The document describes the solid state services provided by ALMAC including polymorph screens, salt/cocrystal screens, amorphous dispersion screens, and crystallization development. It discusses how the solid state group acts as a link between chemistry and formulation to transfer knowledge about active pharmaceutical ingredients. A range of expert services and in-house technologies are available to support drug development including rapid formulation screening, analytical support, and pre-formulation studies.
In this webinar, you will learn:
- The key issues in continuous manufacturing concerning excipients
- How those issues can be addressed
Detailed description:
Continuous manufacturing is a major trend in solid dose formulation. It shows economic and quality benefits, however, hurdles and challenges need to be tackled before getting there. This webinar will address these hurdles and challenges as they relate to excipients.
We will present how continuous manufacturing lines are set up and the benefits users have experienced from them. Feeding of especially small components of formulation combined with bad flow is a major challenge, as well as having a high number of components leading to many feeders. Our answer to these challenges are threefold: betting on multifunctional excipients, and on premixes, either as finished products or as customized projects.
3D Perfusion Bioreactor Technical Presentation3D Biotek
The 3D Perfusion Bioreactor™ is manufactured by 3D Biotek, LLC, an innovative technology company based in North Brunwick, New Jersey. 3D Biotek launched the 3D Perfusion Bioreactor™ in 2011, as a novel alternative to integrate the need for innovative cellular maintenance and increasing trends towards 3-dimensional cell culture. The 3D Perfusion Bioreactor is engineered to perfuse porous 3D polymer Inserts™ in 4 separate polycarbonate chambers able to fit up to 10-scaffolds per chamber. The 3D Insert has been validated by NIST (National Institute of Standards) for its open-pore, ample surface area, and 100% interconnected geometry, important features for direct application in scale-up processes, from cell expansion to recombinant protein production.
In this webinar, you will learn:
- The key issues in continuous manufacturing concerning excipients
- How those issues can be addressed
Detailed description:
Continuous manufacturing is a major trend in solid dose formulation. It shows economic and quality benefits, however, hurdles and challenges need to be tackled before getting there. This webinar will address these hurdles and challenges as they relate to excipients.
We will present how continuous manufacturing lines are set up and the benefits users have experienced from them. Feeding of especially small components of formulation combined with bad flow is a major challenge, as well as having a high number of components leading to many feeders. Our answer to these challenges are threefold: betting on multifunctional excipients, and on premixes, either as finished products or as customized projects.
3D Perfusion Bioreactor Technical Presentation3D Biotek
The 3D Perfusion Bioreactor™ is manufactured by 3D Biotek, LLC, an innovative technology company based in North Brunwick, New Jersey. 3D Biotek launched the 3D Perfusion Bioreactor™ in 2011, as a novel alternative to integrate the need for innovative cellular maintenance and increasing trends towards 3-dimensional cell culture. The 3D Perfusion Bioreactor is engineered to perfuse porous 3D polymer Inserts™ in 4 separate polycarbonate chambers able to fit up to 10-scaffolds per chamber. The 3D Insert has been validated by NIST (National Institute of Standards) for its open-pore, ample surface area, and 100% interconnected geometry, important features for direct application in scale-up processes, from cell expansion to recombinant protein production.
Almac: Development and Scale-up of a Photochemical Route to a Steroidal APISusan1Beattie
Presentation given by Dr Stephen Bell of Almac describing the development and Scale-up of a Photochemical Route to a Steroidal API at OPRD meeting on 25th September 2013 in Lisbon.
Almac - The Manufacture of Peptides for Clinical Trials - 2nd Irish Peptide S...Susan1Beattie
Almac's Steven McIntyre presented in June 2012 at the second Irish Peptide Symposium regarding the manufacture of peptides for clinical trials. See his presentation here.
FDA’s emphasis on quality by design began with the recognition that increased testing does not improve product quality (this has long been recognized in other industries).In order for quality to increase, it must be built into the product. To do this requires understanding how formulation and manufacturing process variables influence product quality.Quality by Design (QbD) is a systematic approach to pharmaceutical development that begins with predefined objectives and emphasizes product and process understanding and process control, based on sound science and quality risk management. A presentation compiled from material freely available on the WEB to introduce the concepts of QbD for beginners.
