Advances in bioavailability. Innovations in delivery technologies and dose forms. Proven results from our team of scientists, researchers, and regulatory experts.
Whatever your challenge, we have an expert who can solve it.
Learn how to move from the bench to the clinic quickly using advanced technologies
Discover how orally disintegrating tablets (ODTs) can be both patient friendly and offer numerous formulation advantages.
How pre-formulation techniques can accelerate early phase development to animal PK and first-in-human studies.
As the Biopharma market evolves, the demand increases for bioprocess technologies.
The effect of salt form selection and polymorphic screening on formulation development.
Brand strategies to leverage innovative consumer preferred dose forms for Omega-3 market.
Innovative products and techniques to develop, scale-up, analyze and process complex biologics.
Crucial factors to transform a pre-clinical compound into a first-in-human candidate.
Learn about the new strategy model for outsourcing.
Key development challenges and promising technologies for delivering pediatric formulations.
Insight on early development, characterizing solid state forms and first-in-human strategies.
Latest formulation approaches on enabling oral route for macromolecule drugs for local treatment.
Effective outsourcing strategies and demonstrating how these can be effective through a case study.
Explore best practices for clinical trial materials logistics for different global region & more.
How novel innovations and integrated fill/finish services can bring your product faster to market.
Unique roller compaction platform designed to achieve clinical and commercial success.
Designing state-of-the-art facilities and suites address customers’ current and future needs.
Revolutionize the way vegetarian products are encapsulated.
Strategies on incorporating patient opinion into early drug design and boost patient adherence.
Technology management approach & process capabilities for reliable supply of drug products.
A guide on creating flexible and custom manufacturing solutions for speciality products.
A parallel formulation feasibility assessment approach to enhance bioavailability.
Discover new developments in ODT technology including delivery of peptides and vaccines.
Explore the most-read articles from 2016, chosen by the Pharmaceutical Manufacturing audience.
Successful spray drying process for clinical and commercial production.
Methods for developing a sound, phase-appropriate formulation for early development.
Learn how Vegicaps can enable you to benefit from the animal-free consumer preference.
A systematic approach to tech transfers and how to focus on technical expertise & flexibility.
Explore the latest biopharma facility investment trends.
Softgel technology for early development to achieve successful formulation and patient outcomes.
Latest softgel technology for targeted and controlled delivery of challenging molecules.
A toolkit of superior technologies to overcome all your molecule’s challenges and processing difficulties to get the optimal dosage form.
Achieve a faster assessment of monoclonal antibody functionality—well before the final molecule is selected.
Explore how orally disintegrating tablets (ODTs) provide an alternative to overcome several challenges.
Utilize OptiForm Solution Suite to provide options for candidate formulations with extensive supporting data.
Expand your offerings with Twist-Off technology for oral & topical OTC applications.
Solutions for better informed decision making and contingency planning in inherently dynamic trials.
Innovative dosage forms that are likely to succeed & create a differentiated products in an increasingly crowded market space.
Create market differentiation and enable products that meet the specific medical needs of individual patients.
Discover the latest solutions and advancement in drug delivery technologies.
Create a supply chain structure that is better suited to meeting the changing demands of today’s more complex studies.
Improve the efficiency, reliability, flexibility & speed to market for your next manufacturing process.
Innovative, integrated approach to rapidly screen biomolecules potential for oral delivery.
Biomanufacturing strategies & integrated approach on improving and de-risking lead selection.
Effectively evaluate the potential of peptides and macromolecules for oral delivery.
Strategies to drive biologics development programs & meet aggressive development timelines.
Insights on how to pick the right candidates for clinical development & revamping projects.
Enhance bioavailability & efficacy while reducing adverse effects with particle size reduction.
Discover how innovative dose forms can meet the consumers’ needs based on age & gender.
Innovative technologies to address OTC specific needs of an aging population.
Strategies & technologies which can minimize the risks of developing new drugs and more.
Better patient treatments fueled by innovations in lipid formulations.
New innovations for OTC brands creating new users, increased usage & stronger market growth.
We are helping innovators develop, deliver & supply superior products improving people’s lives.
Characterize molecules, apply right prediction model, & select ideal delivery technology.
Address the changing nature of clinical trials and the supply of materials for studies.
Innovative network strategies & supply models to support global clinical trials.
Innovative solution for overcoming encapsulation challenges for OTC products.
Efficiently and rapidly overcome complex bioavailability challenges for early stage molecules.
Discover an innovative way to deliver challenging and poorly soluble compounds.
