Contract Services
SPECIAL FEATURE – Outsourcing Formulation Development & Manufacturing: CDMOs Shift to Offer More Specialized Services
Contributor Cindy H. Dubin speaks with several innovative CDMOs to discuss their formulation development and manufacturing capabilities (as well as shifting strategies) for bio/pharma companies of all sizes.
PARENTERAL DEVELOPMENT – Considerations in Developing Complex Parenteral Formulations
Iain MacGilp, PhD, says the path to delivering stable, apparently simple solution, suspension, or emulsion formulations is multi-faceted and requires a constant focus on key control measures through pre-formulation development to commercialization.
EXECUTIVE INTERVIEW – Synteract: Advances in Pediatric Clinical Research & the Promise for the Future
Dr. Martine Dehlinger-Kremer, Vice President, Pediatric Development at Synteract, reviews current and significant challenges in pediatric clinical research, advancement of regulations surrounding them, and where the industry is headed.
SPECIAL FEATURE – Prefilled Syringes & Parenteral Manufacturing: Flexibility for Faster Development
Contributor Cindy H. Dubin interviews several contract manufacturers and device developers who are responsible for creating next-generation parenteral drug delivery.
EXECUTIVE INTERVIEW – PAREXEL: Advancing Patient-Centric Drug Development to Improve Clinical Trial Success
Sy Pretorius, MD, Senior VP, Medical & Scientific Services at PAREXEL, discusses the new Patient Innovation Center and how it is helping to improve the patient experience, enhance study recruitment and retention, reduce costs, and deliver better data.
DRUG DISCOVERY – Zebrafish in Preclinical Drug Development – A Small Fish With Big Returns
Rafael Miñana, PhD, explores the benefits of preclinical outsourcing, the value of zebrafish as an alternative model, as well as the challenges and opportunities of managing a highly diversified portfolio and providing customized solutions.
EXECUTIVE INTERVIEW – PCI Synthesis: Acquisition by Seqens Expands its Pharmaceutical Offerings
Ed Price, President and CEO of PCI Synthesis, reflects on the trends fostering the CDMO industry consolidation and the positive impact it augurs in addressing sponsors’ needs to enter the clinic more quickly and safely.
DRUG DISCOVERY – Validated Phenotypic Approach to Neuropsychiatric Drug Discovery
Emer Leahy, PhD, reviews how the SmartCube platform represents a novel approach to discovering the next generation of breakthrough treatments for schizophrenia and other neuropsychiatric disorders.
ARTIFICIAL INTELLIGENCE – Practical Applications of Artificial Intelligence (AI) for Drug Data Quality & Research
Robert Stanley believes by treating AI as one more tool within a broad data quality toolkit, and by focusing narrowly on specific research and business bottlenecks, it is possible to efficiently bring real practical benefits to research and business.
CHARACTERIZATION CORNER – From Dilute Sample to Clinically Representative Formulation: Analyzing the Higher Order Structure of mAbs Over a Wide Dynamic Range
Jeff Zonderman explains how the characterization of mAbs at high concentration in clinically representative formulations, without the need for dilution or concern for interference from a formulation buffer’s excipient, is vital.
EXCLUSIVE ONLINE CONTENT
Catalent Extends Global Commercial Spray Drying Capabilities
Catalent, Inc. recently announced it has significantly expanded the capacity of its global spray drying operations through an agreement with….
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……..
PHASTAR Enters Technology Partnership With Medidata
PHASTAR recently announced today it has entered into a technology partnership with Medidata Solutions, Inc. PHASTAR will deploy several solutions from the Medidata Rave Clinical Cloud, including Rave EDC, Coder, eCOA, and RTSM.
iBio Announces First Agreement for Fill-Finish Services
iBio, Inc. recently announced the activation of its new cGMP sterile fill-finish services operation via the signing of a supply agreement with a clinical-stage biopharmaceutical company developing breakthrough gene and cell therapies.
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……..