BTMN 636 UMUC Biotechnology and The Regulatory Environment Paper

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BTMN 636

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COUNTERMEASURES INC. (CMI) is a virtual manufacturing company that has a contract to supply 500 doses of recombinant anthrax vaccine to the US Department of Defense (DOD). The Government will test the vaccine in a phase I clinical trial involving military and civilian personnel. The DOD will be the Sponsor and holder of the IND under which the trial will be performed). Since it has no manufacturing facility of its own, CMI subcontracted with MEGATECH Inc. (MTI), a contract manufacturing Organization (CMO) that owns a current Good Manufacturing Practice (CGMP) - compliant manufacturing facility, to manufacture and deliver the vaccines to the Repository at the Trials-R-US (TRU) clinic with whom (DOD) has negotiated to carry out the phase I clinical trial. As the staff at TRU was receiving the vaccines that came in three pallets, they observed that one corner of one pallet had been bashed in and as they unwrapped the outside coverings, they discovered that many of the vials had been crushed and their contents spilled. The two intact pallets were moved into a walk-in temperature-controlled holding area while the third (damaged) was transferred to a separate walk-in temperature controlled area. The vaccine excipient included a rich medium with a broad buffering capacity requiring a storage temperature of 2-4oC. Four days later, the Quality control manager at TRU who had been away on a trip went into the walk-in area where the damaged pallet was being held to complete the paper work he would need to prepare his report to CMI. He immediately noted that it was quite warm in the room, obviously warmer than 10oC.
ASSIGNMENT: Work within your group (see below) to develop a regulatory response to this scenario. Each group should develop a narrative anchored around the above sketch to illustrate and give context to their response. Some aspects of the sketch may not be relevant to your group. Do feel free to add additional components as long as the fundamental elements provided above are preserved. Your assignment is to prepare, submit and post a final group report that addresses the issues assigned to your group by the due date. A grading rubric for the group report is included below (Table 1).
Group 1: Regulatory Affairs Director, DOD
As the IND holder and sponsor,
1. Identify the regulatory risk(s), if any, posed by the damage to one of the pallets and the reported temperature excursion. You may identify other risks too but the emphasis should be on the regulatory considerations for the product and those affected by it.
2. What corrective/preventive action(s) would you put in place to avoid this in the future?
Provide your response as a report that includes citations of applicable laws, regulations, and guidance /points to consider documents to support your responses using the APA reference style. The regulatory risk to work on are

( 1) Temperature and Potency

( 2) Transportation/ storage

Please use these risk and write the preventive (they should be current) and please add the laws

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Running Head: REGULATORY ENVIRONMENT Regulatory Environment Student Name Institutional Affiliation Course Name 1 REGULATORY ENVIRONMENT 2 Introduction Proper handling and storage of vaccine practices play a critical role in protecting people and communities from vaccine-preventable diseases. The quality of the vaccine is a shared responsibility across the supply chain from the time it is manufactured by Current Good Manufacturing Practice (CGMP) until its delivery and administration. The case scenario states that the quality control manager at TRU was away on an away trip. However, he noted the pallets had been damaged and therefore necessitated a report to the CMI (Rollo, 2021). According to the vaccine laws in the United States, the Adverse Event Reporting System regulations specify whom to report the events. The manufacturer is above the recommended temperature in the room. Any temperature readings in the package beyond the recommended by the manufacturer are considered a temperature excursion (Rollo, 2021). The appropriate action for the TRU manager is to take corrective action and correct the temperature readings. As a result, it can prevent the waste and potential need to revaccinate the patients (Shabrov, Lusch & Shadrin, 2015). Safe and secure storage and delivery in compliance with a regulatory framework that guides the handling of the vaccine is critical in ensuring the anthrax vaccine is delivered to the recipients and mitigating the risks of vaccines being diverted to the black market (Food and Drug Administration, 2018). The CMI must develop a proper mechanism to ensure the anthrax vaccines are delivered appropriately and without contamination (Bonie et al., 2010). Some measures may include storage in an undisclosed location, using dummy trucks, and using a GPS tracking system. This report examines the regulatory risks of the anthrax vaccine and corrective actions to prevent a recurrence (Shabrov, Lusch & Shadrin, 2015). Regulatory Risks REGULATORY ENVIRONMENT 3 Hundreds of organizations in the United States solely perform a significant function of vaccine manufacturing. For this reason, it is important to adapt to the operations to satisfy the needs for speed, capacity, and enhanced