The fight against diabetes and obesity
Diabetes and obesity are two widespread conditions that call for swift action: in 2021, the World Health Organization (WHO) declared diabetes as a global epidemic, affecting six percent of the world's population which live with either type 1 or type 2 diabetes. The World Obesity Federation estimates that around four billion people – half of the world's current population – could be severely overweight by 2035.
New GLP-1 treatments
Current treatment strategies aim to prevent diabetes via targeted weight control. Aided by pharmaceutical development, adipose patients find relief in so-called GLP-1 peptides, which help to effectively treat obesity and diabetes. To leverage the potential of new anti-obesity drugs, pharmaceutical manufacturers rely on seamless systems, from filling to medical device assembly.
Packstyles and dosage forms
Highly dosed, subcutaneously injectable obesity treatment drugs enable easy administration. Some medicines only need to be taken once a week and come in auto-injectors or pens. The handy devices support effective self-medication: patients administer the exact dose by the press of a button.
Pens
Pens are based on cartridges, allowing patients to use the devices for up to five doses. In the case of obesity treatment drugs with weekly administration, one pen lasts for one month or longer. All patients need to do is change the needles, which are protected by an inner and outer cap for added safety.
Auto-injectors
Ready-to-use (RTU) syringes are the core of autoinjectors, ensuring lean fill finish processes as well as easy administration. The syringe contains the medicine, which is injected via the needle upon the push of an injection button. Auto-injectors are disposed of after each application, requiring no needle changes.
Ready-to-use pack styles
RTU syringes and cartridges can be processed in large quantities without upstream cleaning, siliconization, and sterilization. Following automated bag and tub opening, syringes are filled and sealed inside their nests. RTU cartridges have higher volumes (up to 10 ml) and are used in novel on-body devices with a pump and monitoring system.
Oral solid dosage forms
Solid anti-obesity drugs for oral intake are currently being developed by several companies, with key players evaluating the potential in pre-clinical and early-phase clinical trials. In contrast to injectable options, OSD alternatives for obesity treatment are expected to require more frequent administration.
Manufacturing of insulin and glucagon-like peptides
Whether you are already selling your anti-obesity drugs or are currently applying for marketing authorization, Syntegon is at your side. As a long-standing equipment and service provider for the pharmaceutical industry, we help you leverage the potential of your weight management products anytime, across the entire value chain.
The new, cost-efficient SVP Essential is a fully automated, ready-to-use system to produce simple parenterals such as analgesics, insulin, and generic drugs.
reduce contamination risks and friction inside the cartridge. Syntegon’s portfolio of compact pharmaceutical cleaning systems for the low, medium and high output ranges prevents potentially harmful substances from compromising operator and patient safety. The integrated application of silicone layers allows easy stopper motion in pens.
Cleaned and siliconized cartridges are heated to 300 degrees Celisus to eliminate any contaminants. Syntegon offers versatile sterilization solutions for an effective treatment of porous loads and liquids in open, semi-sealed, or closed containers.
Following separation, cartridges are first stoppered from below. For suspensions, a glass or stainless-steel ball is added from above. Filling then takes place in several steps. Syntegon offers a wide range of technologies, including valve piston and peristaltic pump for highly customizable operations. Filled cartridges are sealed with an aluminum cap. It includes a septum which is pierced by the needle during use. The aluminum cap is crimped and the cartridge is transported in Akylux boxes.
Syntegon has established a comprehensive portfolio, including open RABS, closed RABS, containment and isolator systems.
State-of-the-art technologies for visual inspection and container closure integrity testing (CCIT), including high voltage leak detection (HVLD), static division (SD), and headspace analysis (HSA).
Our modular assembly systems with scalable levels of automation reliably support the production of standard 4-piece disposable pens and come in different designs according to your desired production rates.
Ready-to-use syringes in auto-injectors (line configuration example):
Our systems enable you to process the two most common container types for obesity treatment drugs: while cartridges call for comprehensive upstream processes like cleaning, siliconization, and sterilization, RTU syringes can be filled right away after tub and bag opening. Both cartridges and syringes require precise stoppering, inspection, and assembly to ensure safe products.
Tubs with syringe nests are packed in either single or double bags. They are loaded into automatic tub and bag opening (ATO/ABO) equipment, where the bags and the tubs’ Tyvek film and top layer are removed. The tubs are then transferred into the filling machine.
In the filling machine, the nests are removed from the tubs to fill and seal the syringes inside the nest. Semaglutides require small filling volumes (e. g., 1.5 ml within a 3 ml cartridge). Products are typically filled in rows in several steps to ensure high filling accuracy. Stoppering is based on vacuum technology for added precision.
Extensive processes call for thorough sterilization to eliminate any contamination in the filled and sealed product. Besides isolator technology, sterilization systems ensure highest product safety: syringes in tubs are sterilized at 121 degrees Celsius applying methods that are gentle on both the packaging and the medicines.
Safe syringes require a 100% inspection of all objects. Fully automated and highly flexible systems cover visual inspection and leak detection on a single platform, checking containers for cosmetic defects, intrinsic and extrinsic contamination, and leaking closures. Built-in de-nesting and re-nesting features make sure the syringes are handled gently during the process.
Flexible assembly platforms make sure that key auto-injector components like syringes, base caps, springs, and actuators are reliably assembled with fast and tool-free changeovers whenever production involves different formats. Various assembly methods (manual, semi-automated, fully automated) enable scalable processes.
The new, cost-efficient SVP Essential is a fully automated, ready-to-use system to produce simple parenterals such as analgesics, insulin, and generic drugs.
“Our long-standing expertise in the filling and sealing of insulin enables us to support producers of anti-obesity drugs with seamless and integrated technologies across the value chain – from filling and sealing to inspection and assembly.”
Markus Burkert, Product Manager Pharma Liquid and Sustainability
“As a provider of drug containment and delivery solutions, it is crucial for us to closely collaborate with fill-finish machine providers to ensure pharmaceutical companies can focus on drug development, while we ensure drug stability, seamless fill & finish processing as well as safe and easy drug administration.”
Fabian Stöcker, Senior Vice President at SCHOTT Pharma
“Our long-standing expertise in the filling and sealing of insulin enables us to support producers of anti-obesity drugs with seamless and integrated technologies across the value chain – from filling and sealing to inspection and assembly.”
Markus Burkert, Product Manager Pharma Liquid and Sustainability