Kemwell expands services

Kemwell Biopharma expansion

At the recent 2013 Interphex meeting in New York City. Christian Ahlmark spoke to Outsourcing Pharma regarding recent Kemwell news, including the most recent FDA Inspection and approval, the new opening of the Biopharmaceutical manufacturing site (supporting biosimilar manufacturing and aseptic fill finish) in Bangalore India, and the new facility expansion plans in the USA, supporting formulation development and analytical testing services.

Interphex 2013

March 22, 2013 by  
Filed under Kemwell News

Kemwell Biopharma will be exhibiting at Interphex 2013 in New York City, NY April 23-25.  Come by our booth #3782 and chat with one of our business development scientists to see how Kemwell can support your 2013 CMC outsourcing needs (Formulation development, clinical manufacturing, analytical testing services, ICH stability testing, contract commercial manufacture, contract biopharmaceutical manufacturing).

INTERPHEX is an annual pharmaceutical and biopharmaceutical trade show for manufacturing and supply chain professionals.  There is a full spectrum of industry products and services related to the pharma and biotech sector. Over 650 suppliers, 1000 products, and 52 conference sessions.  http://www.interphex.com/Show-Info/Show-Info-Overview/

Session tracks include:

Pharma Regulatory QA/QC, Pharma Product Development, Facility and Process design, Pharma Manufacturing, Contract Packaging, Strategic Sourcing.

Keynotes include:

Policy Recommendations for Improving Patient Access to Drugs in Shortage
Congressman Bill Cassidy M.D. (R-LA)

Reorganizing For the  Future : Succeeding In The New Pharmaceutical Industry
Rajesh Nair, President, Indegene

Recalibrating The Pharmaceutical Services Opportunity
Jim Miller, President, PharmSource Information  Services, Inc.

 

 

Kemwell AAPS 2012 Conference & Exhibition

November 7, 2012 by  
Filed under Kemwell News

       Kemwell Biopharma was proud to exhibit at the annual AAPS (American Association of  Pharmaceutical Scientist) October 15-17 in Chicago.  The show was a great success, as Kemwell scientists from India, Sweden, and USA connected with colleagues and customers, and introduced new capability offerings.  Specifically Kemwell’s opening of our state-of-the art biologics manufacturing & fill-finish facility in Bangalore, India

The AAPS is the world’s largest gathering of pharmaceutical scientists, as they meet and re-connect with colleagues and learn more about new research and technologies. This year’s meeting featured workshops, short courses, open forums, and symposia such as:

Prodrug strategies in design, Fundamentals in Formulation and Pharmaceutical Technologies, Successful Development, Registration, and Commercialization of Pharmaceuticals in the QbD paradigm, to name a few.

Also, Some Open forum examples:

Control Strategy Guidelines: A Detailed Look at Draft ICH Guidelines and How Industry will Need to Change How it Develops Drugs
Emerging Markets—Drug Delivery, IP and Regulatory Opportunities
Drug Product Life Cycle Management Strategies with Emphasis on Particle Engineering and Fixed Dose Combinations
Developing and Manufacturing Drug-device Combination Products: The Next Step in Future Drug Delivery Systems
Considerations for the Development, Registration and Commercialization of Antibody Drug Conjugates

We anxiously look forward to next years conference in San Antonio Texas.

About Kemwell:

Kemwell Biopharma is contract provider of CMC services to the pharmaceutical industry.  With manufacturing locations in Bangalore India, and Uppsala Sweden, Kemwell offers services ranging from Clinical (CTM) Manufacturing, Commercial Manufacturing, Formulation Development, Analytical Development, Biopharmaceutical Manufacturing & Packaging/Storage/Distribution. Voted as the “Best Contract Manufacturer in India” by OPPI in 2010,  Kemwell has been serving multinational pharma since 1980 & offers the entire value chain of  services from Phase 1 to Commercial, for Solids, Liquids, Semi-Solids, Biopharmaceuticals, & Injectables. 

Kemwell is 100% dedicated to contract pharmaceutical development and manufacturing. Staffed with experienced scientists from eastern & western cultures, Kemwell understands not only the regulatory landscape, but the values and requirements of small biotech, as well as big pharma. Throughout our journey, we have maintained our pure-play status as a 100% contract services provider without foraying into any branded products of our own.

This has strengthened our core value and work culture that the “Customer Comes First…….Always.” Our commitment to respecting IP rights and working collaboratively with our customers has won the confidence of the top pharma companies of the world, trusting Kemwell to supply some of their highest-selling products for decades.