Cell development and process scale-up for an antibody program with additional processing.
Avoid some of the limitations of conventional tablet dose forms & more.
ODT platform ideal for sublingual delivery of proteins, peptides & vaccines.
Address compounds early on in the development process to reduce costs & attrition rates.
Ensure your technology transfers meet scheduled timelines.
Strategies for oral formulation selection which can lower attrition rates and more.
Address bioavailability challenges faced in biologic development with a focus on oral delivery.
Drive greater speed, flexibility and efficiency into the clinical supply chain.
Discover new approach to optimize oral dose development for macromolecules.
Evaluate trends in emerging fields and cultural change in the clinical trials industry.
Have a rigorous and carefully designed plan as to how to handle the compounds safely.
Ensuring that the necessary supplies of patient kits are in the right place at the right time.
Enhance global supply of vaccines through primary container design & manufacturing efficiency.
Understand the logistics of commercial manufacturing using design of experiments (DOE).
Biotech advances that have revolutionized human health being adapting for veterinary use.
Help improve the lives of animals and the people who care for them.
Explores the benefits of co-micronization with a surfactant and cryogenic micronization.
Reduce complexity & drive efficiency through a hub-based approach within the APAC region.
Strategies to overcome challenges when sourcing comparator compounds for clinical trials.
New developments in ODT technology, including new ways to administer peptides & vaccines.
Differentiate products at the unit dose level & deliver a more recognizable product.
Define key aspects of product performance which must be met when developing a generic pMDI.
High potency vitamin C 20% that delivers an effective amount to the skin for best results.
Insights into the new generation of antibody drug conjugates
Integrated solutions to rapidly screen biomolecules potential for non-invasive delivery route.
Obtain consistent highly pure products, lower manufacturing costs & improve process efficiency.
Rapidly screen biomolecules’ potential for a non-invasive delivery route.
A DLS approach is an innovation needed to meet the challenges of complex clinical trials.
A proactive approach is essential for reducing the risk of supply-related delays and more.
Softgel dosage forms could increase consumer compliance and a faster onset of action.
Address development challenges early on and improve a drug’s path to market.
Address challenges in developing biologics and identify keys to succeed in this dynamic space.
Utilize ADCs as targeted therapeutics for the treatment of cancer & potentially other diseases.
Leverage solid dispersion & particle size reduction technology to enhance bioavailability.
Address the potential compatibility concerns with BFS processed container systems.
Choose a superior alternative to the traditional tablet dosage forms.
Make the right decisions to ensure a successful technology transfer.
Mitigate cross-contamination risk and regulatory issues.
Enhance the global supply of vaccines through container design & manufacturing efficiency.
Select optimal formulation technology to enhance therapeutic performance & patient experience.
Enable precise, programmable, site-selective chemical protein modifications to develop ADCs.
Expedite the development pathway for early phase compounds and enhance bioavailability.
Enhance bioavailability, deliver liquid APIs & more with softgel technology.
Utilize particle size reduction and formulation technologies to optimize the API.
Successfully manufacture oral dosage forms that disperse within 3 seconds & are enjoyable.
Unique technologies to help develop market-leading products across all beauty care categories.
Utilize local supply advantages & overcome comparator sourcing challenges for clinical studies.
Apply the right clinical supply model based on the nature of the study.
Defining the challenges with manufacturing ADCs and how the market is evolving.
Explore theories and strategies used to build successful antibody-drug conjugates designs.
Supplementing cell culture media with copper can reach high yields of highly converted protein.
Explore the challenges with delivering drugs less invasively.
Successfully develop biological therapeutics within an aggressive program timeline.
Boost bioavailability, improve ease & route of administration, and increase patient compliance.
Address unique program requirements with flexible manufacturing solutions.
Identify new technologies and research resources to navigate emerging trends.
Increase the dissolution rates of poorly water-soluble drugs to increase bioavailability.
Explore new drug development tools to optimize Animal Health products.
Utilize the right APAC packing & distribution network to start studies on time & reduce cost.
Increase patient adherence while reducing reformulation time & costs.
Develop & optimize a logical sourcing strategy in the Asia Pac Region.
Identify most suitable drug delivery technology at early stage of drug development.
Provide the ability to taste mask & coat smaller particle size APIs.
Discover the latest solutions for drug development, design, manufacturing & scale-up.
Utilize an all-encompassing approach to enable an effective dosage form faster to market.
Single unit granule formulation allows for high drug load & broad taste-masking techniques.
