Vaccine - Fill & Finish Tech Transfer
With the recent developments in both Moderna's and Pfizer's COVID-19 vaccinations, many pharmaceutical companies are looking for companies to help fulfill their vaccine fill-finish needs.
THERE IS NO ROOM FOR ERROR IN TECH TRANSFER
The speed at which the creation of the COVID-19 vaccines was accomplished is remarkable. This provides a positive outlook for our industry's ability to rapidly and safely advance drug candidates that deliver better results for patients.
Between the COVID-19 vaccine development, the growing need for booster shots, and the ongoing health crisis, the industry has been presented with a new challenge: Vaccine manufacturing capacity.
Biologic/Vaccine Fill & Finish Capabilities
- Batch Sizes from 1L – 1000L
- Vials (2mL – 100mL) - Bosch® FWR 4080
- Clean rooms ranging from class 100 to 100,000
- Glass, COC & COP Vials & Syringes
- 3mL cartridges
- Disposable, single-use technology
- Varying mixing conditions
- Varying temperature conditions
- Refrigerated and frozen storage
Pii's scientists have 25+ years of experience in transferring even the most complicated formulas and processes.
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Why is Vaccine Production Being Transferred?
Moving the production of a vaccine to a new facility is a major decision driven by specific underlying conditions.
Knowing why the transfer is being initiated can quickly steer the receiving facility staff to a starting-point for the project, can help reduce or eliminate unnecessary work, and shorten the time it takes to begin production.
Occasionally, a transfer might be initiated because of a quality issue at the current manufacturer that cannot be resolved or a secondary CDMO is required because their current manufacturer is overbooked.
Transfers with existing quality issues are more complex and the urgent need for a secondary CDMO can create a lot of pressure.
Some vaccine production can be triggered by models predicting seasonal illnesses, driving the need to rapidly increase vaccine manufacturing. When the models miscalculate the peaks, vaccine production is pursued with greater urgency.
As pharmaceutical companies take steps to reduce risk, they are often seeking new CDMO production facilities, excipient and API providers, equipment manufacturers, contract packagers, and more closely considering the location of facilities to patient populations. In this case, the tech transfer is part of a larger supply chain transformation.
No Two Tech Transfers Are Alike
Moving vaccine production to a new facility can occur for a handful of reasons, but analytical methods and manufacturing processes can vary greatly.
When transferring commercial vaccine production, the amount of process data is significant.
When transferring a small clinical trial-batch operation, the tech transfer may pay particular attention to qualifying analytical methods, process evaluations for the drug product, and scalability to GMP equipment. The formulation should have been tested for stability and quality for suitability in future larger commercial-batch production. If not, the tech transfer must include these evaluations. If proper testing was previously done, the records may reveal a problem that could be preempted before production begins, saving valuable time and resources.
Unique Vaccine Personas
Vaccines are complex and the underlying science varies greatly. Some vaccines contain either live attenuated or inactivated organisms and others are built on synthetic particles. Each requires a different manufacturing process, specific equipment, and special operator skills.
All vaccines in the United States are regulated as biological products. Modern vaccine technology using synthetic particles are challenging traditional regulatory oversight models. When transferring vaccine production in which the formulation is derived from synthetic particles, regulatory experts must be an integral part of the tech transfer.
Injection is the most common delivery method for vaccines. Therefore, the primary packaging could be a vial, ampoule, pre-filled syringe, or auto injector. If a pre-filled delivery mechanism is used, the FDA considers it a combination product, a dose in a medical device, and has specific FDA guidance.
Vaccines can often require special temperature control in the manufacturing facility as well as the distribution supply chain. For many vaccines, temperature is a critical quality attribute. Temperature changes place the drug product’s quality at risk, and real-time monitoring is required for vaccines like this and the receiving CDMO must have adequate controls and cold-storage space.
Some vaccines are highly potent, such as innovative cancer vaccines containing mRNA encoding tumor antigens. Vaccines in this category require special handling procedures to protect operators and limit interaction between personnel and drug products to ensure quality. These vaccines must be manufactured in an aseptic environment under strict containment conditions to prevent cross-contamination.