Search Results for: LYOPHILIZATION Lyophilization Cycle Development Le
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.
- SPECIAL FEATURE – Outsourcing Formulation Development & Manufacturing: Early-Stage Partnerships Are On The Rise
Contributor Cindy H. Dubin asked leading CMOs and CDMOs to describe the value-added services they offer with respect to formulation and manufacturing. Solving challenges of insufficient solubility, poor stability, identifying excipient candidates, and particle design topped their list of offerings.
- SPECIAL FEATURE – Formulation Development & Manufacturing – CDMOs Offer Speed, Advanced Technologies, & the Ability to Handle More Potent APIs
Contributor Cindy H. Dubin speaks with some of the industry’s leading CDMOs to highlight their capabilities in the areas of speed, quality, technology, and handling of complex APIs.
Sam de Costa, PhD, believes the launch of two stabilization and drug delivery platforms that have the potential to revolutionize the delivery of vaccines, therapeutics, and diagnostics, while significantly cutting costs, has attracted sharp interest from pharmaceutical and biotech companies around the world.
Thomas Otto believes a specialized CDMO can provide efficient solutions to the many challenges surrounding lyophilized substances. But it should be ascertained they have packaging, manufacturing, and lyophilization expertise.
Alan Shortall believes with dual-chamber syringes and other emerging device technologies now addressing key market requirements for intuitive reconstitution and injection, the pharmaceutical market for therapies suitable for reconstitution and mixing at the point of delivery is poised for significant rates of growth.
- ADVANCED DELIVERY DEVICES – Sophisticated Connected Wearables: Boosting Biologics’ Compliance, Value & Patient Satisfaction
Michael D. Hooven, MSME, says the new, most advanced wearable large-volume injectors available now for clinical trials and commercial application are designed to address the challenges of formulating biologics, delivery complexity, patient compliance, and cost.
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.
Enrico Corona, indicates full scalability between laboratory and production lyophilization units allows for the development or optimization of freeze-drying cycle parameters that yield significant cost savings.
Leon Grother says multiple products are on the market made using a controlled lyophilization process. The fast-dissolving characteristics it can impart have enabled the demands of several challenging patient populations to be met with formulations of important medicines that work well for them.
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.
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…
- LYOPHILIZATION – Making Formulations More Efficient Using the Freeze-Dry Microscopy Pre-Lyophilization Method
Jeffrey McGinn says to minimize cost and streamline this process, many companies developing new parenterals are finding it in their best interest to optimize their lyophilization cycles by looking at pre-lyophilization methods such as freeze-dry microscopy.
- SPECIAL FEATURE – Prefilled Syringes & Parenteral Contract Manufacturing: Biologics Present a New Set of Challenges
Contributor Cindy H. Dubin speaks with leading syringe developers and contract manufacturers to discuss how they are overcoming industry challenges and provides a look at some of the innovative advancements in prefilled syringe technology.
In this exclusive Drug Development & Delivery annual report, handheld injection experts provide their thoughts about the various factors backing the adoption of the devices including ease of use, pain-free delivery, and differentiation for product line extensions.
- SPECIAL FEATURE – Prefilled Syringes & Parenteral Contract Manufacturing: Anticipating the Needs of the Future
Contributor Cindy H. Dubin speaks with several companies in the prefilled syringe and parenteral manufacturing market that are offering a range of services and systems that cater to today’s issues as well as anticipating the needs of the future.
Contributor Cindy H. Dubin speaks with some of the leading companies operating in the injectables arena, and discovers this ever-evolving sector is witnessing some very specific and eye-opening trends that are affecting the market’s growth.
- SPECIAL FEATURE – Prefilled Syringes & Parenteral Contract Manufacturing – Product Differentiation Is Critical
Contributor Cindy H. Dubin speaks with several of these suppliers and manufacturers about the importance of customization and differentiation as the key to pharma companies staying competitive in the prefilled syringe space.
- SPECIAL REPORT – Outsourcing Formulation Development and Manufacturing: An Early Approach Saves Time and Money
In this Special Report, Contributor Cindy H. Dubin asks many of the leading companies in this sector what challenges pharma currently faces in formulation and manufacturing and how they, as third-party providers, are helping to alleviate those burdens.