LYOPHILIZATION - Lyophilization Cycle Development: Lessons Learned & Pitfalls to Avoid May 31, 2017

John W. Burke, MS, says that success in lyophilization transfer and scale-up projects depends on a structured approach to information sharing between a pharma company and its CDMO partner, and should include extensive details about the APIs or bulk drug substance characteristics and planned development and clinical programs.

Alcami Partners With Tanvex to Offer a Complete Solution for Biologics Developers March 13, 2024

Revive Therapeutics Collaborates With Attwill Medical Solutions for the Clinical & Commercial Development of a Novel Lyophilized Formulation of Bucillamine December 18, 2023

Sharp Acquires Berkshire Sterile Manufacturing October 5, 2023

Sharp recently announced the acquisition of Berkshire Sterile Manufacturing (BSM), a Massachusetts-based fill finish contract development and manufacturing organization (CDMO) for….

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.

EXECUTIVE INTERVIEW - Ascendia Pharmaceuticals: Innovative Solutions to Challenging Problems May 1, 2023

Jim Huang, PhD, CEO and Founder of Ascendia Pharmaceuticals, discusses how his company expanded its people, capabilities, and facilities to meet and exceed customer expectations from early to late-state development and how this investment allows Ascendia to continue be an expert in sophisticated formulations, as well as cGMP sterile and non-sterile clinical trial and commercial manufacturing.

FORMULATION FORUM - Changing the Landscape of Nanoparticles for Long-Acting Injectable Drugs March 1, 2023

Jim Huang, PhD, and Shaukat Ali, PhD, say recently, there has been continued interest in parenteral NPs with sustained-release characteristics as more drugs discovered are poorly soluble and less bioavailable, and these challenges have led to enormous opportunities and launch of many drug products to market.

(e-Book) Lyophilization Trends in Pharma & Biopharma Drug Development January 18, 2023

This 30-page eBook is exactly what you have been looking for. Find out what is driving the lyophilization market and how working with a CDMO will save time and money and help you comply with increasing regulatory requirements.

SPECIAL FEATURE - Outsourcing Formulation Development & Manufacturing: Understanding Critical Attributes Earlier in Development Leads to a More Robust Drug Product June 1, 2022

Contributor Cindy H. Dubin speaks with industry leaders on how drug sponsors and CDMOs are collaborating earlier, and highlights how third-party contractors are navigating material shortages and how the industry is shifting to address different therapeutic targets and molecules, such as mRNA.

FREEZE-DRYING MICROSCOPY - Unravelling the Complexities of Freeze-Drying Pharmaceuticals With Advanced Microscopy Techniques May 2, 2022

Paul Matejtschuk, PhD, Prof Yvonne Perrie, and Robert Gurney, PhD, say FDM is being used to analyze the most challenging formulations that require sophisticated stabilization methods. By altering and adapting the three main freeze-drying stages to specific formulations, researchers are providing the tools needed for the pharma industry to improve its drug development processes and maintain drug stability when scaling up to production.

Catalent to Invest $350 Million in Integrated Biologics Drug Substance & Drug Product Manufacturing  April 21, 2022

Catalent recently announced a multi-year $350-million investment at its facility in Bloomington, IN, to expand biologics drug substance and drug product manufacturing….

FREEZE-DRYING MICROSCOPY - Unravelling the Complexities of Freeze-Drying Pharmaceuticals With Advanced Microscopy Techniques April 6, 2022

Paul Matejtschuk, PhD, Prof Yvonne Perrie, and Robert Gurney, PhD, say FDM is being used to analyze the most challenging formulations that require sophisticated stabilization methods. By altering and adapting the three main freeze-drying stages to specific formulations, researchers are providing the tools needed for the pharma industry to improve its drug development processes and maintain drug stability when scaling up to production.

Alcami Adds Additional Formulation Development Capabilities March 7, 2022

Berkshire Sterile to Offer Formulation, Lyophilization & Method Development Services February 9, 2022

Berkshire Sterile Manufacturing (BSM) MA, has recently added formulation, lyophilization, and method development capabilities to complement their clients’ drug productions…..

EXECUTIVE INTERVIEW - Emergent CDMO: Making the Impossible, Possible for Biopharma Innovators October 4, 2021

Catherine Hanley, Vice President & Interim CDMO Business Unit Head at Emergent BioSolutions, discusses the company’s plans for current and future CDMO operations and client partnership opportunities.

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.

LSNE-León Receives Approval From AEMPS to Manufacture Biotechnology-Based Therapeutic Products September 2, 2020

SPECIAL FEATURE - Prefilled Syringes & Parenteral Manufacturing: Innovations, Challenges & Solutions May 5, 2020

Contributor Cindy H. Dubin features several leading companies’ innovations in delivery devices as well as how contract parenteral manufacturers are addressing the ever-demanding challenges, issues, and opportunities related to delivering biologics and small molecules.

LYOPHILIZATION - Process Monitoring During Freeze-Drying May 4, 2020

Gregory A. Sacha, PhD, describes the devices used for process monitoring and how they can be used to detect end points during the process.

ProJect Pharmaceutics Expands Facilities for Formulation & Lyophilization Process Development March 16, 2018

ProJect Pharmaceutics(PJP), specialized in formulation and process development for parenteral drug products, announces that it has extended its safety facilities by laboratories dedicated to handle GMO S2 and BSL-2 based biological products such as live virus vaccines…

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