Syntegon Pharma Technology is pleased to announce that Alex Trombley has joined our team as a Business Development and Process Specialist supporting our pharmaceutical oral solid dosage product line (Huettlin) in North America.
Alex graduated with a degree in Chemical Engineering from the University of Michigan. He has 5 years of experience in oral solid dosage formulation and process development with Eli Lilly. …more
In many of my previous Syntegon articles, I have lamented the high cost of drug product development, with good reason. Developing an oral-solid-dose drug product is an expensive and risky endeavor, with formulation and process development being among the most significant and time consuming challenges.
It is no secret that formulation scientists face a host of hurdles when developing a formulation bound for tablet compression. First and foremost is achieving …more
Compromise no longer; Syntegon’s GKF 60 R&D capsule filler is here! The GKF 60 combines a small machine footprint with the durability, innovation and flexibility you have grown to expect from Syntegon. When designing the GKF 60, our mission was simple, “design it to do everything.” We think you will agree that it does exactly that.
In the OSD product development world there a few hard and fast rules; plans change; timelines shrink; and API is scarce. That is where the flexibility of the GKF 60 comes in. …more
Although Syntegon’s tamping-style capsule filling machines have set the standard for precision and durability in capsule filling for decades, that does not mean we rest on our laurels. At Syntegon, we tirelessly pursue innovations that make our industry leading equipment even better. One of the most important of those innovations to come out of Syntegon’s Waiblingen, Germany facility in recent years is slide gate technology for capsule fillers. …more
Developing a pharmaceutical product within a Research and Development Lab can be a very expensive and time-consuming process for OSD manufacturers. Once a stable product has been developed within the lab setting, scaling up to pilot production can prove even more daunting for scientists. Pilot-scale machines provide pharmaceutical companies the tools to better understand a manufacturing process that was successful at lab scale, while also allowing for batches at less than production scale, where design changes can still be easily executed at less cost. Syntegon offers …more
Join Syntegon at the 2021 Virtual Pharma Expo series event, focused on Oral Solid Dose Manufacturing. On Wednesday, May 5 at 9:30am EDT, Head of Pharma Service and Senior Scientist/Pharmacist Marc Michaelis will be presenting on Continuous Manufacturing. Learn about the benefits of moving from batch production to a continuous process.
Learn more about the event, and register for free here.
Developing an oral solid dosage (OSD) product is not easy; timelines are long, financial risks are considerable and challenges are many. Consequently, significant incentive exists to find efficiencies and streamline the product development process wherever possible. However, one aspect of the pharma development process remains unchanged. Regulatory agencies are unwavering in their demand for evidence that your manufacturing process is stable and the design space well defined; …more
Developing and manufacturing hard-shell capsules with low fill-weights can be an especially challenging task. However, recent innovations provide the tools to make the job of manufacturing such products much easier, while also providing assurance that the capsules you make meet your stringent quality requirements. Whether you need to fill just API into capsules for clinical trials, need to manufacture a low-fill capsule product for dry powder inhalation, or simply have a product formulation that requires low fill-weight, the tools available today can make the job much simpler. …more
COVID-19 is currently challenging our technical professionals in terms of traveling for set-ups and the commissioning of the delivered equipment to our customers worldwide. However, our customers are also suffering from travel restrictions, which make it difficult to carry out a joint Factory Acceptance Tests (FAT) on the manufacturer’s site. A FAT is a process to approve that the equipment aligns with the specifications made for design and functions, before it is dispatched to our customers.
Fluid bed processing has long been used in the Pharmaceutical, Nutraceutical, and Chemical industries as a way to enhance the characteristics of powders, dry products, or apply an active compound or functional coating to the surface of particles or beads, with the objective of controlling release of the product. …more
