biopharma Corner

Sanquin Blood Supply Foundation (Amsterdam, the Netherlands), the Netherlands Cancer Institute (Amsterdam, the Netherlands), and the Netherlands Vaccine Institute (Bilthoven, the Netherlands), have launched the AmpVacs project, which aims to develop a broadly protective synthetic influenza A vaccine component.

Humacyte, Inc. (Research Triangle Park, NC) and Xcellerex, Inc. (Marlborough, MA) have entered into an initial strategic collaboration for Xcellerex to develop a manufacturing process that will enable the production of Humacyte?s lead regenerative medicine product using Xcellerex?s XDR single-use bioreactor system in its FlexFactory.

The Texas Plant-Expressed Vaccine Consortium launched Project GreenVax, a biotherapeutic manufacturing initiative that is designed to show proof-of-concept for a technology that could reduce the time to produce vaccines for infectious disease.

On January 15, 2010, Baxter Biosciences (Deerfield, IL) received a warning letter from the US Food and Drug Administration, citing significant deviations from current good manufacturing practices (cGMPs) in the manufacture of Gammagard (human immune globulin) liquid and Gammagard S/D intermediates at its manufacturing facility in Lessines, Belgium.

The US Food and Drug Administration has issued final guidance to help manufacturers who are developing cell-based viral vaccines to address emerging and pandemic threats.

The US Food and Drug Administration and the European Medicines Agency (EMA) have agreed to a more streamlined process to help regulators better identify and share information throughout the development process of orphan drug and biologic products, which are developed specifically to treat rare medical conditions.

The US Food and Drug Administration and the European Medicines Agency (EMA) have agreed to a more streamlined process to help regulators better identify and share information throughout the development process of orphan drug and biologic products, which are developed specifically to treat rare medical conditions.

Waters Corporation (Milford, MA) and Daiso Co., Ltd. (Osaka, Japan) have entered into a collaborative agreement to globally market and supply Daisogel bulk packing materials for process chromatography.

Repligen Corporation (Waltham, MA) has acquired the assets of BioFlash Partners, LLC (Marlborough, MA), including a technology platform for producing prepacked plug-and-play chromatography columns.

Characterizing the higher order structure (HOS) of protein drugs increases manufacturers' understanding of stability and batch-to-batch variability, and may make it possible to link variants or aggregates to safety and efficacy. Yet at the January 24 CMC Strategy Forum in Washington, DC, regulators expressed concern that methods to characterize the three-dimensional structure of proteins are not routinely applied to biotechnology products.

AstraZeneca will cut 500 research and development positions at its US headquarters in Fairfax, DE.

AstraZeneca will cut 500 research and development positions at its US headquarters in Fairfax, DE.

Salt-tolerant adsorption and unique selectivity are the major advantages of mixed-mode materials over single-mode resins.

New technologies and adaptations of existing technologies can improve platform processes.

New technologies and adaptations of existing technologies can improve platform processes.

To speed up the downstream process, you must get the right data, in the right amount, at the right time. Here's how.

The US Food and Drug Administration has approved velaglucerase alfa for injection (VPRIV) to treat children and adults with a form of the rare genetic disorder Gaucher disease.

The US Food and Drug Administration has approved velaglucerase alfa for injection (VPRIV) to treat children and adults with a form of the rare genetic disorder Gaucher disease.

The US Food and Drug Administration has approved velaglucerase alfa for injection (VPRIV) to treat children and adults with a form of the rare genetic disorder Gaucher disease.

The US Food and Drug Administration has approved velaglucerase alfa for injection (VPRIV) to treat children and adults with a form of the rare genetic disorder Gaucher disease.

This alternative purification method to chromatography is readily scalable and fits a fully disposable downstream process.

German pharmaceutical and chemicals company Merck KGaA will buy US biotech equipment-maker Millipore for $7.2 billion.

Design of experiments is a valuable tool for identifying aspects of a formulation that are critical to product quality.

Sufficient process history is key to the rapid transfer of your process.

The use of mathematical programming methods for automated schedule generation.

Eli Lilly & Company received a warning letter from the US Food and Drug Administration, citing significant deviations from current good manufacturing practices (cGMP) in the manufacture of active pharmaceutical ingredients (APIs) at its facility in Carolina, Puerto Rico.

The US Food and Drug Administration has approved Prevnar 13, a pneumococcal 13-valent conjugate vaccine for infants and young children ages six weeks through five years, manufactured by Wyeth Pharmaceuticals, Inc. (Collegeville, PA), a wholly owned subsidiary of Pfizer, Inc.

