GMP Manufacturing

Anthem specializes in the design, development and manufacturing of APIs and Advanced intermediates, providing comprehensive support from clinical development to commercial-scale production.

Our development process follows Quality by Design (QbD) principles and ICH Q9/Q11 guidelines, ensuring safety, consistency and scalability. We use advanced techniques like FMEA and statistical tools to create cost-effective, environmentally responsible and non-infringing synthetic routes.

Small Manufacturing GMP Manufacturing

1

Synthetic Route Design: Cost-effective, non-infringing processes using flow chemistry, biotransformation and catalysis

2

Process Optimization: Customized solutions to minimize cycle times and maximize reaction efficiency.

3

Scalability: Robust production strategies for seamless transition from lab-scale to commercial manufacturing.

4

Regulatory Support: Streamlined Chemistry, Manufacturing, and Controls (CMC) and Drug Master File (DMF) submissions.

Peptide GMP Manufacturing

Anthem Biosciences leads the way in peptide synthesis, handling sequences of up to 40 amino acids with exceptional purity and efficiency

1

Advanced Synthesis Techniques: Proficiency in Solid Phase Peptide Synthesis (SPPS) and Solution Phase Peptide Synthesis (SPS).

2

Purification Excellence: High-performance systems like Preparative HPLC and Biotage® ensure superior peptide quality.

3

Analytical Rigor: Comprehensive tools for characterization, including Amino Acid Sequencing and TFA Acetate Salt Analysis.

Glycolipid GMP Manufacturing

Glycolipids are vital to cutting-edge drug delivery systems, including lipid nanoparticles (LNPs) used in mRNA vaccines. Anthem excels in their synthesis and scale-up for biopharmaceutical and biotechnology applications.

1

Lipid Synthesis Optimization: High-purity formulations designed for superior drug delivery efficiency.

2

Sophisticated Purification: Dynamic Axial Compression (DAC) and Biotage® Flash Chromatography for precise lipid isolation.

3

Comprehensive Analysis: Tools like HPLC-UV, UPLC-UV, and HRMS ensure top-tier quality and performance.

Oligo Synthesis GMP Manufacturing

Anthem offers advanced GMP-compliant oligo synthesis services.

1

Customizable Synthesis: Scalable solutions for a variety of research and therapeutic needs.

2

Rigorous Quality Assurance: Sequence integrity and purity validated through gel electrophoresis and mass spectrometry.

3

High-Purity Isolation: Advanced chromatography ensures the highest product standards.

HPAPI GMP Manufacturing

Anthem specializes in producing compounds up to OEB 5 standards, supported by advanced containment systems.

1

OEB 5 Containment: Ensuring safety with cutting-edge isolators and all-glass jacketed reactors.

2

ADC Expertise: Development of antibody-drug conjugates (ADCs) using innovative linker-toxin conjugation.

3

Scalability: Seamless transition from lab-scale to commercial manufacturing for high-potent compounds.

Anthem’s GMP Facilities

Unit I - Bommasandra USFDA Approved 24 KL custom synthesis capacity for small molecules, HPAPIs, and peptides.
Unit II - Harohalli USFDA Approved 376 KL large scale custom synthesis capacity.
Unit III - NeoAnthem 25 KL custom synthesis capacity, featuring specialized suites for pilot-scale, peptides, HPAPIs.