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Fourth Annual Optimizing Biologics Formulation Development
January 9, 2012—January 10, 2012
San Diego, CA, USA
CHI PepTalk 2012
January 9, 2012—January 13, 2012
San Diego, CA, USA
European Pre-Filled Syringes
January 18, 2012—January 19, 2012
London, United Kingdom
Latin America: Regulatory Compliance Requirements for Life Science Products
(Focus: Brazil, Mexico, Argentina)
January 19, 2012—January 20, 2012
San Francisco, CA, USA
Enhancing Drug Bioavailability & Solubility
January 25, 2012—January 26, 2012
Boston, MA, USA
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FDA–EMA Joint Manufacturing Inspections to Begin in 2012
The FDA and EMA are moving from “confidence-building to reliance upon” each other in a step-up in cooperation on GMP inspections; the latest move following successful completion of pilot projects this summer. 
FDA Warns Novartis of Violations at Three Plants
In a Warning Letter, FDA cited “significant violations” of CGMP regulations, including several repeat observations, at three Novartis facilities located in Colorado, North Carolina, and Canada.
AstraZeneca to Expand Presence in China
AstraZeneca entered into an agreement to acquire Guangdong BeiKang Pharmaceutical, a privately owned generic-drug manufacturing company based in China, for an undisclosed amount. Upon completion of the acquisition, AstraZeneca will be responsible for the manufacture and commercialization of these medicines.
EMA Addresses Ben Venue Quality Issues
After reviewing the “shortcomings in quality assurance” that were recently identified at Ben Venue Laboratories’s Bedford, Ohio, facility, EMA issued several recommendations, including product recalls for Ecalta and Liminity.
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 Roller bottles help improve yields and scale-up
Thermo Fisher Scientific has introduced its Thermo Scientific Nunc TufRol PS roller bottles for cell-culture production. Nunc TufRol PS roller bottles use polystyrene materials, thus minimizing the effort required to validate cell culture scale-up processes. Designed with indentations at the bottom to facilitate manual and automated handling, TufRol roller bottles are also available with vertical pleats to facilitate emptying and reduce product retention.
TufRol roller bottles were added to the existing Thermo Scientific Nunc InVitro PETG roller-bottle product line. Nunc InVitro PETG roller bottles are molded of polyethylene terephthalate, which is stronger than glass under normal culture applications. These bottles can withstand temperatures as low as –40 °C to accommodate freeze–thaw release protocols. Nunc InVitro roller bottles are available with a poly-D-lysine coating, which is used to promote cell attachment for cell lines that are difficult to grow. In addition, the bottles’ surface area of 1450 cm2 can result in larger product yields, compared with traditional roller bottles. |
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Baxter International has agreed to acquire Synovis Life Technologies, a provider of biological and mechanical products for soft tissue repair used in surgical procedures. As a result of the acquisition, Baxter intends to expand its portfolio of regenerative medicine and its biosurgery franchise. The Synovis board of directors has unanimously approved the transaction and is recommending that its shareholders approve the agreement at an offer price of $28 per share, which equates to $325 million of equity value or approximately $260 million after adjusting for net cash.
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Bristol-Myers Squibb (BMS) and Simcere Pharmaceutical Group, a pharmaceutical company in China, have expanded their partnership, formed in 2010, to include a second collaboration in a different therapeutic area. The companies agreed to codevelop BMS-795311, BMS’s preclinical small-molecule inhibitor of the cholesteryl ester transfer protein (CETP). Under the agreement, Simcere will receive exclusive rights to develop and commercialize BMS-795311 in China while BMS will retain exclusive rights in all other markets. The companies will together determine the strategic development plan to explore the potential of BMS-795311 to treat and prevent progression of cardiovascular disease. Simcere will run and fund initial development work.
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GE Healthcare and M+W Group, an engineering, construction, and project management company, have formed an alliance aimed at assisting the supply of biopharmaceuticals, especially in emerging nations. The alliance will assist countries worldwide to become self-sufficient in the manufacture of biopharmaceuticals such as vaccines, insulin, and biosimilars. Both companies will offer governments and pharmaceutical companies an integrated, cost-competitive approach for the construction of biopharmaceutical manufacturing plants.
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The CRO Quintiles has launched Kun Tuo, a CRO designed to provide services to the Chinese biopharmaceutical industry and multinational biopharmaceutical companies operating in China. Kun Tuo will provide a full range of services, including comprehensive clinical-trial management, regulatory submission preparation, biostatistics, and data management. Kun Tuo and Quintiles will collaborate to develop customized offerings in therapeutic areas, along with vaccines, late-phase studies, medical devices, and diagnostics.
The biopharmaceutical company Receptos, has established a collaboration with Ono Pharmaceutical, an R&D-oriented pharmaceutical company, for the R&D of small-molecule modulators of an undisclosed G-protein coupled receptor target. Under the agreement, Receptos will use its proprietary technology platform to produce high-resolution protein crystal structures of the discovery target and drive Ono’s structure-based drug-design efforts. Receptos will receive from Ono an upfront payment, research funding and success payments, including product development milestones based on the progress of the collaboration.
Do you have news to report on facility expansions, contracts, service agreements, mergers, acquisitions, or personnel appointments? Send press releases to [email protected] |
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Advanced BioScience Laboratories (ABL), a biomedical contract research and manufacturing organization, has appointed Claire Zhang to lead its downstream bioprocessing group. Zhang will direct development and optimization programs for ABL’s commercial and government GMP manufacturing clients.
Eli Lilly’s board of directors has elected Katherine Baicker as a new member, effective Dec. 12, 2011. As a member of the board, Baicker will serve on the public policy and compliance committee.
Pfizer announced that its board of directors has elected President and CEO Ian Read as chairman of the board, effective immediately. Read succeeds George Lorch as the board’s chairman.
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| The Employment Outlook Brightens |
by: Rich Whitworth, Amy Ritter
Readers react to the economic turmoil of the past year and look longingly forward to 2012.
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Coming soon: Pharm Tech's January 2012 issue will feature a look ahead at
biopharmaceuticals. |
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Participate in 9th annual bio-industry study
We hope you will take part in one of the bio industry’s most authoritative, comprehensive analyses. Participants will receive a free summary of the global results, and for each completed survey, BioPlan Associates will donate $10 (up to $10,000) to global health charities. The survey takes between 10–25 minutes, depending on your areas of expertise.
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Oral Drug Delivery
Which of the following breakthroughs has contributed the most to advancing oral drug delivery or oral product forms?
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View the poll archive. |
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