Elite FDA-Inspected Manufacturing Infrastructure
Meeting key deadlines and going to market not only depends on the ability to adapt to processing challenges but also access to the right facilities and proper technologies for your drug product.
Find the Right Partner
Scaling up production of your sterile drug product from clinical to commercial scale is a complicated and challenging process, with many factors to consider.
Finding an appropriately sized CDMO to help you go to market can be difficult, especially when manufacturing capacity shortages are common and many CMOs focus on more established or high-volume products. Check out our webinar to discover what to look for when searching for a CDMO partner for commercial supply
Flexible and Tailored
Bringing a product to market is a long and difficult process with many hurdles encountered along the way. The right partner is out there for commercial-scale aseptic manufacturing, but to find them, you need to know what to look for. Start bridging the gap from clinical to commercial with our teams’ personalized approach.
Experienced and Ready
Located in Bethlehem, PA, we have established our commercial production capabilities by leveraging our decades of knowhow as a leading product developer and clinical stage manufacturer.
Our team and facility are ideally sized and capable of scaling up from small clinical batches to commercial production, so you can rest assured that your drug product will get the care and focus it needs to succeed.
Equipped and Prepared
When a project moves from the clinical to the commercial stage it often brings unforeseen challenges that may cause delays in bringing a drug product to market. Chief among these is a lack of global capacity and infrastructure to successfully scale up sterile products to commercial levels.
LLS Health’s cleanrooms are designed to accommodate custom batch sizes with automated filling and no minimums. Our ISO 5 commercial filling line is ready for 2 – 30 mL liquid vials and ophthalmic bottles. Whether you have a small or large molecule project, we have the expertise and capacity to help.
Founded in Partnership
The CDMO business of LLS Health has been a trusted partner to the pharmaceutical industry for over 20 years, offering formulation development and GMP manufacturing services to a range of companies, including leading pharmaceutical and biotech companies, privately-backed start-ups, governments, foundations, universities, and hospitals.
Our clients include over half of the leading pharmaceutical and biotech companies, governments, foundations, universities, and start-ups. Let us know how we can help bring your product to market.
Get the attention you need from a CDMO.
A Message from Our Team
The pharmaceutical landscape is changing.
High-volume blockbuster drug production is no longer the industry norm, and the push towards personalized medicine means there is a need for flexible manufacturing capacity that serves custom batch sizes.
LLS Health’s aseptic manufacturing facility was designed with the future of pharma in mind. Our purpose-built infrastructure and customer-centric team are ideally suited to take your product to market.
LLS Health’s CDMO Division has spent over twenty years serving the pharmaceutical industry, and we hope to make your product our next success story.
– Rob Lee, President of LLS Health’s CDMO Division