Lysis Pharma specializes in contract development and manufacturing, We are recognized for timely delivery, reliable and high-quality services with a regulatory track record.
We are the industry-leading integrated development and manufacturing service provider for small molecule drug substances and their intermediates.
Active Pharmaceutical Ingredients and Intermediates (APIs)
- API Development and Manufacturing
ServicesWe have an
established history and ongoing service programs with
the full range of customers from virtual companies to
big pharma. Our development and manufacturing services
for APIs routinely support:
- Drug substances requiring advanced synthesis expertise and process development.
API Research and Development
We offer a broad spectrum of research and development services for small molecule APIs using state-of-the-art chemical technologies. To achieve robust and efficient process qualification for scale-up, our API development process utilizes modern tools such as automated workstations and statistical software.
our API development process utilizes modern tools such as automated workstations, statistical software, and reaction calorimetry.
API Research and Development
- Evaluation and API route scouting for early phase or potential projects Process development and technology transfer for small molecule APIs in early phase development and optimization of chemical processes Kilo-lab and small scale production under ISO or cGMP standards Process optimization via simulation Analytical and testing services including identification of impurities and characterization of API products and intermediates
We provide cost-competitive manufacturing on an industrial scale by optimizing chemical processes, utilizing advanced PAT and minimizing unit operations, supported by specialized quality control and quality assurance expertise.
We focus on customer technology, regulatory and development API needs, to deliver:
- easibility studies which include: development of innovative processes and 2nd generation processes (1-3 months) Small scale quantities (10–100 kg, 3–10 chemical steps; APIs) (2-3 months) Process development production of launch quantities (100 kg –5 tons), full regulatory support, validated processes (APIs, HPAPIs) (3-6 months) Support of direct API technology transfers from clients to our industrial plants (1-3 months).
Development and Optimization of Chemical Processes
Our API R&D and manufacturing teams have experience in many types of advanced chemical synthesis techniques. We are always prepared to adopt and optimize your process or offer you many advanced techniques of our own. In either case, our team can provide you with successful development technologies for all of your chemical processing needs.
Analytical method development and validation services supported by experienced analytical scientists and state-of-the-art equipment are integral to any drug development program.
Antibody-drug conjugates (ADCs) act by directly targeting and then killing selected cells, affecting both the growth and behavior of cells
Chemistry is core to Lysis Pharma. We continue our commitment to using standard and advanced chemical technologies to deliver APIs and intermediates to our customers.
Hot – Melt Extrusion
Hot-melt extrusion (HME) technology is an established solid dispersion technology for improving dissolution rate and solubility, and a component of our premier bioavailability enhancement services.