EN | 中文

QUALITY & COMPLIANCE

World-Class Quality Excellence

As a trusted CDMO provider, we are committed to delivering safe, reliable and effective products and services that not only meet but exceed global regulatory standards. To achieve this, we operate a GMP quality management system and quality culture to ensure the highest priority is given to the integrity of our products at every stage.

Workers in clean uniforms and hairnets discussing in a high-tech laboratory surrounded by industrial equipment.
Four professionals shaking hands and conversing in a modern office building with glass and curved architectural design.

QUALITY MANAGEMENT SYSTEM

Integrated Tools & Workflows 

Altruist Biologics’ unified quality organization oversees both quality assurance and quality control across all facilities, delivering a centralized and consistent framework for biologics CDMO operations.  

  • Quality Policy: Integrity Management, Quality First. 
  • Quality Commitment: Compliance, Control and Continuous Improvement. 
  • Quality Culture: Integrity and Ownership. We do the right thing and strive to be right the first time.
  • Documentation Management
  • Change Control
  • Deviation Management
  • CAPA Management
  • Product Complaint
  • Analytical Result Investigation (OOS/OOT)
  • Internal/External Audit
  • Return and Recall
  • Annual Product Review
  • Management Review
  • Quality Risk Management
  • Knowledge Management
  • Material and Supplier Management
  • Validation Management
  • Continuous Improvement 
  • Pre-Job Training: Company basic training, department basic training and department skill training. 
  • Ongoing Training: GMP document training and annual GMP training. 
  • Training Assessment and Effectiveness Evaluation: Written examination, on site operation, on site Q&A, monthly performance report and annual training review.

Altruist Biologics has implemented multiple computerized systems, including ERP, quality control (e.g., LIMS, Empower), quality assurance (e.g., TrackWise, E-DOC), production (e.g., MES, PMS), warehouse (e.g., FMS, WMS), and engineering (e.g., EMS, CMMS, UMS) to support efficient operations. 

The Data Integrity procedure is established to define the requirements of Data Governance in alignment with China GMP, EU GMP, PIC/S GMP, FDA 21 CFR Part 11, and other relevant regulations. 

Generally, the Data Integrity program encompasses three dimensions: Quality System (procedural control), Data Governance (data lifecycle control), and People Accountability (personnel control). Additionally, Data Integrity is embedded within the quality culture to ensure compliance and reliability. 

  • Quality System: Quality-related SOPs (e.g., Internal Audits, CAPA, Change Control, Paper Controls, Supplier Management, Annual Product Review, Computerized System Validation and Operation, etc.) incorporate Data Integrity (DI) requirements to maintain data integrity.  
  • Data Governance: The data lifecycle (generation, processing, use, reporting, retention, and destruction) must adhere to the ALCOA+ principles (Attributable, Legible, Contemporaneous, Original, Accurate, Complete, Consistent, Enduring, Available) for both electronic and paper-based data. For computerized systems, access controls, data security measures, and audit trail reviews are enforced throughout the system lifecycle. 
  • People: The procedure outlines responsibilities for senior management and individuals, emphasizing ethical conduct and zero-tolerance policies. Additionally, mandatory Data Integrity training is integrated into new employee orientation and annual training programs to ensure all employees fully understand Data Integrity requirements. 


Data Integrity controls are implemented both internally and through outsourced third parties. Regular training ensures all employees maintain a thorough understanding of Data Integrity expectations. 

QUALITY ASSURANCE

Compliance at Every Step

Altruist Biologics’ QA framework ensures GMP compliance, guaranteeing products meet the highest standards throughout their lifecycle. All Altruist facilities are fully GMP-certified and operate in strict adherence to global regulations and guidelines, including those of the U.S. FDA, EMA, NMPA, and other major regulatory agencies.

  • Supplier Qualification 
  • Lifecycle Oversight & Real-Time Monitoring 
  • Proactive Internal Audits 
  • Regulatory Support 
  • Comprehensive GMP Training Program 
Worker in a lab suit inspecting bottles on a conveyor belt in a clean, modern laboratory setting.

At a Glance

80+

Client IND Filings

10+

Global Client Audits

30+

Regulatory Inspections

7+

Client Product License Approvals & EUAs

Quality Control

Ensuring End-to-End Compliance

Altruist’s quality control (QC) labs guarantee product integrity and compliance from early development to manufacturing. QC oversight and activities cover pre-production readiness, in-process control/testing and post-production functions, such as drug substance and drug product release, and stability and comparability studies. 

