90% of small molecules face solubility challenges—making micronization a critical step in drug development. In this exclusive Q&A with Pharma's Almanac, TJ Higley, CEO of Microsize (Micronization, Particle Size Engineering, Pharmaceutical Development), shares how the company’s 30+ years of expertise, proprietary jet milling technology, and high-touch service set it apart as a premier micronization partner. What you’ll learn: + The key trends driving increased demand for micronization + How custom-built jet mills optimize particle size reduction + The role of advanced analytical tools in formulation success Read the full Q&A here: https://lnkd.in/ePXtcYCe #pharma #pharmaindustry #lifescience #manufacturing
Microsize (Micronization, Particle Size Engineering, Pharmaceutical Development)
制药业
Quakertown，Pennsylvania 1,801 位关注者
Particle Size Reduction at its Finest
关于我们
Microsize specializes in Particle Size Reduction, Powder Classification, and Analytical Services, catering to a diverse clientele, including small biotechs, Big Pharma, CDMOs (API, Dosage Form, Integrated), and Functional Excipient Companies. Our expertise in milling and micronization processes enables us to develop and manufacture products with unique physical property challenges. We offer high-turn feasibility studies within our development suites, requiring as little as 1-5 grams of API. For highly potent compounds, including cytotoxics (HPAPIs), we provide world-class high containment infrastructure in our R&D labs and GMP suites to match your development stage. Our solutions cover Small Molecule APIs and HPAPIs, Functional Excipients, NCEs, 505b2s, and Generics. We support every phase of development, from Discovery and Phases I-III to Commercial Launch and Generic production. As North America's largest independent pharmaceutical micronization business, Microsize is a pioneer in enhancing dissolution and bioavailability of Active Pharmaceutical Ingredients (APIs). We rapidly develop, scale-up, and process APIs and excipients from grams to multi-metric tons, including highly potent compounds. Choose Microsize as your trusted partner, known for speed, responsiveness, and a high customer-touch business model. Think BIG...Think Microsize.
- 网站
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https://microsize.com/
Microsize (Micronization, Particle Size Engineering, Pharmaceutical Development)的外部链接
- 所属行业
- 制药业
- 规模
- 11-50 人
- 总部
- Quakertown，Pennsylvania
- 类型
- 私人持股
- 创立
- 1994
- 领域
- micronization、particle size reduction、bioavailability、solubility、active pharmaceutical ingredients、GMP、CDMO、CMO、jet milling、particle engineering、API、HPAPI、Excipients、high potency、drug substance、drug product、milling、sieving、cryomilling和co-micronization
地点
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主要
获取路线
20 Pacific Dr
US，Pennsylvania，Quakertown，18951
Microsize (Micronization, Particle Size Engineering, Pharmaceutical Development)员工
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S Milinchuk
Technology Lead | Physical Security Lead
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Michael Bauer
COO Microsize
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Steve Baric
Business development professional in the Technology & Life Science sectors | Synthetic & Bio Process CMC | Crystallization | Particle Engineering |…
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Hillary Pownall, SHRM-CP
HR Generalist | Business Operations
动态
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Excited to be part of DCAT (Drug, Chemical & Associated Technologies Association) next week in NYC! Looking forward to connecting with everyone. Here are the team members on the ground: - TJ Higley, CEO - Derek Hennecke, Board Chair - Steve Baric, Head of Business Development Let's make the most of our time in the city that never sleeps. Reach out to schedule a meeting ??, grab a coffee ?, or enjoy a beer ?? together... ?? https://lnkd.in/e5umm49h Safe travels to all! See you in the Big Apple! ?? #DCAT #DCATWeek #DCATWeek2025 #CDMO #SmallMolecules #API #DS #DP #Solubility #Innovation
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Microsize is renowned among our followers for its expertise in particle size reduction (PSR) utilizing milling/micronization technologies with Seamless Scalability. However, what many may not realize is our consistent ability to meet client needs beyond PSR, providing innovative solutions that elevate in-house capabilities. In instances where a unique requirement arises on a dry powder, consider a conversation with Microsize. Below are some of the diverse dry powder solutions routinely utilized at Microsize: - Blending using batch or continuous technologies - Sieve fractionation (classification) - Hydration of dry powders - Repackaging from Bulk - Foreign matter removal and remediation through sieving, metal detection, and other methods - Ancillary Analytical characterization encompassing Size, Morphology, LOD/KF Water Content, Solid State, Rheology, and more Microsize stands ready to address specialized demands with a comprehensive suite of solutions tailored to exceed expectations.
