Kasyap Cherukuri

Biotechs Bound for the Carolinas. Cambrex (CDMO) will be opening a new Stability Storage Facility via Q1 Scientific Ltd. in Durham (RTP) which is expected to be operational by the end of 2024 including ultralow temperature storage, with an additional phase coming online in the next couple years. Stability storage involves storing drug substances and products under controlled conditions (temp, humidity, light) to maintain their quality and shelf life. The expansion into Durham is part of Cambrex's strategy to grow its biologics business and meet the increasing demand for stability storage services as well as same day and next day delivery to its clients. #biotech #biotechnology #pharma #lifesciences #coldstorage #stability #cambrex #rtp #ultralow

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Fayetteville Secures $30 Million to Address PFAS Contamination; Support Needed for Bioremediation Solutions The Fayetteville Public Works Commission (PWC) has secured $30 million in state and federal funding to address PFAS contamination in the city's water supply. This funding is in addition to more than $60 million already secured for the development of an $80 million Granulated Activated Carbon (GAC) facility, which is expected to be completed in 2028. This facility will significantly increase Fayetteville's ability to filter PFAS from its drinking water. In addition, PWC was awarded $1 million for its Operation Clean & Clear program to inventory water service lines to comply with recent updates to the U.S. Environmental Protection Agency's Lead & Copper Rule. Meanwhile, PWC is upgrading its P.O. Hoffer Water Treatment Plant to expand its powdered activated carbon (PAC) filtration system. This temporary solution will help reduce PFAS levels in drinking water until the GAC system is operational, which is expected to be completed by 2026. https://lnkd.in/dSqxBfPm While this funding is commendable, it is critical to also support innovative #PFAS bioremediation projects. Activated carbon absorption, while effective, is costly and requires a combustion process that is both #energy intensive and a significant source of #CO2 emissions. Therefore, I urge consideration of #bioremediation initiatives such as ASPIDIA that offer sustainable and cost-effective alternatives for PFAS remediation.

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digiM's recent FDA IDIQ contract award marks a big step in advancing the role of microstructure analysis in regulatory assessment for complex generics. This partnership is set to deepen industry knowledge around product quality attributes and release mechanisms in key drug products, from injectables to implants. This recognition highlights the growing impact of microstructure tools like 3D microscopy and AI-based modeling, demonstrating how essential microstructure science is becoming within the pharmaceutical industry. https://lnkd.in/d5sj5Eds

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Biotech weekly news roundup! All of the weeks biggest topics in one place: Illumina enters into $750M agreement with JP Morgan to fund Grail Divestment! https://lnkd.in/gFwA-2Dp Ultragenyx gets the green light to seek FDA approval of Gene Therapy! https://lnkd.in/gTTwKezi Follow / connect with me to keep up to date with all the latest developments in the space! #biotech #bioinformatics #news

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https://lnkd.in/e8JDdhwU Top-Down Structural Characterization of Native Ubiquitin Combining Solution-Stable Isotope Labeling, Trapped Ion Mobility Spectrometry, and Tandem Electron Capture Dissociation Mass Spectrometry

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Biotechs Bound for the Carolinas. Amgen has formally announced an expected expansion in Holly Springs with another biopharmaceutical (drug substance) manufacturing facility as it completes its first Holly Springs facility. The deal with the state of North Carolina involves $6.5MM of incentives tied to hiring goals between 2028 - 2032 with positions expected to pay an average wage of just over $91K. This would increase the current average wage in Wake County and add more clout to the emerging local tech hub in Holly Springs. Amgen employs about 27K total and has been growing via strategic acquisitions, common in the biotech industry, in an effort to continue to grow its pipeline which is arguably the core objective of any biotech firm. Of particular interest is Amgen's efforts in the GLP-1 weight loss / diabetes management niche which is big business in North Carolina and worldwide. Amgen is behind competitors Eli Lilly and Company and Novo Nordisk in this area but is taking a different approach in focusing their therapeutic candidate (#maritide) on helping patients maintain weight loss after they stop taking the drug. If they are able to pull this off it would be particularly notable for FDA fast track approval and future market share forecasts as current therapies are lacking in this specific patient outcome. #biotech #pharma #biopharma #manufacturing #construction #facility #rtp BioPharma Crescent North Carolina Biotechnology Center (NCBiotech) #hollysprings #NC #ncbio #ispe #CRE #triangle #northcarolina #strategy #business #drugs Wake County

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One open-ended interview question I often ask is, "Your colleague is monitoring the temperature of a chemical reaction and doesn’t dare to go for lunch because they have to be ready to stop the reactor if a temperature anomaly occurs. How would you build a system they can trust to observe and react remotely?" The most common response usually comes from programmers eager to describe software that reads a digital sensor and sends email notifications. However, they often miss the mark on an important aspect: “How can they trust such a system?” Validating new software often takes much longer than the few hours needed to build a proof of concept. Another approach people suggest involves buying off-the-shelf sensors. "Let's use this $15 home automation gadget that connects to Wi-Fi and includes an email service.” Many prefer these all-in-one solutions, assuming that the manufacturers have conducted extensive reliability testing. I appreciate this pragmatic approach when possible. But what if a custom solution is needed? It can be useful to think of the solution in terms of building blocks: *Sensors*: These convert physical measurements into digital data. *Loggers*: These devices read from sensors, preprocess data, and submit measurements to a server. *Servers*: These orchestrate multiple sensors, manage access controls, and push data into databases. *Databases*: These are optimized to upload and retrieve time series data. *Visualization Platforms*: These allow for grouping, filtering, and analyzing sensor information, often including built-in alerts. There are numerous software vendors offering suites of tools with customizability promises. These are worth checking out if you have a business-critical operation and lack an internal development team. For others, I highly recommend exploring open-source tools supported by vibrant communities and active developers. Personally, I’m a fan of Timescale— a time series database built on Postgres —and the entire Grafana Labs Observability ecosystem. Security and privacy are crucial considerations before deploying an observability platform in a production lab. Be cautious to not stream ESP32 thermocouple data over your guest Wi-Fi network, even though it would allow your colleague to finally enjoy a peaceful lunch.