Co-crystals for improved physicochemical properties of poorly soluble drug Sana Roohi
Role of co-crystals in enhancement of physicochemical properties like flowability, chemical stability, dissolution characteristics of poorly soluble drugs
Almac: Development and Scale-up of a Photochemical Route to a Steroidal APISusan1Beattie
Presentation given by Dr Stephen Bell of Almac describing the development and Scale-up of a Photochemical Route to a Steroidal API at OPRD meeting on 25th September 2013 in Lisbon.
Almac - The Manufacture of Peptides for Clinical Trials - 2nd Irish Peptide S...Susan1Beattie
Almac's Steven McIntyre presented in June 2012 at the second Irish Peptide Symposium regarding the manufacture of peptides for clinical trials. See his presentation here.
FDA’s emphasis on quality by design began with the recognition that increased testing does not improve product quality (this has long been recognized in other industries).In order for quality to increase, it must be built into the product. To do this requires understanding how formulation and manufacturing process variables influence product quality.Quality by Design (QbD) is a systematic approach to pharmaceutical development that begins with predefined objectives and emphasizes product and process understanding and process control, based on sound science and quality risk management. A presentation compiled from material freely available on the WEB to introduce the concepts of QbD for beginners.
Co-crystals for improved physicochemical properties of poorly soluble drug Sana Roohi
Role of co-crystals in enhancement of physicochemical properties like flowability, chemical stability, dissolution characteristics of poorly soluble drugs
Particle Size Determination and Raman Spectroscopic Evaluation of a Semi-soli...HORIBA Particle
Dr. Robert Lee of Particle Sciences joins HORIBA Scientific to discuss how his company uses the LA-950 particle size analyzer and XploRA raman spectrometer to characterize semi-solid dosage forms.
Prof Alastair Florence
Presentation at EIPG - Royal Pharmaceutical Society Scientific Symposium "Advances in Technology Impacting the Pharmaceutical Industry" at the University of Strathclyde, Glasgow 2015.
Decalcification: Unveiling Structures Beneath the Mineral Veil
What is it? Decalcification removes calcium salts from tissues like bone and teeth, making them soft and sliceable for microscopic analysis.
Why do it? Hardened tissues can't be sectioned effectively and interfere with staining. Decalcification allows clear visualization of cellular and structural details.
How is it done? Different methods exist, like using weak acids or chelating agents, each with its pros and cons. The choice depends on tissue type, processing time, and desired preservation level.
Knowing when to stop: Monitoring techniques like X-rays or physical assessment help determine the optimal endpoint to avoid over-decalcification and tissue damage.
Beyond bone: Decalcification finds applications in diverse fields like paleontology, pathology, and cancer research.
Cray Valley conducted research to determine the effect of anhydride functional additives on reprocessed recycled nylon. The specialty chemical manufacturer also tested the nylon, derived from consumer carpeting, to see if it was possible to impart value added properties to the material while maintaining a low budget. This presentation reviews the processes they used and the test results.
Stability Indicating HPLC Method Development A Reviewijtsrd
High performance liquid chromatography is most powerful tools in analytical chemistry which assessing drug product stability. It is most accurate method for determining the qualitative and quantitative analysis of drug product. Forced degradation plays an important role in development of stability indicating analytical methodology. Stability indicating HPLC methods are used to separate various drug related impurities that are formed during the synthesis or manufacture of drug product. This article discusses the strategies and issues regarding the development of stability indicating HPLC system for drug substance. Forced degradation studies establish degradation pathways of drug substances and drug products. Forced degradation elucidate the possible degradation pathway of the drug substance or the active pharmaceutical ingredient in the drug product. At every stage of drug development practical recommendations are provided which will help to avoid failure. Rushikesh S Mulay | Rishikesh S Bachhav "Stability Indicating HPLC Method Development - A Review" Published in International Journal of Trend in Scientific Research and Development (ijtsrd), ISSN: 2456-6470, Volume-5 | Issue-6 , October 2021, URL: https://www.ijtsrd.com/papers/ijtsrd46342.pdf Paper URL : https://www.ijtsrd.com/pharmacy/analytical-chemistry/46342/stability-indicating-hplc-method-development--a-review/rushikesh-s-mulay
The collaborative project PharmaSea brings European researchers to some of the deepest, coldest and hottest places on the planet. Scientists from the UK, Belgium, Norway, Spain, Ireland, Germany, Italy, Switzerland and Denmark are working together to collect and screen samples of mud and sediment from huge, previously untapped, oceanic trenches. The large-scale, four-year project is backed by almost 10 million euros of funding and brings together 24 partners from 13 countries from industry, academia and non-profit organisations. The PharmaSea project focuses on biodiscovery research and the development and commercialisation of new bioactive compounds from marine organisms, including deep-sea sponges and bacteria, to evaluate their potential as novel drug leads or ingredients for nutrition or cosmetic applications. The Royal Society of Chemistry is responsible for developing a number of capabilities to support the Pharmasea project including a chemical registration system for new compounds, dereplication technologies to assist in the identification of new compounds and search techniques for mass spectrometrists within the project. This presentation will provide an overview of the project and our progress to contributing chemical information technologies to support the effort.
