Authors
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ICH Q9: Attaining a Quality-Business Synergy through Quality Risk Management, ROI Analysis, and Highly Capable FacilitiesThis paper explores the relationship between investing in pharmaceutical manufacturing risk reduction and meeting business objectives.
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New Iron APIsDr. Paul Lohmann® has developed Iron(III) Polymaltose Complex and Iron(II) Bisglycinate as APIs. These organic Salts are available including DMF/ASMF to treat iron deficiency anemia with less gastrointestinal side effects.
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The Importance of Quality Data for Regulatory SubmissionsRegulatory submissions are a critical step in bringing new drugs and medical interventions to market, the success of which heavily relies on the quality and fitness of the data presented to the regulatory bodies.
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Reliance-Based Waivers Become the Predominant Trend in In-Country Testing of Pharmaceutical ProductsThis study reviews changes in in-country testing (registration testing, import testing) requirements and analyzes current trends. In the context of international harmonization of good practices and standards as well as the improved information exchange between national regulatory authorities, in-country testing is considered outdated and redundant in many cases.
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The Changing Landscape For BiosimilarsAs biopharmaceuticals will soon make up 50% of new drug approvals there has been a significant rise in interest in the field of biosimilars.
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Enhancing Process Validation for Sterile Liquid and Freeze-Dried Forms: Part 1AFI representatives of the process validation working group explore and define key elements for an enhanced approach to process validation for sterile liquid and freeze-dried forms.
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Analytical Strategies for Cell and Gene Therapy DevelopmentDeveloping bioassay methods requires a new approach for cell and gene therapy drug development.
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Emergent CDMO Capabilities Overview BrochureEmergent CDMO offers development services, drug substance, and drug product manufacturing for biological products, from preclinical through commercialization. Download our overview brochure to learn more about our end-to-end service offerings.
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Comparing Calibration Technologies for Liquid-Handling Quality AssuranceThe authors consider several common techniques for verifying the accuracy of liquid-handling equipment and offer guidance for finding the appropriate technique for a given instrument.
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Dissolvable Films: Dissolvable Films for Flexible Product Format in Drug DeliveryFor pediatric and geriatric patients, fast-dissolving drug-delivery systems provide an easier way to take medications and vitamins. Oral thin films have evolved to provide systemic delivery of active pharmaceutical ingredients for over-the-counter and soon, prescription drugs. The authors review the practical benefits of dissolvable films, their manufacture, and their market potential.
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The Facility of the FutureCritical considerations for deploying smart, fast, and flexible Life Sciences facilities
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A Single Adulteration Limit for Cleaning Validation in a Pharmaceutical Pilot-Plant EnvironmentAn adulteration limit of 100 ?g/25cm? (4 ?g/cm?) was proposed for pilot-plant facilities. The dynamic changes in equipment, formulation, and residue determination made implementation of a constantly changing, calculated adulteration limit impractical. A single adulteration limit was simpler to communicate and document, making compliance achievable. The limit would be used only after it was determined to be lower than a health-based evaluation and a visual-cleanliness assessment.
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Peer-Reviewed Topical Review: The Importance of Quality in Corrosion-Resistant Alloys in Biopharmaceutical ManufacturingIn this topical review, the authors discuss the rationale behind microstructural requirements for biopharmaceutical equipment and problems that may be encountered during the fabrication of high-performance corrosion-resistant equipment.
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NDC: To Be or Not to Be in EPC?Industry will be challenged to embrace new methods of supply chain collaboration.
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Using Excipients With BiologicsBiologics are large molecular weight molecules primarily formulated for parenteral administration; however, there are some smaller biomolecules that have been formulated for oral use.
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How Responsible Should The Sponsor Be For The Outsourcing Provider's Success?When assessing the competencies of an outsourcing service provider, sponsor companies must pay a great deal of attention to the cGMP compliance level of the provider.
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Assessing Data Integrity Risks in an R&D EnvironmentA data-integrity risk assessment tool has been developed for use with standalone R&D data-acquisition and processing software.
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Overcoming Challenges to Biopharmaceutical Development and Manufacture with Science- and Risk-Based StrategiesMany biologic drug manufacturers encounter similiar challenges; precompetitive collaboration can help resolve these issues. Representatives of the IQ Consortium’s Biologics CMC Leadership Group describe efforts to address the safe handling of biologic drugs in closed-system transfer devices in healthcare settings and the need for phase-appropriate specifications.
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Facilities of the Future: Meeting the Demands of Breakthrough TherapeuticsAs breakthrough therapeutics in the pharma pipeline approach commercialization, pharmaceutical manufacturing facilities must evolve to meet demand.
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QMM for Pharmaceutical Manufacturers– Implications for Drug Manufacturers, API Suppliers and Contract ManufacturersQMM principles and practices can positively influence a sustainable drug supply and bolster the bottom-line of drug manufacturers, API suppliers, and CMO/CDMOs.
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Spray Drying as an Enabling Technology for Inhalation Drug DeliveryParticle performance in a DPI can be optimized by fine-tuning the formulation and manufacturing process parameters.
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Polymer Influence on the Rheological Properties of Co-Processed Microcrystalline Cellulose and Sodium CarboxymethylcelluloseIn this study, researchers evaluated the colloidal microcrystalline cellulose (cMCC) suspending agent—a co-processed material of microcrystalline cellulose and sodium carboxymethyl cellulose (NaCMC)—by using a representative pharmaceutical-grade commercial version of cMCC.
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Characterization of the Performance of Bin Blenders-Part 3 of 3: Cohesive PowdersIn this final part of a series of three articles, the results from experiments involving cohesive materials are discussed in terms of mixing performance, agglomerate comminution, and lubrication of powder mixtures.
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How To Execute Successful Data MigrationsSuccessful migrations require careful planning to meet business needs and maintain data integrity.
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Determining Water Content with a Novel Karl Fischer Titration ApproachA new approach to testing water content in biologics is needed that will give a more accurate determination of actual water content in the biologic.
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Pharma Services Sector Poised for Continued Growth and ConsolidationThe CRO market will see greater consolidation by both financial buyers looking to consolidate smaller players and larger CRO players wanting to expand into value-added specialty service areas.
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Pharmaceutical Compounding Calculations in a Workplace EnvironmentAn ordered process describing calculations activities for compounded dosage forms is described.
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Enhancing Process Validation for Sterile Liquid and Freeze-Dried Forms: Part 1AFI representatives of the process validation working group explore and define key elements for an enhanced approach to process validation for sterile liquid and freeze-dried forms.
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Managing the Complexity of Modern Sterile Product DevelopmentsManaging the intricacies of sterile product development is imperative for successful and compliant outcomes.
