Newsletter | November 10, 2020

11.10.20 -- Evaluating The Potential Impact Of Anti-BCMA Therapies In The Multiple Myeloma Space

Featured Editorial
Industry Insights
An Executive’s Checklist For CDMO Selection

C-level executives must take an early and active role in vetting potential partners using a deeper understanding of the capabilities and characteristics a CDMO should have to successfully bring a product to market.

Cut It Out: The Role Of Gene Editing Technologies In Combating HIV

Despite the public attention and large population impacted by HIV, developing a cure has been particularly difficult. Will gene editing techniques, such as the CRISPR-Cas9 system, change the paradigm?

Is Your Sterile Injectable Ready For Changes In Raw Materials?

Over the life of a drug changes in raw materials are inevitable. But even a small modification can throw your drug out of compliance. Learn how to safeguard drug integrity when raw materials change.

Applying The Four Dimensions Of Sustainability To Create Capacity That Delivers Results Faster

There are no shortcuts to growing capacity that delivers results faster, and maintaining it is difficult. The key ingredient in growing enterprise value is sustainability. Learn how, by applying the principle of sustainability using its four dimensions, finite resources are more wisely used, with extraordinary results: Lead time from concept to commercialization is greatly improved, and patients receive better medications faster.

Never Too Early To Plan For Automation

Your automation strategy can be designed to expand with your business if you consider your choices in the initial stages. Early platform design selections can greatly affect your future flexibility and ability to show compliance throughout regulatory reviews.

Increasing Transparency And Confidence Through Real-Time Data Sharing

A digital transformation of biomanufacturing offers a new path for continuous monitoring and optimization of process performance, which would ultimately lead to greater efficiency in drug production.

Accelerating Advances In Gene Therapy: Improving Downstream Purification Of Viral Vectors

The nonpathogenic adeno-associated virus (AAV) has emerged as the vector of choice for many therapies, but purification of biologically active viral vectors for large-scale commercial use is a challenge. 

Implementing Review-By-Exception RtReports For Manufacturing At BioMarin

In streamlining its batch review process, BioMarin reduced burdens on both its quality assurance and engineering teams while simultaneously speeding time-to-market for its products.

Platform Cell And Gene Therapy Media Development

As the industry moves from small molecules and natural products into biologics, engineered cells, and viral vectors, and, ultimately, to a future where we're manufacturing restorative or regenerative therapies in their entirety, we have a tradeoff between the simplicity of the process and how cost-effective it is. Here we describe our process, highlighting a case study to remove serum from the expansion step of an autologous cell therapy. The challenge is to do so in a cost-effective manner without affecting cell performance.

Paving The Way For Tomorrow’s Medicines

There is a great need for innovative technologies that can improve the success rate for new drug candidates and pave the way for novel therapies to reach the market. Recent advances in nanoparticle engineering technology promise to accomplish precisely this.

Small And Emerging Biopharma Companies Outsourcing Practices

There is no question that the drug development services industry is complex, dynamic, and continuously evolving. While every sponsor company is different, all can benefit from keeping a pulse on current outsourcing practices and the activities being outsourced. Over the past year, ISR conducted several research activities with the aim of better understanding the needs of small and emerging biopharma companies and how they differ from the larger industry players. This article highlights the results of this survey.

Quality Management System Competencies Your Reagent Supplier Should Possess

Evaluating a potential reagent supply partner’s manufacturing capability requires an understanding of how that partner manages and controls their manufacturing operations to ensure your product is delivered on time and to your specifications, every time. Described here are quality system competencies to look for and the benefits of partnering with a supplier who has an established quality system.

Opportunities In Preclinical Development

Finding ways to optimize holistic preclinical development.

Ancillary Supplies: Clinical Trial ‘Must-Haves’ That Require Early Planning

Ancillary supplies are a necessary component in every clinical trial, though these products are often perceived as secondary in importance to investigational medicinal products (IMPs). Janet Williams, senior director, global supply chain management, and Julie Hoffman, senior director of commercial strategy and execution, discuss why ancillaries are as essential as IMPs, and why sponsors should devote as much attention to early planning for ancillary supplies as they do for study drugs.

Sanitary Mixing In Multiagitator Systems

Multishaft mixers are versatile systems used in the production of food, beverage, pharmaceutical, and medical products. This bulletin discusses a few equipment features commonly supplied on multishaft mixers intended for sanitary applications.

Meeting Patient Needs Through Expedited Delivery Of Phase 1 Materials

To quickly deliver their product to patients in need, Reneo Pharma found a partner to provide both product development and clinical packaging services.

Innovative Reformulation Of A Complex, High-Drug-Load, Modified-Release Dosage Form With Reduced Dosing Frequency

A CDMO teams up with oral solid dosage processing innovator Freund-Vector to create an efficient, fast, high-quality drug manufacturing solution that allows for modular and tunable dosage strengths and release rates — despite the challenges of high drug loads, complex dissolution profiles, and incompatible APIs.

Specialized Drug Product Packaging Solutions

Over the last decade the pharmaceutical industry has witnessed significant changes with regard to drug product packaging. With pharma companies developing and bringing more advanced medicines and niche orphan drugs to the market, there has been a notable change in drug product packaging requirements. Developed by commercial packaging experts, this ebook explores some of the biggest trends in the pharmaceutical packaging market.

Why Are Lipid Formulations Commonly Used To Enhance Bioavailability?

A discussion on potential mechanisms of increased absorption with lipid formulations, screening tools used during the development of these formulations, scale-up, and industrialization considerations. 

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