technology. Contractors, regulators, and manufacturers are teaming up to scale up the production of the vaccines (Food and Drug Administration, 2018). The immense volumes distributed, handled, and stored in cold chains must observe by safety laws. The logistical staff, vaccine handlers, and pharmacists at DOD require training on handling the specific CMI distinct vaccine (Black, 2007). Ensuring the value in Anthrax vaccine rollout in DOD encompasses guaranteeing the safety and efficiency of each dose by alleviating quality assurance setbacks. The Clinical Immunization Safety Assessment (CISA) Network is the tool by the FDA to evaluate anthrax vaccine safety. To manufacture a novel batch of anthrax vaccines, CMI must have the required massive input requirements, a massive technical labor force, and an expanded collection of manufacturing facilities (Black, 2007). At the same time, even with ongoing mass-scale manufacturing, state regulators such as U.S Food and Drug Administration (FDA) continue developing vaccine standards. Quality assurance in the context of the Anthrax vaccine remains a vital concept. According to the vaccine laws, the FDA is given authority to oversee, regulate and enforce the vaccine development and research process (Shabrov, Lusch & Shadrin, 2015). The popular model of operation offers details of the delivery of vaccines. This model has possible regulatory risks in delivering vaccines in the United States and elsewhere. Delivering the anthrax vaccines by CMI is a complex task. It requires a chain of accurately synchronized events in temperature-regulated settings to manage, store and distribute these life-saving vaccines (Black, 2007). REGULATORY ENVIRONMENT 4 The risk of potency: The anthrax vaccines should constantly be kept in a controlled temperature range from when they are manufactured until the vaccine is supplied. It is because the temperatures that are extremely high or too low can result in the vaccine losing its potency. Once the vaccine potency is lost, it cannot be recovered or restored. When the vaccines are sent from CMI to the DOD, they are stored in low temperatures and cold storage facilities. The storage and distribution appliances such as refrigerators, cold boxes, freezers, and pallets must conform to the standards and regulations of the World Health Organization (WHO). The inventory management regulations must comply with the WHO rules specific to the anthrax vaccine (Shabrov, Lusch & Shadrin, 2015). The product license may be rendered invalid: Exposing the Anthrax vaccine at the TRU to a temperature beyond the manufacturer's limit is regarded as a break of the cold chain rules and can render its production license invalid (CDC, 2022). As per regulators, the extent of time spent outside the cold chain settings and the temperatures to which the vaccine was exposed can interfere with the vaccine potency and therefore governs the breach's significance. The significance of the breach varies, and TRU should immediately act upon every breach of the cold chain and seek specialists to ascertain the action (Bonie et al., 2010). The fluctuation of the temperature rising above the recommended by the manufacturer may occur while stock-taking and, as such, do not need more action (CDC, 2022). The source of the temperature excursion should be recorded on the temperature document chart, the lowest or highest thermometer reset, and vaccines to be utilized to the expiry date. The practical method is founded on research from the U.S National Institute of Standard and Technology, which has shown that vaccine vials can remain stable despite the constant temperature of 20 minutes despite the constant influx of ambient air into the freezer (Bonie et al., 2010). They should store the vaccines in the original packing to maintain a stable REGULATORY ENVIRONMENT 5 temperature, and manufacturers should ensure that the vaccines have been appropriately stored (Bonie et al., 2010). Risk of loss in product quality: Any vaccination program's success and credibility depend on the safe administration and quality vaccines. The quality is only guaranteed through stringent observance of the vaccine storage, preparation, and handling processes. Damaged vaccine pallet or improper storage or handling may cause vaccine potency or diminish product quality, efficiency, reactogenicity, and effectiveness in some anthrax vaccines. The suboptimal handling of the anthrax vaccine may inadvertently result in patients at the DOD receiving vaccine that has been compromised. While there can be no guarantee of no harm to those who received such vaccines, regulatory challenges may result from the afforded protection in the long and short term. Eventually, the patients may be called for revaccination (Shabrov, Lusch & Shadrin, 2015). The Corruption Risks: The delivery of anthrax vaccine results from public investment by the CMI in exploration and development. A significant amount of the activity has been directed at finding a safe and effective anthrax vaccine for the DOD. It is presumed that the regulatory body is tracking down the candidates that undergo clinical trials on humans (CDC, 2022). The successful implementation of the anthrax vaccine program at DOD will depend on efficient supply chains. The systems will ensure efficient vaccine storage, stock management, and handling. In addition, appropriate temperature regulations in the supply chain and preserving adequate logistical management information