Implement QbD for inhalation product development to ensure drug and device efficacy and safety.
Enable the formulation development of a drug molecule in softgels on industrial scale machines.
Determine the best clinical supply model to reduce risk and improve performance.
Improve product performance & enhance consumer experience with enteric coating.
Meet the high demands of all natural products with innovative dosage form solutions.
Increase chances of success in drug development by focusing on API optimization from the start.
Successfully launch & develop specific requirements for small molecules, like Safinamide.
Suitable path to accelerate development, avoid risk at early phase & enhance bioavailability.
The rise of Krill Oil education, versatile benefits and consumer acceptance.
Successfully complete multiregional clinical trials (MRCT).
Prevent, treat or manage existing conditions to improve aging consumer's quality of life.
Select the most suitable formulation technology to enhance the molecule’s bioavailability.
Efficiently and rapidly solve complex bioavailability challenges for early stage molecules.
The future of non-invasive delivery technologies for large molecules.
Deliver products successfully & economically to emerging markets.
Overcome therapeutic challenges and be prepared for years to come.
Manage a Clinical Supply Chain that is flexibe, traceable, & compliant.
Mitigate risk and drive towards safe and effective drug manufacturing.
Overcome ADC development challenges & improve efficacy and safety.
Generate physically stable & processable amorphous forms of APIs.
Transition from preliminary formulation to commercial drug launch, quickly & cost-effectively.
Unique Consumer Health solutions for OTC, Supplements & Beauty.
Deliver more differentiated dietary supplement products, faster to market.
Strategies and tactics to develop new antibody biosmilar products.
Oral dose development with optimal therapeutic performance.
Ideal solution for consumers seeking an animalfree alternative to gelatin capsules.
Develop liquid capsule fill formulations that are mitigated to prevent abuse.
Limit individual variability of type I & II systems with adequate choice of composition.
Handle small amounts of API or formulation at the early stages of development.
Reduce the potential for iatrogenic transmission of pathogenic viruses.
Design a safe, effective & stable dosage form, and ensure patient compliance.
Successfully achieve taste-masking while maintaining release characteristics.
Develop oral dosage forms of water-insoluble compounds with amorphous solid dispersions.
Monitor crystalline state of a compound during stability studies.
Incorporate high concentrations of various oils in an ODT.
Integrated, tailored solutions to accelerate your path to market.
Enable expanded biotechnology applications of the aldehyde tag.
Reduce the risks associated with traditional aseptic manufacturing.
Deliver compliance and flexibility with a convenient, enjoyable dose form.
Improve compatibility with wider range of excipients to enhance bioavailability & stability.
Risk management to reduce the potential for iatrogenic transmission of pathogenic viruses.
Ease of administration to achieve long-term patient compliance & optimal therapeutic outcomes.
Lipid-based drug-delivery systems to assist in the delivery of poorly soluble drugs.
Reduce supply-related risks related to biosimilar product availability, cost & quality.
Perform dosage form selection in the early phases of drug development.
Chewable technology that is ideal to deliver active ingredients, without the need for water.
Potent compound handling to ensure success for complex & possibly dangerous HPAPIs.
Advanced technology platforms to enhance many biotherapeutics including ADCs.
Generating uniform site-specific ADCs utilizing a chemoenzymatic approach.
Offer new preferred benefits and improved efficacy to achieve differentiation.
Ways of increasing ADC stability and efficacy are still required for these therapies.
Optimize manufacturing parameters like lower processing temperature & thinner softgel shell.
Complex, specialized requirements in micronization, to handle the toughest specifications.
Advanced aseptic glass-free delivery solution for injectable treatments.
The toolkit of technologies based upon lipid-based drug delivery systems.
Achieving a 40-fold increase in production of the antibody.
The cytotoxicity of HPAPIs presents handling challenges.
Choose the right technology to develop an efficient Phase I enabling drug product
Drug delivery solutions need to become more sophisticated and more effective.
in OptiMelt™ Hot Melt Extrudates for Development of Stable Final Dosage Forms
Prepared by OptiMelt™ Hot Melt Extrusion for Optimized Oral Solid Dosage Forms
One such technology that minimizes the risk in biologics processing is ADVASEPT® technology.
An appropriate formulation often requires significant API material.
Solubility screening approaches that can save both time and money.
Scientists now have an arsenal of drug delivery techniques to choose from.
Proven and versatile particle size reduction, micronization and milling technologies
Deliver higher API concentrations in smaller capsules for patient benefits.
