ADVERTISERS INDEX
at the Center of Excellence, Sharp will be offering serialization at five of its packaging sites, with the intention of adding 4-5 lines per quarter through 2017.
Sharp’s decision to make this investment in its Allentown campus was fueled by the increasing industry demand for contract packaging services of bottled and blister-packed pharmaceutical products business, coupled with the explosive growth of specialty product and biologic package outsourcing. According to Doug Hill, Senior Vice President and General Manager of Sharp Packaging Solutions. “Customers with specialty drugs and biologics require complex equipment,” Hill notes. “We have customers with vials that need labeling and serialization, syringes with a label pack-out, oral thin film strips and then those with automatic, self-injected devices requiring special assembly. With our new facility, we have the dedicated space to meet the most demanding requirements.”
Due to the proximity of the new building to Sharp’s current packaging facility with the use of the same management team, processes and procedures, the FDA is considering a campus approach in their evaluation of Sharp. A new registration with the FDA will not be required for the Penn Drive Center of Excellence. “We are working very closely with the FDA,” states Hill. “Their only request so far has been to be advised on when we anticipate the first production for the building. That information will be provided and the Agency will then determine if they will review the building at that time or as part of our next GMP Inspection anticipated in late 2016 or early 2017.”
Advertiser
AAPS Annual Meeting Alphora Research Ash Stevens
Associates of Cape Cod Catalent
ChemOutsourcing CASSS Ei
EMD Millipore Emergent Envigo
Marken Ltd
Parternships in Clinical Trials PDA
PYRAMID Laboratories That's Nice Xcelience
Page 21 6
Tip
Cover 2 Cover 4 31 35
Cover 3 17 1
19 5
25 29 3
27 13
Pharmaceutical Outsourcing | 48 | July/August 2016
Charles River Laboratories Acquires Blue Stream Laboratories
Charles River Laboratories has acquired Blue Stream Laboratories, Inc. Combining Blue Stream with Charles River’s existing discovery, safety assessment, and biologics capabilities creates a leading provider with the ability to support biologic and biosimilar development from characterization through clinical testing and commercialization.
Blue Stream is an analytical contract research organization (CRO) supporting the development of complex biologics and biosimilars. Located in Woburn, Massachusetts, the company is recognized for its expertise in structural and functional protein characterization programs, and the development and validation of assays for current good manufacturing practice (cGMP) lot release and stability programs. Protein characterization is the key element for development and registration of biologic and biosimilar entities.
James C. Foster, Chairman, President and Chief Executive Officer, said, “Our continued investment in expanding our biologics portfolio, through the development of new assays and capabilities, has enabled us to provide a broader testing solution for our clients. This investment is particularly important now, when the number of biologic and biosimilar drugs in development is increasing. The acquisition of Blue Stream will meaningfully enhance the ability of our Biologic Testing Solutions business to compete effectively in this high-growth market segment.”
Website
www.aaps.org/annualmeeting www.aphoraresearch.com www.ashstevens.com www.acciusa.com www.catalent.com
www.chemoutsourcing.com www.casss.org
www.eisolutionworks.com
www.emdmillipore.com/biomarkerassays www.emergentcontractmanufacturing.com www.envigo.com www.marken.com
www.partnershipsinclinicaltrialsusa.com www.pda.org
www.pyramidlabs.com www.thatsnice.com www.xcelience.com
Page 1 |
Page 2 |
Page 3 |
Page 4 |
Page 5 |
Page 6 |
Page 7 |
Page 8 |
Page 9 |
Page 10 |
Page 11 |
Page 12 |
Page 13 |
Page 14 |
Page 15 |
Page 16 |
Page 17 |
Page 18 |
Page 19 |
Page 20 |
Page 21 |
Page 22 |
Page 23 |
Page 24 |
Page 25 |
Page 26 |
Page 27 |
Page 28 |
Page 29 |
Page 30 |
Page 31 |
Page 32 |
Page 33 |
Page 34 |
Page 35 |
Page 36 |
Page 37 |
Page 38 |
Page 39 |
Page 40 |
Page 41 |
Page 42 |
Page 43 |
Page 44 |
Page 45 |
Page 46 |
Page 47 |
Page 48 |
Page 49 |
Page 50 |
Page 51 |
Page 52 |
Page 53 |
Page 54