The US Food and Drug Administration has approved Rituxan (rituximab) to treat certain patients with chronic lymphocytic leukemia.

Sanofi Pasteur (Lyon, France) has recalled an additional six lots of its Influenza A (H1N1) 2009 Monovalent Vaccine in prefilled syringes after routine testing found that the antigen content had declined below the specification limit.

Merck & Co. (Whitehouse Station, NJ) has announced restructuring plans that include reducing its companywide workforce by 15% by the end of 2012.

Novavax will discontinue negotiations for the previously announced collaboration with Madrid-based ROVI Pharmaceuticals.

Following its recent acquisition of Wyeth, Pfizer has 79 manufacturing plants around the world?43 from Pfizer and 36 from Wyeth-and relationships with about 250 contract manufacturers. It?s a wealth of resources, which altogether make 32,000 SKUs. Now, how to consolidate it all?

Vivalis (Nantes, France) has acquired Humalys SAS, a private French biotech research and development company based in Lyon, specialized in the generation of human MAbs.

Repligen Corporation (Waltham, MA) has extended its longstanding relationship with GE Healthcare Bio-Sciences AB by entering into a five-year supply agreement for recombinant Protein A, a consumable used in the manufacture of monoclonal antibodies (MAbs).

GlaxoSmithKline (GSK, London, UK) has begun a series of initiatives, which aim at combating diseases that affect the world?s poorest countries.

Workshops Based on the A-MAb Case Study

TenX Biopharma, Inc. (Philadelphia, PA) has signed a licensing agreement to acquire exclusive worldwide rights to develop and commercialize zanolimumab (HuMax-CD4) from Genmab A/S (Copenhagen, Denmark).

SciClone Pharmaceuticals, Inc. (Foster City, CA) and its partner Sigma-Tau, S.p.A. (Rome, Italy) have received initial topline results in a clinical study evaluating the potential of Zadaxin (thymalfasin) to enhance immune response to the MF59 adjuvanted H1N1 influenza monovalent vaccine, Focetria, from Novartis (Basel, Switzerland).

The US Food and Drug Administration will collaborate with PATH to advance development of a conjugate vaccine to protect children against diseases caused by Streptococcus pneumoniae (pneumococcus), especially pneumonia.

The US Food and Drug Administration will collaborate with PATH to advance development of a conjugate vaccine to protect children against diseases caused by Streptococcus pneumoniae (pneumococcus), especially pneumonia.

In-situ FTIR is used to measure the conversion of sugars and the evolution of dissolvec carbon dioxide inside a fermenter in real time.

Non-ivasive FTIR is used to study skin chemistry and identify diseased cartilage tissue.

In situ FTIR is coupled with reaction analysis software to track the formation and disappearance of a reaction intermediate.

A fully sterilizable analysis head is used for FTIR monitoring of a CHO culture.

Monitoring a crystallization using temperature-corrected in-situ FTIR.

In-Vivo Spectroscopy: Studies of Skin and Cartilage - Remspec Whitepaper

Remspec Accela Form - In-Vivo Spectroscopy: Studies of Skin and Cartilage

Reaction and Process Monitoring: Crystallization - Remspec Whitepaper

Remspec Accela Form - Reaction and Process Monitoring: Crystallization

Remspec Accela Form - Fermentation Monitoring: Dissolved Carbon Dioxide

Remspec Accela Form - Fermentation Monitoring: Mammalian Cell Culture

Fermentation Monitoring: Mammalian Cell Culture - Remspec Whitepaper

Fermentation Monitoring: Dissolved Carbon Dioxide - Remspec Whitepaper

Remspec Accela Form - Reaction and Process Monitoring: Tracking an Intermediate

Reaction and Process Monitoring: Tracking an Intermediate - Remspec Whitepaper

Reaction and Process Monitoring: Tracking an Intermediate - Remspec Whitepaper

Watson Pharmaceuticals has acquired Eden Biodesign for $15 million.

UPLC, QTof, HDMS, and more: A practical guide to the hottest techniques driving the future of biopharmaceutical science.

A Guide to the Biopharmaceutical Lexicon, 2010 edition

If you are looking for additional information (or terms not included in our glossary), here are some places to begin your search.

Trouble at Genzyme and with flu vaccine production illustrates the challenges in producing safe and potent biologics.

How this Big Pharma company successfully implemented disposable technologies in its manufacturing plant.

As facility closures and layoffs continue, CRO and CMO executives are hoping for a better year, despite few positive signs.

