Newsletter | January 8, 2025

01.08.25 -- 2024 Made Us Nervous. Will 2025 Be A Happier New Year?

SPONSOR

We’re ready to help usher your next drug into market! 2025’s first Outsourced Pharma Capacity Update provides a unique, virtual experience and the details necessary to find a CDMO for your specific timeline, volume, and production needs. Join us the last week of January as we draw the curtains on the industry’s best and give you complimentary VIP access to the resources available to support your success. Learn more and register to save your seat!

FEATURED EDITORIAL

2024 Made Us Nervous. Will 2025 Be A Happier New Year?

Chief Editor Louis Garguilo doesn't recall a time of more collective concern over development and manufacturing outsourcing than exhibited during last year's news of Novo Holdings’ purchase of Catalent, and the sale of certain Catalent facilities to Novo Nordisk. That angst was aggravated by the simultaneous drama known as the BIOSECURE Act. Will we have a calmer 2025?

Stage 3a: A Key Indicator For Process Validation Maturity

Process validation's stage 3a serves to reconfirm the assumptions made during design space development and is particularly pronounced for new modalities and emerging processes.

INDUSTRY INSIGHTS

Minimizing API Supply Chain Risks

Partnering with an API CMO can help you navigate challenges you may encounter, ensuring you are using the best quality practices and minimizing delays in getting those medicines to market.

3 Keys To Rare Disease Clinical, Commercial Drug Product Manufacturing

The complex biology of rare diseases creates unique hurdles, making it difficult to design and implement a drug development program. Explore the unique considerations for drug product manufacturing.

Balancing The Scales: The Ups And Downs Of Bioprocess Scale-Up

Delve into the complexities of scaling decisions to gain insights from biopharma developers' and CDMOs' mutual interest in achieving successful scale-ups and strategies for avoiding common pitfalls.

Small Scale, Big Impact: The Advantages Of Flexible Pilot Plant Equipment

Discover the benefits of flexible pilot plant equipment. Seamlessly scale up your processes, optimize your formulations, and save costs with in-house small-volume production.

Key Offerings To Help Support Your OSD On Its Journey To Market

Examine several important factors needed to effectively support oral solid dosage therapeutic manufacturing and overcome the complexities involved.

'Ultra High' Potency Development And Manufacture

A biotech with limited experience in the development and manufacture of high potency compounds sought to develop a process for producing a highly potent API used to treat an unmet oncology need.

SOLUTIONS

Contract Drug Development, Manufacturing, And Analytical Testing Services

Altasciences' manufacturing (CDMO) team provides tailored solutions for each phase of your drug development program. From discovery to market ― they’ve got you covered!

AI-Enabled Route Scouting Service

Lonza's Route Scouting Service empowers biotech partners to overcome the complexities of API development and bring life-changing medicines to market faster.

Capacity Update October 2024: Fill/Finish

Jeff Clement, Executive Director of Technical Sales Drug Product Development and Manufacturing, outlines our global sterile fill-finish and lyophilization capabilities, investments, and expansions.

OUTSOURCED PHARMA CAPACITY UPDATE

Find Your New CDMO At Outsourced Pharma Capacity Update

CDMOs in biologics, cell and gene, and small molecule share their capabilities and available capacities. See for yourself why this virtual event has become a wildly popular resource to identify options for your development and manufacturing needs.

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