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FORMULATION FORUM - Nanoparticle Technologies Used in Ocular Drug Delivery
Shaukat Ali, PhD, and Jim Huang, PhD, describe the basic understanding of eye diseases, challenges in ocular drug delivery, and the future trends in development of innovative drugs.
PREFILLED SYRINGES - Prefilled Syringe Automated Inspection & End-Product Testing
Gregory A. Sacha, PhD, introduces the common equipment available for automated inspection and discusses inspection testing methods for prefilled syringes.
MONOCLONAL ANTIBODIES - The Development of Therapeutic Monoclonal Antibody Products: A Comprehensive Guide to CMC Activities From Clone to Clinic
Howard L. Levine, PhD, and Brendan R. Cooney, provide a guide to product development companies, service providers, investors, and analyst as they work their way through the complex and rapidly evolving world of therapeutic monoclonal antibodies.
FDA UPDATE - The FDA's New Drug Approval Process: Development & Premarket Applications
Kaiser J. Aziz, PhD, in this latest FDA update, emphasizes quality system approaches to the development and availability of new drug information presented in the proposed labeling of the product.
CLINICAL TRIALS - Inconsistencies Prevalent in Study Start-Up
Craig Morgan believes as stakeholders are increasingly aware that better study start-up (encompassing the activities associated with site identification, feasibility assessment, selection, and activation) processes are linked to shorter clinical timelines, the emphasis has been shifting in that direction.
ABITEC & UNIVAR Announce Specialty Lipid Distribution Agreement
ABITEC Corporation has executed a multi-year agreement with distribution partner UNIVAR to promote and sell its specialty lipid products into the Canadian market. The arrangement…
CordenPharma Acquires Pfizer API Manufacturing Facility in Boulder, CO
CordenPharma, a leading Contract Development & Manufacturing Organization (CDMO), has entered into definite agreements to acquire the former Hospira Boulder (Colorado) high containment API site…
CordenPharma Inaugurates Third Development Suite for Highly Potent Oral Solid Dosage
CordenPharma is pleased to announce the completion of its newest early development suite for Highly Potent, oral solid dosage products in CordenPharma Plankstadt (DE). The…
FAQs on What Happens If You Miss the Serialization Deadline
By: Catherine Hanley Serialization affects all stages of the supply chain and with many companies, small and large, unprepared for the scope of regulations…
Pion Inc. Acquires Sirius Analytical Instruments Ltd.
Pion Inc., an industry leader in analytical instrumentation for drug development for the pharmaceutical industry, recently announced the acquisition of Sirius Analytical Instruments Ltd., headquartered in…
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Apellis & Sobi Announce EU Approval of Aspaveli (pegcetacoplan) for Treatment of PNH
Apellis Pharmaceuticals, Inc. and Swedish Orphan Biovitrum AB recently announced the European Commission (EC) has approved Aspaveli (pegcetacoplan), the first and only targeted C3 therapy, for the treatment of….
Pardes Biosciences Initiates First-in-Human Trial for PBI-0451, an Oral Antiviral in Development to Treat & Prevent SARS-CoV-2 Infections
Pardes Biosciences, Inc. recently announced the initiation of a Phase 1 clinical trial, evaluating the company’s lead candidate, PBI-0451 which is being developed as a potential oral….
Clinical Trial Data on the Use of Probiotics in Outpatients With COVID-19
Researchers at the Hospital General Manuel Gea González in Mexico City have reported results from a study designed to assess the impact of four specific strains of probiotics on the rate of remission from infection with SARS-CoV-2….
Designing a CMC Strategy for Accelerated Development of Biotherapeutics
As the pipeline of biologic drugs intended to treat complex disease expands, the typical timeline for drug development seems to be shortening more frequently and with more intensity……..
Designing a CMC Strategy for Accelerated Development of Biotherapeutics
As the pipeline of biologic drugs intended to treat complex disease expands, the typical timeline for drug development seems to be shortening more frequently and with more intensity……..