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Learn with BioPharm International


Welcome to BioPharm International's new Basic Training series, providing tutorials, best practices, and podcasts about how to take a product from discovery to development. The series features articles, interviews, and expertise from the global biotechnology industry about bioprocessing with NIBRT, business strategies and models, and technical solutions.

BIOPROCESSING BOOT CAMP WITH NIBRT

In BioPharm's Basic Training series, experts from the National Institute for Bioprocess Research and Training (NIBRT) provide in-depth looks at key bioprocessing steps.

Downstream Processing: A Primer
NIBRT's Ian Nelligan on what to expect when starting a downstream process. Posted Oct. 2012.

Upstream Processing: A Primer
NIBRT's Ian Nelligan on on what to expect when starting an upstream process, including the choice between single-use and stainless-steel bioreactors. Posted Sept. 2012.

NIBRT's Ray O'Connor on Aseptic Processing
Ray O'Connor, an operations consultant with NIBRT, addresses aseptic processing, including how to avoid contamination and cleanroom best practices. Posted May 2012.

BUSINESS STRATEGIES AND MODELS

Development

Training the Biopharma Industry
Using a competency-based approach to effectively train biopharmaceutical industry staff. Posted Sept. 2012.

Creating a Product Portfolio from the Ground Up
Mike Clayman, CEO of Flexion Therapeutics, talks about his company's strategy to focus on a single therapeutic area. Posted June 2012.

Changing Your Business Model
BioPharm talks with Tarja Mottram, CEO of Action for Results, on design-for-value concepts, management, and cross-functionality. Posted May 2012.

Podcast: Flexion on Business Strategy
Flexion's CEO Mike Clayman on targeting key therapeutic areas as a business strategy. Posted Apr 2012.

Knowledge Management Implementation
Knowledge Management (KM) is one of the most important systems for any biopharmaceutical company. KM is considered to be a vital connection between other management subsystems in an organization. This article focuses on the steps needed for successful implementation of KM in a biopharmaceutical company. Posted Apr 2012.

Small Changes, System-Wide Impact
The butterfly effect is a much cited phenomena where a small change in a system can have a significant effect on the overall state of the system. In a similar way, relatively inexpensive elastomers can contribute disproportionately to the cost of running a biopharmaceutical manufacturing operation. Posted Apr 2012.

Biosimilar Developers Face a Reference-Product Dilemma
Various countries have established legal and regulatory pathways to allow "copies" of an off-patent bio-therapeutic product to be brought to market. However, unlike small-molecule generic drugs, these large, complex protein molecules cannot be absolutely identical to the original. Posted Mar 2012.

Podcast: Key Value Considerations for Growing BioPharm Product Pipeline
In part II of this BioPharm International interview, Tarja Mottram, CEO of Action for Results, focuses on “design for value”—a paradigm shift in how the industry measures and provides evidence for the impact of a product on healthcare outcomes. Posted Feb. 2012.

Podcast: Key Business Considerations for Growing BioPharm Product Pipeline
In this first intervew with BioPharm International, Tarja Mottram, CEO of Action for Results, discusses some of the deeper business considerations for companies planning to grow with a pipeline or portfolio. Posted Feb. 2012.

Drawing External Inspiration for Project Management
Constructing the Empire State Building was clearly fraught with risk. In today’s high-cost, highly competitive drug development environment, where complex compounds require sophisticated technology and great expertise, small biotech companies find themselves particularly vulnerable to risk during early clinical phases, especially because most compounds fail to proceed to late stage development. Posted Feb. 2012.

Key Considerations for Commercializing a Compound
Joerg Zimmerman, director of process development and implementation at Vetter discusses the need to think carefully about the commercialization efforts that must be applied to a compound under development. Posted Jan. 2012.

Biosimilar Development in a Virtual Biotech Environment - Part II
Biosimilar development is not about conducting breakthrough research. Rather, it is about hitting the ground running and pressing the fast-forward button by using existing technologies to ensure first-in-class market access. Posted Dec. 2011.

Biosimilar Development in a Virtual Biotech Set-up - Part I
In this article, the co-founder and CEO of Finox Biotech shares insight into their approach to biosimilar development. Posted Dec. 2011.

Podcast: Finox Biotech's Anjan Selz discusses the need for strong product differentiation — Part 3 of 3
In this final podcast of three, Anjan Selz, cofounder and CEO of Finox Biotech, denounces the destructive nature of focusing only on price in the biosimilar space. Posted Dec. 2011.

