Nextar ChemPharma Solutions provides integrated contract drug development and manufacturing services. They have over 35 experienced employees working in state-of-the-art laboratories and clean rooms. Their services include custom synthesis, formulation development, analytical testing, and GMP manufacturing of clinical trial materials. Nextar has successfully completed over 650 projects for 150 customers, developing over 50 innovative formulations and manufacturing over 25 products for clinical trials.
Kemwell provides extensive mammalian cell culture-based formulation development services. The labs have the capability of performing complete process development, process optimization, scale-up, technology-transfers and process characterization.
Xcelience is a contract research organization that has provided formulation development and clinical trial manufacturing solutions for pharmaceutical companies since 1997. The company is renowned for reliably expediting early development activities to speed potential drugs to clinical trials while applying stage-specific scientific knowledge and experience. Core services include: API Characterization, Analytical Development and Stability Services, Formulation Development, and Clinical Trial Manufacturing, Packaging and Labeling. For more detailed information about Xcelience, visit www.xcelience.com
When Coating runs smoothly: Enhance your Coating Process with a new Particle ...Merck Life Sciences
Watch the presentation of this webinar here: https://bit.ly/3bJypPv
Tablet coating simplified. Finding the perfect coating for your formulation can be challenging. A particle engineered polyvinyl alcohol helps you to optimize your process while maintaining full flexibility in designing the right coating formulation at the right time.
In film coating applications water soluble polymers like polyvinyl alcohol (PVA) take a unique position. PVA can be used in immediate release coatings and provides an exceptional moisture and oxygen barrier. A dedicated particle design allows rapid dissolving times and due to the low viscosities of PVA solutions high solid contents can be obtained leading to a high process efficacy.
The webinar will cover coating formulation development as well as novel technologies for characterization of coated tablets that can easily be implemented during production. Optical coherence technology (OCT) and laser scanning microscopy (LSM) can be valuable tools to assess the coating quality.
In this webinar, you will learn:
• How to create your coating formulation by utilizing a broad excipient toolbox
• Potential advantages of PVA as a stable moisture and oxygen barrier to protect challenging drug substances
• Creating the perfect surface finishing
• How to utilize novel analytical technologies to boost your formulation development
Kemwell provides extensive mammalian cell culture-based formulation development services. The labs have the capability of performing complete process development, process optimization, scale-up, technology-transfers and process characterization.
Xcelience is a contract research organization that has provided formulation development and clinical trial manufacturing solutions for pharmaceutical companies since 1997. The company is renowned for reliably expediting early development activities to speed potential drugs to clinical trials while applying stage-specific scientific knowledge and experience. Core services include: API Characterization, Analytical Development and Stability Services, Formulation Development, and Clinical Trial Manufacturing, Packaging and Labeling. For more detailed information about Xcelience, visit www.xcelience.com
When Coating runs smoothly: Enhance your Coating Process with a new Particle ...Merck Life Sciences
Watch the presentation of this webinar here: https://bit.ly/3bJypPv
Tablet coating simplified. Finding the perfect coating for your formulation can be challenging. A particle engineered polyvinyl alcohol helps you to optimize your process while maintaining full flexibility in designing the right coating formulation at the right time.
In film coating applications water soluble polymers like polyvinyl alcohol (PVA) take a unique position. PVA can be used in immediate release coatings and provides an exceptional moisture and oxygen barrier. A dedicated particle design allows rapid dissolving times and due to the low viscosities of PVA solutions high solid contents can be obtained leading to a high process efficacy.
The webinar will cover coating formulation development as well as novel technologies for characterization of coated tablets that can easily be implemented during production. Optical coherence technology (OCT) and laser scanning microscopy (LSM) can be valuable tools to assess the coating quality.
In this webinar, you will learn:
• How to create your coating formulation by utilizing a broad excipient toolbox
• Potential advantages of PVA as a stable moisture and oxygen barrier to protect challenging drug substances
• Creating the perfect surface finishing
• How to utilize novel analytical technologies to boost your formulation development
Participate in the full, interactive on-demand webinar here: https://bit.ly/ProcessValWebinar
Process validation is a complex step in the transition to commercial scale manufacturing. While Quality By Design (QBD) is the standard option for a risk-mitigating process validation strategy, there are other options for more flexibility and speed. Join our webinar to learn how outsourcing to a CDMO, able to take an adaptive, risk-based validation approach, will accelerate your time to market.
In this webinar, you will discover more about:
• How outsourcing to a CDMO partner in late-stage will increase flexibility and speed
• How a risk-based approach can help you optimize your process validation strategy
• How we have implemented a risk-based approach for our clients via case studies
Excipients selection for high risk formulations Smita RajputMerck Life Sciences
Are you choosing the right excipients for your high risk application? Find out how to select the right excipients and enable your process optimization to improve the total cost of ownership.
