hpapi-laboratory

Overview

Hikal’s State-of-the-Art HPAPI Laboratory

Hikal Ltd. High Potency Active Pharmaceutical Ingredient (HPAPI) Laboratory at the Integrated Innovation Centre, Pune is a cGMP-compliant Laboratory equipped with state-of-the-art isolators designed to meet Occupational Exposure Band 5 (OEB-5) requirements. The lab is purpose-built to support the development of complex oncology and specialty molecules, including components of Antibody Drug Conjugates (ADCs), Peptide Drug Conjugates (PDCs), and Proteolysis Targeting Chimeras (PROTACs).

Core Capabilities

Occupational Exposure Band (OEB-5) compliance with state-of-the-art isolators

Designed for HPAPIs, components of Antibody Drug Conjugates (ADCs), Peptide Drug Conjugates (PDCs), and PROTACs

Supports the entire value chain on lab scale.

Scale flexibility milligrams to ~200 grams per batch

Key Features

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Clean Room

Dedicated clean room facility
ensuring safety

Facility Synergy

Complements validation,
process safety, solid state,
and flow chemistry.

Analytical

HPLC & GC systems and
analysis within the HPAPI
Lab, eliminating cross
contamination

Particle Size Control

Built in milling for precise
particle size specifications

Development Support

Route Scouting, optimization, holistic
development, QBD, IP evaluation,
regulatory & CMC support.

Clinical Support

Preclinical, early phase,
late phase

Polymorphs

Screening, Optimization
& Stress Study

Drug Linker

Payloads- Up to multi grams
Linkers-Up to multi kilograms
Payload-Linker-conjugate-Up to multi grams