Sentry BioPharma Services ApS

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Compliant, Secure, Scalable Outsourcing Strategy

Sentry BioPharma Services ApS (Sentry ApS) is a contract service organization (CSO) which supports the life science industry by offering cGMP temperature-controlled storage, distribution, EMA compliant labeling and packaging services and importation support utilizing Sentry ApS’ Qualified Person. Drug development and commercialization require continuous temperature monitoring and control. Sentry ApS’ diverse offerings protect product integrity throughout the pharmaceutical supply chain. Sentry ApS’ validated software, cGMP storage and drug distribution facility, industry expertise and stringent quality standards support this objective throughout manufacturing, packaging, storage and distribution.

In 2020, an experienced team of pharmaceutical, cold-chain management and quality assurance experts from Sentry BioPharma Services, Inc. with a long tradition of providing custom contract cGMP cold chain storage, labeling, kitting, packaging, and distribution services to serve the exclusive needs of pharmaceutical and biotechnology industries, in cooperation with KLIFO A/S, created Sentry BioPharma Services ApS, a Danish corporation, to provide an EU-based operation providing those same services.

The company’s mission is to deliver compliant, secure, and scalable services to healthcare entities that embrace an outsourcing strategy.

Sentry ApS navigates public and private entities through evolving business, licensing and regulatory landscapes while prioritizing product integrity in all steps of the pharmaceutical cold chain processing cycle.

GMP Validated Temperature Controlled Storage

Sentry ApS’ expertise, quality program, and validated processes present an opportunity to meet any GMP storage need. Validated IT systems, infrastructure and processes can accommodate ICH recommended drug storage ranges while allowing virtually any customized storage environment for the unique and stringent requirements of biological products.

Sentry ApS maintains control over product classifications and locations within its GMP warehouse. This sophisticated inventory management capability supports pharmaceutical packaging, returns, quarantine and controlled drugs. Sentry ApS’ guardianship is evident in the systems implemented and the processes utilized to mitigate risks that may adversely impact product safety, identity, strength, purity and quality (SISPQ).

• Validated temperature monitoring system for each drug storage environment
• Validated GMP warehouse management system
• Redundancy of critical systems to ensure business continuity and control
• Infrastructure for rapid implementation or expansion

Available Storage Environments

• Room Temperature: +15°C to +25°C
• Refrigerated: +2°C to +8°C
• Frozen: -15°C to -25°C
• Ultra-Low: -70°C to -90°C
• Custom Temperature Solutions: 0°C to <-135°C

Labeling, Kitting, and Packaging

Sentry BioPharma Services ApS (Sentry ApS) adds value to labeling, packaging and kitting solutions by managing work flow, cost and the exacting requirements of clients. Sentry ApS specializes in labeling, kitting, and packaging projects of varying scale, complexity and sensitivity to time and temperature. Compliance extends throughout operations, including flexible container labeling (vials, syringes, bottles, etc.) and tertiary packaging design services. Sentry ApS’ expertise helps eliminate excess cost and time-out-of-temperature (TOT) while meeting deadlines.

Custom kitting functions provide clients the ability to store bulk products yet deliver kitted solutions. Sentry ApS performs packaging operations in accordance with kitting protocols co-developed by Sentry ApS and the client.

Supply Chain Management

Biotech and pharmaceutical companies leverage Sentry BioPharma Services ApS’ (Sentry ApS’) industry relationships with a network of CMO service providers and affiliated pharmaceutical cold chain facilities to successfully plan, source, make and deliver temperature-sensitive products. To adapt to the everchanging industry landscape, processes, metrics, best practices and technology are continually evaluated to ensure superior supply chain communication and management effectiveness.

Sentry ApS’ core functions extend to all pharmaceutical supply chain interdependencies. This unified, cohesive approach integrates manufacturers, researchers, distributors, software systems, consultants and channel supply partners to meet emerging customer expectations.

Sentry ApS utilizes biopharma experience and relationships with qualified vendors, brokers and manufacturers to design and implement domestic and international pharmaceutical supply chain solutions.

Quality Assurance

Every aspect of Sentry BioPharma Services ApS (Sentry ApS) reflects a commitment to protecting product integrity: safety, identity, strength, purity and quality (SISPQ). Sentry ApS’ quality assurance team implements a validation master plan with periodic updates to assess and manage risk for pharmaceutical distribution, GMP storage, drug importation, and biopharmaceutical labeling and packaging.

Sentry ApS utilizes standard operating procedures (SOPs), validated inventory and building management systems, and quality agreements to mitigate risk. The company also deploys a continuous improvement program to meet and exceed changing industry and regulatory agency requirements.

Sentry ApS also develops custom solutions and mutually developed agreements to maintain regulatory compliance for clients engaging in drug importation, pharmaceutical labeling and packaging, and international drug distribution. These detailed documents preserve the integrity of pharmaceutical materials and finished drug products throughout the drug supply chain, promoting safe delivery of medicines to the patient.

Qualified Person

A wholly owned subsidiary of Sentry BioPharma Services, Inc., Sentry BioPharma Services ApS (Sentry ApS), located in Copenhagen, Denmark is a contracted service provider for the storage and distribution of pharmaceutical products for manufacturing and clinical trials.

In addition to specializing in ultra-low temperature storage (-70°C to -90°C), Sentry ApS provides QP batch certification and declaration services for client material through an onsite Qualified Person (QP). Sentry’s QP ensures that imported pharmaceutical products meet GMP manufacturing, storage, and supply chain regulations so they can be used in European clinical trials.

The QP also facilitates the export of these materials to countries within the European Union (EU) and outside of the EU as well as to the United Kingdom. Sentry’s QP can audit pharmaceutical manufacturing and storage facilities around the world as well as coordinate with other QP’s to expedite QP to QP agreements to expedite confirmation of GMP compliance.

The Sentry ApS QP in Denmark provides a regulatory path for client materials being stored in the US at Sentry Biopharma Services, Inc. to be imported to clinical sites located in the EU and UK. Given Sentry ApS’ regulatory, storage, and distribution experience of biopharmaceutical materials, clients can meet European Medicine Agency (EMA) regulations while ensuring the integrity of their pharmaceutical products is protected.

Locations

Sentry EU – Copenhagen, Denmark
Smedeland 36
2600 Glostrup
Denmark
+45 69 17 71 66
Email: [email protected]

Sentry US – Corporate Head Quarters – Indianapolis, IN
4605 Decatur Blvd.
Indianapolis, IN 46241
Local: 1-317-856-5889
International: 001-317-856-5889
Email: [email protected]
Fax: 1-317-856-4552

Sentry US – Columbus, IN
13025 N. Executive Drive
Edinburgh, IN 46124
Local: 1-317-856-5889
International: 001-317-856-5889
Email: [email protected]
Fax: 1-317-856-4552

VideoBites

Contract Pharma Sits Down with Alex Mitchell of Sentry BioPharma Services

Vice President of Operations discusses the role of a Qualified Person (QP) in the clinical pharmaceutical space.

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VideoBites

Contract Pharma Sits Down with Alex Mitchell of Sentry BioPharma Services