OptiPact™ Technology, capabilities for Orphan Drugs & Catalent's factors of differentiation.
Reduce the struggle to administer medication to animal populations.
Overcome dose acceptance and therapeutic compliance hurdles.
Macromolecule delivery by targeted delivery and enteric coating techniques.
BASF & Catalent experts discuss the development of HME oral solid dosage forms.
Macromolecules can potentially be converted from injectable to oral drug delivery.
A proven solution for improving physical stability of many oral formulations.
Discover what constitutes an Advanced Asceptic Process and the numerous advantageous.
The path to successfully marketing a biosimilar product and global regulatory environment.
Switching from small to large molecules in pharma, cell line expression and emerging markets.
The future of site-specific conjugation to improve CMC production and therapeutic index.
Innovative oral softgel platform capable of delivering multiple actives.
Learn the fundamentals of the advanced aseptic process utilizing BFS technology.
Learn about how softgel technologies can address API and processing challenges.
Learn more about integrating formulation technology in drug development.
Learn about two major changes to the USP pertaining to <231> & <661>.
BFS technology has been expanding into injectables and into biologics.
Graduate students in pharmaceutical sciences provide commentary on drug delivery topics.
Catalent continues its legacy of innovation with OptiGel Bio™ technology—expanding the versatility of softgel technology to enable the potential oral delivery of macromolecule therapies.
Developing orphan drugs to treat rare diseases is an industry priority.
How integrated development programs can be used to mitigate risk and reduce timelines.
New technology enables a brand to keep its leading market position.
RP Scherer Technology can improve timelines and commercialization potential.
We can help you bring more products to market faster and support your business objectives of driving brand growth and market share. Get to market faster with our library of non-prescription analgesic and cough, cold & allergy softgel products.
Insights in order to eliminate risk inherent to sterile manufacturing environments.
Catalent is using rational conjugate design with selective drug placement.
Learn about Orphan drug development and other fast track product development pathways.
Compatibility of model mAb formulation in glass and Advasept® Vials.
Development of a single process configuration that reduces cost and decreases time.
This project was aimed to develop and fully validate an UPLC method.
This on-demand webinar will identify ways to determine the ideal formulation for your molecule
Catalent Schordorf has expanded controlled release and hot melt extrusion capabilities
Bioconjugates show great promise to improve existing therapeutics.
Learn more about the challenge of continuous supply available to meet clinical study needs,
Commercial success of a drug can be influenced by patient’s perception of the formulation.
Catalent worked with the client to bring a vastly superior sublingual product to market.
Creation of a custom packaging/distribution concept to meet the client’s needs.
Creation of a custom packaging and distribution solution to meet this client’s unique needs.
Identification of the impurities combined with analytical and sample handling challenges.
Case study describing custom batch manufacture of the product at a reasonable cost.
Catalent's OptiGel™ Bio technology can provide a pathway for an IV to oral delivery conversion.
Patient compliance with medication can be especially challenging for pediatric populations.
Extractable and leachable detection methods and best practices.
OptiMelt™ broadly addresses bioavailability enhancement factors at any stage of drug development through commercialization, with integrated teams of scientists and technologies
SMARTag™ ADC technology enables biologic innovators to develop more efficacious antibody drug conjugates faster.
The first-ever survey investigating patient experiences with clinical trial materials
Learn more about our 26 global sites producing approximately 50 billion capsules for more than 5,000 consumer health products marketed in more than 70 countries around the world.
With over 75 years of experience we have the formulation expertise to tailor your API for optimal solubility, bioavailability, and permeability.
A detailed understanding of the material science of the tablet structure
OptiShell™ capsules utilize a patented shell derived from plant polysaccharides that are ideally suited for the encapsulation of higher melting point fill formulations.
Innovative biotechnology company exploring therapeutics for neuroscience indications
With our expertise and capacity across every phase of development, we offer you the peace of mind that comes from having one company manage your supply chain throughout your product’s entire lifecycle.
How Clinical Supply Management Systems can bring efficiencies to support Project Lifecycle
Global manufacturers are exploring the possibility of producing biosimilars
Bracketing, FMEA , tracking, frequency, along with the introduction of randomized media fills.
Unparalleled graphic capability for softgel capsules provides opportunities to differentiate your product at the unit dose level and deliver a more recognizable, protected and differentiated product
Learn about a global alliance to help streamline the clinical trial material supply process and provide an end-to-end clinical trial material supply solution.
What truly distinguishes our services is our network of globally compliant facilities that provides scalable capacity for all commercial-scale projects in any volume – anywhere in the world.
