The topic highlights the significance of engineering data generation to develop robust, safe and reproducible processes. The biggest challenge from a CMO perspective is to develop processes which are robust, scalable and reproducible across manufacturing environments and achieve right first-time. Developing a recipe for any process to achieve first time successful scale up requires adequate data collection within the phase appropriate development philosophy. The decisions made throughout the process development need thorough assessment supported by data to avoid surprises on scale. The most important success factors are the type and extent of data collection at each phase of development. It could be a reaction kinetics or a unit operation such as distillation, crystallization or drying or it could be an elaborate impurity purging study or DoE study to define parameter boundary or developing a transfer function. Over the years, Syngene has acquired significant expertise in generating engineering data at every phase of drug substance development supported with models and simulation. This has enabled us to consistently demonstrate seamless scalability and control over the processes compared to conventional approaches.
Lonza’s UC-II® ingredient has been shown to support optimal joint health at low dosages, by improving comfort, mobility and flexibility.
Research recently published in Osteoarthritis & Cartilage provides further validation for Lonza’s UC-II® brand as a leader in the joint health ingredient space. The study demonstrated that UC-II® undenatured type II collagen diminished deterioration of articular cartilage in a rat model of osteoarthritis (OA).
The dose of the UC-II® ingredient selected for the study represents the clinically tested human equivalent dose of 40 mg per day. As this small size and once-per-day frequency provides an efficacious dose, it may improve consumer compliance.
UC-II® undenatured type II collagen has been shown to help improve joint comfort, mobility and flexibility in people with OA and is statistically significantly more effective than the combination of glucosamine and chondroitin, as measured by WOMAC.
With results showing 86% of respondents are concerned about the scientific proof behind the ingredients they consume, the UC-II® brand presents an ideal opportunity to create compelling, science-backed products that appeal to consumers’ evolving needs for joint health.
The session is designed as an introduction to the pharmaceutical market of Sub-Saharan Africa, and where the opportunities and challenges are for both local, and multinational players.
New requirements for accurate dosing of liquid and suspension pharmaceuticals has driven the development of new and novel dispensing
systems and devices for known delivery pathways such nasal, topical and ophthalmic.
Patient preference, ease of use and ergonomics play a critical role today in the success of
pharmaceutical launches. Devices, therefore, must be developed with performance,
formulation compatibility and extensive consumer testing in mind. Patient adherence,
product repurchase, prescribing and differentiation can be all positively impacted when a
secure fit exists between the dispensing system, the pharmaceutical product, and patient
There are many barriers to entering into this complex service offering, and selection of the right partner is critical for success. This presentation will discuss challenges and complexities of serialization implementation and touch on the what, why and how of serialization.
Break-through innovation in science and technology is rapidly changing the world of pharmaceuticals. In strictly regulated markets of the developed world there is a well-established structure within regulators allowing for the balance of availability of monitored for quality and safe innovative drugs to the patients. The situation in less developed with respect to regulatory scene countries is very different. Huge geographical region of CIS (Commonwealth of Independent States) representing ex-Soviet Union region and consisting of some twelve countries today is of great interest to pharmaceutical companies as one of the emerging markets. Penetration to these markets requires local knowledge of tendencies and problems. Many questions remain yet unanswered on GxP regulations, drug safety, regulatory aspects for biotech, radiopharmaceuticals, orphan drugs. However the convergence dynamics are obvious, allowing to predict the short-term future path of development and differences from the Western world. We present an analysis of the CIS market trends on regulatory affairs and drug safety for the upcoming years.
The polymer industry has a significant role to play in the changing landscape of API delivery. Pharmaceutical industry ‘pain points’ such as injection site discomfort, incorrect usage of self- administered therapies, and side effects due to fluctuating blood serum concentrations, can all be improved by a focus on material selection for combination devices. This briefing will focus on 3 areas of focus:
1. Lowering the coefficient of friction for injection and inhalation devices.
2. Developing thinner, stiffer smart delivery device components to allow more space for increased device functionality.
3. Aligning our polymer excipient technology with evolving small molecule and biologic therapies.
How third party systems of evaluation od APIs and intermediates applied for by manufacturers of APIs and intermediates help improving pharma supply chain in terms of better selection of supplies