BioProcess International Conference 2012

Kemwell Biopharma was proud to attend and exhibit at BioProcess International Conference 2012 in Providence Rhode Island, Oct 8-12.   The world’s largest gathering of industry suppliers & collaborators, BPI is the premier annual bioprocessing event for the development of biologics – covering critical Regulatory, CMC topics, from cell culture, purification, formulation, analytical,  through scale-up and production.

This years meeting agenda included 180+ speakers presenting new and unpublished data to help pharmaceutical & biotech companies navigate the biologics landscape and plan accordingly.

Examples of syposia:

  • Enhancing Manufacturing & Development
  • Product Lifecycle Management
  • Cell Culture & Upstream Processing
  • Developing Truly Continuous Drug Substance Processes
  • Recovery & Purification
  • ADC Development & Production
  • Viral Clearance for Biologics
  • Analytical Technologies
  • Drug Product Development
  • Formulation Strategies for Protein Therapeutics
  • Delivery Strategies for Biologics
  • Vaccine Development & Production

About Kemwell:

Kemwell Biopharma is contract provider of CMC services to the pharmaceutical industry.  With manufacturing locations in Bangalore India, and Uppsala Sweden, Kemwell offers services ranging from Clinical (CTM) Manufacturing, Commercial Manufacturing, Formulation Development, Analytical Development, & Packaging/Storage/Distribution.

 

 

 

Contract Pharma 2012

October 1, 2012 by  
Filed under Kemwell News, Pharma Industry News

 

Contract Pharma magazine held its 11th Annual Contracting & Outsourcing Conference & Tabletop Exhibition, devoted to outsourcing in the pharma and biopharmaceutical industries. The event was held on September 20-21 in New Brunswick, NJ.

Meeting presentations ranged from:

  • Global Pharma/Biopharma Outsourcing Industry Trends 
  • FDA Inspection Trends 
  • Metrics for Measuring Alliance Success 
  • Resizing the Global Contract R&D Services Market 
  • Are CMOs Winning the War Against In-House Capacity?
  • Building a Virtual Pharma Infrastructure
  • Trends in Biopharmaceutical Contract Manufacturing 
  • Pharmaceutical Supply Chain Quality
  • Site Selection Criteria for Contract Service Providers

Kemwell Biopharma was among the 160 exhibitors present at the conference & table top exhibit.  For more information and presentation copies please contact info.usa@kemwellpharma.com.

 

 

Kemwell sponsorship at CBI Bio/Pharmaceutical Manufacturing Outsourcing Conference

June 6, 2012 by  
Filed under Kemwell News

Kemwell Biopharma will be attending and exhibiting at the upcoming CBI Bio/Pharmaceutical Manufacturing conference in Philadelphia PA July 24-25.

Event: Bio/Pharmaceutical Manufacturing Outsourcing

Mitigate Manufacturing Risk and Ensure Quality Oversight through Strategic Partnerships
July 24-25, 2012, Philadelphia, Pennsylvania

With increased scrutiny on the bio/pharmaceutical industry for cost containment, it is more important than ever for companies to learn the most efficient and productive ways to outsource manufacturing and manage costs. In this focused, interactive forum, bio/pharmaceutical executives come together with contract manufacturing organizations to discuss strategies for effective operations, quality oversight and risk mitigation. Join your colleagues to hear the latest regulatory trends, learn best sourcing practices and identify business opportunities in the outsourcing arena.

For further information, contact Christian Ahlmark, christian.ahlmark@kemwellpharma.com or register for the event @ http://www.cbinet.com/conference/pi12003

About Kemwell Biopharma:  With manufacturing locations in India and Sweden, Kemwell offers CMC services ranging from Clinical (CTM) Manufacturing, Commercial Manufacturing, Formulation Development, Analytical Services, & Packaging/Storage/Distribution for solids, liquids, semi-solids, parenterals, & biopharmaceuticals.

Voted as the “Best CMO in India” by OPPI in 2010, Kemwell has been serving multinational pharma since 1980.

Kemwell Product Development News

April 20, 2012 by  
Filed under Facilities update, Kemwell News

April 17th 2012

Kemwell announces the expansion of its new Pharmaceutical Development labs:

Kemwell Biopharma Pvt. Ltd., an India-based formulations contract manufacturer, has expanded its state-of-the-art pharmaceutical development labs in Bangalore, including a 7,500 sq. ft. cGMP pilot facility to support pharmaceutical projects from pre-formulation to finished products.

“We are seeing an increasing demand for contract development services in the global market. Kemwell has invested in a world-class facility with experienced scientists to meet the growing needs of its customers. With the new labs, Kemwell continues to build upon its ongoing commitment to be a high-quality one-stop shop service provider for its customers,” said Anurag Bagaria, Managing Director.

