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Published April 23, 2015
Dako completes corrective actions following Warning Letter Read More »
Published April 16, 2015
Enhancing Life in Every Single Dose Read More »
Insight into the Growing Microbiology Market
By Kristin Brooks, Associate Editor
Published March 10, 2015
Foster Jordan of Charles River discusses key technologies and trends Read More »
Parenteral Manufacturing Market Trends
By Marga Vines , Senior Product Manager, Grifols Partnership
Published March 6, 2015
Switching from concentrated formulas to premixed solutions that are ready to use for injection Read More »
Published March 2, 2015
Many of the pharmaceutical companies we work withcontact us with questions about scaling up the manufacturing process. Read More »
Published February 27, 2015
Will offer production of API using microbial expression systems Read More »
Published February 24, 2015
Forms two business units: Contract Research Services and Research Models and Services Read More »
Published February 2, 2015
To provide upstream process development from single-use biodevelopment center in France Read More »
Published January 28, 2015
2015 PDA Annual Meeting includes a track dedicated to manufacturing performance. Read More »
Published November 18, 2014
System ensures room isolation during fluid transfer Read More »
By S. Harachand, Contributing Editor
Published November 13, 2014
India raises the bar in production quality. Read More »
Next-Gen ADCs: Collaborating to Improve Supply Chains for Development and Technology
By Dr. Cynthia Wooge and Dr. Jyothi Swamy , SAFC
Published November 13, 2014
A look into today’s ADC landscape and how collaboration aims to address ADC customer challenges. Read More »
Clinical Trial Supplies 101: Outsourcing Primer for Virtual Pharma and Biopharma Companies, Part II
By Alex McClung, Xcelience
Published November 13, 2014
Getting packaged investigational materials dispensed to the patients taking part in clinical trials, on time and correctly, requires orchestrating myriad activities. This is the second in a series of articles outlining specific quality concerns associated with packaging clinical trial supplies and how to effectively manage those concerns. Read More »
Assuring Quality from CMO’s
By Dr. Kevin Siver, PhD, Onyx Pharmaceuticals
Published October 1, 2014
Serving Patients is a Privilege. This Privilege Comes with Significant Responsibilities Read More »
Published September 22, 2014
Expands growth platforms for Lab & Academia business pharma and biopharma production Read More »
Strange Ally in the War Against Sepsis
By Agnes Shanley , Editor
Published September 8, 2014
50 years ago this year, scientists first connected an ancient sea creature to testing for life-threatening bacteria Read More »
Published September 3, 2014
CMC to provide development, clinical manufacture of antibody candidate Read More »
Oh Grow Up! Analytical Methods in the Age of PAT
By Emil W. Ciurczak, DoraMaxx Consulting
Published May 1, 2014
Guidances developed for chromatography may not work for Process Analytical Technology. Don’t wait for them to catch up; use other methods. Read More »
Published April 17, 2014
Brown brings 20 years of industry experience Read More »
Published April 8, 2014
Appoints Gyenes as CFO Read More »
By Gil Roth, Editor
Published March 7, 2014
A new Pfizer initiative may transform process technology. Read More »
By Kristin Brooks
Published January 27, 2014
Cognate to provide manufacturing and services for DCVax-L and DCVax-Direct Read More »
Risk Assessment for Single Use Disposable Projects
By Chuck Stock, IPS
Published January 22, 2014
Building quality and value into manufacturing processes Read More »
High Potency Regulations
By Stephanie Wilkins, PharmaConsult US, Inc.
Published November 13, 2013
Uncertainty remains in the quest to define certain products Read More »
By Gil Roth
Published September 16, 2013
Vaccine vet to consult on bio-defense Read More »
Microbiology & Compounding Pharmacies
By Anthony Grilli, FOCUS Scientific
Published September 5, 2013
What the 483s tell us Read More »
By Gil Roth
Published August 12, 2013
Plassche to lead manufacturing, operations Read More »
By Jeff Wilson and Dave Kerns, Key Corporate Services, LLC
Published August 2, 2013
Behavioral interviewing to match job and job-seeker Read More »
Published August 1, 2013
To provide APN311 for late stage trials and market Read More »
4	Sanofi
Published July 17, 2013
174 Avenue de France 75013 Paris France Tel: (33) 1 5377 4000 Fax: (33) 1 5377 4296 www.sanofi.com Headcount  111,974   Year Established 2004   Pharma Revenues… Read More »
By Gil Roth
Published May 29, 2013
Stresses use of Quality Agreements between clients, CMOs Read More »
Published May 20, 2013
A framework for donor and recipient companies to jointly analyze and document the technical and business risks associated with a technical transfer To help drive the tech transfer of partner products, Alkermes sought to develop a risk assessment fra… Read More »
Implementing Process Validation Guidances
By Peter H. Calcott, Ph.D., President, Calcott Consulting LLC
Published March 6, 2013
Complying with FDA and EU for small and mid-sized companies Read More »
Published March 5, 2013
Will provide scale-up, process validation, and commercial scale supply Read More »
Are You Gambling With Your Next Inspection?
By Julie Larsen, BioTeknica, Inc.
Published November 9, 2012
10 Key Questions to Assess Inspection Readiness Read More »
The Data Difference
By Geri Studebaker, Aegis Analytical Corp.
Published November 9, 2012
How CMOs can use data to innovate for better sponsor collaboration Read More »
Published September 24, 2012
Hancock named CEO Read More »
Processing Prefilled Syringes in the Future
By Klaus Ullherr, Robert Bosch GmbH
Published September 6, 2012
How will manufacturers and suppliers approach PFS? Read More »
Continuous Flow Manufacturing
By Aloke Das, Beroe Inc.
Published September 6, 2012
Implications on downstream biologics processing Read More »
By Gil Roth
Published August 29, 2012
$17 mil. deal adds to endotoxin, microbial portfolio Read More »
By Gil Roth
Published June 25, 2012
Donovan to lead Process Solutions unit Read More »
By Gil Roth
Published June 21, 2012
Will assess Daikyo Crystal Zenith technologies for containment Read More »
By Gil Roth
Published June 20, 2012
New program incorporates bio-services from preclinical to commercial Read More »
Building Flexibility
By Kuljit S. Bhatia, DPT Laboratories
Published May 30, 2012
A new business model for a volatile industry Read More »
Published May 28, 2012
Support Services - our commitment to quality Jubilant HollisterStier provides a full-range of support and services to streamline the manufacturing process. We offer on-site assistance from process qualifications and regulatory submittals thr… Read More »
By E. Morrey Atkinson, Ph.D., Cook Pharmica
Published May 4, 2012
. . . But do you know who you are? Read More »
Warning Letters Galore
By Martin Lush, NSF-DBA
Published May 4, 2012
Causes and prevention: What can we learn from the mistakes of others? Read More »
Bio-CMO Industry Trends
By William Downey, HighTech Business Decisions
Published May 4, 2012
Recent initiatives in biopharma contract manufacturing Read More »
Parenteral Packaging Considerations
By Andrea Wagner
Published April 4, 2012
Pairing the product, package and process for parenterals Read More »
Partnering with Potency
By Bernd Schummelfeder and Cristin Grove
Published April 4, 2012
Requirements for outsourcing high containment development activities Read More »


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