William Boomershine, PhD, explains how high-resolution mass spectrometry is a key component to the characterization of novel biologics and biosimilars.
Taras Seniuch, Director of Business Development at SHL’s contract manufacturing organization, SHL Pharma, talks about his company’s unique service offering for its partners.
SPECIAL FEATURE – Outsourcing Formulation Development & Manufacturing: CDMOs Are Innovating for 21st-Century Medicine
Contributor Cindy H. Dubin speaks with some of the industry’s leading CDMOs about the innovations they are developing for next-generation patient care, and how many are making investments that are enabling them to offer more services under one roof.
Luke S. Gill, MSc, MBA, believes understanding and overcoming various challenges in the development of immunotherapeutic agents will be critical to clinical trial success and, ultimately, market approval.
SPECIAL FEATURE – Prefilled Syringes & Parenteral Manufacturing: Drug & Packaging Ensure Safety, Compatibility & Stability
Contributor Cindy H. Dubin highlights some of the key players in the market and where they are focusing their efforts to ensure products are of the highest quality, safe, and easy to use.
Brent Lieffers, Senior Director of Operations, discusses the need for keeping up with trends and technology as an innovative CDMO.
Theresa Bankston, PhD, says the fact that many of these therapies are designed for home delivery by patients or caregivers via subcutaneous injection, combined with increasing complexity of longer-acting formulations, larger injection volumes, and longer injection durations, has raised the bar for seamless injection delivery technology.
CONTAINER CLOSURE SYSTEM – Recent Prefillable Syringe Developments Mirroring Increasing Biotech Drug Product Demands
Stefan Verheyden says the container closure system has become a decisive factor for sustained market success, with autoinjectors and injection pumps as growing areas of interest.
Gregory A. Sacha, PhD, introduces the common equipment available for automated inspection and discusses inspection testing methods for prefilled syringes.
ORALLY INHALED PRODUCTS – Optimizing the Application of In Vitro Test Methods for the Demonstration of Bioequivalence in Orally Inhaled Products
Mark Copley, MEng, and Anna Sipitanou, MSc, examine the testing strategies demonstrating the BE of OIPs, their relevance, and the submission approaches outlined by the FDA and EMA.
EXCLUSIVE ONLINE CONTENT
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