Biological drugs are generally more delicate and sensitive to temperature than their
pharmaceutical counterparts, thus introducing risks into the global biopharma supply chain.
Longer transit times, extreme climate change between origination and destination, and shipping delays all increase the risk profile during transport. Product compromise due to temperature fluctuation can cause millions of dollars in revenue loss and delay delivery of drugs and therapeutics to patients. Sentry Biopharma Services strengthens the pharmaceutical supply chain by helping clients manage these risks.
MATURITY OF PHARMACEUTICAL COLD CHAIN MANAGEMENT
15 years ago cold chain management was still a buzz phrase that only a few companies could actually deliver. However, the unique transportation challenges of biopharma products have driven the need to control temperature variability throughout the drug supply chain which has transformed pharmaceutical cold chain management into a burgeoning industry. Specialized providers like Sentry BioPharma Services now offer dedicated services designed to preserve the integrity of biological products throughout all phases of the pharmaceutical supply chain. Large and small biotech organizations increasingly turn to these specialized providers in a shift from the traditional in-house pharmaceutical logistics model to an outsourced one.
SELECTING A PHARMACEUTICAL SUPPLY CHAIN PARTNER
Although outsourcing to a pharmaceutical supply chain provider can provide many benefits, not every potential partner has the capability to provide services on a global scale. A qualified cold chain logistics expert must be experienced and compliant in all facets of biopharma cold chain management. This includes domestic and international shipping, drug product handling and tracking, GMP storage and international drug distribution. The provider must have the experience, systems and processes in place to handle the diverse and changing needs of the global biopharmaceutical industry. Criteria that biopharma manufacturers should consider when evaluating potential partners include:
- A robust quality system
- Specialized GMP storage facilities and equipment
- A reputation for technological innovation
- Compliance with global pharmaceutical cold chain regulations
- An efficient and reliable biopharma and logistics network
- Anti-counterfeiting capabilities
- Impeccable customer service record
PHARMACEUTICAL COLD CHAIN REGULATIONS & BEST PRACTICES
As pharmaceutical cold chain management has become a more critical component in the global biopharmaceutical supply chain, regulatory agencies and industry associations have been launched solely to develop standards for compliance in this market. Achieving regulatory compliance was a much simpler task in traditional supply chain models of the past. Now, due to an increasingly complex set of social, scientific and political pressures, industry mandates and international regulations have become significantly more stringent. Each country has its own body of rules and guidelines governing the shipment and handling of pharmaceutical and biological products. A qualified pharmaceutical cold chain management and 3PL partner must demonstrate compliance with international guidelines.
In addition to mandates prescribed by external regulatory agencies, the industry has begun to develop its own body of industry-accepted standards for biopharmaceutical distribution and handling. Several prominent groups have been formed throughout the world to discuss regional challenges and issues; collaborate on problem-solving; examine emerging trends; and define industry best practices. A pharmaceutical cold chain management partner should be familiar with the standards being developed by leading international pharmaceutical discussion groups.
REPUTATION FOR PRISTINE QUALITY AND IMPECCABLE CUSTOMER SERVICE
A GMP-compliant third-party logistic (3PL) partner must be committed to excellence in quality control and customer service. As an extension of the drug or vaccine manufacturer’s business, the pharmaceutical 3PL provider must operate as a vested stakeholder to protect product integrity as well as the manufacturer’s business viability and reputation in the marketplace. Measures of excellence in the pharmaceutical cold chain include:
- A corporate culture of accountability and commitment to the mission
- Knowledge of best practices for GMP storage, global drug distribution and vaccine management
- Independent quality assurance personnel, processes and evaluations
- Careful biological product handling and temperature-sensitive product shipping
- A uniformed process for continuously improving quality, operations and customer service
- A singular focus that allows the contract service provider to be an expert
SPECIALIZED GMP STORAGE FACILITIES
At various points in the pharmaceutical supply chain, active pharmaceutical ingredients (APIs), excipients, components, intermediates and finished pharmaceutical products may need to be stored for varying lengths of time, from a few days to a several months. Short-term or long-term GMP storage facilities might be needed to temporarily house: inventory overflow from a primary GMP warehouse; primary or secondary packaging components that are awaiting assembly; finished drug products that are awaiting international drug distribution; and/or inbound pharmaceutical product shipments that are clearing U.S. Customs. While several pharmaceutical small molecule formulations remain stable at ambient temperature conditions, many biologic products must be maintained within tighter temperature tolerances in refrigerated (+2°C to +8°C), frozen (-10°C to -20°C) and ultra-low storage (-70 to -90°C). Traditional pharmaceutical supply chain facilities are not always designed to accommodate these conditions.
In these situations, a cold chain logistics partner can provide immediate access to a state-of-the-art GMP storage facility that has been designed to meet the unique requirements of temperature-sensitive drug products. It must offer: validated, temperature controlled storage and temperature-monitoring equipment; redundant power, cooling and environmental monitoring systems; redundant data storage capabilities; and sophisticated data security systems.
For more information about how Sentry’s cold chain management programs can ensure biological product integrity in every phase of the pharmaceutical supply chain, contact Sentry via email or by phone at 1-866-757-7400.