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Pharma Drug Development

    
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Baxter's BioPharma Solutions business  As a parenterals specialist, Baxter's BioPharma Solutions business offers unique delivery systems and a variety of contract manufacturing solutions to meet complex and traditional sterile manufacturing challenges.
 
cephalosporins/ penicillins Baxter's Round Lake, Illinois facility has the capabilities and controls for manufacture of cephalosporins, penicillins and non-cephalosporin in GALAXY...
 
Formulation & Development Services Helping to overcome technical challenges, including process and formulation development, technology transfer, and analytical methods development, BioPharma...
 
Wockhardt  From development to high-volume commercial manufacture, they utilise more than twenty-five years of contract manufacturing experience to ensure your product is professionally managed all the way to market. The employment...
 
Formulation Services Alyante – is a Wockhardt Business Initiative focused on delivering timely and quality based development services to help improve your research efficiencies...
 
Tablets With over twenty-five years of experience, Wockhardt is equipped with all the expertise necessary to supply quality solid dose formats to our clients. Our...
BASi - Bioanalytical Systems, Inc.  bioanalytical sample analysis automated in-vivo blood sampling toxicology pharmaceutical analysis electrochemistry EC liquid chromatography LC Vetronics
 
Pharmaceutical Analysis Services BASi scientists can provide support for all phases of your drug development, from early stage API method development to post-commercialization product...
Aptalis Pharmaceutical Technologies  Aptalis Pharmaceutical Technologies specializes in product development that leverages our proprietary pharmaceutical technologies in taste masking, customized drug release and bioavailability enhancement.
Myriad RBM, Inc.  Myriad RBM is a CLIA-certified biomarker testing laboratory specializing in cost-effective, high-quality multiplexing services. Our protein immunoassays benefit drug discovery & development from preclinical through Phase...
 
Services Provided Myriad RBM, Inc. is the world’s leading multiplexed immunoassay testing laboratory, providing comprehensive protein biomarker services based on its...
BioVectra Inc.   Contract Manufacturing Organization (CMO). GMP Fermentation and chemical synthesis of API's, PEGylation reagents, highly potent compounds. Reducing and oxidizing reagents for protein chemistry.
 
Contract API Manufacturing FDA Inspected Facilities
 
MPEG Maleimide Polymer for Drug Delivery
 
Metrics, Inc  Metrics Inc. is a CDMO offering contract pharmaceutical research, pharmaceutical development, clinical trial and commercial manufacturing services. Metrics provides FTIM development and Phase I, II and III CTM.
 
Formulations Development Metrics provides pharmaceutical product development including pre-formulation studies, formulation development, Clinical trial batch manufacturing and...
 
Potent and Cytotoxic Drug Handling Metrics’ dedicated and top-of-the-line potent facility and equipment allow us to offer greater services to clients that greatly mitigate potential for...
Capsugel  Capsugel has emerged as a global leader creating innovative dosage forms for the pharmaceutical and dietary supplements industries. Companies look to their leadership to help them formulate new products, enhance existing...
 
Manufacturing & Technical Services Capsugel is committed to providing full manufacturing support – including onsite problem resolution – for our capsule products and equipment. From...
Pacific BioLabs (PBL)  Pacific BioLabs is a contract research organization (CRO) offering testing and research support services to its clients in the medical device, pharm/biopharm, and other industries. Specializing in the biological sciences,...
 
Combination Product Testing Testing to support the development of pharmaceutical devices.
 
Custom Bioscience Studies Please contact BizDev@PacificBioLabs.com for more information. They will have one of our technical experts call you.
Confluence Discovery Technologies, Inc.  Confluence is a Contract Research Organization providing Clients with 125+ Years of Drug R&D know-how and a proven track record having delivered 29 Phase I and 21 Phase II drug programs that resulted in 4 marketed...
 
Cell & Molecular Biology meeting drug target & biomarker requirements
 
Computational & Medicinal Chemistry experience where it counts capabilities to deliver
 
HERMES PHARMA  HERMES PHARMA is a contract research & manufacturing organization that specializes in developing and manufacturing user-friendly solid oral dosage forms - effervescents, chewable tablets, lozenges, ODT and instant drinks.
 
