White Papers / Tech Papers
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Lyophilization of Complex Drug Products: Formulation Challenges and Scale-Up
This whitepaper explains how to navigate complex drug product formulation and freeze-drying cycle development to obtain a successful lyophilized drug product.Released by: Lubrizol Life Science Health
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Navigating a changing healthcare landscape with a focus towards patient centricity
When road conditions change, it is important to check your roadmap if you want to successfully reach your destination. Due to a rapidly changing global healthcare landscape, various developments are affecting the way in which companies are navigating…Released by: Vetter Pharma International GmbH
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Tufts CSDD Study on Accelerating Drug Development
Download this white paper to discover the time savings and financial benefits for drug developers that use Translational Pharmaceutics®.Released by: Quotient Sciences
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MAY THE FLOW BE WITH YOU: CONTINUOUS FLOW MANUFACTURING OF PHARMACEUTICAL INGREDIENTS
While batch process chemistry remains the standard in the pharmaceutical industry, a clear increase in continuous flow processes has emerged over the past decade thanks to the commercialization of preparative flow reactor units. In a recent survey…Released by: Ajinomoto Bio-Pharma Services
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Industrializing Autologous Adoptive Immunotherapies: Manufacturing Advances and Challenges
Cell therapy has proven to be a burgeoning field of investigation, evidenced by hundreds of clinical trials being conducted worldwide across a variety of cell types and indications. Many cell therapies have been shown to be efficacious in humans, suc…Released by: CCRM
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Commercial Scale Manufacturing of Allogeneic Cell Therapy
Allogeneic cell therapy products are generating encouraging clinical and pre-clinical results. Pluripotent stem cell (PSC) derived therapies, in particular, have substantial momentum and the potential to serve as treatments for a wide range of indica…Released by: CCRM
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Ophthalmic Drug Delivery for Retinal Disorders
This whitepaper explores the development and manufacturing considerations associated with ophthalmic drug delivery, with a focus on retinal disorders.Released by: Lubrizol Life Science Health
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Current Trends and Emerging Needs for Microbial Fermentation
Over the last decade, the potential of fermentation-based manufacturing has expanded dramatically due to advances in synthetic biology and genetic engineering.Released by: Evonik
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Simplifying Recombinant Protein Production: Breaking Down the Corynex Protein Expression System
The rise of biologics is having a dramatic impact on how physicians treat many serious and chronic illnesses.Released by: Ajinomoto Bio-Pharma Services
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5 ADC Manufacturing Challenges You Need To Know
Below are five key areas where pharmaceutical manufacturers may face the biggest uphill battles.Released by: Ajinomoto Bio-Pharma Services
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Critical Factors of Fill Finish Manufacturing For Biologics
The bulk drug substance, formulation, and sterile filtering and filling of the final drug product all require special handling procedures.Released by: Ajinomoto Bio-Pharma Services
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Is Your Complex Formulation Process Set Up for Success?
Often, the implementation of specialized equipment and/or processes is necessary to ensure successful formulation.Released by: Ajinomoto Bio-Pharma Services
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Preparing for Your CDMO Selection Process
Finding the CDMO that is right for your company and project can be a daunting task, particularly if this is your first time outsourcing.Released by: Ajinomoto Bio-Pharma Services
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Hot Melt Extrusion for Oral Solid Dosage Forms
HME is an efficient and trusted tool that improves solubility and enables the development of oral solid dosage forms from BCS Class II and IV compounds.Released by: Lubrizol Life Science Health
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Leak Rate Testing for Freeze Dryers: A Scientific Approach
Assurance of the vacuum integrity of freeze - dryers used for the manufacture of sterile pharmaceutical products is essential for GMP operations; however, there is currently no generally accepted scientific rationale for establishing acceptance crite…Released by: Baxter BioPharma Solutions
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Pharmaceutical Development for ADCs: Not as Simple as ABC
Formulation, process, and analytical development for antibody - drug conjugates, or ADCs, is complex. While the development of an aqueous solution formulation may be preferred over a lyophilized product, it is useful to initially pursue a dual path a…Released by: Baxter BioPharma Solutions
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Colbert’s Clean Carton Passes the Test
One Clean Carton™ has been introduced to provide access to packaging that meets the highest standards for sustainable, pharmaceutical and food-safe packaging.
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Polymers for Drug-Device Combination Products
Several polymers are available for drug-device combination product developers, many that meet necessary regulatory requirements.Released by: Lubrizol Life Science Health
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Critical Considerations for Coated Drug-Device Combination Product Development
In this technical brief, you will learn how improved patient outcomes have been made possible by innovation in therapeutic coatings for medical devices.
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Considerations for Development of Lyophilized Biosimilar
This whitepaper discusses considerations for development of a lyophilized biosimilar, as well as a biosimilar case study.Released by: Baxter BioPharma Solutions
