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Avomeen Analytical Services Introduces New Project Director Role
The new position will expand the company’s large-molecule and protein therapeutics services by partnering with biopharmaceutical clients who are navigating the large-molecule product development life cycle.
Protein Analyzer Offers Ability to Measure Protein Titer Directly from Bioreactor
The Tridex Protein Analyzer from IDEX offers the ability to directly measure protein titer from a bioreactor in real time.
Bayer Acquires BlueRock Therapeutics, Boosts Cell Therapy Stake
The acquisition will boost Bayer’s cell-therapy development programs, with an initial focus on neurology, cardiology, and immunology.
PTC Therapeutics Acquires Biologics Facility from Bristol-Myers Squibb
The facility will support gene therapy production and continued development of PTC’s pipeline of investigational medicines.
South Korea’s Biotech Industry Projected to $23.2 Billion by 2022, According to Industry Report
South Korea’s pharma/biotech space is projected to grow to $23.2 billion by 2022, and will likely attract foreign investment, according to a new market report by GlobalData.
Sartorius Stedim Biotech Launches New Mammalian Cell Bank Services
The company has launched new services for mammalian cell bank manufacturing under GMP conditions.
FDA Publishes Guidance on Rare Pediatric Disease Priority Review
The guidance answers questions about how the agency awards priority review vouchers to sponsors of treatments for rare pediatric diseases.
FDA Gives Guidance on Developing Treatments for Fabry Disease
The guidance discusses clinical trial design features that can support approval of treatments of Fabry disease.
Cambrex to be Acquired by Permira Funds
An affiliate of the Permira funds has signed an agreement to purchase Cambrex in an approximately $2.4-billion transaction.
FDA Issues Statement on Compounding Decision
A US District Court in Washington, DC upheld FDA’s interpretation of clinical need when choosing which substances are approved to use for drug compounding.
FDA Assessing Data Accuracy in Zolgensma Approval
The agency is keeping Zolgensma on the market as it evaluates the accuracy of data submitted with the product’s biologics license application.
Colorcon, TruTag Team Up On-Dose Authentication
Under an agreement, Colorcon will incorporate TruTag’s edible microtag technology in its coatings.
The Moon, the Stars, and the Science Lab
Fifty years after the man walked on the Moon, space-based science is benefiting Earth.
Realizing the Potential of Vaccines
As vaccines gain prominence within pharma, there is an expectation that specialized CDMO services will provide opportunities.
Celebrating in Style
Pharmaceutical Technology Europe celebrates 30 years in publishing the latest insights, analysis, and developments of the bio/pharma industry.
The CDMO Evolution
The evolution of CDMOs has led to increased investment in new technologies, capabilities, and expertise.
Niche APIs By Popular Demand
Rapid change towards industry developing and manufacturing niche APIs is leading to smaller-scale facilities that offer higher containment and flexibility.
Partnering Up for Success
To help customers succeed, CDMOs have moved away from the ‘fee-for-service’ model to offer flexible, full-service partnerships.
In Safe Hands
Complex and potent molecules demand greater technical and regulatory expertise to ensure safe handling.
Regulatory Harmony
Harmonization of regulatory guidelines not only reduces workloads for manufacturers and regulators but can potentially help to accelerate patient access to vital therapies.
Tooling Up for Pharma
Instrumentation advancements over the past 30 years have certainly enabled greater efficiency in pharma development and analysis despite slow adoption by the industry.
Raise a Glass to Pharma Vials
Glass vials have come a long way from mere commodities and are now considered an integral part of final drug product.
Analysis and Purification: Instrumental to BioPharma
To deal with the complex requirements of biopharmaceuticals, companies need a sophisticated toolbox of analytical and purification techniques.
One Small Step for Man, One Giant Leap for Pharma Regulators
European Union regulators have taken a significant step towards resolving some of the major supply-chain difficulties behind medicine shortages.
Farther Than the Eye Can See
Machine vision systems have been an integral part of pharma manufacturing and packaging for many years and, with the introduction of stricter safety regulations, are set to become more vital.
Standing the Test of Time
Much has changed in the bio/pharma industry over three decades. In this special feature, the editors take a trip down memory lane, highlighting some of the major happenings of the past 30 years.
The Great Divide? Implications of the SPC Waiver
Europe has introduced a waiver for supplementary protection certificates, polarizing opinions throughout the industry. In this interview, the SPC waiver and its implications for European pharma are discussed.
Fujifilm Extends Regional Presence Through Danish Acquisition
Fujifilm has bought Biogen ApS’ Copenhagen facility for US$890 million.
Drug Importing Back on Center Stage
FDA, Health and Human Services, and the Trump Administration back cheaper foreign drugs to cut pharma costs.
CPhI to Host Korea Conference, Expand Korea Pharmaceutical Hub
CPhI will host the CPhI Korea Conference to focus on the international nature of South Korea’s growth in exports.
