Newsletter | August 26, 2021

08.26.21 -- B. Cepacian: A Case Study On Objectionableness In Drug Manufacturing

 
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Security Of Supply In Cell And Gene Therapy Manufacturing

With so many challenges in cell and gene therapy manufacturing, building an adequate supply chain with the necessary equipment and protocols is critical for companies pursuing these life-saving drugs.

The Embedded CMO Approach From Development Through Commercialization

The right CMO can expedite market launch, and an embedded CMO offers many advantages over other CMO models, including access to the extensive capabilities and know-how of the parent organization.

Full Control Over Binary Blend Feeding A Liquid Chromatography Process: Pt 2

In the second part of our series covering inline blending solutions, we explore controlling the incoming process pressures of each of the valves. 

Accelerated Commercial Supply With Modular Cleanrooms

Modular cleanroom systems are increasingly chosen over a conventional construction approach due to their accelerated design and installation schedule advantages.

Small Molecule APIs: Aligning Drug Strategy With Partnering Strategy

Development of novel small molecule APIs is increasingly turned over to outsourced partners who have become the primary drivers of the product’s overall development and go-to-market strategy. 

Hit Aggressive Timelines With Simplified Supply Chain For Drug Delivery

To bring their lead candidate to patients with a serious, rare, and life-threatening disease, a clinical-stage healthcare company needed to move quickly with lacking resources. 

Particle Analysis Suite Facilitates Flexibility In Dynamic Laboratory

When approached by a client, Flow Sciences was able to supply fiberboard mockups so they could make additional considerations before finalizing the facility design with specific needs.

Successful Mixing Of Medical Paste

A manufacturer was producing medical paste with a 5-to-10-gallon drum using a simple propeller mixer. They were unable to quickly produce the product quantities needed and small batches took a long time.

Highly Potent APIs Are Becoming More Potent And Complex

In this interview, Dr. Andreas Meudt shares his thoughts on key growth trends for HPAPIs and why more pharma companies are outsourcing their production to contract specialists.

“From Benches To Batches:” Transitioning From Clinical To Commercial

Ryan Downey, director of customer operations, commercial development, offers several insights as to why August Bioservices has become one of the most sought-after and fastest-growing CDMOs in the industry.

Challenges Of Moving A Bioconjugate Candidate From Clinic To Market

Drug developers must successfully navigate the journey under the growing pressure of regulation and competition, while carefully managing technical and financial risk.

Fixed-Dose Combination Drug Development: Designing With Agility And Speed

Combining drugs that may have been shelved due to a variety of reasons with established, safe, and approved drugs has the potential to bring safer, effective therapies to patients.

Complex Biologics Development Made Simple

The development and manufacturing of biologics is highly complex, difficult, and costly, because biomolecular processes rely on a variety of dynamic interactions. 

The Next-Generation ODT

An orally disintegrating tablet (ODT) is designed to rapidly dissolve on contact with saliva. This webinar presents the Zydis® ODT technology, a unique freeze-dried tablet, and introduces Zydis Ultra, which incorporates coated APIs for enhanced taste masking at a higher dose strength.

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