In this webinar, you will learn:
• Selection of right excipients for high risk formulation is very critical step
• Low Endotoxin and low bioburden limits are important aspect while selecting raw materials
• Strong regulatory support is crucial for high risk formulation
Excipients selection for high risk formulations like parenteral and ophthalmic applications is very challenging. Excipients should be inert with high purity for such dosage forms because trace amounts of impurities present in excipients can interact with active pharmaceutical ingredient (API) which results in instability of the formulation. This presentation discusses how to select the right excipients for high-risk applications and gives guidance for process optimization by choosing the best combination of filters and excipients to improve the total cost of ownership.
EU GMP Annex 1 Draft: Implications on Sterilizing Grade Filter ValidationMilliporeSigma
Watch the presentation of this webinar here: https://bit.ly/3kk0Qs1
In this webinar, you will learn:
- About the GMP Annex 1 draft regulatory overview
- How to incorporate the integrity testing & PUPSIT in the filtration systems validation
- How to design a bacterial retention test in terms of organism selection and single vs multiple use validation
Detailed description:
In this webinar we will discuss the implications of the EU GMP Annex 1 draft on the filtration of medicinal products and how this impacts the validation studies.
Bacterial Retention Testing is a critical part of the manufacturing validation process and is required by all regulatory bodies worldwide. Using case studies, our experts will explain how the Annex 1 draft is incorporated into the filtration systems validation exercise, specifically for integrity testing & PUPSIT (Pre-Use Post Sterilization Integrity Testing), the selection and justification of the appropriate test organism, and validation implications of single versus multiple use.
The Viscosity Reduction Platform: Enabling subcutaneous (subQ) deliveryMerck Life Sciences
We will introduce an excipient platform that makes it possible to combine excipients in ways that can reduce protein viscosity to a greater extent.
*About challenges arising from high concentrated protein formulations
*The Viscosity reduction Platform: A portfolio of excipients to manage protein viscosity
*Impact of viscosity reducing excipient use on protein stability
*Impact of protein viscosity on syringeability
Participate in the full, interactive on-demand webinar here: https://bit.ly/ProcessValWebinar
Process validation is a complex step in the transition to commercial scale manufacturing. While Quality By Design (QBD) is the standard option for a risk-mitigating process validation strategy, there are other options for more flexibility and speed. Join our webinar to learn how outsourcing to a CDMO, able to take an adaptive, risk-based validation approach, will accelerate your time to market.
In this webinar, you will discover more about:
• How outsourcing to a CDMO partner in late-stage will increase flexibility and speed
• How a risk-based approach can help you optimize your process validation strategy
• How we have implemented a risk-based approach for our clients via case studies
Excipients selection for high risk formulations Smita RajputMerck Life Sciences
Are you choosing the right excipients for your high risk application? Find out how to select the right excipients and enable your process optimization to improve the total cost of ownership.
In this webinar, you will learn:
• Selection of right excipients for high risk formulation is very critical step
• Low Endotoxin and low bioburden limits are important aspect while selecting raw materials
• Strong regulatory support is crucial for high risk formulation
Excipients selection for high risk formulations like parenteral and ophthalmic applications is very challenging. Excipients should be inert with high purity for such dosage forms because trace amounts of impurities present in excipients can interact with active pharmaceutical ingredient (API) which results in instability of the formulation. This presentation discusses how to select the right excipients for high-risk applications and gives guidance for process optimization by choosing the best combination of filters and excipients to improve the total cost of ownership.
EU GMP Annex 1 Draft: Implications on Sterilizing Grade Filter ValidationMilliporeSigma
Watch the presentation of this webinar here: https://bit.ly/3kk0Qs1
In this webinar, you will learn:
- About the GMP Annex 1 draft regulatory overview
- How to incorporate the integrity testing & PUPSIT in the filtration systems validation
- How to design a bacterial retention test in terms of organism selection and single vs multiple use validation
Detailed description:
In this webinar we will discuss the implications of the EU GMP Annex 1 draft on the filtration of medicinal products and how this impacts the validation studies.
Bacterial Retention Testing is a critical part of the manufacturing validation process and is required by all regulatory bodies worldwide. Using case studies, our experts will explain how the Annex 1 draft is incorporated into the filtration systems validation exercise, specifically for integrity testing & PUPSIT (Pre-Use Post Sterilization Integrity Testing), the selection and justification of the appropriate test organism, and validation implications of single versus multiple use.
