Alcami Corporation

Explore common calibration findings from the FDA, learn how to prepare for regulatory audits, and elevate your business's quality and safety measures with our latest white paper! Equip your team with the knowledge to stay compliant and excel in regulated environments by: 🔷 Enhancing accuracy and quality 🔷 Reducing risks and improving safety 🔷 Learning from real data and findings Download the whitepaper ➡️https://hubs.ly/Q02FdDdD0 #FDA #Compliance #Calibration #QualityAssurance #auditready #alcaminow #metrology #scienceandtechnology

🌟 Exciting Announcement! 🌟 We are thrilled to introduce Dr. Edwin Alyea, the esteemed Chief Medical Officer at Duke Cancer Institute, as our keynote speaker for the upcoming Tour and Talk event with PDA Southeast Chapter! Join us on Thursday, July 25th, 2024, from 1:00 p.m. to 5:00 p.m. at the NC Biotech Center in Durham, NC, for an inspiring and insightful session focused on solving common development and manufacturing challenges for small and mid-size biotech companies. Dr. Alyea will kick off the event with his keynote address. Event Details: 🗓️ Date: Thursday, July 25th, 2024 ⏰ Time: Registration starts at 12:30 p.m. | Event from 1:00 - 5:00 p.m. 📍 Location: NC Biotech Center, 15 TW Alexander Dr., Durham, NC 💵 Cost: $25 for PDA members, $35 for non-members, $10 for students Following the keynote, the event will feature presentations from industry leaders, a tour of the Alcami Testing Lab & Manufacturing facility, and networking opportunities. Don't miss this opportunity to gain valuable insights and connect with professionals in the biotech community. Secure your spot today and be part of this impactful event that benefits the The Leukemia & Lymphoma Society. Register Here➡️ https://hubs.li/Q02DzMm10 #Biotech #Healthcare #Event #KeynoteSpeaker #Networking #Biomanufacturing #Pharmaceuticals #Alcami #TourAndTalk

Sign up for the Outsourced Pharma Capacity Update discussing Cell and Gene Therapy, on July 25! Explore the rapidly evolving sectors of cell and gene therapy, encompassing extensive services from procuring and cultivating cells to creating vectors for gene therapy. Alcami Corporation's Elena Dukhovlinova, PhD will present how we can support CGT drug development with end-to-end analytical services for these modalities. Register Here ➡️ https://hubs.li/Q02DvBDv0

Are you looking to outsource your GMP Storage? Not sure where to start? Alcami has partnered with Pharmaceutical Technology to bring you a collection of GMP Pharma Storage Resources to help! Check out the content hub and let our years of experience help you navigate the GMP Pharma Storage landscape. ➡️https://hubs.li/Q02Dq1Qc0 #PharmaStorage #CDMO #PharmTech #GMP

It's important to find the right CDMO for the success of any pharmaceutical or biotech project. 💊💉 A good CDMO should... 🔷Bring valuable expertise and capabilities to the table, ensuring that products are developed with high quality and meet all regulatory standards. 🔷Offer insights into efficient manufacturing practices, cost-effective solutions, and cutting-edge technologies, helping to speed up the time it takes to get a product to market. 🔷Help navigate and reduce risks like compliance issues, supply chain disruptions, and quality control problems. Outsourced Pharma is helping address the difficulty of contracting CDMOs who are ready, willing, and able. Join Alcami's Tyler Ewald, MBA , Sr. Director, OSD Operations and Packaging Services, on July 24 for Outsourced Pharma Capacity Update - Small Molecule! This event is a free interactive digital event where CDMOs share their capabilities and available capacities to assist you in identifying outsourcing options. Register now ➡️https://hubs.li/Q02D1Q3k0

In the last five years, requirements from regulatory agencies emerged regarding the assessment, confirmatory testing, and control of N-nitrosamines in pharmaceuticals, drug delivery systems, and biomedical devices. N-Nitroso compounds are considered highly potent mutagenic carcinogens which are included in the “Cohort of Concern” in ICH M7. Due to the potent nature of these impurities, highly sensitive analytical methods are required to detect nitrosamines. As a result, regulatory agencies such as the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMEA), instituted risk assessment and confirmatory testing deadlines for nitrosamines on all commercial products. Christopher Williams and Chad Bastian dive into what Nitrosamines are, Regulatory Requirements, Analytical technologies, and more. Download here➡️https://hubs.li/Q02CS2kF0 #nitrosamines #labservices #CDMO #AskAlcami #FDA #EMEA #analyticalmethods #riskassessment #commercialproducts