Podcast: Finox Biotech's Anjan Selz on Biosimilar Development — Part 1 of 3
In this first of three podcasts, Anjan Selz, cofounder and CEO of Finox Biotech, describes how he decided to move away from the “me too” approach to biosimilars and focus on product differentiation. Posted Dec. 2011.

Playing the Drug Development Game: Risks and Rewards
Paul Nelles, vice-president of Vetter Development Service, Vetter Pharma-Fertigung GmbH & Co. KG, discusses risks and rewards in drug development. Posted Dec. 2011.

Facilities

Podcast: Future GMP Manufacturing Facility — Part 2 of 3
In this second of three podcast interviews, Dr. Trevor Hallam, chief scientific officer at Sutro Biopharma, describes a future GMP facility for the production therapeutic proteins and peptides. Posted Nov. 2011.

Outsourcing

Unique Considerations When Working with Suppliers
When a pharmaceutical supply chain is compromised, there can be disastrous consequences, not only for consumers, but also for manufacturers. Without comprehensive security measures, pharmaceuticals are susceptible to counterfeit, diversion, dilution, tampering and deliberate contamination — ultimately compromising patient safety. Posted Feb. 2012.

Podcast: Biotech Outsourcing Strategies
Balkrishnen Bhat, senior director and head of chemistry at Regulus, discusses the company's outsourcing strategies. Posted Nov. 2011.

Regulation

Best Quality Practices for Biomedical R&D
Members from an ASQ working group provide analytical methods to enable PAT. Posted Aug. 2012.

Podcast: Finox Biotech's Anjan Selz on Meeting Regulatory Expectations — Part 2 of 3
In this second of three podcasts, Anjan Selz, cofounder and CEO of Finox Biotech, discusses his company's interactions with EMA and FDA. Posted Dec. 2011.

TECHNICAL SOLUTIONS

Drug delivery

Optimizing Drug Delivery for Modern Biologics
For many of today's biologic drugs, formulation and delivery options can present multiple dilemmas when determining product attributes, including frequency of dosing, dose volume, number of treatments, and delivery mechanism. This article discusses opportunities to improve the patient experience through formulation and delivery device technologies. Posted May 2012.

Perspectives in MicroRNA Therapeutics
Kevin Steffy, Charles Allerson, and Balkrishen Bhat, of Regulus Therapeutics provide insight into microRNA biology, and the simplicity of anti-miR oligonucleotide drug delivery, which can restore balance and function to dysregulated microRNA pathways of gene expression. Posted Nov. 2011.

Podcast: MicroRNA Drug Delivery
Balkrishnen Bhat, senior director and head of chemistry at Regulus, discusses core technology in microRNA drug delivery. Posted Nov. 2011.

Upstream

Upstream Processing: A Primer
NIBRT's Ian Nelligan on on what to expect when starting an upstream process, including the choice between single-use and stainless-steel bioreactors. Posted Sept. 2012.

Considerations for Successful Upstream Process Development
Selection of the right cell line, culture medium, and bioreactor conditions is key to setting up the upstream portion of the biopharmaceutical manufacturing process. Posted July 2012.

Choosing an Expression System
BioPharm International's Scientific Editor Amy Ritter talks with Alan Shaw of Vaxinnate about how to choose an expression system for particular biologic products and the advantages of each. E. Coli and CHO systems are discussed. Posted May 2012.

Methods for the Automated Manufacturing of an Autologous Dendritic-Cell Immunotherapy
Tamara T. Monesmith of Argos Therapeutics describes the development of automated equipment that uses functionally closed disposables to perform cellular and ribonucleic acid processing. Posted Dec. 2011.

Podcast: The Future of Drug Design — Part 3 of 3
In this final podcast of three, BioPharm International interviews Dr. Trevor Hallam, chief scientific officer at Sutro Biopharma, a company that has developed a cell-free system for protein expression. Posted Dec. 2011.

Podcast: Cell-free Protein Expression — Part 1 of 3
Dr. Trevor Hallam, chief scientific officer at Sutro Biopharma, discusses a nontraditional approach for expressing therapeutic proteins and peptides. Posted Nov. 2011.

Non-natural Amino Acids and Protein Expression Systems
Trevor Hallam and Christopher Murray of Sutro Biopharma focus on the challenges of successfully designing effective antibody–drug conjugates and introduce a new expression system that may offer some solutions. Posted Nov. 2011.

Downstream

Downstream Processing: A Primer
NIBRT's Ian Nelligan on what to expect when starting a downstream process. Posted Oct. 2012.


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