Code of Conduct

1. Preamble and core values

1.1 Preamble

At ASKA Biotech GmbH, quality is not merely a technical standard, but an expression of our ethical stance. As a specialized partner in the development and manufacture of proteins and immunoassay kits, and as a service provider for study measurement on behalf of our customers, we bear a special responsibility.

1.2 Our core values

Responsibility and quality tailored to your needs:

We are committed to strict compliance with ISO 13485. The highest quality, reliability, and precise fulfillment of product specifications are non-negotiable for us. We continuously invest in the latest technologies and science in order to offer our customers efficient and high-quality solutions that are state-of-the-art.

Customer focus through transparency:

Our customers’ success is our benchmark. We strive for long-term partnerships based on open, fast, and highly qualified communication. We see ourselves not only as a service provider, but also as a customer-oriented problem solver.

Appreciation and development:

Our employees are the key to our success. We promote a working atmosphere characterized by respect, trust, and open communication. We invest in the qualifications of our team and, in return, expect a sense of responsibility and a willingness to actively shape our processes.

Culture of continuous improvement:

Standing still is incompatible with our quality standards. Through internal audits and a culture of learning from mistakes, we are constantly developing our management system in order to not only meet our clients’ expectations, but exceed them.

Fairness and integrity:

Fairness in dealing with business partners and colleagues, as well as responsible use of resources, form the backbone of our corporate policy.

2. Compliance with laws and ISO standards

Legal compliance:

We are committed to strict compliance with all national and international laws and specific regulatory requirements for in vitro diagnostics.

For us, this means much more than simply complying with the rules:

• In the development and production of monoclonal antibodies, recombinant proteins, and immunoassays (such as ELISA, LIA, LFA), we guarantee strict compliance with applicable quality standards and substance regulations.
• When providing laboratory services (study sample measurement), we take the utmost care to ensure data integrity and ethical guidelines are followed. By doing so, we guarantee the validity of our customers’ results and thus protect the safety of the patients at the end of the diagnostic chain.

Quality management:

ISO 13485 certification forms the foundation of our activities and is our promise to our customers that our processes meet the highest international standards. Since our monoclonal antibodies, recombinant proteins, assay kits, and kit components, as well as our measurement results, can form the basis for medical diagnoses, the resulting patient safety is our top priority.

To ensure that we meet these high standards, we are committed to the following guidelines:

• Individual responsibility: Quality is everyone’s responsibility. Each employee is personally responsible for ensuring that their work steps are carried out precisely, in accordance with the applicable customer specifications and in line with our quality management system.
• Data integrity and transparency: We guarantee complete documentation. Results must be traceable, unaltered, and permanently accessible at all times.
• Error culture and prevention: We see the identification of deviations as an opportunity for improvement. By consistently reviewing our processes and proactively minimizing risks, we ensure that only products and services that meet the highest safety and quality requirements leave our premises.

Through this uncompromising focus on quality, we create the basis of trust that is essential for our customers’ success.

Animal welfare and bioethics:

Where animal testing or the use of animal materials is unavoidable, we are committed to adhering to the highest ethical standards and the 3R principle. We pay strict attention to the origin of animal raw materials and require the same from our suppliers.

Export control and trade sanctions:

We strictly comply with all applicable foreign trade laws. We carefully check whether our products, technologies, or services are subject to export restrictions and ensure that we do not conduct business with sanctioned countries or individuals.

3. Integrity in the business environment

Anti-corruption:

We do not tolerate any form of bribery or improper granting of advantages. No employee may demand, accept, or grant personal advantages, gifts, or invitations that are intended to influence a business decision, in order to maintain our professional independence at all times.

Fair competition:

We win customers over with performance and fair prices, not market manipulation. We strictly adhere to antitrust law and do not enter into any illegal agreements with competitors regarding prices, capacities, or market shares. Protecting trade secrets—both our own and those of our customers—is the basis for fair competition in the market.

Conflicts of interest:

Professional decisions are made exclusively on the basis of objective criteria in the interests of our clients. Private interests must not influence our objectivity. Only through this strict separation can we guarantee the neutrality and validity of our diagnostic services.

4. Human rights and working conditions

Prohibition of discrimination:

We cultivate a corporate culture of mutual respect and appreciation.

• Equal opportunities: ASKA Biotech GmbH does not tolerate any form of discrimination or harassment. We guarantee a working environment in which everyone has equal opportunities regardless of gender, ethnic or social origin, religion or belief, age, disability, or sexual orientation and identity.
• Respectful cooperation: Decisions regarding hiring, promotions, or cooperation are based exclusively on qualifications, performance, and professional conduct. Bullying or discrimination have no place in our team.

Health protection and biological safety:

Working in the laboratory requires the utmost care. We ensure a healthy and safe working environment by strictly adhering to all safety regulations.

