Newsletter | November 4, 2019

11.04.19 -- Leasing A Biotech Manufacturing Facility: A Due Diligence Checklist


The BioProcessing Asia Conference was created to advance the contribution of bioprocessing sciences, products, and medical interventions to the region. This e-book provides an illustration of cutting-edge presentations: from the sustainability of biosimilars, to the regulatory climate in Asia, the challenges facing the international bioprocessing community, and the latest technologies for viral vector/vaccine production. Some of the articles you’ll find within the e-book are:

Download the full e-book here: BioProcessing Asia Conference In Review

Featured Editorial
A Due Diligence Checklist For Leasing A Biotech Manufacturing Facility
By Herman F. Bozenhardt and Erich H. Bozenhardt

The road to successfully acquiring a property for a biotech startup is littered with potholes and barriers. This article provides a technical due diligence checklist that the operating organization can use to frame its decision-making process.

Intro To Prefilled Syringe Selection: Staked-In Needles
By Michael Song, Ph.D., AstraZeneca

This is the second part of a two-part article exploring various types of prefilled syringes (PFSs) for biopharmaceutical products. Part 1 looked at needle-free and dual-chamber prefilled syringes. Part 2 examines the various aspects of prefilled syringes with staked-in needles and their impacts. 

Industry Insights
Top 5 Risks Facing Your Small Biopharma Clients Today
Article | By Stephen Lam and Jennifer Stone, Thermo Fisher Scientific

For small biopharma innovators steep development costs are compounded by the fact that large molecules are becoming increasingly complex and present serious clinical or manufacturing problems.

Is Your Complex Formulation Process Set Up For Success?
White Paper | Ajinomoto Bio-Pharma Services

Any company pursuing a drug delivery system that involves a complex formulation must be prepared for the requirements around this type of drug development to achieve successful scale-up.

An End-To-End, Semi-Continuous Process For mAb Production
Application Note | GE Healthcare Life Sciences

See how the different unit operations in a laboratory-scale monoclonal antibody (mAb) process can be connected and integrated into a semi-continuous process.

Innovative Chemicals For Process Intensification In Cell Culture Media
Application Note | MilliporeSigma

Common fed-batch processes use highly concentrated alkaline feeds, which create the need for complex control strategies to minimize pH spikes during feed additions. This brief provides a process guidance for the use of modified amino acids in fed-batch processes.

Biophysical Characterization Of A Therapeutic mAb And Its Associated Antigen-Binding Fragments
Poster | Catalent

Determining size homogeneity of a monoclonal antibody in solution is important for comparability and characterization of these medications. For this study, an IgG antibody was cleaved into antigen-binding fragments using pepsin and papain digestion, followed by protein purification. 

Projected Biologics Portfolios In 2023
Infographic | ISR Reports

In Q22018 ISR surveyed 100 outsourcers of bioprocessing/biologic API manufacturing to learn what they predict their company’s biologics portfolio will look like five years from now.

Evaluating Viral Clearance For Continuous Processes

Tuesday, November 5, 2019 | 11:00 AM EST

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