🔥Hot off the press 🔥 In an era marked by unprecedented therapeutic breakthroughs, analytical lab service providers are diversifying their testing strategies to enhance efficiency and speed. Experts highlight the need for new analytical methods as fast-emerging therapeutic modalities, like cellular and molecular medicines, push the boundaries of current pharmacokinetic and immunogenicity assessments. Read as Contract Pharma dives deep into the versatility of contract labs in their recent feature, including how Alcami Corporation is leading the charge in the CDMO space, offering comprehensive analytical development services for various therapeutic modalities. Our flexibility and agility are demonstrated through method establishment, validation, QC testing, and more. With a recent strategic partnership with Tanvex CDMO, Alcami continues to expand its capabilities, providing end-to-end analytical support from bulk drug production to finished drug product. Read more ➡️https://hubs.li/Q02CHbXf0 #PharmaStorage #MedicalDeviceStorage #LifeSciences #cGMP #Alcami #Biopharma #ControlledStorage #ProductIntegrity #PatientSafety #Efficacy #BusinessSolutions #AmbientStorage #ShelfStable #APIStorage #Pharmaceuticals

Did you know Alcami offers Validated Cold Chain Transportation services? Our specialized courier service ensures safe and compliant cold-chain transportation for both temperature-controlled and non-temperature-controlled local shipments. Whether it's a routine delivery or a specialized run, we can help! Mitigate risk and ensure compliance with documented door-to-door transportation you can trust. ❄️Direct pick-up and delivery from your site. ❄️Customizable run schedules: daily, weekly, monthly or emergency. ❄️Utilization of validated shipping containers. ❄️Temperature-controlled transport (-80C, -20C, 5C, and 15C to 30C) ❄️Real-time shipment monitoring. Learn more about our comprehensive GMP storage and service solutions ➡️https://hubs.li/Q02Ctm3H0 #courierservices #logistics #temperaturecontrolledshipping #reliabledelivery #compliance #coldchain #qualified #validated #pharmaceuticals

Alcami Corporation is thrilled to announce that all of our North Carolina sites were recently recognized with 2023 First Year Gold Safety Awards by the North Carolina Department of Labor! Gold awards recognize facilities that experience less than 50% of the industry accident rate for lost, restricted and recordable incidents.   Our #Wilmington, NC sites received First Year Gold Awards from NC Commissioner of Labor Josh Dobson for the Tech Center, Packaging Stability and Warehouse, and the Manufacturing Center. Our sites in RTP, NC were also recognized for outstanding safety results achieved. We’re extremely proud of our entire team’s strong commitment to safety, and the proactive measures of our Environmental Health & Safety (EH&S) team. It truly makes a difference!    Photo one, Wimington, NC (pictured L to R): NC Commissioner of Labor Josh Dobson, Tyler Ewald, MBA, Stan Harts, and Christopher Williams Photo two, RTP, NC (pictured L to R): Robert Charalambos Tragas, NC Commissioner of Labor Josh Dobson, Anna Dormady, and Alex Drennan #Alcami #SafetyFirst #NCDeptofLabor #EHS #EHS #NCDL #NCDOL

Come Tour and Talk with us! The PDA Southeast Chapter Tour and Talk event benefits the The Leukemia & Lymphoma Society, who has helped fund over 70% of FDA-approved blood cancer treatments since 2016. Join us for a full agenda: 🔷 12:30-1:00 Registration 🔷 1:00-1:30 PDA Southeast & LLS Opening Remarks | Presenter: Lexie Petsikas, LLS 🔷 1:30-2:00 Key Learnings in Sterile Fill-Finish Manufacturing | Presenter: Alex Drennan, Alcami 🔷 2:00-2:15 A look into a CDMO's Microbiology Capabilities | Presenter: Jeremy Mainville, Alcami 🔷 2:15-2:45 Laboratory Biologic Capabilities & Support for Clients | Presenter: Elliot Franco, Ph.D., Alcami 🔷 3:00-5:00 Alcami Biologic Lab & Parenteral Manufacturing Tours | Transportation provided, refreshments served. Register here ➡️https://hubs.li/Q02C6-Yr0 #AskAlcami #CDMO #DrugProductManufacturing #LabServices #PharmaStorage #BioStorage #SterileFillFinish