Applying Royal Society of Chemistry cheminformatics skills to support the Pha...Ken Karapetyan
The collaborative project PharmaSea brings European researchers to some of the deepest, coldest and hottest places on the planet. Scientists from the UK, Belgium, Norway, Spain, Ireland, Germany, Italy, Switzerland and Denmark are working together to collect and screen samples of mud and sediment from huge, previously untapped, oceanic trenches. The large-scale, four-year project is backed by almost 10 million euros of funding and brings together 24 partners from 13 countries from industry, academia and non-profit organisations. The PharmaSea project focuses on biodiscovery research and the development and commercialisation of new bioactive compounds from marine organisms, including deep-sea sponges and bacteria, to evaluate their potential as novel drug leads or ingredients for nutrition or cosmetic applications. The Royal Society of Chemistry is responsible for developing a number of capabilities to support the Pharmasea project including a chemical registration system for new compounds, dereplication technologies to assist in the identification of new compounds and search techniques for mass spectrometrists within the project. This presentation will provide an overview of the project and our progress to contributing chemical information technologies to support the effort.
Preparation and characterization of co-crystals for improved physicochemical ...Sana Roohi
Formulation of co-crystals of BCS class II drug using different co-formers and evaluation for their enhanced physicochemical properties such as solubility, flowability, and dissolution characteristics.
Objective: To investigate the bond strength of resin-modified glass ionomer enhanced with bioactive glass (Activa BioActive-Base/Liner) to composite resin using different dental adhesive systems.
Study Design: In this study, Activa BioActive-Base/Liner (ABA/BL) was placed in cylindrical cavities formed in acrylic blocks. In blocks divided into 6 groups according to the adhesive system to be applied, two-step etch-and-rinse Gluma 2 Bond (Heraeus Kulzer, Germany), one-step self-etch Gluma Self Etch (Heraeus Kulzer), universal system Gluma Universal (Heraeus Kulzer), two-step self-etch Clearfil SE Protect (Kuraray, Japan), one-step self-etch Clearfil S3 Bond Plus (Kuraray), and universal system Clearfil S3 Bond Universal (Kuraray) adhesive systems were applied on ABA/BL. After composite resin (3M ESPE Filtek Ultimate) was applied to the prepared surfaces, the specimens were placed in a universal test device and shear bond strength test was determined. Fracture types were evaluated using a stereomicroscope and scanning electron microscope. Data were analyzed by Shapiro-Wilk, two-way ANOVA, Kruskal-Wallis, and Post-Hoc Multiple Comparisons tests.
Results: In terms of bond strength values, the highest bond value was seen in the two-step self-etch (Clearfil SE Protect) group, and the lowest bond strength value was seen in the universal system (Clearfil S3 Bond Universal) group. There was no statistically significant difference between the adhesive agent groups in terms of bond strength values (p>0.05).
Conclusion: It is thought that choosing the two-step self-etch technique as an adhesive system when resin-modified glass ionomer enhanced with bioactive glass (ABA/BL) is used as the pulp capping/base material will be more appropriate in terms of bond strength.
