4SC AG, a clinical-stage biopharmaceutical company partnered with Patheon, by Thermo Fisher Scientific, whose experienced team helped them overcome active pharmaceutical ingredient (API) manufacturing hurdles, leading to a path toward commercial success.
Given the variety of products currently in development, including potent drugs, outsourcing the development and manufacturing to a CDMO experienced in handling a range of products, in a multi-use facility, has proven to be an effective strategy.
Polysorbate-80 (PS-80) is a surfactant commonly used as an excipient to improve API stability. However, degradation of PS-80 can lead to decreased drug potency or stability, and there is inconsistency in the quality and composition of PS-80 provided by different vendors.
Mid-volume capacity bioreactors offer agility in an unpredictable industry and balance the cost of goods as a program prepares to launch.
The secret to performing a thorough solid-state characterization involves integrating all data that may be generated across various instruments at different laboratories and properly interpreting that data.
Describing the pore of a size exclusion chromatography resin with a single number such as average pore diameter is an oversimplification. The formation of pores is dependent on complex combinations of many parameters.
When CDMOs understand what motivates drug innovators to outsource, who is involved in the service provider selection decision, and which CDMO attributes have the greatest influence on CDMO selection they are able to communicate what is unique about their offering to the right audience at the right time.
This video introduces Singota Solutions, a CDMO focused on getting products to patients faster by being agile, accountable and transparent. A team of industry experts help virtual to large pharma clients reach preclinical and clinical milestones faster with shorter lead times and agile onsite operations. Services in formulation development, finishing and supply chain support Singota’s flagship aseptic filling operations. A gloveless robotic isolator provides highly repeatable and precise filling for high value drug products.
Joe Principe, Vice President of Strategic Partnerships, Patheon, discusses the new set of “must-haves” that are emerging from the increased need for flexibility in outsourced manufacturing partnerships.
Single-use technologies are being seen as the solution to flexibly and cost-effectively address many of the challenges around creating biologics manufacturing capacity.
Pharmaceutical manufacturer and developer, Penn Pharma, has confirmed that its new contained manufacturing facility for producing highly potent products is on track for opening Q1 2013 at an exclusive event held at the British Embassy, Madrid during ICSE.
Lonza’s global R&D center for mammalian cell processes is based in Slough, UK alongside a custom manufacturing facility. Lonza undertakes highly specialized development and manufacturing services for the pharmaceutical and biotechnology industries. Read more about Lonza’s complete range of R&D Services and an array of technologies and skills to best match their customers’ requirements for all stages of product development.
Successful drug product development should integrate formulation, manufacturing process, primary packaging, device and delivery to the patient. Lonza’s Drug Product Services (DPS) offering delivers a holistic approach to DP development that anticipates and prevents problems early, and ensures the result is a product that is fit for purpose.
With nearly 30 years’ experience in supporting all compendial microbiological testing, Nitto Avecia Pharma Services has the in-depth experience, established quality systems, and expertise to best support your product life cycle at any stage.