Boston Cambridge Biotech Networks’ Post

🔍 Regulatory compliance in biopharma is no easy task. The complexities of navigating ever-evolving regulations can seem overwhelming, but they are essential to ensure patient safety and maintaining high-quality standards. For companies like #mAbxience, the challenge goes beyond mere compliance—it’s about turning these complexities into opportunities for growth. 💊🌍 In our latest blog, we dive into the intricate relationship between biopharma manufacturing and regulations, exploring how compliance isn't just a challenge but a strategic advantage. Want to learn how we navigate local and global regulatory requirements to facilitate access to affordable medicines? Click here to read more! https://lnkd.in/d9hh3X6Z #Biopharma #Regulations #Compliance #Biosimilars #CDMO

FDA Finalizes Drug and Biological Product Amount Reporting Guidance and Announces Portal Downtime Today, FDA issued the final guidance for industry: Reporting Amount of Listed Drugs and Biological Products Under Section 510(j)(3) of the FD&C Act. The agency revised and finalized the guidance after considering comments to the draft. The revisions include: Updating the recommended time frame for submitting 2023 calendar year reports to be no later than July 31, 2024, with reports for subsequent years recommended to be submitted no later than March 31 of the following calendar year. Providing recommendations for how to report on drug products in finished package form, drug products not in finished package form, and active pharmaceutical ingredients. Clarifying reporting requirements for registrants across the drug supply chain, including contract manufacturers. Clarifying how FDA plans to use data from the reporting program. Implementation of this final guidance will be delayed until February 26, 2024, to allow for the transition of technical updates to the CARES Act Amount Information Reporting application in the NextGen Portal. On February 26, 2024, FDA will deploy an updated version of the CARES Act Amount Information Reporting application in the NextGen Portal to be consistent with the recommendations in the final guidance. The October 2021 draft guidance will remain available until the updated application is available. Registrants of drug establishments (or their authorized agents) submitting reports should be aware of the following: Until February 22, 2024, continue to submit reports using the current version of the CARES Act Amount Information Reporting application. To accommodate the changes made between the draft and final guidance, the format for submissions will change when the updated version of the application launches. Submissions made using the current format will not work in the updated version of the application. Therefore, all submissions using the current format need to be submitted by no later than February 22, 2024, and all draft reports not submitted by February 22 should be deleted. From February 23-25, 2024, reports cannot be submitted while FDA is updating the CARES Act Amount Information Reporting application in the NextGen Portal. On February 26, 2024, the updated version of the application will launch with updated submission formats. FDA will issue a revised “Reporting Amount of Listed Drugs and Biological Products Technical Conformance Guide” on February 26, 2024, to assist registrants in submitting reports using the updated application and submission formats. With this FDA is better informed and able to take more targeted and timely actions to promote stronger supply chains and reduce drug shortage risks.

Our May blog post is up on the website. This month, we share why you should use publicly available data to prepare for an FDA Inspection. https://wix.to/PadqUjC #newblogpost #qualitysystems #FDAlytics

🗒 FDA: Key Regulatory Updates for Biopharma in 2024 🗒 Let's be really honest: regulatory updates are not the most exciting part of our work as scientists. However, staying informed is critical for keeping innovation on track and avoiding unnecessary hurdles. For those of us working in CHO-based biomanufacturing, here are four regulatory key trends that are worth paying attention to! How is your team adapting to these trends?   #FDA #RegulatoryUpdates #Sustainability #AIbiotech 

📆24 ottobre 2024 Biological Impurities: scientific and regulatory aspects https://lnkd.in/dccsaRfP For a more in-depth understanding, there’s an upcoming CPA Italy webinar training live, hosted by experts from Kymos Group and ASPHALION.  This webinar will cover topics such as the definition of biological drugs, regulatory guidelines, quality attributes, and case studies --------------- Biological impurities in pharmaceuticals are a critical concern, both scientifically and from a regulatory perspective. These impurities can arise from various sources, including the raw materials, manufacturing processes, and even the environment. Here are some key points to consider: 🔎Scientific Aspects ⚗️Sources of Biological Impurities ➡️Microbial Contaminants ➡️Endotoxins ➡️Host Cell Proteins (HCPs) ⚗️Detection and Quantification ➡️Analytical Methods ➡️Quality Control 🔎Regulatory Aspects ⚗️Guidelines and Standards ➡️ICH Guidelines ➡️EMA and FDA Regulations ⚗️Compliance and Documentation ➡️Regulatory Submissions ➡️Good Manufacturing Practices (GMP) #gmp #quality #compliance #regulatory #cpaitaly

Our May blog post is up on the website. This month, we share why you should use publicly available data to prepare for an FDA Inspection. https://wix.to/PadqUjC #newblogpost #qualitysystems #FDAlytics

📌 NEWS \| Publication of two guidelines from the FDA and one from the EMA Two guidelines from the FDA were updated and one from the EMA. 📜 FDA Updates:  FDA Guidance for Industry - Postapproval Manufacturing Changes to Biosimilar and Interchangeable Biosimilar Products - Questions and Answers. FDA Guidance for Industry - Container Closure System and Component Changes: Glass Vials and Stoppers. 🌍 European Medicines Agency Guideline update:  Guideline on the chemistry of active substances. 🔍 ASPHALION experts are on top of these developments, ensuring our clients stay ahead of the curve and in full compliance with regulatory standards.  🔗 Read the full article and changes here: https://bit.ly/3YtFqNA If you need any help, contact us at: info\\@asphalion.com   #FDA #EMA #Biosimilars #DrugManufacturing #RegulatoryAffairs #RA #WeAreAsphalion #WeCare #KnowledgeFromExperience  

Will the EU adjust the aim on the SPC manufacturing waiver to effectively strengthen the #competitiveness of the European pharma #manufacturing industry? We look forward to the #europeancommission's review of the SPC waiver regulation this year!

We talk about sanitary gaskets all the time, but what are they? In this month’s blog, we break down what sanitary gaskets are, why they matter, why regulatory compliance matters, how they are manufactured, and more! Read our blog today > https://bit.ly/3ywzc4s #MarcoRubber #SanitaryGaskets #Pharma #FoodAndBeverage

📌 NEWS | Publication of two guidelines from the FDA and one from the EMA Two guidelines from the FDA were updated and one from the EMA. 📜 FDA Updates:  FDA Guidance for Industry - Postapproval Manufacturing Changes to Biosimilar and Interchangeable Biosimilar Products - Questions and Answers. FDA Guidance for Industry - Container Closure System and Component Changes: Glass Vials and Stoppers. 🌍 European Medicines Agency Guideline update:  Guideline on the chemistry of active substances. 🔍 ASPHALION experts are on top of these developments, ensuring our clients stay ahead of the curve and in full compliance with regulatory standards.  🔗 Read the full article and changes here: https://bit.ly/3YtFqNA If you need any help, contact us at: info@asphalion.com   #FDA #EMA #Biosimilars #DrugManufacturing #RegulatoryAffairs #RA #WeAreAsphalion #WeCare #KnowledgeFromExperience