Search Results for: A Changing Market Demands New
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PHARMACOVIGILANCE AUTOMATION - Improving CRO Efficiency Through Automation January 26, 2024
Emmanuel Belabe says many CROs believe they’ve reached a breaking point as they work to keep up with rising case volumes, data complexities, and changing regulations. To combat these pressures, CROs need access to modern pharmacovigilance (PV) automation that promotes flexibility, scalability, efficiency, and cost-effectiveness.
PHARMACEUTICAL GLOBALIZATION - Navigating Opportunities & Obstacles December 4, 2023
Jürgen Hönig says rapid globalization of the pharmaceutical industry has created new complexities as companies navigate different regulations and government policies, but there are many reasons for optimism, including harmonization, collaboration, and convergence.
EXECUTIVE INTERVIEW - HERMES PHARMA: Reducing Risk, Speeding Development - A CDMO Model Including GCP-Sponsorship to Better Meet the Needs of Pharma Companies September 29, 2023
Dr. Martin Koeberle, Head of Analytical Development & Stability Testing, and Dr. Bernice Wild, Head of Stability Testing and Senior QA Manager GCP, at HERMES PHARMA, discuss the challenges of developing innovative oral medicines, as well as how these new service offerings are helping meet a critical need among companies looking to bring portfolio-enhancing formulations to market.
CELL & GENE THERAPY - Cell & Gene Therapy’s Everest – The Challenges & Opportunities That Will Shape Success September 5, 2023
Samir Acharya, PhD, Rajiv Vaidya, PhD, Laura Kerepesi, PhD, and Cyrill Kellerhals, MBA, provide their unique insights as they explore the challenges cell and gene therapy developers and manufacturers are currently facing, those they can expect to see in the future, and more critically, how to overcome them.
Gerresheimer Expands Technical Competence Center in Wackersdorf August 3, 2023
Gerresheimer is dedicating even more space to small batch production. It has expanded the capacity of its small-batch production (SBP)...SPECIAL FEATURE - Parenteral Drug Delivery: Could a Dose of AI Improve Development? May 1, 2023
Contributor Cindy H. Dubin speaks with several innovative companies to highlight the strides they are currently making toward improving dose accuracy, integrating design safety, and accelerating time to market.
SPECIAL FEATURE - Outsourcing Analytical Testing – Timelines, Regulations & Biologics Drive the Sector January 17, 2023
Contributor Cindy H. Dubin interviews leading CDMOs to discuss not just their analytical service offerings, but their strategies for meeting regulatory challenges and ensuring faster project timelines.
DRUG-ELUTING IMPLANTS - Sustained-Release Implants - A Targeted Approach to Drug Delivery January 16, 2023
Tom Quinci, MSc, believes oncology requires new treatment modalities that are better for patients, and it is time technologies like drug-eluting implants, offering real, achievable advantages, are more widely considered.
Catalent Expands Singapore Clinical Supply Facility for Increased Temperature-Controlled Capabilities September 6, 2022
Catalent recently announced a $2.2-million expansion to its clinical supply facility in Singapore. The investment will increase the site’s footprint...SPECIAL FEATURE - Injection Devices: Three Trends Influencing Development & Delivery September 1, 2022
Contributor Cindy H. Dubin showcases in this annual feature how various innovative device manufacturers are addressing the current trends in their injection designs.
EXECUTIVE INTERVIEW - Catalent: Developing & Delivering Billions of Doses of Drugs Every Year June 1, 2022
Alessandro Maselli, President and Chief Operating Officer of Catalent, talks about his company’s unique approach to drug development partnerships as he prepares to become the company’s new President and Chief Executive Officer on July 1, 2022.
PCI Pharma Services Announces Major Manufacturing Expansion with $100-Million Investment May 11, 2022
PCI Pharma Services recently announced a major expansion of capabilities and capacity in aseptic liquid fill-finish and sterile lyophilization technology with the investment of $100 million into the….
EXECUTIVE INTERVIEW - PCI Pharma Services: Broadening Our Biologics Footprint, Together May 2, 2022
Shawn Cain, SVP Development & Manufacturing at PCI Pharma Services, discusses the recent acquisition, the opportunities this presents to Biopharma companies, and the current trends in the sterile fill-finish industry.
Genezen Appoints Senior Director of Business Development to Support Rapid Growth January 24, 2022
Genezen, Inc., a cell and gene therapy Contract Development and Manufacturing Organization (CDMO) focused on early phase process development, GMP...Univercells Acquires SynHelix, Entering Into Synthetic Biology & the Race to Next-Generation DNA Synthesis January 6, 2022
Univercells S.A. (Univercells) recently announced its acquisition of SynHelix, a biotechnology company that aims to debottleneck biotherapeutics development through an unprecedented robust, scalable, and….
SPECIAL FEATURE - Injection Devices: Designing Simplicity, Safety & Adherence Into One Delivery System August 26, 2021
Contributor Cindy Dubin, in this annual report, speaks with industry innovators and takes a deep dive into the myriad injectables that are currently in development or recently introduced to the market.
Genezen Breaks Ground on cGMP Lentiviral Vector Production Facility June 24, 2021
Genezen Laboratories, Inc., a cell and gene therapy Contract Development and Manufacturing Organization (CDMO) focused on early-phase process development, vector...SPECIAL FEATURE - Outsourcing Formulation Development & Manufacturing: Meeting Demand for Biologics & Specialty Drugs June 2, 2021
Contributor Cindy Dubin highlights the formulation development and manufacturing offerings from some of the leading CDMOs to address a myriad of challenges – from complex compounds to poor solubility to dual-release profiles.
EXECUTIVE INTERVIEW - Pace Analytical® Life Sciences: Delivering Science Better; Advancing Novel Therapies Through the Clinic to Commercialization March 1, 2021
Frank Tagliaferri, PhD, Vice President of Pharmaceutical Development at PLS, discusses his experiences with the company and its recent growth.
CDMO CASE STUDY - AJILITY: Streamlining Drug Product Manufacturing October 1, 2020
Dustin Campbell says the AJILITY platform takes the burden off clients and allows his company to drive, manage, and support their drug product manufacturing, maximizing speed and success, while prioritizing these programs are driven to completion.
