Eiron Benmor - אירון בנמור’s Post

Full control and deep understanding of the process bring you the product with no surprises by the team of professionals you can trust.

We're here to support your global Tirzepatide strategy! With deep peptide API development and manufacturing experience, a large portfolio of generic commercial peptides, and 24 DMFs for 8 peptides already under our belt, we'd be delighted to talk to you today. nGMP samples are available.  For more information visit: https://lnkd.in/ez-CEuic 𝘛𝘪𝘳𝘻𝘦𝘱𝘢𝘵𝘪𝘥𝘦 𝘈𝘗𝘐 𝘪𝘴 𝘤𝘶𝘳𝘳𝘦𝘯𝘵𝘭𝘺 𝘥𝘦𝘷𝘦𝘭𝘰𝘱𝘦𝘥 𝘢𝘯𝘥 𝘱𝘳𝘰𝘥𝘶𝘤𝘦𝘥 𝘧𝘰𝘳 𝘙&𝘋 𝘱𝘶𝘳𝘱𝘰𝘴𝘦𝘴 𝘢𝘯𝘥 𝘳𝘦𝘨𝘶𝘭𝘢𝘵𝘰𝘳𝘺 𝘴𝘶𝘣𝘮𝘪𝘴𝘴𝘪𝘰𝘯𝘴 𝘰𝘯𝘭𝘺. 𝘛𝘩𝘦 𝘴𝘢𝘭𝘦 𝘪𝘴 𝘦𝘹𝘤𝘭𝘶𝘥𝘦𝘥 𝘦𝘹𝘤𝘦𝘱𝘵 𝘧𝘰𝘳 𝘵𝘩𝘦 𝘱𝘶𝘳𝘱𝘰𝘴𝘦𝘴 𝘰𝘧 𝘰𝘣𝘵𝘢𝘪𝘯𝘪𝘯𝘨 𝘰𝘯𝘦 𝘰𝘳 𝘮𝘰𝘳𝘦 𝘮𝘢𝘳𝘬𝘦𝘵𝘪𝘯𝘨 𝘢𝘶𝘵𝘩𝘰𝘳𝘪𝘻𝘢𝘵𝘪𝘰𝘯𝘴 𝘢𝘯𝘥 𝘰𝘯𝘭𝘺 𝘪𝘧 𝘵𝘩𝘦 𝘭𝘢𝘵𝘵𝘦𝘳 𝘴𝘢𝘭𝘦 𝘪𝘴 𝘱𝘦𝘳𝘮𝘪𝘴𝘴𝘪𝘣𝘭𝘦 𝘶𝘯𝘥𝘦𝘳 𝘢𝘯𝘥 𝘪𝘯 𝘢𝘤𝘤𝘰𝘳𝘥𝘢𝘯𝘤𝘦 𝘸𝘪𝘵𝘩 𝘢𝘱𝘱𝘭𝘪𝘤𝘢𝘣𝘭𝘦 𝘭𝘢𝘸. #tirzepatide #glp1 #activepharmaceuticalingredients #tevaapi

