Meranda Parascandola - DSI InPharmatics

August 5, 2021

Published by Meranda Parascandola at August 5, 2021

Why and When Filter Validation is Key to Bringing a Product to Market

Bringing a product to market is a long and complex one, even more so when developing a sterile product, such as injections, ophthalmic preparations, irrigation fluids, dialysis solutions, among others. The only method for removing microorganisms without adversely affecting the product is sterile filtration, and those processes need to be assessed through filter validation to ensure that the filter used to eliminate any microorganisms is the right one.

August 19, 2021

Published by Meranda Parascandola at August 19, 2021

Trust and Expertise: Defining The Value Of The Person-In-Plant

As sponsors have started to shift more and more of their manufacturing to outsourcing partners, relationship building has become an even greater priority. This is where the person-in-plant becomes an invaluable source for building a more trusting relationship with the contract research manufacturer (CMO). Essentially, a person-in-plant is a sponsor employee or, more often, a third-party expert consultant who is present at the contract manufacturing site to observe, support, and provide feedback to all stakeholders.

September 2, 2021

Published by Meranda Parascandola at September 2, 2021

Planning, Preparing and Crafting the Drug Development Report

DSI has seen a lot of pharmaceutical development reports ranging from several hundred pages to a summary of conclusions attached to stacks of data. The latter can make things difficult when it’s time to put a regulatory filing together. It’s become clear that capturing development decisions and data from the outset in a living document is good practice and whether the data collected thus far is supporting development goals. It’s a reference point for what has been completed and what still has to be done.

September 16, 2021

Published by Meranda Parascandola at September 16, 2021

Starting Early: How to Ease the Process of a New Drug Application

Start early, document thoroughly. That’s the lesson for getting through the new drug application or biologics license application (NDA/BLA) process. Long before marketing approval, companies developing new products must apply to conduct clinical trials by submitting an investigational new drug (IND).

September 17, 2021

Published by Meranda Parascandola at September 17, 2021

DSI Announces Virtual Attendance of AAPS PharmSci 360 2021, October 17-20

DSI will be attending the AAPS PharmSci 360 Convention from October 17-20, 2021. Our team will be conducting virtual meetings this year. Please contact us to set up a time to meet. About DSI DSI is a full-service regulatory drug development consulting firm for pharmaceuticals, biologics and new drug and […]

September 17, 2021

Published by Meranda Parascandola at September 17, 2021

DSI Announces Virtual Attendance of Bio Europe Digital 2021, October 25-28

DSI’s recent acquisition by Paris-Based, Product Life Group (PLG), has opened the company to further expand into the European market. We hold prior experience in Europe and ROW but are excited to explore more opportunities in these markets. The addition of PLG’s resources and support will allow DSI to dive […]

October 7, 2021

Published by Meranda Parascandola at October 7, 2021

Avoiding and Addressing Surprises in the API Manufacturing Process

When you’re developing and manufacturing your active pharmaceutical ingredients, the last thing you want to deal with is surprises. Unfortunately, even with the soundest methods, processes, and strategies, problems occur in manufacturing.

November 1, 2021

Published by Meranda Parascandola at November 1, 2021

Microbiological Quality Considerations in Non-Sterile Drug Manufacturing

Mike Carroll, Quality Professional and Aseptic Processing specialist has an extensive history in microbiology and pharmaceuticals. One of his most recent commentaries is on Microbiological Quality Considerations in Non-Sterile Drug Manufacturing, a draft of guidance published in September of 2021

November 4, 2021

Published by Meranda Parascandola at November 4, 2021

How To Tell A Compelling CMC Story In Your NDA/BLA Application

Storytelling is integral to the pharmaceutical regulatory process. It’s really what your new drug application (NDA) or biologics license application (BLA) is all about. It’s about deciphering the data to tell a reviewer how your process and product works.

November 18, 2021

Published by Meranda Parascandola at November 18, 2021

The Do’s And Don’ts of Selecting A Contract Manufacturer

As any pharmaceutical company knows, most drugs don’t make it into the clinic so the medical chemistry process early on involves just a few kilograms of product. But if all goes well, and the drug makes it into the clinic, suddenly the quantities become metric tons or more, and the manufacturing and safety processes become quite different.

December 1, 2021

Published by Meranda Parascandola at December 1, 2021

DSI Announces Virtual Attendance of Biotech Showcase 2022, January 10-19

Each year, healthcare, pharmaceutical, and biotechnology executives attend the JP Morgan Healthcare Conference, some to tout recent developments, others just to bounce from session to session. We work hard at DSI to make life science companies better at what you do in the Chemistry, Manufacturing and Controls (CMC) areas. We’ve […]

January 19, 2022

Published by Meranda Parascandola at January 19, 2022

The Pros and Cons of Outsourcing Manufacturing to China

Trust is important when selecting a contract manufacturing organization (CMO), particularly when offshoring. With more biopharmaceutical companies looking to China-based CMOs, companies need to understand both the opportunities and the challenges the market presents.