Title: Hot melt extrusion an emerging drug delivery technology of 21st Century.

Abstract:

Hot melt extrusion (HME) is emerging technology which is gaining high importance in the pharmaceutical industry as a novel technique for the preparation of various dosage forms and drug delivery systems, for example granules and sustained release tablets. It is a fast growing technology platform that is utilized to solve difficult formulation challenges, primarily in the area of solubilization. Due to fast processing, high degree of automation, absence of solvents, simple and continuous operation and ability to process poorly compactable material into tablet form are some of the main advantages offered over conventional processing by this emerging technique. Applications of HME in pharmaceutical industry continues to grow and recent success of this technique have made it a useful tool of consideration as a drug delivery solution. The use of hot-melt extrusion (HME) within the pharmaceutical industry is steadily increasing, due to its proven ability to efficiently manufacture novel products. . HME involves the application of heat, pressure and agitation through an extrusion channel to mix materials together, and subsequently forcing them out through a die. Twin-screw extruders are most popular in solid dosage form development as it imparts both dispersive and distributive mixing. It blends materials while also imparting high shear to break-up particles and disperse them. HME extrusion has been shown to molecularly disperse poorly soluble drugs in a polymer carrier, increasing dissolution rates and bioavailability. The utilization of hot-soften expulsion (HME) inside the pharmaceutical business is consistently expanding, because of its demonstrated capacity to productively make novel items. The procedure has been used promptly in the plastics business for longer than a century and has been utilized to make clinical gadgets for a very long while. The improvement of novel medications with poor dissolvability and bioavailability brought the use of HME into the domain of medication conveyance frameworks. This has explicitly been appeared in the advancement of medication conveyance frameworks of both strong dose structures and transdermal patches. HME includes the utilization of warmth, weight and tumult through an expulsion channel to combine materials, and along these lines driving them out through a kick the bucket. Twin-screw extruders are generally well known in strong measurement structure advancement as it gives both dispersive and distributive blending. It mixes materials while additionally granting high shear to separation particles and scatter them. HME expulsion has been appeared to molecularly scatter ineffectively dissolvable medications in a polymer bearer, expanding disintegration rates and bioavailability. The most widely recognized trouble experienced in delivering such scatterings is adjustment of shapeless medications, which keeps them from recrystallization during capacity. Pharmaceutical mechanical providers, of the two materials and gear, have expanded their improvement of hardware and synthetic concoctions for explicit use with HME. Unmistakably, HME has been distinguished as a significant and huge procedure to additionally upgrade tranquilize solvency and strong scattering creation. The pharmaceutical improvement of nebulous strong scatterings (ASDs) by hot-liquefy expulsion (HME) is quickly evaluated. A deliberate bit by bit approach is introduced, where thermodynamics, polymer screening, multivariate measurements and procedure enhancement are consolidated, to expand the accomplishment of HME-based medication item advancement. The quality by structure (QbD) idea is acquainted and applied with HME. Steps and devices for its successful execution are given, including hazard evaluation featuring pivotal focuses. The specialized and logical specificities of HME-based ASDs are talked about considering the current worldview of medication advancement and in-accordance with administrative rules from the ICH areas. Contextual investigations of as of late affirmed HME items are introduced. Pharmaceutical improvement expects to give vigorous information through the utilization of deliberate methodologies that permit planning a quality item and its assembling procedure reliably. The data and information gathered from improvement and creation ought to give the logical comprehension to help a plan space, sedate item particulars and procedure controls. The total comprehension of the plan and procedure is united in the Common Technical Document and afterward used to present another medication application to the capable specialists . In HME-based medication items, a powerful pre-definition appraisal is the way in to a fruitful turn of events. A bit by bit approach, beginning with the thermodynamic assessment of a few frameworks, trailed by a polymer screening test combined with multivariate measurable investigation, is helpful to quickly recognize the most encouraging HME frameworks. This is the best approach to abstain from sitting around idly, cash and exertion in bombed synthesis

Biography:

Rashid Mahmood has master degree in analytical chemistry and MS in total quality management. He has 15 years of experience of pharmaceutical quality operations and has participated in many international conferences as a keynote speaker. He has presented various talks in USA, Canada, UK & UAE on cleaning validation, cGMP guidelines, quality risk management,role of mass spectrometry in pharmaceuticals and on new drug delivery dystems. Currently he is working as a General manager technical operations for Surge Lab. which is the best export oriented company of pakistan..

