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.
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.
Gregory A. Sacha, PhD, introduces the common equipment available for automated inspection and discusses inspection testing methods for prefilled syringes.
EXECUTIVE INTERVIEW – MilliporeSigma: Accelerating the Development & Manufacture of Gene Therapies, Immunotherapies & Viral Vaccines
Dave Backer, Head of Virus & Gene Therapy Strategic Initiatives at MilliporeSigma, talks about his company’s expanding GMP capacity to speed development and manufacture of gene therapies, immunotherapies, and viral vaccines.
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.
EXCLUSIVE ONLINE CONTENT
Nevakar Inc. recently announced it entered into an exclusive licensing agreement with Endo International plc’s subsidiary, Endo Ventures Limited, for the development of five differentiated, sterile injectable products in the US and Canada.
Credence MedSystems Closes $12.8-Million Financing to Support Ongoing Development & Scaling of Innovative Delivery Products
Credence MedSystems, Inc., an innovator in injectable drug delivery devices, recently announced the closing of a Series B financing resulting in gross proceeds to the company of $12.8 million.
Avalon GloboCare Forms Strategic Partnership With Weill Cornell Medical College to Co-develop Technologies & Bio-production of CAR-T Therapy
This strategic partnership aims to co-develop bio-production and standardization procedures in procurement, storage, processing, clinical study protocols, and bio-banking for Chimeric Antigen Receptor (CAR)-T therapy, in accordance with the Foundation of Accreditation for Cellular Therapy (FACT) and American Association of Blood Banks (AABB) standards.
Baxter Canada recently announced Health Canada approval for the Spectrum IQ Infusion System with Dose IQ Safety Software. The Spectrum IQ system features new bi-directional electronic medical records (EMR) integration to help…
Croda International Plc and SiSaf Ltd recently announced an exciting new strategic partnership. Croda, the name behind high-performance ingredients and technologies that are relied on by industries and consumers everywhere, has agreed a commercial arrangement with SiSaf, a pioneering UK-based biopharmaceutical company.