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Published May 22, 2015
To provide aseptic and low bioburden clean room dispensing of bulk materials Read More »
2015 Annual Outsourcing Survey
By Tim Wright, Editor
Published May 13, 2015
Herein are the results of our 2015 Annual Outsourcing Survey, where we call on you, the readers. Read More »
Published May 13, 2015
Offers improved compaction properties in direct compression applications Read More »
Published May 12, 2015
To bolster clinical and commercial bulk drug production and fill/finish for gene therapies Read More »
Published May 12, 2015
Will collaborate to identify and validate tumor targets and corresponding TCRs in cancer Read More »
Published May 11, 2015
The acquired business produces active pharmaceutical ingredients and intermediate products Read More »
Published May 8, 2015
Patheon’s Pediatric Services are dedicated to developing palatable formulations, including oral liquids, chewable tablets, dispersible tablets, sachets, oral disintegrating tablets and softgels. This sell sheet discusses the interactions between AP… Read More »
Published May 8, 2015
SoluPath Flex™, the customizable, fixed-price solution to rapidly improve solubility that features a menu of services that includes the price, API volume demand and the length of time required to provide the service. This allows customers to select… Read More »
Published May 8, 2015
The purpose of this study was to evaluate the use of the hot melt granulation technique for improving dissolution and bioavailability of a poorly soluble API. Coating was achieved by adjusting the spray rate and inlet temperatures. The final formulat… Read More »
Published May 8, 2015
The objective of this study was to enhance the solubility and in-vitro dissolution/bioavailability of a low soluble (0.5 mg/mL) BCS Class II compound (API). A mixture approach enabled selection of excipients and to arrive at an optimal ratio based on… Read More »
Published May 8, 2015
The purpose of this work was to study the use of LIBS (Laser Induced Breakdown Spectroscopy) as an in-process monitor for uniformity during an API tablet coating process. In-process measurements were taken up to the coating endpoint, and evaluated to… Read More »
Published May 8, 2015
The purpose of this study was to evaluate the use of a true placebo DoE to create a platform process in which to define a viable active formulation process on a roller compactor. The use of placebo DoE was effective in creating a platform process for… Read More »
Published May 8, 2015
A new customer had received an emergency use authorization from the U.S. FDA. The demand was large, and speed to production was critical. Patheon provided the readily available capacity and expertise to help the company promptly answer the call.… Read More »
Published May 8, 2015
A large pharmaceutical company wanted to develop a bilayer tablet, each layer having different release profiles. One of the layers was low dose and moisture sensitive. There were also layer lamination issues during formulation development and in stor… Read More »
By Emil W. Ciurczak, DoraMaxx Consulting
Published May 6, 2015
Looking at standard methods and references Read More »
By Tim Wright, Editor
Published May 6, 2015
API and solid dosage manufacturing are a strong focus Read More »
Published May 6, 2015
Catalent Completes $52M Expansion at Winchester, KY, Facility Read More »
2015 Outsourcing Survey
By Tim Wright, Editor
Published May 6, 2015
Herein are the results of our 2015 Annual Outsourcing Survey, where we call on you, the readers, to help us benchmark the state of the pharmaceutical outsourcing industry. Read More »
Published May 5, 2015
Contract revenue up 47% in the quarter Read More »
Published April 30, 2015
Exchange rates impact earnings Read More »
Published April 24, 2015
Multi-purpose facility is among the largest bulk API manufacturing facilities for recombinant microbial biologics Read More »
Published April 14, 2015
Will partner to develop new compounds Read More »
Published April 6, 2015
Opens a 1600L/1000L reactor stream, increases throughput for 400L reactors Read More »
Published April 6, 2015
Activities will be transitioned to other facilities, affecting approx. 62 positions Read More »
Biosimilars Improving Efficiency, Cost for All Biologics
By Eric S. Langer and Ronald A. Rader, BioPlan Associates
Published April 1, 2015
Now that the FDA has just approved its first product under biosimilar regulations—Zarxio—containing filgrastim (G-CSF), a biosimilar version of Neupogen from Amgen, we can expect some more rapid shifts in the market. Factors like how this… Read More »
Published March 30, 2015
Will install a new Class 100,000 suite at its North East England facility Read More »
Published March 26, 2015
Combined service offering aims to speed drug development and reduce costs Read More »
Laurus Synthesis Launches US Operations
Published March 20, 2015
Opens facility in Woburn, MA Read More »
API Sourcing Trends
By Kristin Brooks, Contract Pharma
Published March 19, 2015
Ed Price of PCI Synthesis addresses trends, regulatory and supply chain hurdles, and quality concerns Read More »
Published March 12, 2015
Will provide cGMP manufacture for clinical and commercial supply Read More »
Published March 11, 2015
New site will offer fully integrated formulation development services Read More »
Published March 11, 2015
High containment site is in Edinburgh, UK and part of the Macfarlan Smith division Read More »
Solid Dosage Manufacturing Trends
By Tim Wright, Editor
Published March 6, 2015
Big Pharma continues to unload in-house manufacturing, partnering with contract service providers that can meet their cGMP needs. Read More »
Newsmakers: Margaret Timony
Published March 6, 2015
What’s Happening at DCAT Week ’15? Read More »
Outsourcing Budgets Continue to Shine
By Eric S. Langer, BioPlan Associates
Published March 6, 2015
Preliminary study data indicates continued spending on outsourcing Read More »
By Emil W. Ciurczak, DoraMaxx Consulting
Published March 6, 2015
A look at highlights from IFPAC 2015 Read More »
Published March 4, 2015
Expands API development and manufacturing capabilities 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 23, 2015
Will develop TGF beta receptor kinase inhibitors Read More »
Published February 17, 2015
To provide custom biomanufacturing for commercial production Read More »
Published February 5, 2015
Generic sales slide under European business strategy Read More »
Published February 4, 2015
SUPAC Guidelines and Regulatory Strategy Read More »
Published February 3, 2015
Expands custom chemical and biochemical manufacturing portfolio Read More »
Published January 30, 2015
Continuous manufacturing and QbD expand, supply chain concerns persist Read More »
By Emil W. Ciurczak, DoraMaxx Consulting
Published January 29, 2015
A new generation of equipment will help generate products with less cost and effort, while being made more efficiently. Read More »
Heavy Metals in Drug Products
By Nikki Schopp, Team Leader in charge of ICP-MS, ICP-OES and AA testing, SGS
Published January 29, 2015
The potential presence of trace amounts of heavy metals in drug products is a real cause for concern with regulators. Read More »
Supplier Selection: A Roadmap to a Good Start
By George Tyson, CMC and supply chain consultant
Published January 29, 2015
Good supplier selection is a key element of success in the pharmaceutical industry today. Read More »

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