DRL MCQ 11.pptx

Additive Manufacturing in Pharma Explore the innovative world of 3D printing and its emerging applications within the pharmaceutical industry. What is Additive Manufacturing? Additive Manufacturing Traditional Manufacturing Creating a 3D object by laying down successive layers of Creating an...

Additive Manufacturing in Pharma Explore the innovative world of 3D printing and its emerging applications within the pharmaceutical industry. What is Additive Manufacturing? Additive Manufacturing Traditional Manufacturing Creating a 3D object by laying down successive layers of Creating an object by removing material from a larger material. block or shape. Advantages of 3D Printing in Drug Development 1 3 Precision 🔍 2 Low Cost 💰 Allows for precise dosage Reduces expenses on forms and customized preclinical testing and drug delivery to meet increases efficiency in patient needs. drug development. Speed 🚀 Shortens the time of drug development, allows for fast prototyping and a faster go-to-market. Challenges of using Additive Manufacturing in Pharma Regulation & Certification Complex regulatory pathways, long certification processes, and safety risks are some issues surrounding 3D printed pharmaceuticals. 1 Quality Control 2 3 Technology Adoption Ensuring that every 3D printed drug meets required There are infrastructural and training barriers to standards and specifications poses a challenge. overcome, as well as the need for standardization in materials, design and printing processes. Types of Drugs that can be 3D Printed Solids 🎴 Orals 🧑‍🔬 Tablets, capsules, and other Specially-designed tablets that formulations with a high dose of dissolve in the mouth or rapidly active ingredients. disintegrate on contact with saliva. Implantable 🧴 Durable and biocompatible implants or scaffolds for tissue engineering. Inhalables 💨 Powders or sprays that enter through the respiratory tract and quickly deliver medication to the lungs. Real World Examples 3D Printed Pills 3D Printed Implants 3D Printed Inhaler The FDA-approved drug SPRITAM Bespoke titanium implants were AstraZeneca developed a smart demonstrated the potential of used to reconstruct a cancer inhaler that uses 3D printing customized dose formulation. patient's pelvis. technology to enhance drug delivery. Impact of 3D Printing on Personalized Medicin Traditional Medicine Personalized Medicine One-size-fits-all approach. Customized dosages and delivery. Generic drugs with limited options. Targeted therapies for specific medical needs. Wastage due to incorrect dosage or use. Decreased waste and increased patient satisfaction due to better medicine efficacy. Regulatory Considerations for 3D printing in Pharma FDA Approval 📝 Intellectual Property 💼 Legal Liability 👨‍⚖️ Any 3D printed device or drug There are questions surrounding Inaccuracies in a 3D printed must meet the safety and patentability of 3D printed drugs, and pharmaceutical or device may effectiveness standards set by the how companies can protect their IP result in legal claims and questions FDA. Infrastructural changes may be necessary for quality control and standardization. around risk management. Future Direction for Additive Manufacturing in Pharma 1 Customized Dosage Forms 👥 Bespoke medicines may be designed according On demand Manufacturing 🚛 2 Pharmaceutical manufacturers may be able to to a patient’s individual needs, leading to better therapeutic outcomes and decreased wastage. produce drugs on-demand, with 3D printing enabling decentralization and personalized distribution. 3 Drug Development Acceleration ️🌡 3D printing may accelerate drug discovery and development, thanks to the ability to create prototypes quickly and at a lower cost. Blockchain in Pharma Manufacturing The use of blockchain technology in pharma manufacturing has the potential to increase supply chain transparency, improve regulatory compliance, and enhance patient safety. Let's explore how. The Basics of Blockchain Blockchain technology is a decentralized and immutable ledger that enables secure, transparent, and tamper-proof data sharing across a network of participants. Each block contains a cryptographic hash of the previous block, creating a secure chain of information blocks. Mining Validation Smart Contracts Miners compete to solve complex Nodes on the network validate new Self-executing contracts with the mathematical problems to add a new blocks and ensure a consensus on the terms of the agreement between block to the chain. accuracy of the information. buyer and seller directly written into lines of code. Why Blockchain is Useful in Phama Manufacturin The pharmaceutical industry is one of the most regulated industries, with a complex and global supply chain involving multiple parties, making it ideal for blockchain technology. Supply Chain Traceability Regulatory Compliance Patient Safety Blockchain can increase supply Blockchain can help the Blockchain can strengthen chain transparency, improve pharma industry to comply with patient safety by ensuring that traceability, and reduce regulatory requirements, drugs are genuine and counterfeits. including FDA regulation. unadulterated. Real-World Examples of Blockchain in Pharma Manufacturing In 2020, Pfizer joined the MediLedger project, a blockchain-based platform for verifying product identity and return management purposes. Several other pharmaceutical companies also partnered, including Genentech, McKesson, AmerisourceBergen, Cardinal Health, and Pfizer Inc. 1 Trusted Cannabis Supply Chain IBM partnered with a leading Australian medicinal cannabis company to deliver traceability and efficiency. 2 Merck's Blockchain-Powered Project Merck launched a blockchain-powered project in 2019 aimed at improving transparency and compliance in the pharma supply chain. 3 MedConcert's Clinical Trial Record-Keeping MedConcert is a blockchain-based system that aims to provide secure and transparent record-keeping for clinical trial data. Challenges and Limitations of Implementing Blockchain in Pharma Manufacturing While blockchain technology offers several benefits, there are also challenges and limitations to consider, including: 1 Regulatory Uncertainty 2 System Integration 3 Data Privacy and Security Regulatory Integrating Data sharing in a frameworks for existing pharma blockchain blockchain are manufacturing network must still in their and supply chain prioritize data infancy, and it systems with privacy and remains to be blockchain security concerns. determined how technology may they will apply to be challenging. the pharma industry. Data Privacy and Security in Blockchainbased Systems Blockchain offers several privacy and security advantages, including strong encryption, reduced reliance on intermediaries, and data immutability. Private blockchain networks also enable data to be shared among trusted parties while ensuring privacy. However, potential risks may include: Data Breaches Data breaches can occur if blockchain credentials are lost or stolen. 51% Attack A 51% attack could occur if over half the nodes in a blockchain network were malicious, leading to falsified transactions and information. Regulatory Compliance The absence of a clear regulatory framework for blockchain and data protection raises challenges for pharma companies. The Future Potential of Blockchain in Pharma Manufacturing The use of blockchain in pharma manufacturing is still in its early stages. However, blockchain technology has the potential to revolutionize the way drugs are manufactured, transported, and administered, offering benefits for all industry stakeholders. • Improved patient safety and drug efficacy • Increased supply chain resilience and transparency • Greater efficiency and cost savings for pharma companies Conclusion and Key Takeaways The pharma industry is poised to benefit significantly from the adoption of blockchain technology, with potential enhancements to supply chain transparency, patient safety, and regulatory compliance. While blockchain technology is still relatively new in the pharma industry, companies that embrace it early on may gain a competitive edge and lead the way in a rapidly evolving industry. 27/08/23