In an increasingly competitive US marketplace, diagnostics companies that develop lyophilized products and liquid formulations need to get their products to market as quickly and efficiently as possible – all while ensuring that these are high quality, stable and scalable. For these companies, it is particularly important to reduce cold-chain logistics, enhance formulation performance, and increase product shelf life.
Combining research and development (R&D), consultancy, and small-batch production under one roof, Biopharma Technology LLC offers flexible, end-to-end CDMO solutions that answer these key challenges. From R&D to manufacturing, we provide a host of services to ensure a seamless formulation development process from start to finish.
Whether you are new to lyophilization or an established practitioner, Biopharma Technology LLC’s US-based lyo center is on hand to support you at every stage of your project, including product assessment, proof of concept, formulation development, cycle development, troubleshooting, scale up and technical transfer.
Why Choose Biopharma Technology LLC?
As part of Biopharma Group, US division Biopharma Technology LLC, benefits from over 35 years of lyophilization expertise and is widely recognized as an industry leader in lyophilization standards and technology. Drawing on this experience, we offer expert diagnostics partnerships for contract R&D and manufacturing, while providing access to advanced facilities, technology and equipment.
When working with Biopharma Technology LLC, your organization retains full ownership of all products, processes, and intellectual property (IP) developed as part of the partnership agreement. This means that you can maintain autonomy over all of the outputs and innovations that result from the project, enabling you to fully integrate these into your operations, auditing, business strategy and brand.
Having completed over 5000+ projects across 30 countries, Biopharma Technology LLC’s scientists have the flexibility, agility and capacity to meet your company’s specific requirements. Throughout these projects, our R&D services have demonstrated an average reduction of 80% in product storage costs for our customers, as well as a 60% decrease in their production costs.
Biopharma Technology LLC also specializes in in-vitro diagnostics for the point of care sector. We are equipped to provide expert advice on complying with the European Union’s In Vitro Diagnostics Regulation (IVDR), which is a requirement for US molecular diagnostics companies looking to export products to countries outside the US.
By collaborating with Biopharma Technology LLC, your lyophilized product and liquid formulation development operations benefit from:
- ISO accreditation: Biopharma Technology LLC is ISO 9001 and ISO 13485 accredited, ensuring full compliance with regulations.
- Secure US shipping: Secure shipping across the US is assured for all formulations – from -80°C to ambient temperatures.
- Flexible capacity: Our team can produce up to 7,000 lyobeads per hour using our LyobeadPRO™ lyobead generator.
- Competitive pricing: Biopharma Technology LLC offers competitive pricing for its CDMO diagnostics services, helping you to reduce your organization’s supply chain costs.
R&D and Manufacturing Services For the Diagnostics Industry
Biopharma Technology LLC offers an array of lyophilization services for those developing diagnostic reagents in the USA. These services are delivered through our in-depth expertise in thermal and critical event analysis techniques, which utilize our Lyostat FDM and Lyotherm frozen state analyzer. We use these methods to complete comprehensive research on your liquid and dried product formulations – whether they are developed independently or in partnership with us – to provide you with a robust understanding of your product’s stability, quality, and solubility.
Harnessing this research, our team can also assist you in creating efficient and effective product development processes, which help to future-proof your formulations.
Diagnostics R&D / Analytical Lab Services
- Formulation & lyo-cycle development
- Proof-of-concept studies
- Scale up and technical transfer
- Troubleshooting
- Technical transfer to production facilities
Diagnostics Manufacturing
- Contract freeze drying for lyocakes
- Lyobeads technology
- Quality Control & ISO compliance
- Packaging & kitting services
- Packing service for non-standard products