The Viscosity Reduction Platform: Enabling subcutaneous (subQ) deliveryMerck Life Sciences
We will introduce an excipient platform that makes it possible to combine excipients in ways that can reduce protein viscosity to a greater extent.
*About challenges arising from high concentrated protein formulations
*The Viscosity reduction Platform: A portfolio of excipients to manage protein viscosity
*Impact of viscosity reducing excipient use on protein stability
*Impact of protein viscosity on syringeability
Under repeated impact composite domes subjected 6 J energy, changes locally with
increasing drop height. The action of the dynamic load generates reactions at the
support and bending moments at points on the surface of the composite. The peak loads
were noted to increase and stabilise about some mean value; and the 150mm diameter
shell was more damage tolerant compared to the 200 mm diameter one.
Abstract: Potential functions and Fourier series method in the cylindrical coordinate system are employed to solve
the problem of moving loads on the surface of a cylindrical bore in an infinite elastic medium. The steady-state
dynamic equations of medium are uncoupled into Helmholtz equations, via given potentials. It is used that because
of the superseismic nature of the problem, two mach cones are formed and opened toward the rear of the front in the
medium. The stresses and displacements are obtained by using integral equations with certain boundary conditions.
Finally, the dynamic stresses and displacements for step loads with axisymmetric and nonaxisymmetric cases are
obtained and discussed in details via a numerical example. Moreover, effects of Mach numbers and poisson's ratio
of medium on the values of stresses are discussed.
This document inculcates the diversified range of Value Added Services offered by Kanban Infosystem Pvt. Ltd in addition to the generic services rendered by them to the clients.
This paper presents an algorithm for shape optimization of composite pressure
vessels head. The shape factor which is defined as the ratio of internal volume to weight of
the vessel is used as an objective function. Design constrains consist of the geometrical
limitations, winding conditions, and Tsai-Wu failure criterion. The geometry of dome shape
is defined by a B-spline rational curve. By altering the weights of control points, depth of
dome, and winding angle, the dome shape is changed. The proposed algorithm uses genetic
algorithm and finite element analysis to optimize the design parameters. The algorithm is
applied on a CNG pressure vessel and the results show that the proposed algorithm can
efficiently define the optimal dome shape. This algorithm is general and can be used for
general shape optimization
By choosing Covance as a single, centralized CMC analytical laboratory, you can obtain higher quality analytical data more efficiently and at lower cost/fewer resources than by working with multiple providers/CMOs. This analytical data is the key to knowledge and quality risk management throughout the product lifecycle.
Biopharmaceutical and cell therapy productsKeaty More
3P Biopharmaceuticals is a European-based Contract Development and Manufacturing Organization (CDMO) specialized in the process development and GMP manufacture of biopharmaceutical and cell therapy products from early stages (POC,PC) up to clinical and commercial.
Aarti Pharmalabs Ltd specializes in the clinical phase and commercial production of APIs and NCEs, intermediates, regulatory starting materials, key building blocks and xanthine derivatives. Our offerings include process R&D, analytical method development and validations, stability studies, scale-up and process optimization, process validations and commercial production. The quality and purity of our products have enabled us to be the leading Active Pharmaceutical ingredients manufacturers in India.
Global Pharmaceutical (CRAMS) Contract Research And Manufacturing Services Provided by AMRI - Mr. Prashant Salve - AGM (Global Business Development) Email: prashant.salve@amriglobal.com
Spread over more than 1,05,000 sq. ft. area, Cadila Pharmaceuticals’ R & D facilities, recognized by the Department of Science & Technology, Government of India, are manned by more than 300 scientists. A centralized Quality Control & Analytical Research Laboratory has been set up to meet the domestic and international quality standards. The Company has expanded operations by building further on already existing set-up by investing in new premises, to include modern, state-of-the-art amenities. One of the few companies in the country carrying out collaborative research, Cadila Pharmaceuticals taps the best scientific talent in the country and has collaborations with more than 30 leading Research and Development centers in India.
To know more about Cadila Pharmaceuticals visit: http://cadilapharma.com/
Integrity Bio is a protein formulation development, fill finish, and drug delivery CMO. Injectable formulations include protein,antibody, vaccine, and peptide. http://www.integritybio.com
Stabicon has been ambitiously established in 2010. Professionally managed with 75 scientists from diverse background expertise. Our organization is specialized in managing product quality process, upgrading and introducing advanced technology into products. we are proud to lay a foundation for prosperous future in prevention and cure segment, future medicine & FMCG business.