structures. It is critical in safeguarding the vaccine supply and preventing any disruptions from manufacturing to distribution (CDC, 2022). Improper handling and storage of vaccines may result in corruption risks in vaccine deployment. In addition, anthrax vaccines are also at risk once they arrive at the DOD facility if there are no regulatory measures. REGULATORY ENVIRONMENT 6 Administration error in storing or handling the anthrax vaccine is a significant concern for carer and recipient patients at the DOD. It could result in minimal confidence in the manufacturer of the vaccine or vaccination program in its entirety (Shabrov, Lusch & Shadrin, 2015). While it is acknowledged that the cold chain regulations break and administration faults can result from the well-managed organizations or clinics, when they happen, an informed decision is required as to whether the vaccine has been contaminated and whether the anthrax vaccine presents any risks to the patients (CDC, 2022). The efficient management of faults would ensure patient safety, preserve patients' confidence in the vaccination program and minimize the waste from damaged pallets. Although every anthrax vaccine incident will require to be investigated individually, managing these incidents should be consistent with alleviating misunderstandings for vaccine manufacturers and recipients of vaccines. The learned lessons from the damaged pallet and temperature excursion incident at CMI should be lessons learned (Shabrov, Lusch & Shadrin, 2015). The occurrence should be shared and utilized for future practice and to avoid reappearance. Corrective or Preventive Actions Monitoring vaccine temperature: The vaccine storage equipment should constantly be monitored as part of the daily responsibilities to ensure vaccine supply viability and patient safety (Bower et al., 2019). Routine monitoring activities will aid in identifying temperature excursions faster and institute immediate actions to correct them, preventing patients' loss or potential revaccination. Power disruption can destroy the vaccine supply even with appropriate equipment and temperature monitoring practices. For this reason, precautionary measures should be in place to protect the power supply (Bower et al., 2019). Building into distribution redundancy: The CMI manufacturing company and allocation teams can alleviate future distribution risks by rapidly finding the points of failure in delivering REGULATORY ENVIRONMENT 7 the anthrax vaccine and creating redundancies at the initial stages. For instance, at TRU, where the warehouses will be installed with ultracold freezers, the dry ice could be an alternative for power loss or machine failure (Bower et al., 2019). During the delivery to the DOD, the company could identify the sources of dry ice to replenish the cool box as necessary. Also, the company could utilize the feedback loops where they could capture the disruption in the supply chain in real-time. As a result, the gathered data could be used to design the best procedures and practices to avoid future losses (Shabrov & Shadrin, 2016). Using the point of care managing and handling of the stock: If the demand for anthrax vaccine reduces to the limits where the point of care stocks is consumed instantly, the vaccine stocks could be distributed to the stations with higher demand. Proper planning should ensure that over-stockpiling is avoided, thus ensuring the cold chain maintenance and prevention of the risks to the DOD administration site (Black, 2007). CMI should design the long-term storage where it is not practical by restocking the dry ice or prioritizing freezer size (Shabrov & Shadrin, 2016). Resilience Planning: The CMI manufacturers can collaborate with world suppliers of raw materials and contractual vaccine producers to design redundancies where possible in the handling, distributing, and managing the anthrax vaccine (Bower et al., 2019). Additionally, better diversity of the world dealers is required to satisfy the regulatory approvals of the vaccine. CMI could negotiate contracts with CGMP early by offering the incentives for distributors to invest early in increasing production and maintaining enough stock of the vaccines (Shabrov & Shadrin, 2016). Additionally, the CMI manufacturers could reevaluate stock management to lessen the risk of stockouts in primary materials (Wahab, 2010). The association between the government and CGMP in the safe delivery of anthrax vaccines: The constant liaising with the government is critical for scaling vaccine manufacture and REGULATORY ENVIRONMENT 8 maintaining high production quantity. In several instances, CMI manufacturers and its delivery companies CGMP could work closely with the government to manage the resource allocation and storage (Bower et al., 2019). There should be constant collaboration on the public health and economic impacts of faltering the outsourcing of the raw products and enhancing the production lines for the anthrax vaccine (Shabrov & Shadrin, 2015). Also, the contract manufacturers such as the CGMP could collaborate with the government to design technology transfer timelines and create new ways of upgrading to more volumes of vaccines to the administration site and enhancing inventory management to the last mile distribution (Shabrov & Shadrin, 2015). Scaling manufacturing the existing and new facilities: As the manufacturers accelerate the operations in the new manufacturing facilities, they could look for