDoE Studies
Solubility studiesDissolution studiesMethod developmentMethod validationMethod transfersStability studiesParticle size measurement*DSC/XRPD/SEM/Hot stage microscopy*
*more services provided by qualified partner labs
Product registration and CMC supportClinical studiesProject management
ARD
SS
Formulation Development II Analytical Development II Commercial Manufacturing
Your strategic product development partner for regulated markets
Integrated Services
R&D
RA
CSR
Site
Portfolio
Submission
Formulary
Sales & Marketing
Marketing & BD
Projects
Agreement
New
Supply
Avaca CDMO Avaca ANDA
Operational excellence is in our DNA
Formulation Development II Analytical Development II Commercial Manufacturing
Maturity Model
R&D in India, US regulatory business registrations, agreements Establishing US R&D and operations
Commercial site operations in India Capacity expansion and addition of clientele
Business Dev. >> Partner BD Firms >> Key Industry Partners
2018-2020 2020-2022 2022-2025 > 2025
Matrix organization delivering value
Formulation Development II Analytical Development II Commercial Manufacturing
Commercial Plan
▪ Commercial manufacturing, packaging and testing.
▪ Meeting US FDA, MHRA, Health Canada, ROW cGMPrequirements.
▪ Control systems to ensure laboratory and manufacturing dataintegrity.
▪ Featuring customer experience lounge to observemanufacturing operations in real time.
▪ Transparent operations model incorporating extensive glasspanels and modern design.
▪ State-of-the-art design to eliminate cross contamination.
▪ Streamlined man and material flow.
Formulation Development II Analytical Development II Commercial Manufacturing
Modernizing commercial supply operations
R&D Facility
Scalable R&D operations
Formulation Development II Analytical Development II Commercial Manufacturing
R&D Facility Layout
Formulation Development II Analytical Development II Commercial Manufacturing
Optimal man and material flow, dedicated AHUs
Thank You
Your product is our responsibility
Corporate : Cellix Bio Pharma, Plot No.1177B, Road No.56, Jubilee Hills, Hyderabad - 500033, Telangana, India.Phone: +91 40 23545946
R&D: Facility #153, P-3, IDA Pashamylaram, Hyderabad 502307 TS
Commercial: 41/1A1, Jaggayyapet, Amaravathi 521457 AP Reg.
Office: 40-6/1-7, Revenue Col., Vijayawada 530010 AP
www.cellixbiopharma.comwww.avacapharma.com
Formulation Development II Analytical Development II Commercial Manufacturing