1. Nextar ChemPharma Solutions
Ltd :
Accelerating your drug to first-in-humans
Contract Formulation
Development, Manufacturing &
Analytical Services
Compliant with
cGMP, GLP, ISO 13485 and ISO 9001
2. Business Profile
•Outsourcing company providing fully integrated
one-stop-shop contract drug development and
manufacturing partner
•Located at the Weizmann Science Park,
the heart of Israel's life science industry
•35 experienced high-skilled professional employees
•Over 1400 m 2 state-of-the-art labs and clean rooms
•cGMP, GLP & ISO 13485 internationally recognized
certifications from regulatory agencies
4. Spectrum of Services
Method development
& Validation
Bioanalytical
Raw material testing
Services
& release
GMP Production
Formulation
development Packaging for
clinical trials
Custom chemical
synthesis QA/QC services
5. Custom chemical synthesis
• Active pharmaceutical ingredients (API)
• Synthesis of new analogs to strengthen your patent
portfolio
• Intermediates
• Impurities
• Metabolites
• Reference standards
6. Formulation Services –
Finding innovative solutions for your drug
candidate
•Formulation development of injectables, topical
creams, ophthalmic solutions, suspensions, emulsions,
capsules, tablets, foams
•Reformulation, repositioning, repurposing of generic
drugs
•Formulation development of innovative NCE,
cytotoxics and biologicals
•Improvement of solubility and bioavailability
•Taste masking of bitter drugs
•Preparation of formulations for preclinical
efficacy/toxicity studies
7. Systematic approach to develop the
most appropriate formulation
through:
• Ionization of functional groups and salt
formation
• Drug complexation with cyclodextrins
• Formation of stacking complexes to increase
drug solubility
• Drug dissolution in water-miscible cosolvent
systems
• Micellation by non-ionic-surfactants
• Self-emulsifying drug delivery systems
• Nanoencapsulation in lipid-based drug
delivery systems (liposomes, oil-in-water
8. Analytical Services :
Speeding up your R&D process
• Development and validation of
analytical and bio-analytical
methods
• Full range of stability tests and
monitoring according to ICH
guidelines
• Forced degradation studies
• Analysis and profiling impurities
• Dissolution and drug release
profiling
• Determination of leachables and
extractables
9. Contract manufacturing & packaging
• GMP plant approved by Israel Ministry
of Health & EU (PIC/s)
• Clinical trial material (CTM)
manufacturing for US and EU clinical
trials according to FDA and EMA
standards
• CTM production for Phase I, II, III
studies
• Full CTM formulation, manufacturing,
packaging and release testing
• IND and IMPD support documentation
(CMC)
• Full quality support for all clinical
materials
10. GMP certified manufacturing plant
• Manufacturing of all types of dosage
forms: parenteral solutions, lyophilized
sterile products, ophthalmic drops,
suspensions, emulsions, topical creams,
capsules and tablets
• Clinical supplies and testing of cytotoxics
and scheduled drugs
11. GMP certified manufacturing plant
• Sterile manufacturing of injectables and
lyophilized powders in Class 100 (ISO 5)
clean rooms
• Validation of aseptic filling into vials,
syringes or dropper bottles
12. Successful case studies at
reduced costs and timelines
• Lyophilized peptide formulation with increased stability
and safety
• Formulation development and GMP manufacturing of
freeze-dried vaccine formulation with a very limited
amount of API
• Repositioning of a generic drug as a slow release tablet
formulation with improved pharmacokinetic profile for
new indication
• Formulation of water-insoluble anticancer drug with
maximal bioavailability
• Process development, upscaling and GMP manufacturing
of sterile implantable protein gel for cartilage
regeneration
• Formulation optimization and GMP clinical supply in
prefilled syringes of a phospholipid-based sustained
release gel formulation to provide a sub-dermal depot
for local anesthetics
13. Nextar’s GLP studies contribute to
registration of new combined medical
devices
• Development of analytical methods for stability and
release of new transdermal patch
• Compatibility and stability studies for two different
new insulin pumps
• Development of analytical assays for washing solutions
of a stent for coronary vessels
• Development of analytical methods and testing of
cleansing solution for wound treatment
14. Achievements
• No. of projects performed: 650
• No. of current customers: 150
• Over 50 innovative formulations developed
• Process development, upscaling &
manufacturing of over 25 products for
clinical trials
15. Our Advantages
• High-quality, cost effective, reliable and
integrated chempharma solutions, for a full
range of pharmaceutical and analytical
services
• Complies with international trend for
outsourcing
• One-stop-shop with GLP/GMP certifications
• Formulation and manufacturing services
optimized to accelerate your drug candidate
to early clinical stage
• Regulatory advice through drug
development
process
• Significant saving of time and money