The two-one-sided t-test compares the equivalency of two data sets.

How to improve facility design and predict capacity.

The US Food and Drug Administration is requesting $4.03 billion to promote and protect public health as part of the President's fiscal year 2011 budget?a 23% increase over the agency?s current $3.28 billion budget.

Membrane chromatography ensures purity at high flow rates.

One might look at QbD's plodding growth and conclude that it is never going to make it to graduation.

London-based pharmaceutical company AstraZeneca plans to slash 8,000 jobs, or 12% of its work force, by 2014 to cut costs.

Waters Accela Form - New ACQUITY UPLC H-Class System: Reliable Peptide Mapping

New ACQUITY UPLC H-Class System: Reliable Peptide Mapping - Waters Apps Note

New ACQUITY UPLC H-Class System: Reliable Peptide Mapping - Waters Apps Note

New ACQUITY UPLC H-Class System: Reliable Peptide Mapping - Waters Apps Note

Sanofi Pasteur, the vaccines division of the Sanofi-Aventis Group, has signed an agreement with KaloBios Pharmaceuticals for the development of humanized antibody fragment to both treat and prevent Pseudomonas aeruginosa infections.

Sanofi Pasteur, the vaccines division of the Sanofi-Aventis Group, has signed an agreement with KaloBios Pharmaceuticals for the development of humanized antibody fragment to both treat and prevent Pseudomonas aeruginosa infections.

The US Food and Drug Administration has approved Sanofi Pasteur's Fluzone High-Dose, an inactivated influenza virus vaccine for people ages 65 years and older, to prevent disease caused by influenza virus subtypes A and B.

The US Food and Drug Administration has approved Sanofi Pasteur's Fluzone High-Dose, an inactivated influenza virus vaccine for people ages 65 years and older, to prevent disease caused by influenza virus subtypes A and B.

The US Food and Drug Administration has approved Sanofi Pasteur's Fluzone High-Dose, an inactivated influenza virus vaccine for people ages 65 years and older, to prevent disease caused by influenza virus subtypes A and B.

BiondVax Pharmaceuticals Ltd, an Israeli biopharmaceutical company, has completed Phase 1-2 clinical trials of its Multimeric-001 universal flu vaccine.

The US Food and Drug Administration has approved Genentech's Actemra (tocilizumab) to treat adults with moderate to severe rheumatoid arthritis who have not adequately responded to or cannot tolerate other approved therapies for rheumatoid arthritis.

The results of BioPharm International's fourth annual salary survey, conducted in the fall of 2009, shows that women lag behind their male counterparts.

Shire plc (Cambridge, MA) has submitted a biologics license application (BLA) with the FDA for Replagal (agalsidase alfa), its enzyme replacement therapy for Fabry disease.

Shire plc (Cambridge, MA) has submitted a biologics license application (BLA) with the FDA for Replagal (agalsidase alfa), its enzyme replacement therapy for Fabry disease.

Shire plc (Cambridge, MA) has submitted a biologics license application (BLA) with the FDA for Replagal (agalsidase alfa), its enzyme replacement therapy for Fabry disease.

Buyer's Guide Form

Buyer's Guide Form

Genzyme (Cambridge, MA) will outsource fill-and-finish operations for its drugs Cerezyme, Fabrazyme, Myozyme, and Thyrogen to Illinois-based Hospira, Inc.

Recombinant vector technologies can improve the yield and lower the cost of egg-based influenza vaccine production.

The viscosity of oily emulsions can reduce filter capacity and bacterial retention.

The viscosity of oily emulsions can reduce filter capacity and bacterial retention.

The viscosity of oily emulsions can reduce filter capacity and bacterial retention.

Clinical studies have shown that treatment with thymosin alpha 1 increases response to vaccination.

Clinical studies have shown that treatment with thymosin alpha 1 increases response to vaccination.

Clinical studies have shown that treatment with thymosin alpha 1 increases response to vaccination.

This article presents ongoing research at VIDO-InterVac for the development of safer and more effective adjuvants. These include adjuvants that stimulate innate immunity in the body and combination adjuvants.

The companies that have survived the financial meltdown are well placed to adapt to the new environment that we now are entering.

Key considerations for defining your overall control strategy.

Demand for new vaccines and therapies in 2010 will be offset by concerns about drug prices and product safety.

How will implementing Quality by Design strategies affect your compliance status?

A systematic classification system makes supplier quality management feasible, even if you are dealing with hundreds of suppliers worldwide.