Search Results for: LYOPHILIZATION Lyophilization Cycle Development Le
Articles
SPECIAL FEATURE - Excipients: Advanced Biologics Require Innovative Excipient Science March 29, 2024
Contributor Cindy H. Dubin speaks with several leading companies to discuss novel and functional excipients being developed, the role they will play in reformulations and new formulations, and their versatility in drug delivery.
SPECIAL FEATURE - Improving Bioavailability & Solubility: The Never-Ending Quest February 29, 2024
Contributor Cindy H. Dubin speaks with several companies to review their innovative technologies in this annual report on bioavailability and solubility.
FORMULATION FORUM – Nanosuspensions - An Enabling Formulation for Improving Solubility & Bioavailability of Drugs December 4, 2023
Jim Huang, PhD, and Shaukat Ali, PhD, focus on the role of excipients and methods for preparation and application of nanosuspensions in injectable, ocular, topical, and oral drug delivery.
PRIMARY CONTAINER CLOSURE SYSTEMS - In From the Cold: Realizing the Benefits of Primary Packaging Innovation for Lyophilized Drug Products September 29, 2023
Neal Higgins discusses the benefits and challenges associated with lyophilization before reviewing some of the current macro influences, West’s design philosophy and QBD blueprint, and data to demonstrate the efficacy of the 4040 elastomer platform.
EXCIPIENT TECHNOLOGY - A Juggling Act: Factors at Play in Your Choice of Solubilizing Parenteral Excipients June 5, 2023
Joey Glassco, MBA, says the power of novel excipients such as Apisolex polymer could revolutionize the parenteral drug development landscape, effectively solubilizing a wide range of APIs without compromising on safety or stability.
EXECUTIVE INTERVIEW - PCI Pharma Services: The Global, Integrated CDMO Partner of Choice April 3, 2023
John Ross, Senior Vice President of Development and Manufacturing at PCI Pharma Services, discusses what it means to be the partner of choice in a very dynamic industry.
PLATFORM TECHNOLOGY - An Alternative Solution for Peptide Drug Formulation April 3, 2023
Michael Neely introduces a unique technology platform and provides examples of how it has solved difficult formulation problems while adding significant commercial value to the resulting drug products.
Choosing the Best Drug Stability Solution for a Parental Product March 3, 2023
The development of an injectable drug product always comes with the question of the best approach to retaining the product’s stability. We asked Dr. David Brett, Product and Service Manager at Vetter, what must be considered to deal with the….
EXECUTIVE INTERVIEW - Alcami: Unlocking the Potential of Transformative Medicine for 40 Years November 30, 2022
Mike Babics, Vice President, Parenteral Services at Alcami, discusses the company’s recent expansions in formulation and analytical development, manufacturing, release testing, and biostorage of clinical and commercial drug products for both solid dosage and parenteral products.
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….
SPECIAL FEATURE - PFS & Parenteral Drug Delivery: Self-Injection is Very Much the “New Normal” May 2, 2022
Contributor Cindy H. Dubin showcases how leading CDMOs and drug delivery developers are responding to current market trends to create ergonomic technologies that are patient friendly, easy to use, reduce needle anxiety, and feature improved packaging materials.
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.
SPECIAL FEATURE - Solubility & Bioavailability: Utilizing Enabling Technologies March 1, 2022
Contributor Cindy H. Dubin interviews several leading companies on how they are using innovative technologies, such as lipid nanoparticles to achieve a high drug loading, combining anti-solvent continuous crystallization with micro-mixing technology to control crystallization and reduce crystal size, and how a robotic capsule can improve bioavailability in the range of 47% to 78%.
SPECIAL FEATURE - PFS & Parenteral Manufacturing: How COVID-19 Changed the Market May 3, 2021
Contributor Cindy Dubin explores how device developers and parenteral contract development and manufacturing organizations (CDMOs) are addressing current challenges, as well as advancements in customized device design, the continuous effort to incorporate safety and human factors, and how COVID-19 is shaping the future of the market.
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.
IMAGE-BASED CHARACTERIZATION - Non-Invasive, Quantitative Characterization of Lyophilized Drug Product Using Three-Dimensional X-Ray Microscopy Analytics January 13, 2020
Shawn Zhang, PhD, Johnathan Goldman, PhD, Xiaodong Chen, PhD, et al present a new method that not only characterizes quantitatively the microstructures of the lyophilized drug samples, but also presents the potential to correlate the microstructures with physical properties to optimize parameters in drug formulation, cycle development, process scale-up, stability control, and administration.
AB BioTechnologies Expands Services With Addition of Preclinical Manufacturing Capabilities October 7, 2016
AB BioTechnologies, Inc. recently announced it is expanding its services to include preclinical manufacturing at its Bloomington, IN, facility. New...EXECUTIVE INTERVIEW - PYRAMID: Prescription for Building Success Through Partnerships October 3, 2016
Medhat Gorgy, President and CEO of PYRAMID Laboratories, Inc., discusses his success in building futures with his clients and more importantly, the lessons he’s learned along the way.
EXECUTIVE INTERVIEW - ALTHEA: Giving Biopharmaceutical Companies the Power To Make October 5, 2015
David Enloe, Althea’s President and CEO, discusses his company’s business strategy, why companies choose Althea, trends in the CMO industry, and how the company is growing since the acquisition of Ajinomoto.