Newsletter | September 18, 2023

09.18.23 -- cGMP Requirements For Automated Facility Monitoring Systems


If you have authority to choose and/or manage CDMO relationships and need to secure capacity for your large molecule development or commercial programs, don’t miss Outsourced Pharma Capacity Update. This multiday event is conveniently grouped by molecule type and will feature partners in biologics development and manufacturing on October 3rd sharing their capabilities and available capacities in short, digestible presentations, all from a virtual platform!


CGMP Requirements For Automated Facility Monitoring Systems

To assess facility control, most organizations use facility monitoring systems to monitor the manufacturing workspaces continuously. Let's take a deeper look at current good manufacturing practice (cGMP) requirements for the design and operation of such automated systems, including a look at total particle counting.


De-Risking Biosimilar Development With Commercially Proven Autoinjectors

Discover how a biopharmaceutical company can de-risk the launch process by choosing a suitable autoinjector technology and partner.

A Five-Point Strategy For Building A CMC Dossier

Building a robust CMC package to streamline the path to FIH trials can help establish a quality foundation to support the development phases toward commercialization.

Accelerating Cell Line Development From DNA To Master Cell Bank

Cell line development is a complicated process, and partnering with a CDMO is an effective strategy to ensure these products are manufactured with speed and quality.

Top 3 Things Your Sterile Fill/Finish Operator Wants You To Know

Sterile fill/finish operations can be complex. Every day, operators on the floor answer the question, "What are the top things customers should consider when beginning this step?"

3 Trends Shaping Drug Development And Manufacturing Strategies

As treatments grow in complexity and global demand rises, review the trends shaping the industry and how a CDMO can help companies navigate the path to commercialization.

Manufacturing Of Cytotoxic And Noncytotoxic Drugs In A Multiproduct Facility

The experience and expertise of the CMO is crucial to avoid the risk of cross-contaminated product, as failures in this process can pose risk to the end-user.

The Benefits Of Downstream Process Connection Technology

Single-use downstream applications including chromatography, filtration, and purification create difficult environments for components due to chemicals across a wide pH range.

Early Development To Clinic: De-Risking A Bioconjugate’s Journey

The journey of a novel bioconjugate into the clinic is complex and uncertain. Explore the particular challenges when moving a candidate from early development into the clinic.


Key Elements To Drug Product Process Characterization For Liquid And Lyophilized DP To Support A BLA Submission

Discover strategies proven to significantly improve timelines and success to market, as industry experts guide you through important initial steps to consider and implement during the process design phase. Understand Lonza’s approach to process characterization and explore recent learnings pertaining to adapting to new Annex I requirements for sterile manufacturing. Click here to learn more.


Sterile Formulation And Fill/Finish For Early-Phase Clinical Trials

Ascendia’s team of scientists have decades of combined experience in sterile supplies for clinical trials, making them expert at solving the most difficult formulation challenges.

Get Your Biologic To Clinic And Market Faster

We have the passion to help you accelerate, simplify, and de-risk your biologics from development and manufacturing to fill/finish, clinical supply, and commercial launch.

HiTrap And HiScreen Fibro PrismA Units

Ready-to-use Fibro PrismA units for capturing mAbs and Fc-containing recombinant proteins help meet the demand for increased efficiency and flexible multiproduct facilities.

Drug Development Strategy Solutions

Navigate complex challenges experienced throughout drug development to ensure a seamless progression and maximize the potential for success in the life sciences industry.

Outsourcing To A Trusted, Veteran Team

JoAnne Jacobs details the roots behind our team and purpose: delivering best-in-class CDMO services to help fulfill the increasing need for injectable drug product supply.


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.


More On The Modalities That Matter To You

The Outsourced Pharma newsletter delivers daily outsourcing insights for specific therapeutic modalities. On Mondays and Thursdays, we cover Biologics outsourcing. On Tuesdays, Cell & Gene Therapies. And on Wednesdays and Fridays, Small Molecule DrugsUpdate your topic preferences to receive the newsletter(s) of interest to you.

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