We're here to support your global Tirzepatide strategy! With deep peptide API development and manufacturing experience, a large portfolio of generic commercial peptides, and 24 DMFs for 8 peptides already under our belt, we'd be delighted to talk to you today. nGMP samples are available.  For more information visit: https://lnkd.in/ebs5WEpw 𝘛𝘪𝘳𝘻𝘦𝘱𝘢𝘵𝘪𝘥𝘦 𝘈𝘗𝘐 𝘪𝘴 𝘤𝘶𝘳𝘳𝘦𝘯𝘵𝘭𝘺 𝘥𝘦𝘷𝘦𝘭𝘰𝘱𝘦𝘥 𝘢𝘯𝘥 𝘱𝘳𝘰𝘥𝘶𝘤𝘦𝘥 𝘧𝘰𝘳 𝘙&𝘋 𝘱𝘶𝘳𝘱𝘰𝘴𝘦𝘴 𝘢𝘯𝘥 𝘳𝘦𝘨𝘶𝘭𝘢𝘵𝘰𝘳𝘺 𝘴𝘶𝘣𝘮𝘪𝘴𝘴𝘪𝘰𝘯𝘴 𝘰𝘯𝘭𝘺. 𝘛𝘩𝘦 𝘴𝘢𝘭𝘦 𝘪𝘴 𝘦𝘹𝘤𝘭𝘶𝘥𝘦𝘥 𝘦𝘹𝘤𝘦𝘱𝘵 𝘧𝘰𝘳 𝘵𝘩𝘦 𝘱𝘶𝘳𝘱𝘰𝘴𝘦𝘴 𝘰𝘧 𝘰𝘣𝘵𝘢𝘪𝘯𝘪𝘯𝘨 𝘰𝘯𝘦 𝘰𝘳 𝘮𝘰𝘳𝘦 𝘮𝘢𝘳𝘬𝘦𝘵𝘪𝘯𝘨 𝘢𝘶𝘵𝘩𝘰𝘳𝘪𝘻𝘢𝘵𝘪𝘰𝘯𝘴 𝘢𝘯𝘥 𝘰𝘯𝘭𝘺 𝘪𝘧 𝘵𝘩𝘦 𝘭𝘢𝘵𝘵𝘦𝘳 𝘴𝘢𝘭𝘦 𝘪𝘴 𝘱𝘦𝘳𝘮𝘪𝘴𝘴𝘪𝘣𝘭𝘦 𝘶𝘯𝘥𝘦𝘳 𝘢𝘯𝘥 𝘪𝘯 𝘢𝘤𝘤𝘰𝘳𝘥𝘢𝘯𝘤𝘦 𝘸𝘪𝘵𝘩 𝘢𝘱𝘱𝘭𝘪𝘤𝘢𝘣𝘭𝘦 𝘭𝘢𝘸. #tirzepatide #glp1 #activepharmaceuticalingredients #tevaapi #peptides

For the past year, the FDA has released revised guidance documents essential for QC professionals. Check out the links below for valuable insights: 1) Control of Nitrosamine Impurities in Human Drugs: https://lnkd.in/eR47A5Ch 2) Container Closure System and Component Changes for Glass Vials and Stoppers: https://lnkd.in/eaNU6pWd 3) Q2(R2) Validation of Analytical Procedures: https://lnkd.in/eswUyWbB 4) Policy for Testing Alcohol (Ethanol and Isopropyl Alcohol) for Methanol: https://lnkd.in/e-Ej5vPe 5) Testing of Glycerin, Propylene Glycol, Maltitol Solution, Hydrogenated Starch Hydrolysate, and Sorbitol: https://lnkd.in/eSS82q9x Stay informed and up to date with the latest guidance to enhance quality control practices. #FDA , #QualityControl , #GuidanceDocuments

Here is another observation from a recent FDA Warning Letter.  The FDA Guide to the Inspections of High Purity Water Systems discusses the challenges with attaching hoses to use-points in pharmaceutical water systems.  Specifically, it mentions the concern for non-sterile air remaining in the hose after it is drained and the possible risk of contamination.  Several different use-point design configurations as well as sound operational procedures, as part of a validated hose management program, can mitigate this risk.  However, submerging the hose in a bucket of stagnant water is not one of them, even if the use-point valve is leaking.

⚡Cleaning Validation Tip: Implementing TOC as a process analytical technology for cleaning systems can improve knowledge and control of the cleaning process beyond testing final rinse water quality at a single moment in time. #CleaningValidation #Pharma #LifeSciences #Sievers https://bit.ly/4ghIUsX

In October 2024, the FDA released an updated guidance on the bioequivalence of immediate-release solid oral dosage forms. This new guideline outlines essential standards and methodologies for establishing bioequivalence, helping ensure that medicinal products meet the necessary quality, efficacy, and safety standards. Check out the full guidance below for all the details and insights. #Bioequivalency #GMP #Quality #OralSolisDosageForm

Which is better for USP <797> compliance: the single or dual-plate #protocol? The dual-plate protocol offers a faster turnaround time and better fungal recovery, providing more certainty for your results. However, the single-plate protocol is also acceptable under USP <797>. Your choice should align with your SOPs and regulatory requirements. Explore more about these protocols in our blog: https://ow.ly/m7A230sHcGw #USP797 #RegulatoryCompliance #Compliance #Pharmacy #CompoundingPharmacy #SOP

Sarfaraz, how would BPS handle efficacy based CQAs that can differ from biosimilar to biosimilar, e.g., glycosylation specific CQAs.

When accuracy matters, RTDs (Resistance Temperature Detectors) are the go-to choice. 📏🌡 They can provide readings with tolerances as low as ±0.1°C, making them ideal for industries like pharmaceuticals and food processing. Need precision? We’ve got you covered! #RTD #ProcessControl #PrecisionMatters