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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


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.


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


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 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


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).


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).


Granulation technologies that fit


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


QbD process development


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.


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


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).


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.


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.


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


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


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.


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).


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.


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)


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


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


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


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.


Modernizing commercial supply operations

R&D Facility

Scalable R&D operations


R&D Facility Layout


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


[email protected]

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