• Handling hazardous substances: The protection of employees and the environment is an absolute priority, especially when working with hazardous substances and genetic engineering procedures and biological agents in accordance with the German Genetic Engineering Act (GenTG) and the German Biological Agents Ordinance (BioStoffV). We ensure that all laboratory equipment, protective equipment, and procedures comply with the latest state of the art and legal safety and protection levels.
• Prevention and training: Every employee is obliged to consistently apply the safety guidelines. We proactively minimize risks through regular training and continuous review of our processes.
• Responsibility: We promote an environment in which potential safety risks are addressed openly and immediately in order to protect the health of the entire team in the long term.

5. Resource efficiency and environmental protection

In our laboratories and production facilities, we strive to keep our ecological footprint as small as possible. For us, resource efficiency means combining scientific excellence with environmental sustainability.

Energy management and water management:

Through continuous optimization of our facilities—particularly in the areas of air conditioning and ventilation technology through heat recovery or manufacturing—and the use of modern technologies, we are sustainably reducing our consumption of electricity and technical gases. Since water is an essential resource for our cleaning and production processes, we use it extremely responsibly; this applies in particular to the energy-intensive production of ultrapure water.

Waste minimization:

We reduce the use of raw materials and disposable laboratory items to the necessary minimum. Chemical and biological waste is disposed of properly in strict compliance with environmental regulations and with the aim of closing material cycles wherever possible.

Sustainable procurement:

We take environmental aspects into account in our purchasing decisions and give preference to suppliers who also adhere to high environmental standards. We minimize our emissions through efficient logistics processes. We pay attention to the environmental compatibility and sustainability of our supply chains right from the procurement of our raw materials.

Human rights in the supply chain:

We expect our suppliers not only to be environmentally conscious, but also to strictly adhere to human rights, in particular the prohibition of child and forced labor and the guarantee of fair working conditions.

6. Data protection, information security, and intellectual property

The protection of information is the basis for the trust of our customers and partners. We treat data and intellectual property with the same care as if it were our own.

6.1 Protection of intellectual property and confidentiality

Our customers’ project data and our own technical knowledge are our most valuable assets. To protect these assets, ASKA Biotech GmbH relies on extensive security measures. These are continuously optimized by our quality management system to ensure seamless data protection and information security at all times.

Confidentiality:

We are committed to strict confidentiality of all non-public information entrusted to us in the course of our business activities. This applies to all customer-specific orders, such as contract development, contract production, and measurement data from studies.

Protection of property:

We respect the intellectual property of third parties just as we protect our own. The unauthorized use or disclosure of trade secrets is prohibited.

6.2 Data protection (GDPR) and patient data

As a contract service provider that measures human sera and plasmas, we also bear a high level of responsibility toward the individuals concerned.

Handling of personal data:

We process data from test subjects, customers, and employees strictly in accordance with the provisions of the General Data Protection Regulation (GDPR) and other relevant laws. Personal data is only collected and used if this is legally permissible and necessary for the specific purpose (e.g., a clinical study or an employment relationship).

Information security and behavior on social media:

Every employee shares responsibility for the security of our IT systems and data.

We act professionally and with the utmost discretion on social networks (e.g., LinkedIn). We are aware that even seemingly harmless information or photos can reveal details about customer projects and confidential partnerships. To protect the trust of our clients, we take great care not to publish any customer references, project details, or sensitive data, and to maintain ASKA Biotech’s reputation as a reliable partner.

Pseudonymization and security:

In the area of sample measurement, we use technical and organizational measures to ensure that data is protected using state-of-the-art technology and that the anonymity or pseudonymization of test subjects is maintained.

Transparency:

We handle the information entrusted to us responsibly and protect it from unauthorized access or loss using modern IT security standards.

7. Implementation, reporting, and consequences

This Code of Conduct is binding for all employees and management. We promote a culture of trust.

Contact points and reporting channels:

We encourage all employees and business partners to seek open dialogue if they have any questions or uncertainties. The management is available as a confidential point of contact for reports of possible violations of this Code of Conduct or applicable law.

Contact:

• In person or by telephone to the management
• By email to: compliance@aska-biotech.de (access exclusively by the management)
• By post/anonymously: ASKA Biotech GmbH, Attn: Management – Confidential, Veltener Str. 12, D-16761 Hennigsdorf

Protection of whistleblowers:

We guarantee that all reports will be treated as strictly confidential. Employees who report misconduct in good faith will not suffer any disadvantages as a result.

Sanctions:

Violations jeopardize the reputation of ASKA Biotech GmbH and our customers, as well as the safety of our customers’ patients. Such violations will not be tolerated and may result in labor, civil, or criminal consequences.