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Title: TMAC™: A novel affimer® drug conjugate platform to modulate the TME

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The Affimer platform is an antibody mimetic scaffold based on the human protease inhibitor, Stefin A and we have generated a range of antagonists against several key checkpoints such PD-L1. With our anti-PDL1 Affimer Fc we have demonstrated total tumour regression in mouse syngeneic models in combination with Talabostat and immunity to rechallenge with tumour cells, showing that we have achieved an immune memory response. Conjugating talabostat to an affimer antagonist using a novel FAP-alpha cleavable linker (TMAC™), we have demonstrated tolerability and efficacy in mouse syngeneic models.

Biography:

Amrik has a PhD in biochemistry/protein engineering from the university of leicester after which he spent 6 years at the Institute of Biotechnology, Cambridge University investigating bacterial pathways involved with the metabolism of illicit drugs and high explosives. In 2002, Amrik joined domantis Ltd developing domain antibodies. Following the acquisition of domantis by GSK, he became head of topical delivery (Biopharm Discovery Unit), supporting the development of biotherapeutics for delivery into the eye, skin and lung. In 2013 he joined Avacta as chief scientific officer to develop the Affimer platform for therapeutic use.

Title: Industrial Practices for Determining Biopharm Products’ Critical Quality Attributes (CQAs).

Abstract:

Analytical methods have been playing a major role in creating in vitro and in vivo product characterization packages. Compiling both sets of data helps in-depth understanding of product’s quality attributes (QA) and helps in the determination of product’s CQAs. It is proven that some CQAs have impact on the product’s safety and biological profiles. Biopharm industry is now revising their testing strategies to accelerate product development. This talk will connect analytical, CQAs, and clinical outcomes in product’s development.      Analytical methods have been playing a major role in creating in vitro and in vivo product characterization packages. Compiling both sets of data helps in-depth understanding of product’s quality attributes (QA) and helps in the determination of product’s CQAs. It is proven that some CQAs have impact on the product’s safety and biological profiles. Biopharm industry is now revising their testing strategies to accelerate product development. This talk will connect analytical, CQAs, and clinical outcomes in product’s development.      

Title: New health care facility commissioning and readiness to go live

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Healthcare commissioning process should be safety and quality-oriented activities which validate and document the performance of not only facility but system as well, during the process commissioning team will verify to see if the original or defined objective and criteria are met. Understand the content, definition of commissioning that will take place. Clearly describe the timeline activities of commissioning processes 3. Evaluate the readiness before opening especially need to undertake risk assessment and the identification of potential hazards and the required strategies to eliminate or protect against these hazards during commissioning. Ingrained safety culture in everything we do during commissioning is crucial, therefor after identifying a group of commissioning team members we aligned the definition of hospital commissioning which is facility commissioning and clinical operations commissioning. project projective and identified seven medical flows, we also use simulation for activation during commissioning processes. Input should be also provided from all vertical team like radiology, inpatient, general surgery ect. As well as horizontal team like pharmacy, patient access, finance ect. It is also important to deliberately test emergency response at the same time, in our case, there are 5 major risks are identified and emergency response are also planned and tested making sure contingency plans are in place in case of potential disruptions. The goal is to make sure staff are really focus on safety and keep that mindset throughout the code response process. Commissioning checklist is a useful tool to be put into use throughout the whole processes making sure all aspects are covered, we also developed a simulation evaluation tool to identify gaps and potential improve opportunities. After diagnosing the problems and creating solutions we simulate the suggested solutions as well to choose the most effective and efficient solution which is used to create relevant policies and procedures that reflect the changes we made

Biography:

Wu Mingshu Alicia who works as quality & safety and patient experience director in a private cancer hospital in Guangzhou China. She has rich experience in greenfield hospital setting ups and quality & safety management. She successful led JCI & TUV accreditation for a high-end private women & children’s hospital in 2017.

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