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Almost every conversation I had at #AACR last week mentioned the looming FDA LDT regulation. Luckily, Megan Nacar is hosting a webinar with 6 policy, reg, and reimbursement leaders. Should be an insightful discussion!

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"In a short but sweet Guidance issued last week, FDA proposed a dramatic change to the way it evaluates interchangeable biosimilars. For the last 14 years, an applicant could get approval of a biosimilar as a standard biosimilar or an interchangeable biosimilar, but the interchangeable biosimilar presented a higher hurdle to approval: Applicants needed to show that a patient could be switched from the Reference Product to the biosimilar and back without issue. But, as time has marched on and FDA’s experience with interchangeable biosimilars grown, the Agency’s 'experience has shown that . . . the risk in terms of safety or diminished efficacy is insignificant following single or multiple switches between a reference product and a biosimilar product.' Indeed, 9 of the 13 interchangeable products FDA has approved thus far have not included switching studies. Accordingly, FDA issued this new draft guidance that, when finalized, will revise certain sections of another guidance document, Considerations in Demonstrating Interchangeability With a Reference Product, which was written before FDA had received and reviewed any interchangeable biosimilar applications." #FDA #Guidance #CDER #CBER #Biosimilars #Interchangeability #SwitchingStudy https://lnkd.in/eW_Tsv8j

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This is a great observation from Benchling's industry survey I can't stop thinking about. It highlights that it's time for #labautomation (vendors and internal teams) to start rolling up sleeves and start delivering on the lab of the future promises the technology has promised. Comment why you think hardware has dropped so much after only a year?

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The FDA has issued the latest version of "Bioresearch Monitoring Technical Conformance Guide: Technical Specifications Document" (version 3.1). This version will likely be in place for a significant length of time as a road map for constructing this part of the NDA or BLA that you submit. Peter Calcott of calcott consulting provides a summary and analysis in this new Clinical Leader article. https://lnkd.in/dqHpcu9G #regulatorycompliance #BIMO #clinicaltrials

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Good read

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Happy Friday-Eve, LinkedIn! I've studied the PD-1 expression in T cells initiating apoptosis in tumor cells. I've studied the links between RAGE receptors and Alzheimer’s. I've studied links between rpg1/4 genes and wheat stem rust resistance in barley. I even named my dog Stryker because Medtronic and Abbott don't sound as scary at the dog park. My journey has always been scientific innovation, as a student or as a service provider. 🔬 In this nerdy analogy, Stryker represents an NK Cell, and that toy? Well, let's call it a cell, but really, that's your business ventures. Stryker's keen senses help him determine if a toy is worth playing with (aka if your company is in good health) or if it needs a little TLC. So, what markers does Stryker sniff out to determine if the cell is healthy or not? Here are a few things: High turnover rate? Struggling to fill technical positions? Need staffing support from highly specialized experts? Missing project deadlines? Limited hiring budget but need more support? Need project/short term based staff but don't know when and how? If you nodded yes to any of these questions, don't worry! Stryker won't trigger an immune response, but it's a sign that your "cell" might need some fine-tuning. And that's where I come in. My specialty? Crafting creative talent solutions tailored to your unique needs. Whether it's reducing overtime, streamlining onboarding, or boosting team morale, consider me your go-to resource for all things talent-related. I'm not just here to offer solutions; I'm here to make a difference because I believe advancing science means advancing society. Shoot me an email at [email protected] or book an appointment via my LinkedIn page. It's free, and don't worry, unlike Stryker, I promise I won't bite! Let's geek out together and unlock the next breakthrough for your business. Disclaimer: Just one tennis ball was harmed during the making of this post. #ScienceGeek #TalentSolutions #Innovation #LinkedInNetworking

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Are you tired of the complex traditional processes for Environmental Monitoring Performance Qualifications (EMPQs)? Check out our latest article where experts Ziva Abraham, President and Founder of Microrite, Inc., and Doug Botkin, Scientific Portfolio Specialist of Charles River, share insights on practical applications and commonly asked questions to ensure product integrity and patient safety.   #microlab #cleanroom #validations #empq #isoguidelines #environmentalmonitoring #patientsafety

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New approach methods (NAMs) continue to pave the way for more effective human risk assessments for FDA-regulated compounds. To help guide best approaches to these emerging methods, the FDA has released “Potential Approaches to Drive Future Integration of New Alternative Methods for Regulatory Decision-Making,” the latest report detailing recommendations from a NAMs subcommittee of the FDA Science Board. Read on to learn the six recommendations: https://lnkd.in/gxZYjtMG

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I love to see these posts about our Professional MS graduates who are thriving in their careers after graduation! Davidson School of Chemical Engineering Professional Master's Program

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