Newsletter | April 29, 2021

04.29.21 -- COVID-19's Impact On Outsourced Small Molecule Manufacturing

 
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Optimize Chemical Synthesis, Formulation In Complex Molecule Development

Finding a balance between a complex API, its formulation, and its synthesis requires equipment, knowledge, and processes more extensive than those typically required for traditional drug development.

The Power Of Digital Transformation

The pharmaceutical contract services supply chain is not traditionally a sector where technology is a first mover. Approximately 18 months ago, however, PCI Pharma Services determined that there were sufficient proof points in the industry indicating that it should incorporate digital transformation as core to its business strategy. While the company continues this journey, PCI Pharma Services is already realizing both measurable and intangible benefits.

Why Choose A Commercial HPAPI Manufacturer For Your Clinical Program?

Switching from an early-phase CDMO to a commercial-scale manufacturer for your highly potent active pharmaceutical ingredient (HPAPI) projects can be costly and lead to project delays.

Automating Cell Therapy Systems For Better Results

Cell therapy treatments are often made at a small-scale, require days of manual preparation, and are usually produced for use in a clinical trial. What if it were possible to get results on a much broader scale?

The Hidden Costs Of Multiple-Vendor Contract Manufacturing

Should you opt for a selection of unrelated service providers or a single-source contract manufacturer that can handle every step of the process?

A Cost-Effective Approach To Cleaning Validation And Verification

A pharmaceutical contract services organization encounters many compounds at different phases of development and varying customer requirements. From fully developed large-scale manufacturing and packaging to a single development batch, the contract services organization must be prepared to handle multiple compounds in the same facility.

Providing Sterility Assurance Between Single-Use And Stainless Systems

As numerous biopharmaceutical manufacturers have gained firsthand experience with the benefits of incorporating single-use systems into their facilities, they are looking to expand its use in both upstream and downstream applications. This is no surprise, as increased volume and diversity of pharmaceutical products is causing manufacturers to design their facilities based on shorter production runs with multiple changeovers. Meeting these demands requires operational flexibility.

The Future Of Shipping In Modern Medicine: Reusable vs. Single-Use Shippers

A shipping solution that maintains the temperature of a product in its journey to the patient and also preserves the intent of the medication, the safety of the investment, and the lives of the patients who depend on them.

The Role Of pH And Residue In Pharmaceutical Cleaning

A great deal is known about how pH affects aqueous critical cleaning. Typically, alkaline cleaners are used on oily residues and acidic cleaners are used on inorganic residues.

Installation Considerations For Vaporized Hydrogen Peroxide (VHP)-Resistant Remote Particle Counters

This application note details key design considerations when implementing vaporized hydrogen peroxide (VHP)-resistant continuous particle counters in critical GMP controlled cleanroom environments.

Metered Dry Powder Addition For Continuous And Batch Coating Processes

Twin screw feeders can provide consistent and metered delivery of dry powders directly into coating equipment.

Meet Aggressive Timelines By Simplifying Your Drug Delivery Supply Chain

To bring their lead candidate to patients with a serious, rare, and life-threatening disease, a clinical-stage healthcare company needed to move quickly while lacking resources. One integrated offering allowed for individual approaches to their drug substance, drug product, and clinical trial packaging needs.

Serialization And Aggregation Of Drug Products

A pharma company found a solution that allowed the operator to conveniently assign the units from a lower packaging level to a higher level and, in this way, to set up the hierarchical relationships in the database.

Bridging The Gap From Clinical-To-Commercial Packaging

This e-book examines the impact of specialty products and the packaging challenges associated with them, addressing the benefits of small-volume commercial packaging and supply chain partner selection.

CCI Testing To Develop ASTM Standard No. F3287-17

The poster explains a mass extraction technology especially suitable for pharmaceutical container closure integrity testing (CCIT) applications, acknowledged by an ASTM standard.

Three Years Faster To Market: How To Accelerate Your Biopharmaceutical Development Into The Digital Age

With COVID-19 severely disrupting research and development (R&D) operations, pharma leaders need to prepare even more than before to safeguard patients and employees, adapt operations for recovery in a pandemic economy, and deliver drugs to market quickly where these products are most needed. In this webinar we tackle some of the key challenges affecting manufacturing, data management, and R&D in the lab.

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