BioPharm International, September 2022 Issue

Advances in Drug Delivery and Areas for Improvement

September 02, 2022

Cover Story

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While a variety of innovations have already impacted the drug delivery landscape, improving sustainability and having the ability to make smaller volumes of drug products still require work.

Streamlining Bulk mAb Manufacturing

September 02, 2022

Development

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The projected growth in the biosimilars market will require increased bulk mAb manufacturing.

Brazilian Regulation of Biosimilar Products: What Is Important to Know

September 02, 2022

Peer-Reviewed Research

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This article introduces the requirements for a biosimilar license in Brazil and addresses questions about their quality, safety, and efficacy.

How Predictive Modeling Can Benefit Bioreactor Performance

September 02, 2022

Upstream Processing

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A predictive modeling approach can offer tighter process control, which can optimize bioreactor output.

Approaches to Scaling Up Chromatography Processes

September 01, 2022

Downstream Processing

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Scaling up chromatography resins requires a thorough understanding of their intended use.

Closure Options Expand

September 01, 2022

Manufacturing

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Product safety and security are paramount when it comes to container closures.

Industry 1VQ Solutions: Change of Lot or Extension of Shelf-life of Reference Standard

September 01, 2022

Quality

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Change of lot or extension of reference standard shelf-life is considered low risk and should be downgraded from prior-approval to being managed in the Pharmaceutical Quality System (PQS) only based on a science and risk-based approach.

Adventitious Agent Testing for Viral Vectors

September 01, 2022

Analytics

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A holistic view of the product, manufacturing, and ultimate use of the viral vector is required.

Protecting Both Intellectual Property and Progress

September 01, 2022

BioBusiness

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The Hatch Waxman safe harbor provision exempts otherwise infringing uses of patented materials if they are in furtherance of a regulatory submission, but the use of patented research tools may fall outside its protection.

New Legislation Overhauls Medicare Drug Pricing and Benefits

September 01, 2022

Regulatory Beat

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Pharma loses battle to block price negotiations, but implementation faces many challenges.

Robust Bioanalytical Studies Can Aid in Regulatory Submissions

September 01, 2022

Outsourcing

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It is important to understand regulatory requirements and study challenges to develop and validate the appropriate methods for a bioanalytical study program at the clinical stage.

Vaccine Disconnect

September 01, 2022

From the Editor

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More than anything else MonkeyPox and COVID-19 have shown that we are interdependent, no matter what continent you call home.

Best Practices for Developing a Third-Party Auditing SOP

September 01, 2022

Ask The Expert

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A process flow diagram can help create an agreed-upon process flow for a third-party standard operating procedure, says Siegfried Schmitt, VP Technical at Parexel.

What Does Cost Mean?

September 01, 2022

From the CEO

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While the cost of certain medicines are alarmingly high, they can be considered a bargain measured against a lifetime of traditional costs.