HERMES PHARMA specializes in developing and manufacturing user-friendly solid oral dosage forms We offer expert advice and practical customized solutions at every point along the pharmaceutical value chain: - New product design - Formulation and...
LGM Pharma  LGM Pharma is focused on providing our clients with the latest news and updates on compounds and molecules required in the Research & Development arena. Most importantly, we are constantly updating our inventory offering...
 
Adalimumab LGM Pharma is an Adalimumab CAS# 331731-18-1 API supplier based in the USA. Inquire about DMF, cGMP, price, availability, delivery, purity, and more.
SEPS Pharma  Welcome to SEPS Pharma SEPS Pharma is a privately held pharmaceutical company with a hybrid business model engaged in drug delivery and development combining internal product development programs and drug product...
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Pharma Drug Development - Product Reviews

ABC Labs focuses on “phase-appropriate” drug-development services
Jeff Kelly, Online Industry Editor

Not all stages of the drug-development process are created equal. So scientists at Analytical Bio-Chemistry Laboratories don’t treat them the same.

“At different points in the development process, you’re looking to determine different types of information,” said Kristein King, vice president of strategy and workforce development at the Columbia, Mo.-based firm. “We help clients devise a strategy to make the most use of their money.” ... Read More


BIOCIUS focuses on speeding up drug screening
Jeff Kelly, Online Industry Editor

For BIOCIUS, speed is everything. Well, just about everything.

The Wakefield, Mass.-based firm specializes in drug screening and discovery technology and services. Its RapidFire platform can determine the chemical make-up of a given compound in a matter of seconds, according to Jennifer Rossi, director of marketing and corporate communications at BIOCIUS. That’s significantly faster than using high-pressure liquid chromatography, a more common approach to drug screening, which can take up to 10 minutes, Rossi said ... Read More


New partnerships in drug development spur trust as well as cost efficiency.

With the rise of biotech firms, the establishment of new compounds in the early drug development pipeline, and outsourcing to Pharmaceutical Drug Development services have become commonplace. Yet, these firms are emerging as trusted partners in regulatory matters internationally, experts in specific diagnostic trials, and proficient in streamlining early phase trials. And, with typical drug development from discovery to market ringing at just short of $1 billion USD and 12 years, drug development services become an attractive option to offset the costs of time and resources.

Best in Class Pharmaceutical Drug Development feature:

  • Full-scale simulations for physiological and economical modeling
  • The ability to take over development projects mid-phase and integrate data and results
  • Regulatory expertise to ensure compliance at all levels of bureaucratic and governmental oversight

Top Considerations Before Outsourcing Pharmaceutical Drug Development:

Many vendors espouse the virtues of outsourcing drug development to free up cash and resources to allocate to more core competencies for drug company clients, such as manufacturing. If this is your reason for buying, it is crucial to ensure a financial plan that sees the redeployment of internal resources to those critical areas. A modeling of the outsourced plan and budget should include a boost in productivity in a corresponding business unit due to the resources reallocation. 

Key Vendors to Consider

1. Based in Miami, Cetero’s Central Laboratory anchors their Clinical Pharmacology unit. The Clinical Laboratory is licensed in areas including Hematology, Chemistry, Coagulation, Urinalysis, Special Chemistry, Serology, and Viral Markers. Focusing heavily in allergy and asthma research, Cetero is the only professional CRO that has developed and fully validated models in the Environmental Exposure Chambers (EEC) for cGCP compliant studies. The EEC Model is a validated, rapid and FDA-accepted clinical solution for the development of small molecule drugs, immunotherapies and therapeutic devices.

2. With their Clinical Trial Simulation, Archimedes, Inc. aims to save clients valuable cash assets by modeling outcomes prior to full phase execution. Archimedes enables clients to conduct realistic clinical trial simulations to distinguish their drug’s clinical and economic benefits from standard treatments and competitor drugs. Additionally, the firm focuses on comparative effectiveness of one drug to an emerging solution, and helps clients more accurately answer questions regarding costs and target markets through healthcare modeling.

3. Specializing in antibodies, Covance prides itself on delivering solutions to client’s clinical challenges with unique solution sets, including biopharmaceutical services, clinical and nonclinical services, strategic partnering and other strategies for development. The company asserts that it generates more drug development data for the regulatory evaluation of efficacy than any other firm in the world. As so, Convance maintains a long history of successful collaborative relationships to drive down R&D costs. 

