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.
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.
Steven Kaufman believes that with autoinjectors in high demand by the biopharma industry, gas-powered delivery systems may have the solution to many of the difficulties the industry is facing.
SCALE-UP & MANUFACTURING – Smart Formulation, Processing & Engineering Solutions to Solve Drug Product Scale-Up & Manufacturing Challenges With Minimum to No Regulatory Impact
Anil Kane, PhD, MBA, explains how many smart formulation process or engineering solutions can be applied to overcome challenges of the material properties to successfully manufacture quality products at the development and commercial scale with minimum to no clinical or regulatory impact.
SPECIAL FEATURE – Injection Devices: Manufacturers Focus on 21st Century Technology While Still Tackling Traditional Challenges
Contributor Cindy H. Dubin highlights some of the key companies in the injectable delivery market that are focusing on advanced technology as well as the more traditional challenges related to breakage, leaching, and needlestick prevention.
Contributor Cindy H. Dubin highlights some of the analytical testing services that leading contractors offer aimed at the increasing complexities of today’s pharmaceutical pipelines.
Craig Morgan believes metrics are indeed critical to efforts to rein in clinical trials that are either poorly initiated or have incurred unforeseen events, which place the original timelines and/or budgets at risk of overages.
EXCLUSIVE ONLINE CONTENT
Catalent to Open Second Clinical Supply Facility; Enables Broader Integrated Solutions for Global & Local Customers
Catalent Pharma Solutions recently announced its plans to invest $2.5 million in a new, second clinical supply facility in Shanghai, China, due to open in early 2019. When completed, the facility is expected to employ 100 people and will double Catalent’s total clinical storage capacity in China.
PCI Pharma Services, a full-service provider of specialist outsourced drug manufacturing, clinical trial services, and commercial packaging to the global biopharmaceutical industry, recently announced the expansion of its Clinical site at Rockford, IL.
Alcami Corporation recently announced its collaboration with Medicines Development for Global Health (MDGH), a not-for-profit Australian biopharmaceutical company dedicated to the development of affordable medicines and vaccines for neglected diseases prevalent in low and middle-income countries.
Hovione recently announced a plan to increase production capacity in oral dosage forms in Portugal to strengthen the integrated offering. New commercial-scale equipment for blending, tableting, and coating will complement existing development small-scale equipment.
By 2050, it is projected that the proportion of people aged 65 and older will be more than double that of children aged 5. This global phenomenon is also leading to an increasing number of people suffering from chronic diseases, such as diabetes and osteoporosis.