The 15,000 sq. ft. facility has capabilities to handle solids, injectables (large and small molecules), liquids and semi-solids dosage forms. Currently, the labs have 80 scientists with the ability to scale up to 150 scientists. Our scientists have extensive expertise in developing formulations for conventional and specialized dosage forms, including sustained release (SR) and modified release (MR) solids, liquids, and injectables.

Kemwell has the capability to offer customers pharmaceutical services that include pre-formulation, formulation development, analytical method development and validation, process optimization and scale-up, packaging development, pivotal batch manufacturing, stability batch manufacturing, stability studies, clinical batch manufacturing, labeling for blinded studies, preparation of placebo batches, tech transfer as well as commercial manufacturing. This enhanced facility coupled with our commercial manufacturing network on the same site, enables Kemwell to offer a wider scale of services for the development, testing and commercialization of large and small molecules. In Sweden, Kemwell also provides services for QP release. Says Anurag Bagaria, “Kemwell’s sites in India and Sweden can work in harmony to provide the customer with the best solution from both worlds”.

About Kemwell Biopharma Pvt. Ltd:

Bangalore-based Kemwell Biopharma Pvt. Ltd. (www.kemwellbiopharma.com) is a leading provider of formulations contract development and manufacturing services for multinational pharmaceutical companies for 30 years. From facilities in India & Sweden, Kemwell manufactures tablets, capsules, liquid orals, external drops, ointments, gels and creams. Kemwell’s customers include 5 of the top 10 pharmaceutical companies in the world. With 100% commitment to pure play contract manufacturing, Kemwell has no branded products of its own in the market, thereby avoiding any conflict of interest with its customers. Kemwell has recently built a new state-of-the art biologics manufacturing facility in Bangalore in collaboration with Boehringer Ingelheim to offer process development and cGMP manufacturing services for drug substance and drug product.

Kemwell Biopharma to exhibit at Interphex 2012

March 12, 2012 by  
Filed under Kemwell News

Kemwell Biopharma will be attending Interphex 2012 May 1-3, in New York City.  Come see us at booth 1354

INTERPHEX – bringing together key pharma and biotech professionals with suppliers to create innovative solutions at the industry’s largest event.  The conference will cover Regulatory, Product Development, Facility & Process Design, Manufacturing, Packaging, and Supply Chain.

Kemwell Biopharma is contract provider of CMC services to the pharmaceutical industry.  With manufacturing locations in Bangalore India, and Uppsala Sweden, Kemwell offers services ranging from Clinical (CTM) Manufacturing, Commercial Manufacturing, Formulation Development, Analytical Development, & Packaging/Storage/Distribution.

Voted as the “Best Contract Manufacturer in India” by OPPI in 2010,  Kemwell has been serving multinational pharma since 1980 & offers the entire value chain of CMC services from Phase 1 to Commercial, for Solids, Liquids, Semi-Solids, Biologics, & Injectables.

Kemwell attending DCAT in New York March 12-15, 2012

March 12, 2012 by  
Filed under Kemwell News

Kemwell Biopharma will be attending the annual DCAT meeting in NYC.

Drug, Chemical & Associated Technologies Association, Inc. (DCAT) is the premier business development association whose membership is comprised of companies that manufacture, distribute or provide services to the pharmaceutical, chemical, and related industries.

Christian Ahlmark, Director of Corporate Development will be attending on behalf of Kemwell. christian.ahlmark@kemwellbiopharma.com

With manufacturing locations in India and Sweden, Kemwell offers CMC services ranging from Clinical (CTM) Manufacturing, Commercial Manufacturing, Formulation Development, Analytical Services, & Packaging/Storage/Distribution for solids, liquids, semi-solids, parenterals, & biopharmaceuticals.

Voted as the “Best Contract Manufacturer in India” by OPPI in 2010, Kemwell has been serving multinational pharma since 1980.

Biosimilar Manufacturing

March 12, 2012 by  
Filed under Biopharmaceuticals

With the global market for biosimilars forecast to exceed $4 billion by 2015, there is a great deal of focus on the development and commercialization of biopharmaceuticals, particularly bringing cost-effective biologic theapeutics to patients.

Kemwell Biopharma is gearing up to meet the demand at our NEW BioPharmaceutical manufacture facility in Bangalore India. In Q3 of 2012, Kemwell will offer full service contract biopharmaceutical process development, manufacturing, formulation, and fill-finish capabilities at our newest 15,000 m2 (135,000 sq ft) Bangalore, India facility.