GMP Manufacturing

Ensuring Quality, Safety and Compliance in Biologics Production

Anthem Biosciences operates state-of-the-art GMP facilities designed specifically for the complex requirements of biologics, meeting stringent regulatory guidelines from agencies such as the FDA, EMA, and WHO.

Comprehensive Manufacturing Capabilities

1 Multi-Product GMP Facilities

Anthem’s manufacturing suites are equipped with stainless steel and single-use bioreactors ranging from 50L to 30,000L, supporting both microbial and mammalian production platforms.

2 Mammalian Fermentation

Dedicated single-use bioreactors (200L to 2000L) optimized for CHO, HEK293, and other mammalian cell lines producing complex glycosylated proteins.

3 Microbial Fermentation

Stainless steel fermenters (50L to 30kL) for bacterial and yeast-based biologics, including recombinant proteins and enzymes.

Upstream and Downstream Processing

1 Upstream Process Control

Rigorous monitoring and optimization of cell culture and fermentation parameters to maximize yield and maintain product quality.

2 Downstream Purification

Advanced chromatography, filtration, and centrifugation techniques to remove impurities and concentrate the biologic drug substance.

3 Formulation and Filling

Development of stable formulations with appropriate excipients, followed by aseptic filling under controlled environments to prevent contamination.

Quality Assurance and Regulatory Compliance

1 cGMP Adherence

All manufacturing activities comply with current Good Manufacturing Practices, ensuring product safety, efficacy, and regulatory acceptance.

2 Environmental and Contamination Controls

Strict cleanroom standards, validated sterilization processes, and personnel training minimize microbial and particulate contamination risks.

3 Documentation and Validation

Comprehensive batch records, process validation, and quality control testing support regulatory submissions and product release.

Advanced Technologies and Best Practices

1 Single-Use Systems and Automation

Adoption of disposable bioreactors and automated fluid handling reduces cross-contamination risk and accelerates tech transfer.

2 Quality by Design (QbD)

Implementation of QbD principles and risk management ensures robust, reproducible manufacturing processes.

3 Supply Chain Security

Redundant sourcing and capacity planning safeguard uninterrupted biologics supply to meet patient needs globally.

Partner with Anthem Biosciences for GMP manufacturing excellence that delivers safe, high-quality large molecule therapeutics with regulatory confidence and scalable efficiency.