The ultimate goal of formulation development is a stable product. In the case of a protein product, that can be defined as delivering the correct dose, in the native secondary and tertiary structure, without unintended chemical modifications, and free of extrinsic and intrinsic particles. In many cases, a lyophilized formulation can provide the highest probability of technical success. A well-designed product development plan can develop a phase 1 product quickly, while laying the foundation for commercial product success.
Tiziana Life Sciences plc, a clinical stage biotechnology company developing targeted drugs for cancer and inflammatory diseases, recently announces the enrolment of the first patient in its phase IIa clinical trial with milciclib, a novel inhibitor of cyclin-dependent kinases (CDKs), in patients with refractory hepatocellular carcinoma (“HCC”)
Althea’s complete range of drug Process Development capabilities offers the tools to address your needs. We develop processes for producing small quantities of proteins for early testing or establish robust, reliable and scalable processes that enable a strong commercial advantage. Althea also provides access to a proprietary drug delivery platform, called Crystalomics® technology, for the development of alternative drug delivery formulations of second generation drug substances.
Comprehensive contract development. Reliable cGMP manufacturing. Gain a competitive advantage in both by choosing Patheon for your biopharmaceuticals and biosimilars. You’ll have access to end-to-end, fully integrated services for both drug substances and drug products, delivered on time and on budget. A simplified supply chain that accelerates development and keeps you ahead in the rapidly changing world of biologics.
Considering that 90% of drug candidates have bioavailability issues, making sure your program is prepared for all phases of clinical trials from the very start is the fast way forward. Patheon Solubility Enhancement Services approaches BCS II and IV drug substance solubility issues a fundamentally different way that identifies the solubility enhancement technologies most likely to work before you get started. That helps eliminate rework and worry later on.
Piramal Pharma Solutions (PPS) is pleased to welcome Ash Stevens LLC as a part of the Piramal Group. Leveraging five decades of Ash Stevens’s operational experience and technical expertise, Piramal’s service offering now includes High Potency API (HPAPI) development and manufacturing capabilities. Located in Riverview, USA, our state-of the-art FDA licensed cGMP facility offers a full range of scale and containment options for high potency API manufacturing.