Several large stainless steel tanks in a well-lit, clean laboratory environment with overhead lighting.

Our QC team ensures every element of pre-production—from cell banks and raw materials to analytical methods, equipment, and facility environments—is qualified and aligned with the highest quality standards.

  • Cell bank Testing (Qualified contracted testing suppliers): Comply with ICH Q5 series, WHO, FDA, USP, EP, JP 
  • Material Testing: Comply with ChP, USP, EP, JP 
  • Analytical Method: Lifecycle Management, including Development and Qualification, Transfer, Validation/Verification, Ongoing monitoring, Retirement 
  • Equipment: Lifecycle Management, including URS, Commissioning and Qualification, Operation and Maintenance 
  • Facility environments: Environmental Monitoring, Process Water Monitoring, Process Gas Monitoring

We perform critical In-Process Control (IPC) testing as well as Drug Substance/Drug Product (DS/DP) release testing to safeguard product quality and regulatory compliance throughout manufacturing.  

  • Compendial Testing 
  • Protein Concentration 
  • Titer 
  • N-glycan Profile 
  • Identification Test (Peptide Mapping/iCIEF/MS/LC-MS) 
  • Flow Cytometry 
  • Bioassay 
  • Purity 
  • Impurity 
  • Charge variants

We provide a tailored stability program integrated with our LIMS platform for the generation of GMP drug substance/drug product stability data. Our controlled stability chambers and their stability storage settings (temperature and humidity) are maintained per ICH guidelines.

  • Stability study under ICH 
  • Potency (ELISA, Bioassay) 
  • Compendial Testing 
  • N-glycan Profile 
  • Purity 
  • Impurity 
  • Charge variants 
  • Identification Test (Peptide Mapping/iCEIF/MS/LC-MS) 
  • Flow Cytometry

We perform routine environmental and utility monitoring of facility-related samples (surface, water systems, clean air, clean gas, etc) to ensure our controlled environments are maintained for the manufacturing of high-quality products. 

We have fully integrated advanced GMP QC systems into our operations. 

  • Laboratory Information Management System (LIMS) 
  • Other key data systems: TrackWise, Empower, SAP, Labsolution, Lab X, Softmax Pro, FMS, OpenLab and PCS7  

ROBUST IP PROTECTION & SECURITY

Security. At The Core.

At Altruist Biologics, we understand the importance of protecting intellectual property (IP) throughout all stages of our partnerships. We are committed to safeguarding our clients' proprietary information, knowledge, and innovations to the fullest extent possible. 

By adhering to these stringent measures, we ensure that all information, knowledge, innovation, and client IP are safeguarded throughout the entire lifecycle of our partnerships, including manufacturing processes. Our unwavering commitment to IP protection underscores our dedication to maintaining the trust and confidence of our clients.

Our comprehensive approach to IP protection encompasses the following measures.

Before any sensitive information exchange occurs, we establish robust confidentiality agreements to legally bind all parties involved. These agreements outline the scope of confidentiality and the obligations of each party to protect confidential information.

We implement stringent access controls within our facilities to limit access to confidential data and proprietary technologies. Only authorized personnel with a legitimate need-to-know are granted access to sensitive information.

Our IT systems are equipped with state-of-the-art security measures to safeguard digital information. We employ encryption, firewalls, and other advanced technologies to prevent unauthorized access, data breaches, or cyber-attacks.

Altruist Biologics manufacturing facilities are equipped with physical security measures to prevent unauthorized entry and protect against theft or tampering. Access to production areas is strictly controlled, and surveillance systems monitor critical areas at all times. 

We prioritize employee training and awareness programs to instill a culture of confidentiality and IP protection. Our staff undergo regular training sessions to reinforce the importance of safeguarding sensitive information and recognizing potential security risks.

We conduct regular risk assessments to identify potential vulnerabilities in our systems and processes. Any identified risks are promptly addressed through proactive mitigation strategies to prevent potential breaches or leaks.

When collaborating with third-party vendors or subcontractors, we rigorously vet their capabilities and adherence to IP protection protocols. Contracts and agreements include provisions to ensure that third parties uphold the same standards of confidentiality and security. 

We continuously monitor our IP protection practices and seek opportunities for improvement. Feedback from clients, internal audits, and industry best practices guide our efforts to enhance our security measures and adapt to evolving threats. 

CONTACT

Connect With Our Team

Discover how we can support you at every stage of clinical development and commercial-scale manufacturing.