Dr. Henning Falck, Division Director Particle Technology, Neuhaus Neotec GmbH, Germany
Fluidised Bed processing is widely used in the industry not only for pharmaceutical applications. The fluid bed technology for drying/cooling purposes, agglomeration, spray granulation, microencapsulation and coating of powders, granules, pellets and other dosage forms provide a wide field of most different applications.
Fluid bed processes can be carried out in batch or continuous operation mode. Pharmaceutical industry still today is dominated by batch operations. But in the recent years pharmaceutical companies are squeezed more and more to improve their cost structure and productivity. Therefore continuous processing options get into the focus.
Both batch and continuous Fluid Bed processing options are both very well suited to produce pharmaceutical substances that fulfill all demands regarding the final product specification. The choice of the correct processing mode depends on the individual situation and set targets. Most of the challenges of the pharmaceutical production which are very well addressed with batch type equipment can also be matched with continuous plants but there are differences which are worth to know.
Dr. Hamid Ghandehari, Professor at the Departments of Pharmaceutics & Pharmaceutical Chemistry & Bioengineering, Director of Utah Center for Nanomedicine & Co-Founder and Co-Director of the Nano Institute of Utah, University of Utah, Utah, USA
Recent efforts in our laboratory involve the design and development of recombinant polymers for localized drug and gene delivery and as liquid embolics, use of external triggers such as plasmonic photothermal effect and high intensity focused ultrasound to improve delivery of polymer therapeutics to prostate tumors, and investigation of the influence of structural features of silica nanoparticles on their cellular uptake and toxicity. This talk will be an overview of findings from these investigations.
Dr. Vinod Labhasetwar, Professor, Department of Biomedical Engineering, Lerner Research Institute, Cleveland Clinic, Cleveland, Ohio, USA
Nanoparticle-based drug delivery systems can potentially overcome several barriers to drug delivery, reduce toxicity to the patient, and thus improve therapeutic outcomes. Over time, nanoparticles have undergone evolution from simple to more complex systems, yet the nanoparticle formulations developed as “nanomedicine” for clinical use remain quite simple. Our laboratory research has shown that simple nanoparticle formulations, developed with a solid rationale, are very effective in treating complex conditions. This overview will describe nanoparticles that are straightforward in design yet effective in treating complex diseases in animal models. One example is a formulation that successfully treats bone metastasis, considered the primary cause of death in many types of cancers but more particularly in prostate and breast cancers. A second example is a formulation that effectively modifies the after-effects of stroke. This presentation will also define the challenges in moving complex nanoparticles through regulatory pathways and the scale-up process toward eventual commercialization.
Mr. Sudesh Shetty, Partner KPMG, Mumbai, India
This session will throw light on:
The key challenges and opportunities that the Indian Pharmaceutical Industry is facing in global marketplace. This will include a brief on cGMP compliance, particularly data integrity, and, Uniform Code of Pharmaceutical Practice (UCPMP).
KPMG’s Pharma Outlook for 2030: Catalyzed by a range of new and disruptive technologies, the pharmaceutical companies need to prepare for future which will not only reduce the risk of decreasing income but also create new opportunities for growth. KPMG’s ‘Pharma Outlook 2030’ dwells into the key trends that will revolutionize the pharmaceutical industry and how it will be driven by advancement in technology, ground breaking therapies and increased access to data by patients.
Dr. Per Falk, Executive Vice President R&D & Chief Scientific Officer, Ferring Pharmaceuticals, Switzerland
The ambition of drug delivery technology is to optimize the benefit/safety profile of a drug as well as to improve convenience for patients. While drug delivery by itself is an area of strong innovation, other macro trends in the pharmaceutical industry trigger the need for a further technology push.
Examples of such trends are a shift to larger molecules and new modalities, i.e. cell based and gene therapy, and the rising importance of device technologies together with personalized care and digital applications.
At Ferring, innovative drug delivery is historically one focus area in R&D. Recently launched Rekovelle (recombinant follicle stimulating hormone) for the treatment of female infertility is combining the above trends with the administration of a large molecule with an injection pen based on individual dosing, which is easily established by a digital app.
Prof. Kannan Rangaramanujan, Arnall Patz Distinguished Professor of Ophthalmology & Co-Director, Center of Nanomedicine, Johns Hopkins School of Medicine, Baltimore, Maryland, USA
Neuroinflammation, mediated by activated microglia and astrocytes, plays a key role in the pathogenesis of cerebral palsy (CP), autism, and most other debilitating central nervous system (CNS) disorders. ‘Appropriate’, targeted manipulation of neuroinflammation can bring novel approaches for treated diseases, increasing the drug efficacy and decreasing the side effects (a major issue with many CNS therapeutics). However, targeted delivery of drugs to specific cells in the CNS is a challenge. To address this, we take advantage of the unique, intrinsic, pathology-dependent, brain uptake of dendrimers (with no targeting moieties) in disease models of CNS and retinal disorders. Upon systemic administration, hydroxyl-terminal poly(amidoamine) dendrimers localize selectively in activated microglia and astrocytes in animals with CP. Such selective localization has been broadly validated in pre-clinical models of brain and retinal injuries in more than 25 small and large animal models, including primates. The potential mechanism for such selective uptake will be discussed. Building on these findings, we have designed and synthesized dendrimer-drug conjugates which have shown significant promise for many brain and ocular disorders. Two examples of this approach of targeted, systemic therapy for neuroinflammation, one for pediatric brain injury and one for age-related macular degeneration, representing two opposite ends of the age spectrum, will be presented.
Dr. Dilwyn Patterson, Senior Product and Process Manager, GEA Process Engineering Limited, Hampshire, UK
The growing interest in novel drug delivery systems has led to challenges for the production of particles which require to have delayed, modified or sustained release profiles. An overview of the technologies which can be used to produce particles with controlled release characteristics will be discussed
Dr. Matthias Wacker, Head of Pharmaceutical Technology and Nanosciences, Fraunhofer-Institute for Molecular Biology & Applied Ecology (IME), Germany
Today, many of the newly developed pharmaceuticals and medical devices take advantage of nanotechnology. Many of these nanomedicines have been utilized to improve diagnosis and treatment of life-threatening diseases. However, with a rising number of formulations that contain particles in the nanoscale, there is also a high potential for unexpected risks and side effects posing a threat to human health and the environment. Regulatory authorities all over the world carefully observe recent developments in this area, striving to find a balance between consumer safety and the interests of the industry. While the new legislation demands nanospecific risk assessment for these substances, a public controversy has been raised about the safety of nanotechnology in general. Recent progress in the regulatory framework and safety considerations relevant to product development will be presented.
Nanotechnology holds great potential for the formulation of poorly soluble compounds as well as in the targeted delivery of drug molecules. At present, there are only few technologies available to investigate the in vitro release of drugs from next-generation nanotherapeutics.
Release testing plays a pivotal role in pharmaceutical formulation development and quality control. Therefore, many efforts have been made to sensitively detect this parameter in vitro. An outline of current methodology and applications in formulation development and quality control will be presented.