opportunities to accelerate capacity as rapidly as possible. Several digital analytics tools could increase the capacity and scale more rapidly (Bower et al., 2019). The company could also accelerate the technology transfer timelines. Some of the operations that the company could conduct include engineering runs, stability studies, and validation run simultaneously, and the companies could both speed up and expand the production (Wahab, 2010). Quality and assurance in the TRU facilities: The company should organize with regulators, contract manufacturers, and the system to ensure that handling processes and the package meets the long-established guidelines (Shabrov & Shadrin, 2015). The higher throughput can be realized through close coordination and understanding, considering the higher probability of attaining quality standards. Similarly, the investors can cooperate in setting up standards for the production of anthrax vaccines by employing new biotechnology inventions (CDC, 2022). Incorporating the best guidelines at the repository facilities and manufacturing help create a strategic plan for new REGULATORY ENVIRONMENT 9 production facilities. It enhances the production speed while meeting the necessary standards of anthrax vaccine quality (CDC, 2022). Establishing predictable supply plans: Each contracted manufacturer can stick to a clearly defined strategy in constant communication with the production control tower with the skilled teams to prioritize tasks across the functions. They can perform consistent cross-functional risk assessments that ensure quality is not compromised and involve evaluation progress at each periodic interval (Bower et al., 2019). Conclusion Although not a single company is in charge of handling the anthrax vaccine distribution in DOD across the current operating model, the risks should be fully addressed through stakeholder collaboration. To create this collaboration, the working teams at the DOD could meet with CMI, CGMP, and TRU to identify the risks of improper handling of the anthrax vaccine, evaluate the potential and likelihood impact, and determine whether specific risks have evolved and urgent need to address them. These groups can align with primary organizations to handle the issues while building scenarios to test the responses to the crises. Managing the risks that accompany improper handling of the vaccines could be established with convincing metrics and communications(CDC, 2022). At this point, defined roles, activities, and risk management capabilities could be recognized, creating accountability across the stakeholders in the supply chain (CDC, 2022). Most importantly, the company could undertake the critical steps to ensure distributors, governments, and manufacturers of the anthrax vaccine facilitate and minimize the setbacks related to immense anthrax vaccine deployment at DOD. As a result, it will help in the efficient and effective rollout of anthrax vaccines (Shabrov & Shadrin, 2015). REGULATORY ENVIRONMENT 10 References Black, L. (2007). Informed Consent in the Military: The Anthrax Vaccination Case. AMA Journal Of Ethics, 9(10), 698-702. https://doi.org/10.1001/virtualmentor.2007.9.10.hlaw1-0710 Bonie, R., Dennison, K., & Adepoju, N. (2010). Vaccine Cold Chain: Part 1. Proper Handling and Storage of Vaccine. AAOHN Journal, 58(8), 345-346. https://doi.org/10.3928/0891016220100801-03 Bower, W., Schiffer, J., Atmar, R., Keitel, W., Friedlander, A., & Liu, L. et al. (2019). Using Anthrax Vaccine in the United States: Recommendations of the Advisory Committee on Immunization Practices, 2019. MMWR. Recommendations And Reports, 68(4), 1-14. https://doi.org/10.15585/mmwr.rr6804a1 CDC. (2022). Vaccination Laws. Center for Disease and Control. Retrieved 12 June 2022, from https://www.cdc.gov/phlp/publications/topic/vaccinationlaws.html. CDC. (2022). Vaccine storage & handling toolkit. Centers for Disease Control and Prevention, National Center for Immunization and Respiratory Diseases. Food and Drug Administration. (2018). Anthrax. U.S. Food and Drug Administration. Retrieved 12 June 2022, from https://www.fda.gov/vaccines-blood-biologics/vaccines/anthrax. Gleim, S., & Smyth, S. (2018). Scientific underpinnings of biotechnology regulatory frameworks. New Biotechnology, 42, 26-32. doi: 10.1016/j.nbt.2018.01.004 Rollo, B. (2021). Five Shipping Challenges That Put Vaccine Delivery at Risk. Supplychainbrain.com. Retrieved 12 June 2022, from https://www.supplychainbrain.com/blogs/1-think-tank/post/32581five-shipping-challenges-that-put-vaccine-delivery-at-risk. REGULATORY ENVIRONMENT 11 Shabrov, R., & Shadrin, A. (2015). Licensing of pharmaceutical activities: regulatory issues. Remedium. Journal About The Russian Market Of Medicines And Medical Equipment, (10), 58-63. doi: 10.21518/1561-5936-2015-10-58-63 Shabrov, R., & Shadrin, A. (2016). Public procurement of medicinal products: new regulations - old problems. Remedium. Journal About The Russian Market Of Medicines And Medical Equipment, (4), 8-19. doi: 10.21518/1561-5936-2016-4-8-19 Shabrov, R., Lusch, N., & Shadrin, A. (2015). Law against counterfeit medicines and nutritional supplements. Remedium. Journal About The Russian Market Of Medicines And Medical Equipment, (1-2), 8-13. doi: 10.21518/1561-5936-2015-1-2-8-13 Wahab, S. (2010). India's biotechnology policies and biosafety regulations. African Crop Science Journal, 3(3). doi: 10.4314/acsj.v3i3.54534
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