In today's enviroment solution providers are preferred over CMO's.
CMOs share their opinions on the prospects for their businesses.
An interview with Catalent's Scott Houlton.
Our new, state of the art biologics manufacturing facility—with expanded mammalian cell line engineering and biomanufacturing capabilities utilizing single-use systems—offers increased flexibility and scale to support your growth.
This presentation discusses challenges when considering LBDDS.
Specialized analytical and formulation tools aid in successful, timely Development of LBDDS.
Key considerations for selection, benefits, limitations, and future prospects.
Bend Research and Catalent enter into an agreement to provide integrated solutions.
This webcast will highlight the latest omega-3 drug developments.
This article explores importing clinical trial materials to South America.
Catalent expert Mike Jenkins explains the change Catalent's facility is making.
Explore recent advances in regards to tablet technologies.
Catalent expert interviewed at INTERPHEX 2011 about the blow/fill/seal process.
A comparison between GPEx® and traditional cell line engineering technology.
This article looks into current problems in assuring virological safety of biopharmaceuticals.
Providing a definition for virus safety is nebulous at best.
Catalent expert, Mike Merges, explores practical considerations for bioassays.
Project management is becoming more important as companies increase outsourcing.
Explore overcoming challenges in the tech transfer of biopharma products.
Catalent expert discusses how Catalent is becoming a one-stop shop for global customers.
With our broad range of experience and deep expertise, we have the talent and unique technologies to transform your concepts into excellent results.
Removal of impurities is critical in the purification process for production of final products.
Integrating quality by design into sterile manufacturing facilities is becoming more important.
As a leader in integrated services from molecule to market, we offer stability services for preclinical and clinical studies, drug registration, and commercial products.
Learn about how talent and technology can help grow a company.
This presentation focuses on improving oral delivery for poorly soluble/permeable drugs.
The process of designing, optimizing, validating and implementing your bioassay should be a transparent part of the development cycle that fast-tracks your commercial objectives—not a bottleneck
Integrated services generating fast results Catalent provides the biotechnology industry with an unparalleled range of integrated product development and testing services designed to speed your product development from bench to clinic.
Absence of evidence is not evidence of absence.
Explore the issues with technical transfer in regardss to complex pharmaceutical products
Because of the growing significance of specialty polymers, a need to fully characterize these materials for structure and purity has emerged.
Investigate the relationship between poorly-soluble drugs and disintegration time of (ODTs)
Evaluate the pharmacokinetic behavior of nanosized fenofibrate administered orally
Disintegration and dissolution characteristics of novel, polysaccharidebased shell softgels
Determination of elemental impurities in support of USP <232> and <233>
Development of digestion methods for determination of elemental impurities
Development and validation of a method for determination of bismuth
From formulation to specialty packaging, this article explores patient adherence.
With over twenty years in inhalation product development, Catalent has the broadest range of development services across all inhaled dose forms.
Explore the power of dual detection methods to identify impurties.
An overview of stability studies during drug product lifecycles.
New data shows drug delivery has a positive impact on patient compliance.
This presentation details a case study about a phase III global trial.
With global strategic expertise that extends globally, our consultants provide the best solutions for both established and novel pharmaceutical dosage forms across a wide range of therapeutic areas.
Learn more about Catalent's extensive range of advanced, aseptic fill-finish product offerings, tailored to meet the unique needs of each customer provide reliable supply with our network of manufacturing sites.
Find more information on how advanced technologies can create tailored solutions for your toughest drug development challenges and drive faster development timelines.
Softgel technology has been increasingly applied across a wide range of applications including prescription medicines, consumer health, vitamins & mineral supplements and cosmetics.
Softgel is the drug delivery solution of choice that solves complex formulation, solubility, bioavailability, and development challenges, bringing more molecules to market faster.
Our state-of-the-art systems and innovative proprietary technologies will provide you with a strong continuum of services to support your product development needs.
With more than 80 years of experience, our extensive range of technological capabilities can help solve the most complex bioavailability, solubility, and permeability challenges unique to your molecule.
With our broad range of experience and deep expertise, we have the talent and unique technologies to transform your concepts into excellent results.
Our global network of facilities can provide scalable, cost-effective, customized manufacturing options for your complex treatments.
VP of Corporate Strategy and Development discusses emerging drug-delivery technologies.
