Search Results for: LYOPHILIZATION Lyophilization Cycle Development Le
Articles
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.
PCI Pharma Services Begins Installation of Sterile Fill-Finish & Lyophilization Line as Part of $100-M New Facility Expansion May 2, 2024
PCI Pharma Services has begun installation of key equipment for its newest sterile fill-finish facility on the company’s Bedford, NH campus. Twin lyophilizers and a state-of-the-art large-scale isolator….
SPECIAL FEATURE - Prefilled Syringes & Parenteral Delivery: Next-Gen Injections Feature Technology & Reconstitution April 30, 2024
Contributor Cindy H. Dubin highlights innovations from key players in parenteral delivery and prefilled syringes, with focuses on safety, meeting regulatory requirements, cost, fill/finish, and dosing.
Alcami Partners With Tanvex to Offer a Complete Solution for Biologics Developers March 13, 2024
Alcami Corporation recently announced a new strategic partnership with Tanvex CDMO, a biologics developer offering pre-clinical to commercial biologic CDMO...Revive Therapeutics Collaborates With Attwill Medical Solutions for the Clinical & Commercial Development of a Novel Lyophilized Formulation of Bucillamine December 18, 2023
Revive Therapeutics Ltd. recently announced it has signed a collaboration agreement with Attwill Medical Solutions LP (AMS) for the clinical...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
Alcami recently announced the addition of a 3,800 ft² Non-GMP Formulation Development Laboratory (FDL). The dedicated Non-GMP formulation development space,...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
LSNE Contract Manufacturing recently announced that the Spanish Agency of Medicines and Medical Devices (AEMPS) has approved the manufacturing of...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.