4. Symyx Isentris for SharePoint is a collection of Microsoft SharePoint Web parts that improves project team data collaboration in analysis and gives scientists access to real-time project information. Additionally, Symyx provides a host of software solutions that aid in database access, decision support, lab execution and analysis, cheminformatics and others. Symyx is dedicated to supporting their product offerings through a variety of portals for quick problem resolution. The firm will also consult on software implementation and correct solution choosing.

5. Therapure Biopharma’s Drug Development focuses on the development of therapeutic proteins – representing one-third of all new drug developments. The firm provides end-to-end trial services, process and test development, as well as final release testing, filling, packaging and shipping services. Therapure has compiled an extensive listing of proprietary products based on hemoglobin—most designed to treat infectious disease, anemia, and cancer. Protein modifica-tion technology allows clients to boost efficacy and half-life.

Pharmaceutical Drug Development
Definition: Pharmaceutical Drug Development offers "outsourced" research support to the pharmaceutical and biotechnology industries. These “outsourced” firms provide clients with research services to aid in the drug and medical device research and development process, including product development, formulation and manufacturing; clinical trial management (preclinical through phase IV); clinical, medical and safety monitoring; preclinical, toxicology, and clinical laboratory services for processing trial samples; data management, biostatistics and biomedical writing services, especially in preparation for an FDA New Drug Application or NDA. See also Clinical Research Organizations or CROs.

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Pharma Drug Development Research Library

Accelerating Generic Approvals: 5 Keys to Being First to Market
BASi - Bioanalytical Systems, Inc.
BASi White Paper: Accelerating Generic Approvals In the game of generics, the first to market is the winner. At a time when many of the most successful drugs are reaching the patent cliff, opening the floodgates for generic substitutes, generic companies are rushing to target the best candidates and enter the market first. And they are relying more heavily than ever on qualified outsource ...
 
BIACORE Technical Brief
Confluence Discovery Technologies, Inc.
TECHNICAL BRIEF: Biacore® DISCOVERY TECHNOLOGIES Surface Plasmon Resonance Biacore® BiacoreG® is a surface plasmSorncresonance (SPR) based ana- G 3 Surface PlGaTsPmoGn -O lytical instrumeGnt. BGiacore technology allows gSeOneSration of ResonancPeax PYK2 high quality data on the interactions between proteins and G -1 GTP other molecules, including small moSleHcCule drug candidates. FAK CrK These ...
 
Using Quality by Design (QbD) for Process Optimization of a Novel Oral Solid Dosage Form
Metrics, Inc
Joe Cobb and his team used the principles of QbD to improve the robustness of a core tablet for a novel modified release oral solid dosage form. View the AAPS 2012 poster and watch a short video about how Metrics applies the principles of QbD to solve formulation development issues.
 
Preclinical Toxicology: Points to Consider in Program Design
Pacific BioLabs (PBL)
Drug development is a high-risk enterprise. The typical new drug takes 10-12 years to get to market and costs up to $500 million. Pharmaceutical companies face continually increasing challenges in drug development— shorter product life cycles, global competition, as well as daunting technical and regulatory hurdles. Meanwhile, as a result of the Human Genome Project and high throughput drug ...
 
Driving Winning Partnerships: Principles & Practices
Aptalis Pharmaceutical Technologies
Successful alliance management is a key indicator for top-performing pharmaceutical companies. Managing partnerships well is especially important for companies that devote significant resources to developing new products through collaboration. We have a robust pipeline of such co-development partnerships and has devoted significant effort in recent years to ensuring our alliance management ...
 

Pharma Drug Development Video

BASi Pharm Analysis Video BASi - Bioanalytical Systems, Inc. BASi scientists can provide support for all phases of your drug development, from early stage preclinical method development/sample analysis to ...
 
Custom Engineered Potent Equipment Metrics, Inc Take a tour of Metrics potent products development and manufacturing suite. See our custom engineered equipment.
 
Pharma Drug Development BASi - Bioanalytical Systems, Inc. Information

Pharma Drug Development News

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