This presentation deals with the challenges of using suppliers from around the globe
Catalent executive discusses excellence in compliance in Pharmaceutical Formulation & Quality
As the use of “universal” HPLC detectors and charged aerosol detectors become more common
Discussion around the latest trends and issues involving solubility.
Advances in medical discoveries are for nothing if the medicine isn't taken.
Focuses on new innovation drug delivery devices for patient-administered therapies
What sets our GPEx® technology apart from traditional methods is its spot-on reliability by ensuring that stable transductions occur in virtually 100% of target cells.
As the catalyst to improve the total performance of your products, we provide customizable, specialty fill-finish solutions that efficiently drive the most effective patient outcomes.
As the market leader in sterile manufacturing, we offer the latest in innovative fill-finish processes as well as advanced needle safety to improve performance and ensure a patient’s safety.
Learn more about how we design tailored solutions with our superior GPEx® cell line engineering, the SMARTag™ ADC Technology Platform, clinical manufacturing, and integrated services to deliver advanced biologic solutions.
Catelent CEO John Chiminski discusses our offerings
Learn more about how Catalent offers great science, a strong technological infrastructure and extensive expertise to our cosmetic customers with to drive modern trends.
When you use Catalent for pharmaceutical sourcing, you get a global distribution network that can deliver what you need, where you need it and when you need it. Always in the right condition.
Catalent’s chewable is the ideal platform to deliver actives straight into the mouth using our innovative taste masked fill material solutions encapsulated in dissolving shells.
The GOLD program is an intensive, two-year leadership development opportunity designed for university graduates who have a strong desire to accelerate their career growth.
Backed by our team of over 1,000 highly trained scientists, we offer the latest in innovative fill-finish processes, and specialty devices such as auto-injectors.
New study shows superior patient compliance with oral fast dissolve delivery.
Presentation on ensuring viological safety of biologicals
Exploration of the largest trends in the prefilled syringe and autoinjection devices
Prefilled Syringes Pinpoint Stability, Compatability, and Safety
‘Lean’ is a familiar term in European manufacturing since markets are more competitive
New strategies in formulation development are helping overcome molecule challenges
Softgel Technology as a Lipid-Based Delivery Tool for Bioavailability Enhancement
The aseptic blow-fill-seal (B/F/S) systems have experienced growth.
Case Study: Marchesini Group for Catalent Pharma Solutions: Efficient Syringe Packaging
Catalent experts talk about the increasing demand of prefilled syringes
Presentation detailing inhaled products as well as emerging technologies in this area
Clinical trials are a critical step in the approval process for new drugs.
Peptides can counteract many mechanisms of aging that were not possible to address in the past. Check out their possible capabilities.
Selection of a solid-state form is an important decision in development of small molecule API's
VP of business development discusses blow/fill/seal market and offerings
Fish gelatin support of nanoparticle formation of poorly water-solubles during wet milling
The striking efficiency gains Catalent has achieved with the Lean System for Managing
Modern healthcare challenges and predictions for pharmaceutical market growth
General review of Catalent’s new technology that optimizes API and profitability
Validate method for determination of extractable & leachable silicone oil
Effect of a Kollicoat Top-coat on the physical stability of enteric-coated softgels
Study on the impact of emulsion liposomal liquid and lyophilized liposomal formulations.
Why oral disintegrating tablets are so important to the industry’s oral dose form kit
How manufacturers can partner with contract packagers in new and increasingly complex ways
Explore a cGMP manufacturing model for reducing operating costs and speeding up drugs to market
Pros and cons of options, plus discussion of global problems and lack of foreign security
Laser diffraction particle size analysis – a robust and efficient alternative
Development procedures to reduce antibody effect on Protein Z, with validation results
Study shows import plasticizer level, & potential for migration from coating to shell
Determination of residual solvents in API by headspace GC-MS needs multiple analyses
Implications of FDA release and responsive technologies available to the manufacturer
The more efficient a bioassay method transfer, the faster to regulatory submission
Approach to validate from preclinical development to final commercial implementation
Rapid development model for formulation feasibility & accelerated stability evaluation
Method to separate un-derivatized protein Z (uTPZ) from derivatized TPZ in 3 species
Validate responsive ELISA for the detection of IPZ in monkey, rat, and human serum fluid
Robust options available for micro-dosing inhalation powders with some important caveats
Study investigates design using synthetic molecule recognizing immunoglobulin in serums
Novel approach to validate a method for the determination of water content
New shell and hot-filling that are highly viscous or semi-solid at room temperature
Proven, acceptable NMR spectroscopy test for common EMAs in raw materials and APIs