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"Seemless Scaleability" is a widely used term but with Microsize (Micronization, Particle Size Engineering, Pharmaceutical Development) the proof statements & use cases are numerous to support the meaningful value it can bring to clients during drug development. Does your provider have the ability to start feasibility (< 5 grams) and begin process development at the gram level scale (500 grams) but have the installed CAPEX to scale to metric tons (and any volume in between) in one house? 1) Wide inventory of suites and equipment scales, 2) Same test method developed at onset and used all the way through to approved NDA, 3) Streamlined scaleup of process to the "right" scale for launch 4) Proven commercial cGMP systems over 30 years to de-risk NDA approval * 70% of Microsize revenue is from sizing commercially approved GMP regulated powders * Highest volume API product processed = 200MT/annually in a single suite 1/2 of the year. * 1.5 MT/annually OEB 4 HP-API product processed under isolation/containment * With >20 active clinical trial scale products in pipeline Reach out to Steve Baric to learn more on how Microsize can "Seemlessly Scale" your micronization process.
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We are excited to?once again?be attending DCAT (Drug, Chemical & Associated Technologies Association)! ?? Schedule a meeting: https://lnkd.in/e5umm49h TJ Higley, CEO Derek Hennecke, Board Chair Steve Baric, Head of Business Development ?? Learn why Microsize (Micronization, Particle Size Engineering, Pharmaceutical Development) is the partner of choice for the global #pharma & #CDMO community looking to develop and optimize cGMP #micronization and #milling operations. We look forward to meeting you and discussing your #DS & #DP project requirements! #DCAT #DCATWeek #DCATWeek2025 #CDMO #SmallMolecules #APIs #Solubility #Innovation
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Microsize was glad to collaborate with Nanozen to employ state of the art technology to verify OEL levels on a multistep HPAPI contained process. Real time, second by second data was generated to create a better understanding of risk areas and correlate to operator processes around contained transfers. We were able to detect a problematic gasket real time, replace it and retest/verify effectiveness in same test sequence saving time and expense. Standard side by side air filter HPLC testing would have “hid” this spike due to dilution of these samples associated with longer collection period (15min). Nanozen real time detection provided a game changing solution for our ESH SMEs!
President and CTO at Nanozen Industries| SMEPAC Services for OEB 3-6 APIs and HPAPIs | Containment Leak and OEB Performance Testing with real-time sensor custom calibrated to surrogates and your HPAPIs.
Real-time HPAPI monitoring incorporates ISPE SMEPAC principles to isolate leaks in pre-test stage, greatly?increase?the efficiency, the?efficacy, and the accuracy of the SMEPAC process by detecting and eliminating short-term exposure spikes that can be overlooked by SMEPAC traditional, and cause health hazards and environmental contamination. #powderhandling #processtechnology #pharmaceutical #pharma #automation #digitaltransformation #ISPE #ISPEDACH
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Understanding and mitigating risk in #smallmolecule development is a challenge all pharma companies must address. Microsize (Micronization, Particle Size Engineering, Pharmaceutical Development) is co-hosting a seminar along with our partners Corealis Pharma Inc., Tedor Pharma Services, and The Solubility Company to discuss anticipating and understanding the #risks inherent in SM development and key #strategies that can be employed to mitigate those risks... all while keeping budgets, timelines, and objectives front of mind. Please join me and my colleagues for a workshop we are sponsoring at MassBio HUB in the heart of Cambridge, MA, on Thursday, Feb 6, from 4:30 to 7:30 pm. 4:30 pm Registration 5:00 pm Technical Programming 6:30 pm Networking Reception The workshop is free to attend, but space is limited, so register now! ?? https://lnkd.in/e7YNeBmb Speakers include: > TJ Higley, MSc., CEO of Microsize > Yves Roy, Phd, President of Corealis > Matthew Fodor, PhD, MBA, The Solubility Company > Laura Iorio, CEO of Tedor #smallmolecule #drugdevelopment #drugsubstance #drugproduct
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#DCATWeek is quickly approaching, and we are looking forward to connecting with industry leaders, expanding our collaborations, and building on relationships. Click the link to schedule a meeting: https://lnkd.in/e5umm49h Or contact TJ Higley, Derek Hennecke, or Steve Baric directly. Look forward to seeing you in NYC! #CDMO #API #particleengineering #micronization
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As 2024 comes to a close, Microsize would like to wish our clients, partners and friends Happy Holidays! A year of great progress on business, quality and innovation fronts that continues at a feverish pace right up to the holiday break next week! Thank you for making 2024 a great year and exciting 2025 to look forward to! #particleengineering #micronization #bioavailability #wherematters
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