Keywords: adhesive systems, bioactive materials, bond strength, cariostatic agents, composite resins, dental materials, fluorides, glass ionomer, glass ionomer cements, materials testing, vital pulp therapy
Similar to Almac solid state presentation 2013 (20)
2. Solid State Services
Polymorph
Polymorph
screens
screens
Preformulation
Preformulation Salt/Cocrystal
Salt/Cocrystal
support
support screens
screens
Routine Amorphous
Routine Solid state
Solid state Amorphous
physicochemical
physicochemical dispersion
dispersion
testing services
services screens
testing screens
Drug substance
Drug substance Crystallisation
Crystallisation
and drug product
and drug product development
development
trouble shooting
trouble shooting
Legal
Legal
support
support
2
3. Purpose
ALMAC Solid
Chemistry Formulation
state
group
Our solid state group acts as a link, for the seamless
transfer of knowledge and understanding of the API
between chemistry and formulation
3
4. Adding value
Form Selection Process development
•Screens for polymorphs, •Crystallization issues
salts, cocrystals and
amorphous forms •Crystal shape / PSD control
•Identify the best physical form •Solid-liquid separation
for development
•Form robustness
•Detailed interpretive report
with recommendations
Product development Scale up
•Purity
•API robustness to process
conditions •Yield
•Qualitative and quantitative •Solvent efficiency
determination of physical form
in dosage forms
4
5. Adding value
Range of expert services – Analytical,
biologics, pre-formulation, and
formulation.
Faster and smarter solutions
Efficient development timelines
Producing enhanced products
5
6. Almac Advantage
• Vast experience and knowledge gained from years of
industry experience
• Clients range from virtual companies to multinationals
• Studies designed to the customer needs and API
properties
• Significant expertise in supporting Discovery and Early
Clinical phase development projects
• Excellent understanding of the requirements for process
development and drug product development
6
7. In house Technologies
formufast™
rapid formulation micro screens for preclinical formulations
• Ideal for use where material is limited
• Identify excipients based on solubilising capacity
• A rational formulation development program for poorly soluble drugs
• The risks associated with drug precipitation can be minimised.
• Not just solubility in media, but the solubilising capacity in the GI tract
The following screens are available
• formufast™ PO
• formufast™ IV
• formufast™ SD
7
8. Research at Almac
• PhD sponsored at QUB titled - Raman studies of the formation and
structure of pharmaceutically relevant crystals.
• Identified the following
– Crystal orientation was identified to effect the reproducibility of Raman data, investigated
methods to remove these effects.
– PCA identified a consistent component which is strongly indicative of the presence of nuclei
at the preliminary stages of crystal formation.
– XRD / Raman the combination of these two techniques provides valuable information about
the crystal.
Excitation
Crystal
Excitation
Solution
Ex
1600 1400 1200 1000 800 600 400 cit
at ion
XXII International Conference On Raman Spectroscopy, Volume 1267, 724-725, 2010
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9. Research at Almac
• Cocrystals are unique crystalline solids made from stoichiometric
amounts of API and pharmaceutically-acceptable coformers
• New, patentable solid forms that can exhibit improved properties
– Crystallinity, solubility, stability, flow properties, hygroscopicity
• Study to improve solubility/BA of poorly soluble Fenamic acids
– Pharmaceutically-acceptable coformers selected
– Screening generated cocrystals for several fenamic acids with different
coformers
• Improved aqueous stability of cocrystals
• Robust crystallisations developed using phase diagrams
Crystal Growth & Design, 11(8), 3522-3528, 2011
9
10. Research at Almac
• Cocrystals are unique crystalline solids made from stoichiometric
amounts of API and pharmaceutically-acceptable coformers
• New, patentable solid forms that can exhibit improved properties
– Crystallinity, solubility, stability, flow properties, hygroscopicity
• Study to improve solubility/BA of poorly soluble Fenamic acids
– Pharmaceutically-acceptable coformers selected
– Screening generated cocrystals for several fenamic acids with different
coformers
• Improved aqueous stability of cocrystals
• Robust crystallisations developed using phase diagrams
Crystal Growth & Design, 11(8), 3522-3528, 2011
9